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Risperidone: Drug information

Risperidone: Drug information
(For additional information see "Risperidone: Patient drug information" and see "Risperidone: Pediatric drug information")

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
ALERT: US Boxed Warning
Increased mortality in elderly patients with dementia-related psychosis:

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Risperidone is not approved for the treatment of patients with dementia-related psychosis.

Brand Names: US
  • Perseris;
  • RisperDAL;
  • RisperDAL Consta;
  • Rykindo;
  • Uzedy
Brand Names: Canada
  • AG-Risperidone;
  • APO-Risperidone;
  • JAMP-Risperidone;
  • JOI-Risperidone;
  • Mar-Risperidone;
  • MINT-Risperidon;
  • MYLAN-Risperidone ODT [DSC];
  • Perseris;
  • PMS-Risperidone;
  • PRO-Risperidone;
  • RisperDAL Consta;
  • RisperDAL [DSC];
  • RIVA-Risperidone;
  • SANDOZ Risperidone;
  • TARO-Risperidone;
  • TEVA-Risperidone
Pharmacologic Category
  • Antimanic Agent;
  • Second Generation (Atypical) Antipsychotic
Dosing: Adult

Dosage guidance:

Dosing: Although manufacturer's labeling includes a maximum dose of up to 16 mg/day, doses >8 mg/day are generally not recommended (Ref).

Agitation/Aggression associated with psychiatric disorders, substance intoxication, or other organic causes

Agitation/Aggression (severe, acute) associated with psychiatric disorders (eg, schizophrenia, bipolar disorder), substance intoxication, or other organic causes (alternative agent) (off-label use) :

Note: Antipsychotics are appropriate when psychosis is suspected to be the primary cause of agitation/aggression (Ref). Other agents are used preferentially in some intoxications (eg, stimulants) or alcohol withdrawal (Ref). Depending on presentation, may combine with a benzodiazepine.

Oral: Initial: 1 to 2 mg; may repeat every 2 hours to a maximum daily dose of 6 mg (Ref).

Agitation/Aggression and psychosis associated with dementia, severe or refractory

Agitation/Aggression and psychosis associated with dementia, severe or refractory (alternative agent) (off-label use):

Note: For short-term use while addressing underlying causes of severe symptoms (Ref). In patients without a clinically significant response after an adequate trial (eg, up to 4 weeks), taper and withdraw therapy. Only continue in patients with demonstrated benefit; attempt to taper and withdraw at regular intervals (eg, ≤4 months). Patients with dementia with Lewy bodies are at increased risk for severe adverse reactions; caution is required even with low doses (Ref).

Oral: Initial: 0.5 mg/day in 2 divided doses; may increase dose based on response and tolerability in increments of 0.5 mg/day at intervals ≥2 days up to 1 mg/day (Ref).

Bipolar disorder

Bipolar disorder:

Acute mania or acute episodes with mixed features (labeled use) or acute hypomania (off-label use) (monotherapy or adjunctive therapy):

Oral: Initial: 1 to 3 mg/day in 1 or 2 divided doses; may adjust dose based on response and tolerability in increments of 1 mg/day at intervals ≥24 hours to a usual dose of 4 to 6 mg/day; in general, assess full effect for ≥1 week before further advancing up to 8 mg/day (usual maximum) (Ref).

Maintenance treatment (monotherapy or as adjunct to antimanic therapy):

Oral: Continue dose and combination regimen that was used to achieve control of the acute episode (Ref)

IM ER suspension (alternative route):

Note: Establish tolerability using oral risperidone before first injection. Due to delayed onset of the first ER IM injection, an oral antipsychotic at an effective dose is overlapped for the first 3 weeks.

Initial: 25 mg every 2 weeks; in patients with a history of treatment-refractory illness or requiring high doses of antipsychotics, some experts initiate at 37.5 mg (Ref). If insufficient response, may increase dose in increments of 12.5 mg no sooner than every 4 weeks to a maximum dose of 50 mg every 2 weeks (Ref).

Conversion between oral and IM ER suspension: The manufacturer's labeling does not provide dose conversions to IM ER suspension based on current oral dose. Some experts recommend converting to IM ER suspension at the usual starting dose and titrating according to response (Ref). Some experts recommend the following conversions from oral to IM ER suspension (Ref):

≤3 mg/day oral = 25 mg IM ER suspension every 2 weeks.

>3 to ≤5 mg/day oral = 37.5 mg IM ER suspension every 2 weeks.

>5 mg/day oral = 50 mg IM ER suspension every 2 weeks.

Delusional disorder

Delusional disorder (alternative agent) (off-label use):

Oral: Initial: 1 to 2 mg/day in 1 or 2 divided doses; may increase dose based on response and tolerability in increments of 1 mg/day every 2 weeks; usual dose is ~5 mg/day in 2 divided doses; maximum dose: 8 mg/day (Ref).

Delusional infestation

Delusional infestation (delusional parasitosis) (off-label use):

Oral: Initial: 0.5 mg/day in 1 or 2 divided doses; may increase dose based on response and tolerability gradually (ie, weekly) up to 2 to 4 mg/day in 1 or 2 divided doses. Doses up to 8 mg/day may be necessary in some patients (Ref). After achieving adequate response, maintain for at least 1 to 3 months before attempting to taper (Ref).

Huntington disease–associated chorea, moderate to severe

Huntington disease–associated chorea, moderate to severe (alternative agent) (off-label use):

Oral: Initial: 0.5 to 2 mg/day in 1 or 2 divided doses; may increase dose based on response and tolerability in increments of 1 mg/day every week; some patients may require doses up to 10 mg/day (Ref).

Major depressive disorder, treatment resistant

Major depressive disorder (unipolar), treatment resistant (adjunctive therapy with antidepressant) (off-label use):

Oral: Initial: 0.25 to 0.5 mg/day; may increase dose based on response and tolerability in increments of 0.25 to 1 mg/day every 3 to 7 days up to 3 mg/day. Usual effective dose: 1 to 1.5 mg/day (Ref).

Obsessive-compulsive disorder, treatment resistant

Obsessive-compulsive disorder, treatment resistant (augmentation to antidepressants) (off-label use):

Oral: Initial: 0.25 to 0.5 mg/day; may increase dose based on response and tolerability in increments of 0.5 to 1 mg/day every 3 to 7 days; usual dose: 0.5 to 2 mg/day; doses up to 3 mg/day may be needed for optimal response (Ref).

Schizophrenia

Schizophrenia:

Oral: Initial: 1 to 2 mg/day in 1 to 2 divided doses; may increase by 1 to 2 mg/day at intervals ≥24 hours to usual dosage range of 2 to 6 mg/day. In general, assess full effect for ≥1 week before further advancing, if needed, to 6 to 8 mg/day (usual maximum). Note: Doses up to 16 mg/day have been evaluated in clinical trials and are approved according to manufacturer's labeling but are associated with increased adverse effects and generally are not recommended (Ref).

IM ER suspension:

Note: Establish tolerability using oral risperidone before first injection. Due to delayed onset of the first IM ER suspension injection, an oral antipsychotic at an effective dose is overlapped for the first 3 weeks.

Initial: 25 mg every 2 weeks; may increase dose based on response and tolerability in increments of 12.5 to 25 mg every 4 weeks; maximum dose: 50 mg every 2 weeks (Ref). Dosage adjustments should not be made more frequently than every 4 weeks.

Conversion between oral and IM ER suspension: The manufacturer's labeling does not provide dose conversions to IM ER suspension based on current oral dose. Some experts recommend converting to IM ER suspension at the usual starting dose and titrating according to response (Ref). Some experts recommend the following conversions from oral to IM ER suspension (Ref):

≤3 mg/day oral = 25 mg IM ER suspension every 2 weeks.

>3 to ≤5 mg/day oral = 37.5 mg IM ER suspension every 2 weeks.

>5 mg/day oral = 50 mg IM ER suspension every 2 weeks.

SUBQ ER suspension:

Note: Establish tolerability with oral risperidone before starting SUBQ ER suspension injection. Neither a loading dose nor overlap with oral risperidone is needed. Initiate the day after the last dose of oral therapy.

Monthly injection (Perseris):

Usual dose: SUBQ: 90 or 120 mg once monthly. Do not administer more than one 90 or 120 mg injection per month.

Monthly or every-2-months injection (Uzedy):

Usual dose: SUBQ: 50 to 125 mg once monthly or 100 to 250 mg every 2 months.

Conversion between oral and SUBQ ER suspension:

Monthly injection (Perseris):

Oral dose of 3 mg/day is equivalent to SUBQ ER suspension injection of 90 mg once monthly.

Oral dose of 4 mg/day is equivalent to SUBQ ER suspension injection of 120 mg once monthly.

Monthly or every-2-months injection (Uzedy):

Oral dose of 2 mg/day is equivalent to SUBQ ER suspension injection of 50 mg once monthly or 100 mg every 2 months.

Oral dose of 3 mg/day is equivalent to SUBQ ER suspension injection of 75 mg once monthly or 150 mg every 2 months.

Oral dose of 4 mg/day is equivalent to SUBQ ER suspension injection of 100 mg once monthly or 200 mg every 2 months.

Oral dose of 5 mg/day is equivalent to SUBQ ER suspension injection of 125 mg once monthly or 250 mg every 2 months.

Conversion between SUBQ ER suspension Uzedy once monthly and Uzedy every-2-months ER suspension injection: Administer the first dose of the new dosing regimen on the next scheduled date of administration in the original dosing regimen. Then proceed with new dosing schedule.

Tourette syndrome, management of tics

Tourette syndrome, management of tics (off-label use):

Oral: Initial: 0.25 to 0.5 mg/day; may increase gradually based on response and tolerability in increments of ≤1 mg/day every ≥2 days up to 6 mg/day; usual dose: 2.5 to 4 mg/day (Ref).

Discontinuation of therapy:

Oral: In the treatment of chronic psychiatric disease switching therapy rather than discontinuation is generally advised if side effects are intolerable or treatment is not effective. If patient insists on stopping treatment, gradual dose reduction (ie, over several weeks to months) is advised to detect a re-emergence of symptoms and to avoid withdrawal reactions (eg, agitation, alternating feelings of warmth and chill, anxiety, diaphoresis, dyskinesias, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor, vertigo) unless discontinuation is due to significant adverse effects. Monitor closely to allow for detection of prodromal symptoms of disease recurrence (Ref).

Long-acting injection: Switching to other treatments is generally advised if side effects are intolerable or treatment is not effective. However, if a patient insists on stopping treatment, gradual dose reduction to avoid withdrawal reactions is generally not needed with long-acting injectable antipsychotics. The risk of withdrawal symptoms from discontinuation of long-acting injectables is low because the rate of drug elimination is slow. Monitor closely to allow for detection of prodromal symptoms of disease recurrence (Ref).

Switching antipsychotics: An optimal universal strategy for switching antipsychotic agents has not been established. Strategies include cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic) and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). In patients with schizophrenia at high risk of relapse, the current medication may be maintained at full dose as the new medication is increased (ie, overlap); once the new medication is at therapeutic dose, the first medication is gradually decreased and discontinued over 1 to 2 weeks (Ref). Based on clinical experience, some experts generally prefer cross-titration and overlap approaches rather than abrupt change (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

The renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.

Note: Risperidone is extensively hepatically metabolized to 9-hydroxyrisperidone (9-OH-RIS [paliperidone]) (active metabolite) that is mainly excreted by the kidney (Ref). Risperidone and 9-hydroxyrisperidone clearance are decreased by ~60% in patients with CrCl <60 mL/minute/1.73 m2, which may increase risk of adverse effects (eg, orthostatic hypotension, QT prolongation) (Ref).

Altered kidney function:

Oral:

CrCl >60 mL/minute: No dosage adjustment necessary (Ref).

CrCl 30 to 60 mL/minute: Initial: Administer 50% to 75% of the usual indication-specific dose; titrate cautiously based on tolerability and response in increments of no more than 0.5 mg twice daily and no more frequently than recommended for patients with normal kidney function; doses >1.5 mg twice daily should be titrated at intervals of ≥1 week. Maximum dose should not exceed 75% of the usual indication-specific dose (expert opinion derived from Gründer 2019; Snoeck 1995; manufacturer's labeling).

CrCl 10 to <30 mL/minute: Initial: Administer 50% of the usual indication-specific dose (Ref). Titrate cautiously in increments of no more than 0.5 mg twice daily and no more frequently than recommended for patients with normal kidney function; doses greater than >1.5 mg twice daily should be titrated at intervals of ≥1 week. Maximum dose should not exceed 50% of the usual indication-specific dose (expert opinion derived from Gründer 2019; Snoeck 1995; manufacturer's labeling).

CrCl <10 mL/minute: Consider alternative agent. If necessary, administer 25% of the usual indication-specific dose; titrate cautiously based on tolerability and response in increments of no more than 0.5 mg once daily and no more frequently than recommended for patients with normal kidney function (Ref).

IM ER suspension: Must establish response and tolerability using oral risperidone before first injection; the manufacturer recommends patients should tolerate an oral dose of at least 2 mg/day before converting to IM ER suspension in patients with impaired kidney function. Due to delayed onset of the first IM ER suspension injection, an oral antipsychotic at an effective dose is overlapped for the first 3 weeks.

CrCl >60 mL/minute: No dosage adjustment necessary (Ref).

CrCl 10 to ≤60 mL/minute:

Use with caution. Therapeutic drug monitoring and/or careful monitoring for dose-related side effects is recommended (Ref).

Initial: 12.5 to 25 mg every 2 weeks; dose may be increased based on response and tolerability in increments of 12.5 mg no more frequently than every 4 weeks (Ref).

CrCl <10 mL/minute:

Avoid use (preferred). If necessary, use with caution and closely monitor for adverse effects along with therapeutic drug monitoring.

Initial: 12.5 to 25 mg every 2 weeks; do not exceed 25 mg every 2 weeks (Ref).

SUBQ ER suspension:

Monthly injection (Perseris):

CrCl >60 mL/minute: No dosage adjustment necessary (Ref).

CrCl 10 to 60 mL/minute: Use with caution (has not been studied); closely monitor for adverse effects along with therapeutic drug monitoring (if available) (Ref). Note: Use should only be considered in patients able to achieve and tolerate an oral dose of at least 3 mg/day; if tolerated and effective, transition to 90 mg SUBQ ER suspension injection (Perseris) monthly.

CrCl <10 mL/minute: Avoid use (Ref).

Monthly injection (Uzedy):

CrCl >60 mL/minute: No dosage adjustment necessary (Ref).

CrCl 10 to ≤60 mL/minute: Use with caution (has not been studied); closely monitor for adverse effects along with therapeutic drug monitoring (if available) (Ref). Note: Initiate with oral dosing (titrate up to ≥2 mg/day); if tolerated and effective, transition to 50 mg SUBQ ER suspension injection (Uzedy) monthly (Ref).

CrCl <10 mL/minute: Avoid use (Ref).

Hemodialysis, intermittent (thrice weekly): Not significantly dialyzed (Ref):

Oral: Use with caution (has not been studied). Dose as for CrCl <10 mL/minute (Ref). Doses up to 2 mg/day have been tolerated in case reports (Ref).

IM ER suspension: Avoid use (preferred). If necessary, use with caution and closely monitor for adverse effects along with therapeutic drug monitoring. After establishing response and tolerability of at least 2 mg oral risperidone, 12.5 to 25 mg every 2 weeks may be initiated with 3 weeks of oral supplementation; do not exceed 25 mg every 2 weeks (Ref).

SUBQ ER suspension: Avoid use (Ref).

Peritoneal dialysis: Unlikely to be significantly dialyzed (high protein binding, moderate Vd) (Ref).

Oral: Use with caution (has not been studied). Dose as in CrCl <10 mL/minute (Ref).

IM ER suspension: Avoid use (preferred). If necessary, use with caution and closely monitor for adverse effects along with therapeutic drug monitoring. After establishing response and tolerability of at least 2 mg oral risperidone, 12.5 to 25 mg every 2 weeks may be initiated with 3 weeks of oral supplementation; do not exceed 25 mg every 2 weeks (Ref).

SUBQ ER suspension: Avoid use (Ref).

CRRT:

Oral: Use with caution (has not been studied). Dose as for CrCl 10 to 30 mL/minute (Ref).

IM, SUBQ ER suspension: Avoid use (Ref).

PIRRT (eg, sustained, low-efficiency diafiltration):

Oral: Use with caution (has not been studied). Dose as for CrCl 10 to 30 mL/minute (Ref).

IM, SUBQ ER suspension: Avoid use (Ref).

Dosing: Hepatic Impairment: Adult

Oral: Note: Limiting initial doses to 1 mg daily (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope. The mean free fraction of risperidone in plasma may be increased by 35% in patients with hepatic impairment.

Mild or moderate impairment (Child-Pugh class A or B): There are no dosage adjustments provided in the manufacturer’s labeling; reduce dosage.

Severe impairment (Child-Pugh class C): Initial: 0.5 mg twice daily; titration should progress slowly in increments of no more than 0.5 mg twice daily; increases to dosages >1.5 mg twice daily should occur at intervals of ≥1 week.

IM ER suspension: Initiate with oral dosing (0.5 mg twice daily for 1 week then 1 mg twice daily or 2 mg once daily for 1 week); if tolerated, begin 25 mg IM ER suspension every 2 weeks; continue oral dosing for 3 weeks after the first IM injection. An initial IM dose of 12.5 mg may also be considered.

SUBQ ER suspension: Use with caution; has not been studied.

Monthly injection (Perseris): Initiate with oral dosing (titrate up to 3 mg/day); if tolerated and effective, transition to 90 mg SUBQ ER suspension injection (Perseris) once monthly.

Monthly injection (Uzedy): Initiate with oral dosing (titrate up to ≥2 mg/day); if tolerated and effective, transition to 50 mg SUBQ ER suspension injection (Uzedy) monthly .

Dosing: Adjustment for Toxicity: Adult

Severe neutropenia (ANC <1,000/mm3): Discontinue treatment.

Dosing: Older Adult

Note: Avoid for behavioral problems associated with dementia or delirium unless alternative nonpharmacologic therapies have failed and patient may harm self or others. If used, consider deprescribing attempts to assess continued need and/or lowest effective dose. Of note, use in certain indications may be appropriate (eg, schizophrenia, bipolar disorder) (Ref).

Dosages in the lower range of recommended adult dosing are generally sufficient with late-onset-schizophrenia or psychosis (Ref).

Bipolar mania (monotherapy or as an adjunct to lithium or divalproex):

Oral: Initial: 0.5 mg twice daily; titrate slowly. Note: Limiting initial dose to 1 mg/day (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope. Additional monitoring of renal function and orthostatic blood pressure may be warranted.

IM ER suspension: Refer to adult dosing.

Schizophrenia:

Oral: Initial: 0.5 mg twice daily; titrate slowly. Note: Limiting initial dose to 1 mg/day (in 2 divided doses) may reduce the risk of orthostatic hypotension/syncope. Additional monitoring of renal function and orthostatic blood pressure may be warranted.

IM, SUBQ ER suspension: Refer to adult dosing.

Dosing: Pediatric

(For additional information see "Risperidone: Pediatric drug information")

Bipolar mania

Bipolar mania: Children and Adolescents 10 to 17 years: Oral: Initial: 0.5 mg once daily; dose may be adjusted if needed, in increments of 0.5 to 1 mg/day at intervals ≥24 hours, as tolerated, to a dose of 2.5 mg/day. Doses ranging from 0.5 to 6 mg/day have been evaluated; however, doses >2.5 mg/day do not confer additional benefit and are associated with increased adverse events; doses >6 mg/day have not been studied. Note: May administer 1/2 the daily dose twice daily in patients who experience persistent somnolence. In patients ≥11 years, use of long-acting IM risperidone has been described (see "Parenteral therapy").

Delirium

Delirium: Limited data available; optimal dose not established; experience suggests risperidone be considered for hypoactive or mixed delirium (Ref) dosing should be individualized to response and decreased as soon as appropriate (Ref):

Infants: Very limited data available: Oral: 0.05 to 0.1 mg once daily at bedtime or twice daily (Ref). Dosing based on experience with implementation of PICU assessment scales and treatment protocols, small open-label trials which included infants, and case series (Ref).

Children <5 years: Oral: Initial: 0.1 to 0.2 mg once daily at bedtime; doses may be increased based upon response; dosing based on experience with implementation of PICU assessment scales and treatment protocols, small open-label trials, and expert recommendations (Ref).

Children ≥5 years and Adolescents: Oral: Initial: 0.2 to 0.5 mg once daily at bedtime; may titrate to lowest effective dose every 1 to 2 days; usual range: 0.2 to 2.5 mg/day in divided doses 2 to 4 times daily; some have suggested maximum daily dose dependent upon patient weight: <20 kg: 1 mg/day; 20 to 45 kg: 2.5 mg/day; >45 kg: 3 mg/day (Ref).

Disruptive behavior disorders

Disruptive behavior disorders (eg, conduct disorder [CD], oppositional defiant disorder [ODD]): Limited data available:

Note: A systematic review suggested a high-quality of evidence that risperidone has a moderate effect on disruptive and aggressive behavior in pediatric patients with CD or ODD (with/without attention-deficit/hyperactivity disorder [ADHD]) with average IQ; in ODD or CD pediatric patients (with/without ADHD) with subaverage IQ, a moderate quality of evidence that risperidone has a moderate to large effect (Ref). In patients ≥11 years, use of long-acting IM risperidone has been described (see "Parenteral therapy").

Children ≥4 years and Adolescents: Oral: Initial: 0.01 mg/kg/dose once daily for 2 days, then 0.02 mg/kg/dose once daily; suggested initial fixed dose in patients <50 kg: 0.25 mg/day, and ≥50 kg: 0.5 mg/day. May further increase on weekly basis as tolerated to 0.06 mg/kg/dose once daily; usual maximum daily dose: 2 mg/day; improvement in target symptoms typically within 1 to 4 weeks (Ref). A large multicenter, double-blind, placebo-controlled trial including 335 patients (n=172 in treatment group; mean age: 10.9 ± 2.93 years) reported that a mean dose of 0.02 mg/kg/day resulted in significant positive changes in efficacy measurements/behavior scales and significantly longer time to symptom recurrence compared to placebo (Ref). Note: May divide dose and administer 1/2 the daily dose twice daily if breakthrough symptoms occur in the afternoon or evening or sedation.

Irritability including aggression, temper, tantrums, self-injurious behavior, and quickly changing moods associated with autism

Irritability including aggression, temper, tantrums, self-injurious behavior, and quickly changing moods associated with autism:

Children ≥5 years and Adolescents <18 years: Note: Individualize dose according to patient response and tolerability:

15 to 20 kg: Oral: Initial: 0.25 mg once daily; after ≥4 days, may increase dose to 0.5 mg/day; maintain this dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose in increments of 0.25 mg/day at ≥2-week intervals. Doses ranging from 0.5 to 3 mg/day have been evaluated; however, therapeutic effect reached plateau at 1 mg/day in clinical trials. Following clinical response, consider gradually decreasing dose to lowest effective dose. May be administered once daily or in divided doses twice daily.

≥20 kg: Oral: Initial: 0.5 mg once daily; after ≥4 days, may increase dose to 1 mg/day; maintain this dose for ≥14 days. In patients not achieving sufficient clinical response, may increase dose in increments of 0.5 mg/day at ≥2-week intervals. Doses ranging from 0.5 to 3 mg/day have been evaluated; however, therapeutic effect reached plateau at 2.5 mg/day (3 mg/day in pediatric patients >45 kg) in clinical trials. Following clinical response, consider gradually decreasing to lowest effective dose. May be administered once daily or in divided doses twice daily.

Schizophrenia

Schizophrenia: Adolescents 13 to 17 years: Oral: Initial: 0.5 mg once daily; dose may be adjusted if needed, in increments of 0.5 to 1 mg/day at intervals ≥24 hours, as tolerated, to a dose of 3 mg/day. Doses ranging from 1 to 6 mg/day have been evaluated; however, doses >3 mg/day do not confer additional benefit and are associated with increased adverse events. Note: May administer 1/2 the daily dose twice daily in patients who experience persistent somnolence. In patients ≥11 years, use of long-acting IM risperidone has been described (see "Parenteral therapy").

Tourette syndrome, tics

Tourette syndrome, tics: Limited data available; efficacy results variable (Ref): Compared to placebo, risperidone is probably more likely to reduce tic severity; reserve treatment for situations where benefits outweigh the risks; use lowest effective dose; monitor patients for movement, hormonal and metabolic adverse effects (Ref).

Children ≥7 years and Adolescents: Oral: Initial: 0.25 to 0.5 mg once daily at night; may gradually titrate every 4 to 5 days in 0.25 to 0.5 mg increments to usual reported therapeutic range: 0.25 to 6 mg/day divided in twice daily doses (Ref).

Parenteral therapy: Limited data available:

Note: Tolerability with oral risperidone should be established prior to transition to IM risperidone; based on pediatric trials and experience in adult patients, oral risperidone should be continued for 3 weeks after the first IM administration to ensure adequate therapeutic plasma concentrations are reached (Ref). Most commonly reported in situations to improve or ensure medication adherence.

Extended-released IM suspension (Risperdal Consta): Children ≥11 years and Adolescents: Maintenance therapy: Usual dose: IM: 25 to 37.5 mg every 2 weeks; dosing dependent on oral risperidone dosing regimen (some patients may require lower initial IM dose of 12.5 mg); titration at intervals of ≥4 weeks to higher doses (eg, 50 mg) may be necessary; most experience is in adolescent patients diagnosed bipolar disorder, schizophrenia, and CD (Ref).

Discontinuation of therapy: Children and Adolescents: American Academy of Child and Adolescent Psychiatry (AACAP), American Psychiatric Association (APA), Canadian Psychiatric Association (CPA), National Institute for Health and Care Excellence (NICE), and World Federation of Societies of Biological Psychiatry (WFSBP) guidelines recommend gradually tapering antipsychotics to avoid withdrawal symptoms and minimize the risk of relapse (Ref); risk for withdrawal symptoms may be highest with highly anticholinergic or dopaminergic antipsychotics (Ref). When stopping antipsychotic therapy in patients with schizophrenia, the CPA guidelines recommend a gradual taper over 6 to 24 months and the APA guidelines recommend reducing the dose by 10% each month (Ref). Continuing antiparkinsonism agents for a brief period after discontinuation may prevent withdrawal symptoms (Ref). When switching antipsychotics, three strategies have been suggested: Cross-titration (gradually discontinuing the first antipsychotic while gradually increasing the new antipsychotic), overlap and taper (maintaining the dose of the first antipsychotic while gradually increasing the new antipsychotic, then tapering the first antipsychotic), and abrupt change (abruptly discontinuing the first antipsychotic and either increasing the new antipsychotic gradually or starting it at a treatment dose). Evidence supporting ideal switch strategies and taper rates is limited and results are conflicting (Ref).

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosage adjustment for toxicity: Children ≥5 years and Adolescents: Severe neutropenia (ANC <1,000/mm3): Discontinue treatment.

Dosing: Kidney Impairment: Pediatric

There are no pediatric specific dosage recommendations; based on experience in adult patients, dosing adjustment suggested.

Dosing: Hepatic Impairment: Pediatric

There are no pediatric specific dosage recommendations; based on experience in adult patients, dosing adjustment suggested.

Adverse Reactions (Significant): Considerations
Activating/sedating effects

Both activating effects (eg, akathisia, restlessness) and sedating effects (eg, sedated state, drowsiness) may occur with risperidone in all ages and lead to nonadherence or discontinuation. Sedation may result in subsequent falling, particularly in older adults. Individual patient experience can vary depending on the person's sensitivity toward activation or sedation and the dose used (Ref).

Mechanism: Dose-related (Ref); sedation is believed to be due to H1 antagonism leading to potential CNS depressant effects (Ref).

Risk factors:

• Young age (in general, children and adolescents appear to be at higher risk for sedation due to antipsychotics compared to adults (Ref); in studies that included risperidone in children and adolescents, younger age has been associated with activating symptoms and higher age has been associated with sedating symptoms) (Ref)

• Specific antipsychotic (risperidone is generally considered to be mildly sedating at usual therapeutic doses in comparison with other antipsychotics) (Ref)

Angioedema

Potentially life-threatening angioedema has been reported very rarely following oral and IM administration (Ref).

Mechanism: Unknown but both a nonallergic and allergic mechanism have been proposed, including IgE-related hypersensitivity, kinin-dependent processes, or C1-esterase inhibition deficiencies (Ref).

Onset: Varied; onset following oral therapy has been reported anywhere from <24 hours following a single initial dose to months after initiation (Ref); onset following parenteral administration usually occurs in the first 48 to 72 hours after injection (Ref).

Risk factors:

• Dose: Usually occurs after increasing the dose of risperidone (Ref), although has also been reported following a single dose (Ref)

• Concurrent use of ritonavir, a weak inhibitor of CYP2D6, may increase risperidone levels leading to cases of angioedema (Ref)

Dyslipidemia

Antipsychotics are associated with dyslipidemia in adult and pediatric patients, which is a component of the metabolic syndrome observed with this pharmacologic class. Although data are inconsistent regarding risperidone’s risk, the following events have been observed: Increased serum cholesterol, decreased HDL cholesterol, and/or increased serum triglycerides (Ref).

Mechanism: The mechanism is not entirely understood and is likely multifactorial (Ref).

Onset: Varied; metabolic alterations from antipsychotics can develop in as short as 3 months after initiation (Ref).

Risk factors:

• Children and adolescents may be at increased risk for increased serum triglycerides (Ref)

• Schizophrenia (regardless of medication use) is associated with a higher rate of morbidity/mortality compared to the general population primarily due to cardiovascular disease (Ref)

• Specific antipsychotic: Risperidone is usually considered to have a low to intermediate risk for causing lipid abnormalities in adults, although data are inconsistent (Ref)

Extrapyramidal symptoms

Risperidone is frequently associated with extrapyramidal symptoms (EPS), also known as drug-induced movement disorders. Antipsychotics can cause 4 main EPS: Acute dystonia, drug-induced parkinsonism, akathisia, and tardive dyskinesia (Ref). EPS presenting as dysphagia, esophageal dysmotility, or aspiration have also been reported with antipsychotics, which may not be recognized as EPS (Ref).

Mechanism: EPS: Dose-related; due to antagonism of dopaminergic D2 receptors in nigrostriatal pathways (Ref). Tardive dyskinesia: Time-related (delayed); results from chronic exposure to dopamine 2 receptor antagonists leading to up-regulation of these receptors over time (Ref).

Onset:

Antipsychotics in general:

Acute dystonia: Rapid; in the majority of cases, dystonia usually occurs within the first 5 days after initiating antipsychotic therapy (and even with the first dose, particularly in patients receiving parenteral antipsychotics) or a dosage increase (Ref).

Drug-induced parkinsonism: Varied; onset may be delayed from days to weeks, with 50% to 75% of cases occurring within 1 month and 90% within 3 months of antipsychotic initiation, a dosage increase, or a change in the medication regimen (such as adding another antipsychotic agent or discontinuing an anticholinergic medication) (Ref).

Akathisia: Varied; may begin within several days after antipsychotic initiation but usually increases with treatment duration, occurring within 1 month in up to 50% of cases and within 3 months in 90% of cases (Ref).

Tardive dyskinesia: Delayed; symptoms usually appear after 1 to 2 years of continuous exposure to a dopamine 2 receptor antagonist and almost never before 3 months with an insidious onset, evolving into a full syndrome over days and weeks, followed by symptom stabilization and then a chronic waxing and waning of symptoms (Ref).

Esophageal dysfunction (associated with EPS): Varied; ranges from weeks to months following initiation (Ref).

Risk factors:

EPS (in general):

• Prior history of EPS (Ref)

• Higher doses (Ref)

• Younger age (in general, children and adolescents are usually at higher risk for EPS compared to adults) (Ref)

• Specific antipsychotic: Risperidone is usually associated with a moderate to high propensity to cause EPS (Ref).

Acute dystonia:

• Males (Ref)

• Young age (Ref)

Drug-induced parkinsonism:

• Females (Ref)

• Older patients (Ref)

Akathisia:

• Higher antipsychotic dosages (Ref)

• Polypharmacy (Ref)

• Mood disorders (Ref)

• Females (Ref)

• Older patients (Ref)

Tardive dyskinesia:

• Age >55 year (Ref)

• Cognitive impairment (Ref)

• Concomitant treatment with anticholinergic medications (Ref)

• Diabetes (Ref)

• Diagnosis of schizophrenia or affective disorders (Ref)

• Female sex (Ref)

• Greater total antipsychotic exposure (especially first-generation antipsychotics) (Ref)

• History of extrapyramidal symptoms (Ref)

• Substance misuse or dependence (Ref)

• Race (White or African descent). Note: Although early literature supported race as a potential risk factor for tardive dyskinesia (Morgenstern 1993), newer studies have challenged this assertion (Ref).

Esophageal dysfunction (associated with EPS):

• Certain comorbidities such as neurologic degenerative disease, dementia, stroke, Parkinson disease, or myasthenia gravis (Ref)

• Older adults >75 years of age (may be risk factor due to age-related muscle atrophy, cognitive impairment, reduced esophageal peristalsis) (Ref)

Hematologic abnormalities

Leukopenia, neutropenia, and thrombocytopenia have been reported rarely with risperidone (Ref). Agranulocytosis has also been reported very rarely (Ref).

Mechanism: Unclear and poorly understood (Ref).

Onset: Varied; in general, drug-induced neutropenia usually manifests after 1 or 2 weeks of exposure and agranulocytosis usually appears 3 to 4 weeks following initiation of therapy; however, the onset may be insidious (Ref). In general, drug-induced thrombocytopenia usually occurs 5 to 15 days after initiation of therapy (Ref).

Risk factors:

• History of antipsychotic-induced neutropenia (Ref)

• Older adults (Ref)

• History of drug-induced leukopenia/neutropenia or low white blood cell count/absolute neutrophil count

Hyperglycemia

Antipsychotics are associated with hyperglycemia in adult and pediatric patients, to varying degrees, which is a component of the metabolic syndrome observed with this pharmacologic class. Although data are inconsistent regarding risperidone’s risk, the following events have been observed: Increased serum glucose (fasting) and mild insulin resistance to some cases of new-onset diabetes mellitus and diabetic ketoacidosis (Ref).

Mechanism: The mechanism is not entirely understood and is likely multifactorial (Ref).

Onset: Varied; new-onset diabetes has been observed within the first 3 months to a median onset of 3.9 years (Ref).

Risk factors (in general):

• African American race (Ref)

• Males (Ref)

• Younger adults (Ref)

• Preexisting obesity, poor exercise habits, or other risk factors for diabetes, including family history of diabetes (Ref)

• Exposure to other agents that also increase the risk of hyperglycemia (Ref)

• Specific antipsychotic: Risk of hyperglycemia and/or new onset diabetes appears to be low to moderate with risperidone, although data are inconsistent (Ref).

Hyperprolactinemia

Risperidone commonly causes hyperprolactinemia in adult and pediatric patients, which may lead to gynecomastia, galactorrhea not associated with childbirth, amenorrhea, sexual disorder, and infertility (Ref). Although long-term effects of elevated prolactin levels have not been fully evaluated, some studies have also suggested a possible association between hyperprolactinemia and an increased risk for breast and/or pituitary tumors and osteopenia/osteoporosis (Ref).

Mechanism: Dose-related and possibly time-related; antagonism of dopamine D2 receptors in the tuberoinfundibular dopaminergic pathway which causes disinhibition of prolactin release resulting in hyperprolactinemia (Ref); risperidone has been shown to cause a strong, more prolonged receptor blockade, resulting in a more pronounced and continuous increase in serum prolactin (Ref).

Onset: Varied; onset is typically within a few weeks following initiation or dosage increase, but may also arise after long-term stable use (Ref).

Risk factors:

• Specific antipsychotic: Risperidone is considered a prolactin-elevating antipsychotic with a high risk for hyperprolactinemia (Ref)

• Higher doses (Ref)

• Females (particularly those of reproductive age) (Ref)

• Children and adolescents (Ref)

Mortality in older adults

Older adults with dementia-related psychosis treated with antipsychotics are at an increased risk of death compared to placebo. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature (Ref). In addition, an increased incidence of cerebrovascular effects (eg, cerebrovascular accident, transient ischemic attacks), including fatalities, have been reported in placebo-controlled risperidone trials in older adults with dementia-related psychosis (Ref). Of note, risperidone is not approved for the treatment of dementia-related psychosis.

Mechanism: Unknown; possible mechanisms include arrhythmia, cardiac arrest, and extrapyramidal effects that may increase the risk of falls, aspirations, and pneumonia (Ref).

Risk factors:

Antipsychotics in general:

• Higher antipsychotic dosage (Ref)

• Dementia-related psychosis (eg, Lewy body dementia, Parkinson disease dementia)

• Older adults

Neuroleptic malignant syndrome

All antipsychotics have been associated with neuroleptic malignant syndrome (NMS), although the incidence is less with second-generation (atypical) antipsychotics compared to first-generation (typical) antipsychotics. There are case reports of NMS with risperidone monotherapy, although most involve concomitant administration of another psychotropic agent (Ref).

Mechanism: Non-dose-related; idiosyncratic. Believed to be due to a reduction in CNS dopaminergic tone, along with the dysregulation of autonomic nervous system activity (Ref).

Onset: Varied; in general, most patients develop NMS within 2 weeks of initiating an antipsychotic, and in some patients, prodromal symptoms emerge within hours of initiation; once the syndrome starts, the full syndrome usually develops in 3 to 5 days (Ref). However, there are many cases of NMS occurring months after stable antipsychotic therapy (Ref).

Risk factors:

Antipsychotics in general:

• Males (twice as likely to develop NMS compared to females) (Ref)

• Dehydration (Ref)

• High-dose antipsychotic treatment (Ref)

• Concomitant lithium or benzodiazepine (potential risk factors) (Ref)

• Catatonia (Ref)

• Polypharmacy (Ref)

• Pharmacokinetic interactions (Ref)

• IM administration (Ref)

• Rapid dosage escalation (Ref)

• Psychomotor agitation (Ref)

Additional risk factors for risperidone:

• Poor metabolizers of CYP2D6 (may be at increased risk) (Ref)

Orthostatic hypotension

Orthostatic hypotension and accompanying dizziness, tachycardia, and syncope may occur, particularly with rapid titration and/or in older adults (which may result in subsequent falling and fracture) (Ref).

Mechanism: Orthostatic hypotension is attributed to alpha-1 receptor antagonism (Ref).

Onset: Rapid; per the manufacturer's labeling, orthostatic hypotension is most common during dose initiation, re-initiation, or increase.

Risk factors:

• Known cardiovascular disease (history of myocardial infarction or ischemic heart disease, heart failure, or conduction abnormalities) or cerebrovascular disease

• Known predisposing conditions (eg, hypovolemia/dehydration)

• Concomitant medications that also cause or exacerbate orthostatic hypotension (eg, tricyclic antidepressants, antihypertensive medications)

• Older adults

• Rapid dose titration (Ref)

QT prolongation

Risperidone has been associated with prolonged QT interval on ECG , including reports of torsades de pointes (TdP), occurring predominately in patients with other TdP risk factors or receiving concomitant agents that can prolong the QTc interval and/or increase risperidone concentrations (Ref). Of the antipsychotics, risperidone is usually associated with a moderate risk for QTc-prolongation (particularly in older patients) (Ref). In a study in 28 healthy psychiatric patients reaching steady state on risperidone monotherapy (6 to 16 mg/day), the mean change in QTc was 3.6 to 3.9 ms (Ref).

Mechanism: Risperidone prolongs cardiac repolarization by blocking the rapid component of the delayed rectifier potassium current, although other mechanisms might also be involved (Ref).

Risk factors:

Drug-induced QTc prolongation/TdP (in general):

• Females (Ref)

• Age >65 years (Ref)

• Structural heart disease (eg, history of myocardial infarction or heart failure with a reduced ejection fraction) (Ref)

• History of drug-induced TdP (Ref)

• Genetic defects of cardiac ion channels (Ref)

• Congenital long QT syndrome (Ref)

• Baseline QTc interval prolongation (eg, >500 msec) or lengthening of the QTc by ≥60 msec (Ref)

• Electrolyte disturbances (eg, hypokalemia, hypocalcemia, hypomagnesemia) (Ref)

• Bradycardia (Ref)

• Hepatic impairment (Ref)

• Kidney impairment (Ref)

• Coadministration of multiple medications (≥2) that prolong the QT interval or increase drug interactions that increase serum drug concentrations of QTc prolonging medications (Ref)

• Substance use (Ref)

Additional risk factors for risperidone:

• Slow CYP2D6 metabolizers or patients taking other drugs that inhibit CYP2D6 (eg, fluoxetine, paroxetine) (Ref)

Sexual dysfunction

Antipsychotics have been associated with sexual disorders in both males and females. Antipsychotic treatment has been associated with effects on all phases of sexual activity (libido, arousal, and orgasm); however, many patients with schizophrenia experience more frequent sexual dysfunction, with or without antipsychotic treatment. The following adverse reactions have been observed with risperidone: Decreased libido, erectile dysfunction, and abnormal orgasm (Ref). In addition, priapism has been reported with risperidone (Ref).

Mechanism: Antipsychotic-induced sexual dysfunction has been attributed to many potential mechanisms, including dopamine receptor antagonism, dopamine D2 receptor antagonism in the infundibular dopaminergic pathway causing hyperprolactinemia, histamine receptor antagonism, cholinergic receptor antagonism, and alpha-adrenergic receptor antagonism (Ref). Of note, risperidone is associated with a high propensity for hyperprolactinemia (Ref). Priapism is believed to be caused by alpha-1 adrenergic antagonism; risperidone has a relatively high affinity for alpha-1 adrenergic receptors (Ref).

Risk factors:

• Hyperprolactinemia (although a correlation with sexual dysfunction has been observed, a relationship has not been confirmed) (Ref)

• Schizophrenia (the prevalence of antipsychotic-induced sexual dysfunction in patients with schizophrenia is high [~50% to 60% compared with 31% of men in the general population]) (Ref)

• Specific antipsychotic: Risperidone is associated with a high prevalence of sexual dysfunction (Ref).

Temperature dysregulation

Antipsychotics may impair the body’s ability to regulate core body temperature, which may cause a potentially life-threatening heat stroke during predisposing conditions, such as heat wave or strenuous exercise. There are also several case reports of potentially life-threatening hypothermia associated with risperidone use (Ref).

Mechanism: Non-dose-related; idiosyncratic. Exact mechanism is unknown; however, body temperature is regulated by the hypothalamus with involvement of the dopamine, serotonin, and norepinephrine neurotransmitters. D2 antagonism may cause an increase in body temperature, while 5-HT2A (serotonin) receptor antagonism may cause a decrease in body temperature. Of note, risperidone has pronounced 5-HT2A receptor antagonism, with stronger affinity for 5-HT2A receptors than for D2 receptors. In addition, antagonism of peripheral alpha-adrenergic receptors has also been suggested as a factor in the hypothermic effect by inhibiting peripheral responses to cooling (vasoconstriction and shivering) (Ref).

Onset: Hypothermia: Varied; antipsychotic-induced hypothermia cases indicate a typical onset in the period shortly after initiation of therapy or a dosage increase (first 7 to 10 days) (Ref).

Risk factors:

Heat stroke:

• Psychiatric illness (regardless of medication use) (Ref)

• Dehydration (Ref)

• Strenuous exercise (Ref)

• Heat exposure (Ref)

• Concomitant medications possessing anticholinergic effects (Ref)

Hypothermia:

• In general, predisposing risk factors include: Older adults, cerebrovascular accident, preexisting brain damage, hypothyroidism, malnutrition, shock, sepsis, adrenal insufficiency, diabetes, disability, burns, exfoliative dermatitis benzodiazepine use, alcohol intoxication, kidney or liver failure (Ref)

• Schizophrenia (regardless of antipsychotic use) (Ref)

Weight gain

Risperidone is associated with significant weight gain (increase of ≥7% from baseline) in all ages, which is a component of the metabolic syndrome observed with this pharmacologic class (Ref).

Mechanism: Multiple proposed mechanisms, including actions at serotonin, dopamine, histamine, and muscarinic receptors, with differing effects explained by differing affinity of antipsychotics at these receptors (Ref).

Onset: Varied; antipsychotic-induced weight gain usually occurs rapidly in the initial period following initiation, then gradually decreases and flattens over several months with patients continuing to gain weight in the long term (Ref).

Risk factors:

• Family history of obesity (Ref)

• Parental BMI (Ref)

• Children and adolescents (Ref)

• Rapid weight gain in the initial period: Younger age, lower baseline BMI, more robust response to antipsychotic, and increase in appetite; rapid weight gain of >5% in the first month has been observed as the best predictor for significant long-term weight gain (Ref)

• Duration of therapy (although weight gain plateaus, patients continue to gain weight over time) (Ref)

• Schizophrenia (regardless of medication) is associated with a higher prevalence of obesity compared to the general population due to components of the illness, such as negative symptoms, sedentary lifestyles, and unhealthy diets (Ref)

• Specific antipsychotic: Risperidone is considered to have an intermediate/moderate propensity for causing weight gain; olanzapine and clozapine are associated with a high risk (Ref)

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.

>10%:

Endocrine & metabolic: Hyperprolactinemia (children and adolescents: 49% to 87%; adults: <4%), weight gain (≥7% kg increase from baseline: 8% to 42%) (table 1)

Risperidone: Adverse Reaction: Weight Gain

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

Comments

33%

7%

Children and adolescents

0.5 to 6 mg/day

Oral

Schizophrenia, bipolar mania, autistic disorder, or other psychiatric disorders

448

375

≥7% gain in body weight

42%

18%

Adults

120 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

112

107

≥7% gain in body weight

33%

18%

Adults

90 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

105

107

≥7% gain in body weight

10%

6%

Adults

25 mg every 2 weeks

IM extended-release injection

Schizophrenia

90

83

≥7% gain in body weight

8%

6%

Adults

50 mg every 2 weeks

IM extended-release injection

Schizophrenia

87

83

≥7% gain in body weight

21%

3%

Adults

>8 to 16 mg/day

Oral

Schizophrenia or bipolar mania

158

597

≥7% gain in body weight

9%

3%

Adults

1 to 8 mg/day

Oral

Schizophrenia or bipolar mania

769

597

≥7% gain in body weight

Gastrointestinal: Constipation (5% to 17%), increased appetite (children and adolescents: 4% to 44%; adults: 2% to 4%), nausea (3% to 16%), upper abdominal pain (adolescents: 13% to 16%), vomiting (children and adolescents: 10% to 20%; adults: <4%)

Genitourinary: Urinary incontinence (children: 16%; adults <4%)

Nervous system: Akathisia (≤11%) (table 2), anxiety (6% to 16%), dizziness (3% to 16%) (table 3), drooling (children: 12%; adults: <4%), drowsiness, extrapyramidal reaction (2% to 35%), fatigue (children and adolescents: 18% to 31%; adults: 1% to 9%), headache (12% to 21%), insomnia (adults: 25% to 32%), parkinsonism (6% to 28%) (table 4), sedated state, tremor (children and adolescents: 8% to 11%; adults: 2% to 24%; including head titubation)

Risperidone: Adverse Reaction: Akathisia

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

8%

2%

Children and adolescents

3 to 6 mg/day

Oral

Bipolar mania

61

58

0%

2%

Children and adolescents

0.5 to 2.5 mg/day

Oral

Bipolar mania

50

58

10%

4%

Children and adolescents

4 to 6 mg/day

Oral

Schizophrenia

51

54

9%

4%

Children and adolescents

1 to 3 mg/day

Oral

Schizophrenia

55

54

9%

3%

Adults

1 to 6 mg/day

Oral

Bipolar mania

448

424

11%

6%

Adults

50 mg every 2 weeks

IM extended-release injection

Schizophrenia

103

98

10%

3%

Adults

2 to 8 mg/day

Oral

Schizophrenia

366

225

10%

3%

Adults

>8 to 16 mg/day

Oral

Schizophrenia

198

225

7%

4%

Adults

120 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

117

118

4%

6%

Adults

25 mg every 2 weeks

IM extended-release injection

Schizophrenia

99

98

3%

4%

Adults

90 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

115

118

Risperidone: Adverse Reaction: Dizziness

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

16%

5%

Children and adolescents

0.5 to 2.5 mg/day

Oral

Bipolar mania

50

58

13%

5%

Children and adolescents

3 to 6 mg/day

Oral

Bipolar mania

61

58

8%

2%

Children and adolescents

0.5 to 4 mg/day

Oral

Irritability associated with autistic disorder

107

115

14%

2%

Children and adolescents

4 to 6 mg/day

Oral

Schizophrenia

51

54

7%

2%

Children and adolescents

1 to 3 mg/day

Oral

Schizophrenia

55

54

3%

1%

Adults

12.5 to 50 mg every 2 weeks

IM extended-release injection

Bipolar I disorder

154

149

6%

5%

Adults

1 to 6 mg/day

Oral

Bipolar mania

448

424

11%

6%

Adults

50 mg every 2 weeks

IM extended-release injection

Schizophrenia

103

98

7%

2%

Adults

2 to 8 mg/day

Oral

Schizophrenia

366

225

7%

6%

Adults

25 mg every 2 weeks

IM extended-release injection

Schizophrenia

99

98

4%

2%

Adults

>8 to 16 mg/day

Oral

Schizophrenia

198

225

Risperidone: Adverse Reaction: Parkinsonism

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

12%

3%

Children and adolescents

3 to 6 mg/day

Oral

Bipolar mania

61

58

6%

3%

Children and adolescents

0.5 to 2.5 mg/day

Oral

Bipolar mania

50

58

8%

1%

Children and adolescents

0.5 to 4 mg/day

Oral

Irritability associated with autistic disorder

107

115

28%

11%

Children and adolescents

4 to 6 mg/day

Oral

Schizophrenia

51

54

16%

11%

Children and adolescents

1 to 3 mg/day

Oral

Schizophrenia

55

54

25%

9%

Adults

1 to 6 mg/day

Oral

Bipolar mania

448

424

17%

8%

Adults

>8 to 16 mg/day

Oral

Schizophrenia

198

225

15%

9%

Adults

50 mg every 2 weeks

IM extended-release injection

Schizophrenia

103

98

14%

8%

Adults

2 to 8 mg/day

Oral

Schizophrenia

366

225

8%

9%

Adults

25 mg every 2 weeks

IM extended-release injection

Schizophrenia

99

98

Respiratory: Cough (children: 17%; adults: 2% to 4%), nasopharyngitis (children: 19%; adults: 3% to 4%), rhinorrhea (children: 12%; adults: <4%)

Miscellaneous: Fever (children: 16%; adults: 1% to 2%)

1% to 10%:

Cardiovascular: Bradycardia, bundle branch block, chest discomfort, chest pain, ECG changes, first-degree atrioventricular block, hypertension (3%), hypotension, orthostatic dizziness, orthostatic hypotension, palpitations, peripheral edema (≤3%), prolonged QT interval on ECG, syncope (≤2%) (table 5), tachycardia

Risperidone: Adverse Reaction: Syncope

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

2%

0%

Adults

25 mg every 2 weeks

IM extended-release injection

Schizophrenia

99

98

1%

0%

Adults

50 mg every 2 weeks

IM extended-release injection

Schizophrenia

103

98

0.8%

N/A

Adults

N/A

IM extended-release injection

Schizophrenia

1,499

N/A

0.2%

N/A

Adults

N/A

Oral

Schizophrenia

2,607

N/A

Dermatologic: Acne vulgaris (2%), eczema, pruritus, skin rash (1% to 8%), xeroderma (1% to 3%)

Endocrine & metabolic: Amenorrhea (4%), decreased HDL cholesterol, decreased libido, galactorrhea not associated with childbirth, gynecomastia, hyperglycemia, increased serum cholesterol (2% to 6%) (table 6), increased serum triglycerides (3% to 7%) (table 7), increased thirst (children: 7%), irregular menses, menstrual disease, menstruation (delayed), weight loss (1% to 4%)

Risperidone: Adverse Reaction: Increased Serum Cholesterol

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

Comments

4%

2%

Children and adolescents

0.5 to 6 mg/day

Oral

Schizophrenia, bipolar mania, autistic disorder, or other psychiatric disorders

80

42

<170 mg/dL to ≥200 mg/dL

2%

2%

Adults

90 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

104

109

≥300 mg/dL

2%

2%

Adults

120 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

111

109

≥300 mg/dL

6%

3%

Adults

>8 to 16 mg/day

Oral

Schizophrenia or bipolar mania

96

368

<200 mg/dL to ≥240 mg/dL

4%

3%

Adults

1 to 8 mg/day

Oral

Schizophrenia or bipolar mania

516

368

<200 mg/dL to ≥240 mg/dL

Risperidone: Adverse Reaction: Increased Serum Triglycerides

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

Comments

7%

2%

Children and adolescents

0.5 to 6 mg/day

Oral

Schizophrenia, bipolar mania, autistic disorder, or other psychiatric disorders

113

65

<150 mg/dL to ≥200 mg/dL

3%

1%

Adults

1 to 8 mg/day

Oral

Schizophrenia or bipolar mania

301

180

<500 mg/dL to ≥500 mg/dL

3%

1%

Adults

>8 to 16 mg/day

Oral

Schizophrenia or bipolar mania

121

180

<500 mg/dL to ≥500 mg/dL

Gastrointestinal: Abdominal distress (1% to 3%), abdominal pain, anorexia, decreased appetite (6%), diarrhea (1% to 8%), dyspepsia (3% to 10%), gastritis, gastroenteritis, sialorrhea (1% to 10%), stomach discomfort (2% to 6%), toothache (≤3%), xerostomia (2% to 10%)

Genitourinary: Cystitis, delayed ejaculation, erectile dysfunction, glycosuria, infrequent uterine bleeding, mastalgia, sexual disorder, urinary tract infection

Hematologic & oncologic: Anemia, neutropenia

Hepatic: Increased gamma-glutamyl transferase, increased liver enzymes, increased serum alanine aminotransferase, increased serum aspartate aminotransferase

Hypersensitivity: Facial edema, hypersensitivity reaction

Infection: Infection, influenza, viral infection

Local: Abscess at injection site, induration at injection site, injection-site reaction, local pain (buttock), localized infection, pain at injection site, swelling at injection site

Nervous system: Abnormal gait (4%), agitation, akinesia, asthenia (1% to 2%), ataxia, depression, disturbance in attention (4%), dysarthria, falling, hypoesthesia (2%), lethargy, malaise, myasthenia, nervousness, pain (1% to 4%), paresthesia, procedural pain, seizure, sleep disturbance, vertigo

Neuromuscular & skeletal: Abnormal posture, arthralgia (2% to 4%), back pain (1% to 7%), dyskinesia (adults: 6%), dystonia (≤6%) (table 8), hypokinesia, increased creatine phosphokinase in blood specimen (1% to 2%), limb pain (≤8%), muscle rigidity (≤3%), muscle spasm (3%), musculoskeletal chest pain, musculoskeletal pain (5%), myalgia, neck pain, tardive dyskinesia

Risperidone: Adverse Reaction: Dystonia

Drug (Risperidone)

Placebo

Population

Dose

Dosage Form

Indication

Number of Patients (Risperidone)

Number of Patients (Placebo)

6%

0%

Children and adolescents

0.5 to 2.5 mg/day

Oral

Bipolar mania

50

58

5%

0%

Children and adolescents

3 to 6 mg/day

Oral

Bipolar mania

61

58

6%

0%

Children and adolescents

4 to 6 mg/day

Oral

Schizophrenia

51

54

2%

0%

Children and adolescents

1 to 3 mg/day

Oral

Schizophrenia

55

54

5%

1%

Adults

1 to 6 mg/day

Oral

Bipolar mania

448

424

4%

2%

Adults

>8 to 16 mg/day

Oral

Schizophrenia

198

225

3%

2%

Adults

2 to 8 mg/day

Oral

Schizophrenia

366

225

0.9%

3%

Adults

120 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

117

118

0%

3%

Adults

90 mg every 4 weeks

SUBQ extended-release injection

Schizophrenia

115

118

Ophthalmic: Blurred vision (2% to 7%), conjunctivitis, decreased visual acuity

Otic: Otalgia, otic infection

Respiratory: Bronchitis, dyspnea, epistaxis (≤2%), flu-like symptoms, nasal congestion (4% to 10%), paranasal sinus congestion (2%), pharyngitis, pharyngolaryngeal pain (3% to 10%), pneumonia, respiratory tract infection (8%), rhinitis (9%), sinusitis

Frequency not defined:

Cardiovascular: Cold extremity, flushing

Dermatologic: Cheilitis, dermatitis (acarodermatitis), erythema of skin, hyperkeratosis, maculopapular rash, night sweats, onychomycosis, papular rash, seborrhea, seborrheic dermatitis of scalp, skin discoloration, skin lesion

Endocrine & metabolic: Diabetic coma, hypertriglyceridemia, pituitary neoplasm, polydipsia

Gastrointestinal: Bruxism, esophageal motility disorder, fecal incontinence, fecaloma, oral hypoesthesia, tongue paralysis, tongue spasm

Genitourinary: Anorgasmia, breast engorgement, breast hypertrophy, breast secretion, breast tenderness, dysuria, hypomenorrhea, pollakiuria, vaginal discharge

Hematologic & oncologic: Eosinophilia, granulocytopenia

Nervous system: Blunted affect, cerebral ischemia, cerebrovascular accident, cerebrovascular disease, chills, cogwheel rigidity, coma, confusion, impaired consciousness, loss of balance, mask-like face, movement disorder, restlessness, speech disturbance, transient ischemic attacks, trismus, unresponsive to stimuli, voice disorder

Neuromuscular & skeletal: Joint stiffness, joint swelling, muscle twitching, rhabdomyolysis, torticollis

Ophthalmic: Abnormal eye movements, crusting of eyelid, dry eye syndrome, eye discharge, eye infection, glaucoma, lacrimation, ocular hyperemia, photophobia, visual disturbance

Otic: Otitis media, tinnitus

Respiratory: Aspiration pneumonia, bronchopneumonia, hyperventilation, nasal mucosa swelling, rales, respiratory congestion, respiratory distress, tonsillitis, tracheobronchitis, wheezing

Postmarketing:

Cardiovascular: Atrial fibrillation, deep vein thrombosis (Konnakkaparambil Ramakrishnan 2021), edema (Liu 2020), pulmonary embolism, torsades de pointes (Beach 2018), ventricular tachycardia (Mazhar 2010)

Dermatologic: Alopecia, cellulitis, cutaneous nodule, dermal ulcer, Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Diabetes mellitus (new onset) (Farwell 2004), diabetic ketoacidosis (Ely 2013), heatstroke (Gomez Ramos 2012), hypoglycemia (Nagamine 2016), increased serum glucose (fasting) (Murashita 2007), insulin resistance (Sukasem 2018), precocious puberty, SIADH (Lee 2015), water intoxication

Gastrointestinal: Dysgeusia, dysphagia (Crouse 2018), intestinal obstruction, oromandibular dystonia (Yoshimura 2016), pancreatitis (Kawabe 2014)

Genitourinary: Abnormal orgasm (Nagaraj 2009), ejaculation failure (Cichon 2023), priapism (Ateb 2022), retrograde ejaculation (Cichon 2023), urinary retention (Ou 2021)

Hematologic & oncologic: Agranulocytosis (Finkel 1998), hematoma, leukopenia (Dernovsek 1997), thrombocytopenia (Semba 2009), thrombotic thrombocytopenic purpura

Hepatic: Jaundice

Hypersensitivity: Anaphylaxis, angioedema (Samra 2018)

Nervous system: Catatonia (Mall 2008, Parraga 2006), hyperthermia, hypothermia (Razaq 2004), mania (Terao 1998), neuroleptic malignant syndrome (Aboraya 2002), somnambulism, stuttering (Sood 2022)

Ophthalmic: Blepharospasm (Yoshimura 2016), cataract (Balamurugan 2020), intraoperative floppy iris syndrome (with cataract surgery) (Ford 2011)

Respiratory: Sleep apnea

Miscellaneous: Tissue necrosis

Contraindications

Hypersensitivity (eg, anaphylaxis, angioedema) to risperidone, paliperidone, or any component of the formulation.

Warnings/Precautions

Concerns related to adverse effects:

• Anticholinergic effects: May cause anticholinergic effects (confusion, agitation, constipation, xerostomia, blurred vision, urinary retention); use with caution in patients with decreased gastrointestinal motility, urinary retention, BPH, xerostomia, or visual problems. Relative to other neuroleptics, risperidone has a low potency of cholinergic blockade (Richelson 1999).

• Suicidal ideation: The possibility of a suicide attempt is inherent in psychotic illness or bipolar disorder; use with caution in high-risk patients during initiation of therapy. Prescriptions should be written for the smallest quantity consistent with good patient care.

Disease-related concerns:

• Cardiovascular disease: Use with caution in patients with severe cardiac disease, hemodynamic instability, prior myocardial infarction or ischemic heart disease.

• Hepatic impairment: Use with caution in patients with hepatic disease or impairment; dosage reduction is recommended.

• Renal impairment: Use with caution in patients with renal disease; dosage reduction is recommended.

• Seizures: Use with caution in patients at risk of seizures, including those with a history of seizures, head trauma, brain damage, alcoholism, or concurrent therapy with medications which may lower seizure threshold.

Dosage form specific issues:

• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer’s labeling.

• Dispersible tablet: Inform patients with phenylketonuria that dispersible tablets contain phenylalanine.

• SUBQ injection site reactions: Following each SUBQ injection, a lump may develop and persist for several weeks; it will decrease in size over time. Do not rub or massage the injection site.

Other warnings/precautions:

• Discontinuation of therapy: When discontinuing antipsychotic therapy, gradually taper antipsychotics to avoid physical withdrawal symptoms and rebound symptoms (APA [Keepers 2020]; WFSBP [Hasan 2012]). Withdrawal symptoms may include agitation, alternating feelings of warmth and cold, anxiety, diaphoresis, dyskinesia, GI symptoms, insomnia, irritability, myalgia, paresthesia, psychosis, restlessness, rhinorrhea, tremor, and vertigo (Lambert 2007; Moncrieff 2020). The risk of withdrawal symptoms is highest following abrupt discontinuation of highly anticholinergic or dopaminergic antipsychotics (Cerovecki 2013). Patients with chronic symptoms, repeated relapses, and clear diagnostic features of schizophrenia are at risk for poor outcomes if medications are discontinued (APA [Keepers 2020]).

Warnings: Additional Pediatric Considerations

Long-term usefulness of risperidone should be periodically re-evaluated in patients receiving the drug for extended periods of time. Similar to adult experience, the American Academy of Child and Adolescent Psychiatry (AACAP) guidelines recommend gradually tapering antipsychotics to avoid discontinuation syndrome (withdrawal) symptoms and minimize the risk of relapse (AACAP [McClellan 2007]).

Product Availability

Rykindo (risperidone extended-release injectable suspension): FDA approved January 2023; anticipated availability currently unknown. Information pertaining to this product within the monograph is pending revision. Rykindo is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder in adults. Consult the prescribing information for additional information.

Uzedy: FDA approved April 2023; anticipated availability is unknown. Information pertaining to the product within the monograph is pending revision. Uzedy is an extended-release injectable suspension administered subcutaneously every 1 to 2 months for the treatment of schizophrenia in adults. Consult prescribing information for additional information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Prefilled Syringe, Subcutaneous:

Perseris: 90 mg (1 ea); 120 mg (1 ea)

Solution, Oral:

RisperDAL: 1 mg/mL (30 mL) [contains benzoic acid]

Generic: 1 mg/mL (30 mL)

Suspension Prefilled Syringe, Subcutaneous:

Uzedy: 50 mg/0.14 mL (0.14 mL); 75 mg/0.21 mL (0.21 mL); 100 mg/0.28 mL (0.28 mL); 125 mg/0.35 mL (0.35 mL); 150 mg/0.42 mL (0.42 mL); 200 mg/0.56 mL (0.56 mL); 250 mg/0.7 mL (0.7 mL) [latex free]

Suspension Reconstituted ER, Intramuscular:

RisperDAL Consta: 12.5 mg (1 ea); 25 mg (1 ea); 37.5 mg (1 ea); 50 mg (1 ea)

Generic: 12.5 mg (1 ea); 25 mg (1 ea); 37.5 mg (1 ea); 50 mg (1 ea)

Suspension Reconstituted ER, Intramuscular [preservative free]:

Rykindo: 25 mg (1 ea)

Rykindo: 25 mg (1 ea) [contains polysorbate 80]

Rykindo: 37.5 mg (1 ea)

Rykindo: 37.5 mg (1 ea) [contains polysorbate 80]

Rykindo: 50 mg (1 ea)

Rykindo: 50 mg (1 ea) [contains polysorbate 80]

Tablet, Oral:

RisperDAL: 0.5 mg, 1 mg [contains corn starch]

RisperDAL: 2 mg [contains corn starch, fd&c yellow #6(sunset yellow)alumin lake]

RisperDAL: 3 mg [contains corn starch, quinoline yellow (d&c yellow #10)]

RisperDAL: 4 mg [contains corn starch, fd&c blue #2 (indigo carm) aluminum lake, quinoline yellow (d&c yellow #10)]

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Tablet Disintegrating, Oral:

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Generic Equivalent Available: US

May be product dependent

Pricing: US

Prefilled Syringe (Perseris Subcutaneous)

90 mg (per each): $2,608.93

120 mg (per each): $3,478.61

Solution (RisperDAL Oral)

1 mg/mL (per mL): $6.57

Solution (risperiDONE Oral)

1 mg/mL (per mL): $4.87 - $5.59

Suspension Prefilled Syringe (Uzedy Subcutaneous)

50MG/0.14ML (per 0.14 mL): $1,537.44

75MG/0.21ML (per 0.21 mL): $2,306.28

100MG/0.28ML (per 0.28 mL): $3,075.12

125 mg/0.35ml (per 0.35 mL): $3,843.84

150MG/0.42ML (per 0.42 mL): $4,612.56

200MG/0.56ML (per 0.56 mL): $6,150.12

250 mg/0.7 mL (per 0.7 mL): $7,687.68

Suspension Reconstituted ER (RisperDAL Consta Intramuscular)

12.5 mg (per each): $368.77

25 mg (per each): $737.47

37.5 mg (per each): $1,106.26

50 mg (per each): $1,475.05

Suspension Reconstituted ER (risperiDONE Microspheres ER Intramuscular)

12.5 mg (per each): $350.33

25 mg (per each): $700.60

37.5 mg (per each): $1,050.94

50 mg (per each): $1,401.30

Suspension Reconstituted ER (Rykindo Intramuscular)

25 mg (per each): $703.69

37.5 mg (per each): $1,055.59

50 mg (per each): $1,407.49

Tablet, orally-disintegrating (risperiDONE Oral)

0.25 mg (per each): $4.48

0.5 mg (per each): $4.92

1 mg (per each): $5.50 - $5.74

2 mg (per each): $8.95 - $9.34

3 mg (per each): $11.29 - $11.78

4 mg (per each): $15.16 - $15.82

Tablets (RisperDAL Oral)

0.5 mg (per each): $5.53

1 mg (per each): $5.88

2 mg (per each): $9.83

3 mg (per each): $11.54

4 mg (per each): $15.50

Tablets (risperiDONE Oral)

0.25 mg (per each): $3.90

0.5 mg (per each): $4.27 - $4.28

1 mg (per each): $4.55

2 mg (per each): $7.60 - $7.61

3 mg (per each): $8.93

4 mg (per each): $12.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Prefilled Syringe, Subcutaneous:

Perseris: 90 mg (1 ea); 120 mg (1 ea)

Solution, Oral:

RisperDAL: 1 mg/mL ([DSC]) [contains benzoic acid]

Generic: 1 mg/mL (30 mL, 60 mL, 100 mL, 120 mL)

Suspension Reconstituted ER, Intramuscular:

RisperDAL Consta: 12.5 mg (1 ea); 25 mg (1 ea); 37.5 mg (1 ea); 50 mg (1 ea)

Tablet, Oral:

Generic: 0.25 mg, 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Tablet Disintegrating, Oral:

Generic: 0.5 mg, 1 mg, 2 mg, 3 mg, 4 mg

Administration: Adult

Oral: May be administered without regard to meals.

Oral solution can be administered directly from the provided calibrated oral dose syringe or may be mixed with water, coffee, orange juice, or low-fat milk, but is not compatible with cola or tea.

Risperdal M-Tab should not be removed from blister pack until administered. Do not push tablet through foil (tablet may become damaged); peel back foil to expose tablet. Using dry hands, place immediately on tongue. Tablet will dissolve within seconds and may be swallowed with or without liquid. Do not split or chew.

IM ER suspension: Shake syringe vigorously just before injection. Administer IM into either the deltoid muscle or the upper outer quadrant of the gluteal area. For IM use only; do not administer IV. Avoid inadvertent injection into vasculature. Injection should alternate between the two arms or buttocks. Do not combine two different dosage strengths into one single administration. Do not substitute any components of the dose-pack; administer with needle provided (1-inch needle for deltoid administration or 2-inch needle for gluteal administration). Administer entire contents of the vial to ensure correct dose is provided.

SUBQ ER suspension: Administer SUBQ ER suspension into the abdomen or back of the upper arm. Choose an injection site with adequate SUBQ tissue that is free of skin conditions (eg, bruising, excessive pigment [including tattoo], infection, tender, callused, hard, irritation, lesions, nodules, redness, scarring or stretch marks).

Monthly injection (Perseris): It is recommended that the patient is in the supine position. Rotate injection sites. When product reaches room temperature for ≥15 minutes, administer with 18G x 5/8" safety needle provided. There may be a lump at the injection site for several weeks; this will decrease in size over time. Do not rub injection site; be aware of the placement of any belts, waistbands, sleeves, cuffs, or other clothing parts. Refer to manufacturer’s labeling for product-specific detail.

Monthly or every-2-months injection (Uzedy): Do not substitute any components of the dose pack; when product reaches room temperature for ≥30 minutes, administer with 21G x 5/8” needle provided. Resistance will be experienced during administration; do not use excessive force in an attempt to deliver medication faster. Refer to manufacturer’s labeling for product-specific detail.

Administration: Pediatric

Oral: May be administered without regard to meals.

Oral solution: May administer directly from the manufacturer provided calibrated oral syringe or may mix with water, coffee, orange juice, or low-fat milk; do not mix with cola or tea.

Orally disintegrating tablets: Do not remove tablet from blister pack until ready to administer; do not push tablet through foil (tablet may become damaged); peel back foil to expose tablet; use dry hands to remove tablet and place immediately on tongue; tablet will dissolve within seconds and may be swallowed with or without liquid; do not split or chew tablet.

Parenteral: Extended-release suspension (Risperdal Consta): IM: Children ≥11 years and Adolescents: For IM injection by a health care provider; do not administer IV. Shake syringe vigorously just before injection. Administer IM into either the deltoid muscle (using a 1-inch needle) or the upper outer quadrant of the gluteal area (using a 2-inch needed). Avoid inadvertent injection into vasculature. Injection should alternate between sides of the body. Do not combine 2 different dosage strengths into 1 single administration or use a different syringe other than the one provided to administer a partial dose. Do not substitute any components of the dose-pack. Administer entire contents of the vial to ensure correct dose is provided. For single use only; discard vial and vial adapter after use.

Use: Labeled Indications

Long-acting IM injection:

Bipolar disorder: As monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar I disorder.

Schizophrenia: Treatment of schizophrenia.

Oral:

Bipolar mania: As monotherapy or as adjunctive therapy to lithium or valproate for the treatment of acute mania or acute episodes with mixed features associated with bipolar disorder in adults or as monotherapy for the treatment of acute mania or acute episodes with mixed features associated with bipolar disorder in children and adolescents 10 to 17 years of age.

Irritability associated with autistic disorder: Treatment of irritability associated with autistic disorder in children and adolescents 5 to 17 years of age, including symptoms of aggression toward others, deliberate self-injuriousness, temper tantrums, and quickly changing moods.

Schizophrenia: Treatment of schizophrenia in adults and adolescents 13 to 17 years of age.

Subcutaneous injection:

Schizophrenia: Treatment of schizophrenia in adults.

Use: Off-Label: Adult

Agitation/Aggression (severe, acute) associated with psychiatric disorders (eg, schizophrenia, bipolar disorder), substance intoxication, or other organic causes; Agitation/Aggression and psychosis associated with dementia, severe or refractory; Bipolar disorder, hypomania; Delusional disorder; Delusional infestation (delusional parasitosis); Huntington disease–associated chorea; Major depressive disorder (unipolar), treatment resistant; Obsessive-compulsive disorder, treatment resistant; Tourette syndrome

Medication Safety Issues
Sound-alike/look-alike issues:

RisperiDONE may be confused with reserpine, rOPINIRole

RisperDAL may be confused with lisinopril, reserpine, Restoril, rOPINIRole

Older Adult: High-Risk Medication:

Beers Criteria: Antipsychotics are identified in the Beers Criteria as potentially inappropriate medications to be avoided in patients 65 years and older due to an increased risk of stroke and a greater rate of cognitive decline and mortality in patients with dementia. Evidence also suggests there may be an increased risk of mortality with use independent of dementia. Avoid antipsychotics for behavioral problems associated with dementia or delirium unless alternative nonpharmacologic therapies have failed and patient may harm self or others. In addition, antipsychotics should be used with caution in older adults due to their potential to cause or exacerbate syndrome of inappropriate antidiuretic hormone secretion (SIADH) or hyponatremia; monitor sodium closely with initiation or dosage adjustments in older adults. Use of antipsychotics may be appropriate for FDA approved indications including schizophrenia, bipolar disorder, Parkinson disease psychosis, adjunctive therapy in major depressive disorder, or for short-term use as an antiemetic (Beers Criteria [AGS 2023]).

Metabolism/Transport Effects

Substrate of CYP2D6 (major), CYP3A4 (major), P-glycoprotein/ABCB1 (major); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapy

Aclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Adagrasib: May enhance the QTc-prolonging effect of RisperiDONE. Adagrasib may increase the serum concentration of RisperiDONE. Management: Consider alternatives to this combination. If combined, monitor for increased risperidone toxicities, including QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Agents With Seizure Threshold Lowering Potential: May enhance the adverse/toxic effect of RisperiDONE. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Alcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl). Risk C: Monitor therapy

Alizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Amifampridine: Agents With Seizure Threshold Lowering Potential may enhance the neuroexcitatory and/or seizure-potentiating effect of Amifampridine. Risk C: Monitor therapy

Amisulpride (Oral): May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk C: Monitor therapy

Amisulpride (Oral): Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Amisulpride (Oral). Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Anticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapy

Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Risk C: Monitor therapy

Anti-Parkinson Agents (Dopamine Agonist): Antipsychotic Agents (Second Generation [Atypical]) may diminish the therapeutic effect of Anti-Parkinson Agents (Dopamine Agonist). Management: Consider avoiding atypical antipsychotic use in patients with Parkinson disease. If an atypical antipsychotic is necessary, consider using clozapine, quetiapine, or ziprasidone at lower initial doses, or a non-dopamine antagonist (eg, pimavanserin). Risk D: Consider therapy modification

ARIPiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

ARIPiprazole Lauroxil: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of ARIPiprazole Lauroxil. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Armodafinil: May decrease serum concentrations of the active metabolite(s) of RisperiDONE. Armodafinil may decrease the serum concentration of RisperiDONE. Risk C: Monitor therapy

Artemether and Lumefantrine: May increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Asenapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Asenapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Azelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Azithromycin (Systemic): May enhance the QTc-prolonging effect of RisperiDONE. Azithromycin (Systemic) may increase the serum concentration of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Benperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Benperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Blonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin. Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modification

Blood Pressure Lowering Agents: May enhance the hypotensive effect of Antipsychotic Agents (Second Generation [Atypical]). Risk C: Monitor therapy

Botulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Brexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone. Risk C: Monitor therapy

Brexpiprazole: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Brexpiprazole. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Brimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Bromopride: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk X: Avoid combination

Bromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Buprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine. Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modification

Cabergoline: May diminish the therapeutic effect of Antipsychotic Agents. Risk X: Avoid combination

Cannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Cannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products. Risk C: Monitor therapy

Cariprazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Cariprazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Ceritinib: May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Chloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapy

Chlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modification

Chlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapy

Chlorprothixene: Anticholinergic Agents may enhance the anticholinergic effect of Chlorprothixene. Risk C: Monitor therapy

Cimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium. Risk X: Avoid combination

Clarithromycin: RisperiDONE may enhance the QTc-prolonging effect of Clarithromycin. Clarithromycin may increase the serum concentration of RisperiDONE. Management: Monitor for increased risperidone toxicities, including QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

ClomiPRAMINE: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of ClomiPRAMINE. QT-prolonging Antipsychotics (Moderate Risk) may enhance the serotonergic effect of ClomiPRAMINE. This could result in serotonin syndrome. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and serotonin syndrome/serotonin toxicity (SS/ST) or NMS when these agents are combined. Patients with additional risk factors for QTc prolongation or SS/ST may be at even higher risk. Risk C: Monitor therapy

Clothiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Clothiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

CloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine. Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modification

CNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapy

CYP2D6 Inhibitors (Moderate): May increase the serum concentration of RisperiDONE. Risk C: Monitor therapy

CYP2D6 Inhibitors (Strong): May increase the serum concentration of RisperiDONE. Management: Careful monitoring for risperidone toxicities and possible dose adjustment are recommended when combined with strong CYP2D6 inhibitors. See full interaction monograph for details. Risk D: Consider therapy modification

CYP3A4 Inducers (Moderate): May decrease serum concentrations of the active metabolite(s) of RisperiDONE. CYP3A4 Inducers (Moderate) may decrease the serum concentration of RisperiDONE. Risk C: Monitor therapy

CYP3A4 Inducers (Strong): May decrease serum concentrations of the active metabolite(s) of RisperiDONE. CYP3A4 Inducers (Strong) may decrease the serum concentration of RisperiDONE. Management: Careful monitoring for reduced risperidone efficacy and possible dose adjustment are recommended when combined with strong CYP3A4 inducers. See full interaction monograph for details. Risk D: Consider therapy modification

CYP3A4 Inhibitors (Strong): May increase the serum concentration of RisperiDONE. Risk C: Monitor therapy

Dabrafenib: May enhance the QTc-prolonging effect of RisperiDONE. Dabrafenib may decrease the serum concentration of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Also monitor for reduced risperidone efficacy. Risk C: Monitor therapy

Daridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Deutetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for akathisia, parkinsonism, or neuroleptic malignant syndrome may be increased. Risk C: Monitor therapy

DexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine. Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modification

Difelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Dimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Domperidone: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Domperidone. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

Donepezil: May enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

Doxylamine: CNS Depressants may enhance the CNS depressant effect of Doxylamine. Risk C: Monitor therapy

DroPERidol: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of DroPERidol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

DroPERidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of DroPERidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Eluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline. Risk X: Avoid combination

Encorafenib: RisperiDONE may enhance the QTc-prolonging effect of Encorafenib. Encorafenib may decrease the serum concentration of RisperiDONE. Management: Careful monitoring for reduced risperidone efficacy and possible dose adjustment are recommended when combined with encorafenib. Additionally, monitor for increased QTc interval prolongation and arrhythmias. See full interaction monograph for details. Risk D: Consider therapy modification

Erythromycin (Systemic): RisperiDONE may enhance the QTc-prolonging effect of Erythromycin (Systemic). Erythromycin (Systemic) may increase the serum concentration of RisperiDONE. Management: Monitor for increased risperidone toxicities, including QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Esketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Fexinidazole: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Fexinidazole. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Flunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine. Risk X: Avoid combination

Flunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam. Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modification

Fluorouracil Products: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Fluorouracil Products. Management: Monitor for QTc interval prolongation and ventricular arrhythmias, including torsades de pointes when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Flupentixol: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Flupentixol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Flupentixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Flupentixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

FluPHENAZine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of FluPHENAZine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Galantamine: May enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

Gastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic). Risk C: Monitor therapy

Glucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased. Risk C: Monitor therapy

Glycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation). Risk X: Avoid combination

Glycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Guanethidine: Antipsychotic Agents may diminish the therapeutic effect of Guanethidine. Risk C: Monitor therapy

Haloperidol: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Haloperidol. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and serotonin syndrome/serotonin toxicity (SS/ST) or NMS when these agents are combined. Patients with additional risk factors for QTc prolongation or SS/ST may be at even higher risk. Risk C: Monitor therapy

Haloperidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Haloperidol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Huperzine A: May enhance the neurotoxic (central) effect of Antipsychotic Agents. Risk C: Monitor therapy

HydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modification

Iloperidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iloperidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Imipramine: May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). QT-prolonging Antipsychotics (Moderate Risk) may enhance the serotonergic effect of Imipramine. This could result in serotonin syndrome. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and serotonin syndrome/serotonin toxicity (SS/ST) or NMS when these agents are combined. Patients with additional risk factors for QTc prolongation or SS/ST may be at even higher risk. Risk C: Monitor therapy

Iohexol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iohexol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iohexol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iomeprol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iomeprol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iomeprol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Iopamidol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Iopamidol. Specifically, the risk for seizures may be increased. Management: Discontinue agents that may lower the seizure threshold 48 hours prior to intrathecal use of iopamidol. Wait at least 24 hours after the procedure to resume such agents. In nonelective procedures, consider use of prophylactic antiseizure drugs. Risk D: Consider therapy modification

Ipratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Itopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride. Risk C: Monitor therapy

Ixabepilone: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Kratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Lemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modification

Levoketoconazole: QT-prolonging Agents (Moderate Risk) may enhance the QTc-prolonging effect of Levoketoconazole. Risk X: Avoid combination

Levosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride. Risk X: Avoid combination

Lithium: May enhance the neurotoxic effect of Antipsychotic Agents. Lithium may decrease the serum concentration of Antipsychotic Agents. Specifically noted with chlorpromazine. Risk C: Monitor therapy

Loop Diuretics: May enhance the adverse/toxic effect of RisperiDONE. Risk C: Monitor therapy

Loxapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Loxapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Lumateperone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lumateperone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Lurasidone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Lurasidone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Magnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mequitazine: Antipsychotic Agents may enhance the arrhythmogenic effect of Mequitazine. Management: Consider alternatives to one of these agents when possible. While this combination is not specifically contraindicated, mequitazine labeling describes this combination as discouraged. Risk D: Consider therapy modification

Methotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants. Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modification

Metoclopramide: May enhance the adverse/toxic effect of Antipsychotic Agents. Risk X: Avoid combination

MetyroSINE: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for extrapyramidal symptoms and excessive sedation may be increased. Risk C: Monitor therapy

Mianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapy

Minocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Mirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron. Risk C: Monitor therapy

Molindone: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Molindone. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Nabilone: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Nitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption. Risk C: Monitor therapy

OLANZapine: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of OLANZapine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

OLANZapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of OLANZapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Olopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Ondansetron: May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation, ventricular arrhythmias, including torsades de pointes, when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Opioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists. Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Orphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine. Risk X: Avoid combination

Oxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Oxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combination

Oxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products. Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modification

OxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE. Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modification

Paliperidone: RisperiDONE may enhance the adverse/toxic effect of Paliperidone. Management: Additive paliperidone exposure is expected with this combination. Consider using an alternative combination when possible. Risk D: Consider therapy modification

Paraldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde. Risk X: Avoid combination

Peginterferon Alfa-2b: May decrease the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Peginterferon Alfa-2b may increase the serum concentration of CYP2D6 Substrates (High risk with Inhibitors). Risk C: Monitor therapy

Pentamidine (Systemic): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Perampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Periciazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Periciazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Perphenazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Perphenazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

P-glycoprotein/ABCB1 Inhibitors: May increase the serum concentration of RisperiDONE. Risk C: Monitor therapy

Pimozide: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Pipamperone [INT]: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Pipamperone [INT]. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Piribedil: Antipsychotic Agents may diminish the therapeutic effect of Piribedil. Piribedil may diminish the therapeutic effect of Antipsychotic Agents. Management: Use of piribedil with antiemetic neuroleptics is contraindicated, and use with antipsychotic neuroleptics, except for clozapine, is not recommended. Risk X: Avoid combination

Polyethylene Glycol-Electrolyte Solution: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Polyethylene Glycol-Electrolyte Solution. Specifically, the risk of seizure may be increased. Risk C: Monitor therapy

Potassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combination

Potassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate. Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium citrate. Risk X: Avoid combination

Pramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combination

Procarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Prochlorperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Prochlorperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Promazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Promazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Propafenone: May enhance the QTc-prolonging effect of RisperiDONE. Propafenone may increase the serum concentration of RisperiDONE. Management: Monitor for increased risperidone toxicities, including QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Propofol: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Propofol. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): May enhance the CNS depressant effect of RisperiDONE. QT-prolonging Agents (Highest Risk) may enhance the QTc-prolonging effect of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for QTc interval prolongation and ventricular arrhythmias. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk D: Consider therapy modification

QT-prolonging Antidepressants (Moderate Risk): QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of QT-prolonging Antidepressants (Moderate Risk). QT-prolonging Antipsychotics (Moderate Risk) may enhance the serotonergic effect of QT-prolonging Antidepressants (Moderate Risk). This could result in serotonin syndrome. Management: Monitor for QTc interval prolongation, ventricular arrhythmias, and serotonin syndrome/serotonin toxicity (SS/ST) or NMS when these agents are combined. Patients with additional risk factors for QTc prolongation or SS/ST may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Antipsychotics (Moderate Risk): May enhance the QTc-prolonging effect of RisperiDONE. QT-prolonging Antipsychotics (Moderate Risk) may increase the serum concentration of RisperiDONE. Specifically, thioridazine may increase concentrations of risperidone. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Class IC Antiarrhythmics (Moderate Risk): RisperiDONE may enhance the QTc-prolonging effect of QT-prolonging Class IC Antiarrhythmics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-Prolonging Inhalational Anesthetics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Kinase Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Miscellaneous Agents (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Moderate CYP3A4 Inhibitors (Moderate Risk): May enhance the QTc-prolonging effect of RisperiDONE. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QT-prolonging Quinolone Antibiotics (Moderate Risk): May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QUEtiapine: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of QUEtiapine. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

QUEtiapine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of QUEtiapine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Quinagolide: Antipsychotic Agents may diminish the therapeutic effect of Quinagolide. Risk C: Monitor therapy

QuiNIDine: May enhance the QTc-prolonging effect of RisperiDONE. QuiNIDine may increase the serum concentration of RisperiDONE. Management: Consider alternatives to this drug combination. If combined, monitor for risperidone toxicities, including QTc interval prolongation and TdP. Risperidone dose adjustment may also be needed. See full monograph for details. Risk D: Consider therapy modification

Quinidine (Non-Therapeutic): May enhance the QTc-prolonging effect of QT-prolonging CYP2D6 Substrates. Quinidine (Non-Therapeutic) may increase the serum concentration of QT-prolonging CYP2D6 Substrates. Risk X: Avoid combination

Ramosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron. Risk C: Monitor therapy

Revefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin. Risk X: Avoid combination

Rivastigmine: Anticholinergic Agents may diminish the therapeutic effect of Rivastigmine. Rivastigmine may diminish the therapeutic effect of Anticholinergic Agents. Management: Use of rivastigmine with an anticholinergic agent is not recommended unless clinically necessary. If the combination is necessary, monitor for reduced anticholinergic effects. Risk D: Consider therapy modification

Ropeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased. Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modification

Rufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapy

Saquinavir: QT-prolonging Antipsychotics (Moderate Risk) may enhance the QTc-prolonging effect of Saquinavir. Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Secretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin. Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modification

Serotonergic Agents (High Risk): May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, serotonergic agents may enhance dopamine blockade, possibly increasing the risk for neuroleptic malignant syndrome. Antipsychotic Agents may enhance the serotonergic effect of Serotonergic Agents (High Risk). This could result in serotonin syndrome. Risk C: Monitor therapy

Sertindole: May enhance the QTc-prolonging effect of QT-prolonging Agents (Moderate Risk). Risk X: Avoid combination

Sodium Phosphates: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Sodium Phosphates. Specifically, the risk of seizure or loss of consciousness may be increased in patients with significant sodium phosphate-induced fluid or electrolyte abnormalities. Risk C: Monitor therapy

Sulpiride: Antipsychotic Agents may enhance the adverse/toxic effect of Sulpiride. Risk X: Avoid combination

Suvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant. Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary. Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modification

Tetrabenazine: May enhance the adverse/toxic effect of Antipsychotic Agents. Specifically, the risk for NMS and extrapyramidal symptoms may be increased. Risk C: Monitor therapy

Thalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide. Risk X: Avoid combination

Thiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics. Risk C: Monitor therapy

Thioridazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thioridazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Thiothixene: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Thiothixene. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Tiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium. Risk X: Avoid combination

Trifluoperazine: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Trifluoperazine. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Trimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Triptorelin: Hyperprolactinemic Agents may diminish the therapeutic effect of Triptorelin. Risk X: Avoid combination

Umeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combination

Valerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapy

Valproate Products: May enhance the adverse/toxic effect of RisperiDONE. Generalized edema has developed. Risk C: Monitor therapy

Vemurafenib: RisperiDONE may enhance the QTc-prolonging effect of Vemurafenib. Vemurafenib may increase the serum concentration of RisperiDONE. Management: Monitor for increased risperidone toxicities, including QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Voriconazole: May enhance the QTc-prolonging effect of QT-prolonging Antipsychotics (Moderate Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor therapy

Zolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem. Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg for men who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modification

Zuclopenthixol: Agents With Seizure Threshold Lowering Potential may enhance the adverse/toxic effect of Zuclopenthixol. Specifically, the risk of seizures may be increased. Risk C: Monitor therapy

Zuranolone: May enhance the CNS depressant effect of CNS Depressants. Management: Consider alternatives to the use of zuranolone with other CNS depressants or alcohol. If combined, consider a zuranolone dose reduction and monitor patients closely for increased CNS depressant effects. Risk D: Consider therapy modification

Food Interactions

Oral solution is not compatible with beverages containing tannin or pectinate (cola or tea). Management: Administer oral solution with water, coffee, orange juice, or low-fat milk.

Reproductive Considerations

Risperidone may cause hyperprolactinemia, which may cause a reversible decrease in reproductive function in females.

If treatment with an atypical antipsychotic is needed in a woman planning a pregnancy, use of an agent other than risperidone is preferred (Larsen 2015). When using the IM injection, patients should notify health care provider if they intend to become pregnant during therapy or within 12 weeks of last injection.

Pregnancy Considerations

Risperidone and its metabolite cross the placenta (Newport 2007). Agenesis of the corpus callosum has been noted in one case report of an infant exposed to risperidone in utero; relationship to risperidone exposure is not known. Antipsychotic use during the third trimester of pregnancy has a risk for extrapyramidal symptoms (EPS) and/or withdrawal symptoms in newborns following delivery. Symptoms in the newborn may include agitation, feeding disorder, hypertonia, hypotonia, respiratory distress, somnolence, and tremor. These effects may be self-limiting and allow recovery within hours or days with no specific treatment, or they may be severe requiring prolonged hospitalization.

When using the IM injection, patients should notify health care provider if they become pregnant during therapy or within 12 weeks of last injection.

The ACOG recommends that therapy during pregnancy be individualized; treatment with psychiatric medications during pregnancy should incorporate the clinical expertise of the mental health clinician, obstetrician, primary health care provider, and pediatrician. Safety data related to atypical antipsychotics during pregnancy is limited. As a result, routine use is not recommended. However, if a woman is inadvertently exposed to an atypical antipsychotic while pregnant, continuing therapy may be preferable to switching to an agent that the fetus has not yet been exposed to; consider risk:benefit (ACOG 2008). If treatment is initiated during pregnancy, use of an agent other than risperidone is preferred (Larsen 2015).

Health care providers are encouraged to enroll women 18 to 45 years of age exposed to risperidone during pregnancy in the Atypical Antipsychotics Pregnancy Registry (1-866-961-2388 or http://womensmentalhealth.org/research/pregnancyregistry/).

Breastfeeding Considerations

Risperidone and its active metabolite, 9-hydroxyrisperidone, are present in breast milk.

The relative infant dose (RID) of risperidone is 1.5% and the RID of 9-hydroxyrisperidone is 5.5% when calculated using the highest breast milk concentration located and compared to a weight-adjusted maternal dose of 2 mg/day. Per the manufacturer, the RID for risperidone and the metabolite range between 2.3% and 4.7% of the weight-adjusted maternal dose.

In general, breastfeeding is considered acceptable when the RID of a medication is <10% (Anderson 2016; Ito 2000). However, some sources note breastfeeding should only be considered if the RID is <5% for psychotropic agents (Larsen 2015).

The RID of risperidone was calculated using a milk concentration of 3 ng/mL, providing an estimated daily infant dose via breast milk of 0.45 mcg/kg/day. The RID of 9-hydroxyrisperidone was calculated using a milk concentration of 11 ng/mL, providing an estimated daily infant dose via breast milk of 1.65 mcg/kg/day. These milk concentrations were obtained following maternal administration of oral risperidone 2 mg/day, with sampling occurring 3 hours after the maternal dose following 6 days of therapy; treatment started 1 week postpartum (Aichhorn 2005). Peak milk concentrations appear to be within 2 to 4 hours after an oral maternal dose (Aichhorn 2005; Hill 2000; Ilett 2004).

In general, infants exposed to second generation antipsychotics via breast milk should be monitored weekly for the first month of exposure for symptoms, such as appetite changes, insomnia, irritability, or lethargy (Uguz 2016). According to the manufacturer, the decision to breastfeed during therapy should consider the risk of infant exposure, the benefits of breastfeeding to the infant, and benefits of treatment to the mother. Based on available information, use of agents other than risperidone in breastfeeding women is preferred (Larsen 2015; Pacchiarotti 2016; Uguz 2016).

Dietary Considerations

Oral: May be taken without regard to meals. Dispersible tablets contain phenylalanine.

Monitoring Parameters

Frequency of Antipsychotic Monitoringa,b

Monitoring parameter

Frequency of monitoring

Comments

a For all monitoring parameters, it is appropriate for check at baseline and when clinically relevant (based on symptoms or suspected adverse reactions) in addition to the timeline.

b ADA 2004; APA [Keepers 2020]; De Hert 2011; Gugger 2011; manufacturer's labeling.

c Risk factors for extrapyramidal symptoms (EPS) include prior history of EPS, high doses of antipsychotics, young age (children and adolescents at higher risk than adults), and dopaminergic affinity of individual antipsychotic.

d Risk factors for tardive dyskinesia include age >55 years; females; White or African ethnicity; presence of a mood disorder, intellectual disability, or CNS injury; and past or current EPS.

Adherence

Every visit

Blood chemistries (electrolytes, renal function, liver function, TSH)

Annually

CBC

As clinically indicated

Check frequently during the first few months of therapy in patients with preexisting low WBC or history of drug-induced leukopenia/neutropenia

Extrapyramidal symptoms

Every visit; 4 weeks after initiation and dose change; annually. Use a formalized rating scale at least annually or every 6 months if high risk.c

Fall risk

Every visit

Fasting plasma glucose/HbA1c

12 weeks after initiation and dose change; annually

Check more frequently than annually if abnormal. Follow diabetes guidelines.

Lipid panel

12 weeks after initiation and dose change; annually

Check more frequently than annually if abnormal. Follow lipid guidelines.

Mental status and alertness

Every visit

Metabolic syndrome history

Annually

Evaluate for personal and family history of obesity, diabetes, dyslipidemia, hypertension, or cardiovascular disease

Prolactin

Ask about symptoms at every visit until dose is stable. Check prolactin level if symptoms are reported.

Hyperprolactinemia symptoms: Changes in menstruation, libido, gynecomastia, development of galactorrhea, and erectile and ejaculatory function

Tardive dyskinesia

Every visit; annually. Use a formalized rating scale at least annually or every 6 months if high risk.d

Vital signs (BP, orthostatics, temperature, pulse, signs of infection)

Every visit (at least weekly during first 3 to 4 weeks of treatment); 4 weeks after dose change.

Weight/Height/BMI

8 and 12 weeks after initiation and dose change; quarterly

Consider monitoring waist circumference at baseline and annually, especially in patients with or at risk for metabolic syndrome.

Consider changing antipsychotic if BMI increases by ≥1 unit.

Some experts recommend checking weight and height at every visit.

Reference Range

Risperidone plus 9-hydroxy-risperidone:

Timing of serum samples: Draw trough just before next dose (Hiemke 2018).

Therapeutic reference range: 20 to 60 ng/mL (SI: 48.8 to 146.4 nmol/L) (Hiemke 2018). Note: Dosing should be based on therapeutic response as opposed to serum concentrations; however, therapeutic drug monitoring can be used to confirm adherence (APA [Keepers 2020]).

Laboratory alert level: 120 ng/mL (SI: 292.8 nmol/L) (Hiemke 2018).

Mechanism of Action

Risperidone is a benzisoxazole atypical antipsychotic with high 5-HT2 and dopamine-D2 receptor antagonist activity. Alpha1, alpha2 adrenergic, and histaminergic receptors are also antagonized with high affinity. Risperidone has low to moderate affinity for 5-HT1C, 5-HT1D, and 5-HT1A receptors, weak affinity for D1 and no affinity for muscarinics or beta1 and beta2 receptors.

Pharmacokinetics (Adult Data Unless Noted)

Note: Following oral administration, the pharmacokinetics of risperidone and 9-hydroxyrisperidone in children were found to be similar to values in adults (after adjusting for differences in body weight).

Onset of action:

Agitation: Orally disintegrating tablet: Median time to calm: 70 minutes (Normann 2006).

Bipolar disorder, acute mania: Oral: Initial effects may be observed within days of treatment with continued improvements over 1 to 2 weeks (Goikolea 2013; Tohen 2000; Welten 2016).

Major depressive disorder, unipolar: Oral: Initial effects may be observed within 1 week with continued improvements over 6 to 12 weeks (Wen 2014).

Schizophrenia: Oral: Initial effects may be observed within 1 to 2 weeks of treatment with continued improvements through 4 to 6 weeks (Agid 2003; Levine 2010).

Absorption:

Oral: Rapid and well absorbed; food does not affect rate or extent.

IM: <1% absorbed initially; main release occurs at ~3 weeks and is maintained from 4 to 6 weeks; release ends by 7 weeks.

SUBQ:

Monthly injection (Perseris): Two absorption peaks; first release occurs immediately after injection and second release occurs around 10 to 14 days; therapeutic levels maintained for 4 weeks after injection.

Monthly or every-2-months injection (Uzedy): Two absorption peaks, one resulting in therapeutic concentrations within 6 to 24 hours, followed by a second peak around 8 to 14 days; therapeutic levels maintained for 28 or 56 days after injection, depending on dose (Perlstein 2022; manufacturer’s labeling).

Distribution: Vd: 1 to 2 L/kg

Protein binding, plasma: Risperidone 90%; 9-hydroxyrisperidone: 77%; Note: Risperidone free fraction may be increased by ~35% in patients with hepatic impairment due to decreased concentrations of albumin and alpha-1 acid glycoprotein.

Metabolism: Extensively hepatic via CYP2D6 to 9-hydroxyrisperidone (similar pharmacological activity as risperidone); N-dealkylation is a second minor pathway; Note: 9-hydroxyrisperidone is the predominant circulating form and is approximately equal to risperidone in receptor binding activity; clinical effects are from combined concentrations of risperidone and 9-hydroxyrisperidone; clinically important differences between CYP2D6 poor and extensive metabolizers are not expected (pharmacokinetics of the sum of risperidone and 9-hydroxyrisperidone were similar in poor and extensive metabolizers).

Bioavailability:

Oral: 70%; Tablet (relative to solution): 94%; orally-disintegrating tablets and oral solution are bioequivalent to tablets.

IM: Deltoid IM injection is bioequivalent to gluteal IM injection.

Half-life elimination:

Active moiety (risperidone and its active metabolite 9-hydroxyrisperidone):

Oral: 20 hours (mean); prolonged in elderly patients.

Extensive metabolizers: Risperidone: 3 hours; 9-hydroxyrisperidone: 21 hours.

Poor metabolizers: Risperidone: 20 hours; 9-hydroxyrisperidone: 30 hours.

IM: 3 to 6 days; related to microsphere erosion and subsequent absorption of risperidone.

Risperidone: SUBQ:

Monthly injection (Perseris): 9 to 11 days.

Monthly or every-2-months injection (Uzedy): 14 to 22 days.

Time to peak, plasma:

Oral: Risperidone: Within 1 hour; 9-hydroxyrisperidone: Extensive metabolizers: 3 hours; Poor metabolizers: 17 hours.

SUBQ:

Monthly injection (Perseris): Risperidone: First peak: 4 to 6 hours; Second peak: 10 to 14 days.

Monthly or every-2-months injection (Uzedy): Risperidone and 9-hydroxyrisperidone: First peak: Results in therapeutic concentrations within 6 to 24 hours; Second peak: 8 to 14 days.

Excretion: Urine (70%; primarily as active metabolite); feces (14%) (Mannens 1993).

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: CrCl 10 to 60 mL/minute: Clearance of parent drug and active metabolite decreased ~60%.

Hepatic function impairment: Mean free fraction of risperidone in plasma increased approximately 35%.

Older adult: Oral: Renal clearance of parent drug and active metabolite was decreased.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Risperdal | Risperdal consta | Rispitab;
  • (AR) Argentina: Altexina | Dozic | Dropicine | Dropicine flash | Restelea | Riatul | Risperdal | Risperdal consta | Risperidona dosa | Risperidona fabra | Risperin | Rispex | Roxodyn | Sequinan | Seroxina;
  • (AT) Austria: Aleptan | Okedi | Risperdal | Risperdal consta | Risperidon | Risperidon +Pharma | Risperidon 1A Pharma | Risperidon actavis | Risperidon Alternova | Risperidon genericon | Risperidon hexal | Risperidon Pfizer | Risperidon ratiopharm | Risperidon sandoz | Risperidon stada | Risperidone Ratiopharm;
  • (AU) Australia: Apo risperidone | Noumed risperidone | Ozidal | Resdone | Rispa | Risperdal | Risperidone actavis | Risperidone an | Risperidone Generic Health | Risperidone generichealth | Risperidone pfizer | Risperidone sandoz | Risperidone-GA | Rispernia | Rixadone;
  • (BD) Bangladesh: Frenia | Resco | Riscord | Risdon | Rispa | Risperdal consta | Risperdex | Rispolux | Sizodon;
  • (BE) Belgium: Risperdal | Risperidone accord | Risperidone eg | Risperidone Ratiopharm | Risperidone sandoz | Risperidone teva | Risperimylan | Risperiphar | Rispimedica;
  • (BG) Bulgaria: Medorisper | Neorisp | Resperon | Risperdal | Rispolept | Rispolept consta | Rispolux | Rissar | Ronydal | Speridan | Torendo | Torendo q;
  • (BR) Brazil: Esquidon | Perlid | Respidon | Ripevil | Risleptic | Rispalum | Risperdal | Risperidon | Risperidona | Risperix | Riss | Viverdal | Zargus;
  • (CH) Switzerland: Risperdal | Risperdal consta | Risperidon actavis | Risperidon Helvepharm | Risperidon Mepha | Risperidon sandoz | Risperidon Spirig | Risperidon Streuli | Risperidon teva | Risperidon zentiva;
  • (CI) Côte d'Ivoire: Respal;
  • (CL) Chile: Dagotil | Goval | Radigen | Rimox | Risperdal | Spiron ft;
  • (CN) China: Chan ke | Jing ping | Ke tong | Risperdal | Risperdal consta | Suo le | Wei si tong | Zhuo fei | Zhuo fu;
  • (CO) Colombia: Isperin | Peridon | Risdona | Risnia | Risofren | Risperdal | Risperdal consta | Risperidona | Risperidona mk | Risperimed | Rispolux | Sicopidol | Spiron | Tractal | Uni senidrin | Zyrisp;
  • (CZ) Czech Republic: Apo Risper | Medorisper | Rileptid | Risepro | Rispen | Rispera | Risperdal | Risperdal consta | Risperidon farmax | Risperidon orion | Risperidon ratiopharm | Risperidon Vipharm | Rispolux | Risset | Rorendo;
  • (DE) Germany: Belivon | Okedi | Rehablit | Risocon | Rispe Q | Rispecare | Risperdal | Risperdal consta | Risperdoc | Risperid Heumann | Risperidon | Risperidon 1 A Pharma | Risperidon AAA | Risperidon Accord | Risperidon Acis | Risperidon actavis | Risperidon AL | Risperidon Aristo | Risperidon Atid | Risperidon aurobindo | Risperidon Aurus | Risperidon basics | Risperidon Beta | Risperidon Biomo | Risperidon CT | Risperidon devatis | Risperidon Esparma | Risperidon Hennig | Risperidon Heumann | Risperidon hexal | Risperidon Hormosan | Risperidon kohne pharma | Risperidon mylan | Risperidon Neuraxpharm | Risperidon Pfizer | Risperidon puren | Risperidon ratiopharm | Risperidon Real | Risperidon sandoz | Risperidon stada | Risperidon teva | Risperidon Volkspharma | Risperidon Winthrop | Risperidone Biomo | Risperigamma | Rispolept | Rispolept consta;
  • (DK) Denmark: Risperanne;
  • (DO) Dominican Republic: Avanxe | Evolux | Goval | Peridona | Rempil | Ridona | Ripexil | Risdon | Risdoril | Risperdal | Risperdal consta | Risperidona | Risperidona mamey | Risperin | Uniridona | Xicoretic;
  • (EC) Ecuador: Goval | Risperdal | Risperdal consta | Risperidona | Risperoxial | Rispolux | Spiron;
  • (EE) Estonia: Medorisper | Rispen | Risperidone accord | Rispolept | Rispolept consta | Risset;
  • (EG) Egypt: Apexidone | Itorisperidone | Psychodal | Riscure | Risdal | Risidrone | Rispadex | Risperdal | Schizodal | Sigmadone | Zesperone;
  • (ES) Spain: Arketin | Calmapride | Diaforin | Okedi | Risperdal | Risperdal consta | Risperdal flas | Risperidona Actavis | Risperidona alter | Risperidona Aphar | Risperidona apotex | Risperidona aristo | Risperidona Asol | Risperidona Aurobindo | Risperidona aurovitas | Risperidona bayvit | Risperidona Bexal | Risperidona cinfa | Risperidona curaxys | Risperidona davur | Risperidona edigen | Risperidona farmalider | Risperidona kern pharma | Risperidona krka | Risperidona Mabo | Risperidona Mylan | Risperidona mylan pharmaceuticals | Risperidona Normon | Risperidona Pharmacia | Risperidona Qualigen | Risperidona ranbaxy | Risperidona Ratiopharm | Risperidona Sandoz | Risperidona Stada | Risperidona Sumol | Risperidona tarbis | Risperidona Tecnigen | Risperidona teva | Risperidona tevagen | Risperidona ur | Risperidona winthrop;
  • (ET) Ethiopia: Risdone | Rispharm | Rispons;
  • (FI) Finland: Rismyl | Rispazin | Risperdal | Risperdal consta | Risperidon actavis | Risperidon bmm pharma | Risperidon hexal | Risperidon krka | Risperidon orion | Risperidon Pfizer | Risperidon ratiopharm | Risperidon sandoz | Risperidon teva | Risperidone Stada;
  • (FR) France: Risperdal | Risperdalconsta lp | Risperdaloro | Risperidone actavis | Risperidone Almus | Risperidone alter | Risperidone Arrow | Risperidone biogaran | Risperidone cristers | Risperidone eg | Risperidone evolugen | Risperidone Mylan | Risperidone Panpharma | Risperidone Qualimed | Risperidone Qualimed Generiques | Risperidone Ranbaxy | Risperidone Ratiopharm | Risperidone sandoz | Risperidone teva | Risperidone Wyvern medical | Risperidone Zydus;
  • (GB) United Kingdom: Okedi | Risperdal | Risperdal consta | Risperidone Kent | Risperidone sandoz;
  • (GR) Greece: Adovia | Axelabron | Belasperdal S | Capulton | Depolan | Deteron | Dixine | Helposper | Isipredon | Lassen | Linipon | Lucipral | Natibo | Novoris | Orotral | Psychordal | Ribex | Ridoron | Rifocus | Ripepral | Risenar | Risgal | Risidral | Rispalm | Rispefar | Rispelen | Rispen | Risperascol | Risperdal | Risperdal consta | Risperidone/generics | Risperidone/Teva | Risperom | Risperoprol | Rispersan | Rubrum | Sperelax | Wisperdon | Zafitral;
  • (HK) Hong Kong: Apo risperidone | Pms risperidone | Rison | Risperdal | Risperdal consta;
  • (HR) Croatia: Prospera | Risdonal | Risnia | Rispen | Risperidon Pliva | Rispolept | Rispolept consta | Rispolux | Risset;
  • (HU) Hungary: Hunperdal | Perdox | Rileptid | Ripedon | Rispe | Risperdal | Risperdal consta | Risperidon orion | Risperidon ratiopharm | Risperidone teva | Risperwin | Rosipin | Ziperid;
  • (ID) Indonesia: Neripros | Nodiril | Noprenia | Persidal | Risperdal | Risperdal consta | Rizodal | Zofredal;
  • (IE) Ireland: Perdamel | Rispal | Risperdal | Risperdal consta | Risperger | Rispeva | Rispone | Sperizak;
  • (IL) Israel: Risperdal | Risperdal consta | Risperidex | Rispond;
  • (IN) India: Alrison | Don | Eauris | Genrest | Halodone | Peridon | Psydon | Psyorid | Regrace | Repadone | Respidon | Respimed | Resque | Restek | Restonorm | Ridon | Rinext | Rion | Ris | Riscalm | Riscon | Riscure | Risdone | Risgold md | Risnia | Risp | Risperdal | Rispid | Rispond | Ristab | Riswel | Rozidal | Rpdone | Rythem | Sizodon | Sizodon md | Sizomax | Sycodone | Zepid | Zisper;
  • (IQ) Iraq: Ripredon | Risperodel | Rispersaf;
  • (IT) Italy: Risperdal | Risperidone actavis | Risperidone AHCL | Risperidone alter | Risperidone Arrow | Risperidone aurobindo | Risperidone dr reddy's | Risperidone Mylan | Risperidone Ranbaxy | Risperidone Ratiopharm;
  • (JO) Jordan: Raxidone | Respal | Respirox | Ribex | Risdone | Risperdal | Risperdal consta | Rispharm;
  • (JP) Japan: Risperdal | Risperidone Amel | Risperidone kunihiro | Risperidone meek | Risperidone sawai | Risperidone Towa;
  • (KE) Kenya: Masrone | Respidon | Risdone | Risna | Risobon | Risperdal | Rispons | Sizodon;
  • (KR) Korea, Republic of: I peridone | Iperidone | Myungmoon risperidone | New ripedone | Pms risperidone | Riopedone | Ripedine | Ripedone | Riperidon | Riperil | Risdal | Risdon | Risdone | Risoperin | Rispedone | Rispeldon | Rispen | Risperdal | Risperdal consta | Risperin | Rispidon | Rispodon | Rispri | Samsung risperidone | Spendalin | Uniperidone | Weridone;
  • (KW) Kuwait: Ribex | Ridon | Risdone | Risperdal | Risperdal consta | Rispons;
  • (LB) Lebanon: Depia | Lucipral | Pms risperidone | Raxidone | Razvan | Respirox | Rischotic | Rispefar | Risperdal | Risperdal consta | Risperidone biogaran;
  • (LT) Lithuania: Aleptolan | Medorisper | Rileptid | Rispaxol | Rispen | Risperdal | Risperidone teva | Rispolept | Rispolept consta | Risset | Torendo q;
  • (LU) Luxembourg: Risperdal | Risperidon mylan | Risperidone eg | Risperidone jc | Risperidone Ratiopharm | Risperidone sandoz;
  • (LV) Latvia: Aleptolan | Medorisper | Risperdal | Risperidone accord | Risperidone teva | Rispolept | Rispolept consta;
  • (MA) Morocco: Isperid | Prisdal | Risperdal | Risperidone gt;
  • (MX) Mexico: Kronoax | Limbik | Lost Per | Norispez | Reskizof | Risotor | Risperdal | Risperdal consta | Risperdal quicklet | Risperidona | Rispolux | Silderec | Tipedsina | Upmotev | Zenodone | Zesperone;
  • (MY) Malaysia: Apo risperidone | Intasrisdone | Resicalm | Respidon | Risperdal | Risperdal consta | Risperone | Rozidal | Zesperone MD;
  • (NG) Nigeria: Milton risperidone | Milzocate | Risdal | Risper | Risperidone sandoz;
  • (NL) Netherlands: Okedi | Risperdal | Risperdon | Risperidon | Risperidon Accord | Risperidon sandoz | Risperidon teva;
  • (NO) Norway: Risperdal | Risperdal consta | Risperidon | Risperidon actavis | Risperidon krka | Risperidon sandoz | Risperidon stada | Rispolept consta;
  • (NZ) New Zealand: Apo risperidone | Drreddys risperidone | Noumed risperidone | Ridal | Risperdal | Risperidone actavis | Risperidone dr reddy | Risperon;
  • (PE) Peru: Denoral | Risperdal | Risperidona | Risperite | Rozidal | Sizodon | Zeclonex;
  • (PH) Philippines: Aspidon | Renuvie | Reone | Residon | Respixl | Ridonex | Rileptid | Riscare | Risdin | Risdin ODT | Risdoplus | Risgen | Rispedin | Rispen | Risperdal | Risperdal consta | Risperidone consta | Rispolux | Rispond | Risponz | Ritemed risperidone | Sizodon | Steviso | Zysda;
  • (PK) Pakistan: Apprid | Arsodon | Bedone | Benzisox | Biodin | Bioris | Bris | Buzon | Devidone | Donresp | Espidone | Fleelax | Isrip | Lirc | Mozart | Mytodone | Neo risp | Neoris | Novril | Oridone | Oris | Peridal | Persch | Persept | Primed | Psyper | Raze | Recept | Remet | Resigrin | Resimon | Resjun 1 | Resjun 2 | Resperose | Respimed | Respivant | Reves | Revoc | Rezcalm | Ridal | Riscalm | Riscare | Risdopa | Risha | Rislet | Risp | Risperdal | Risperiscot | Rispinol | Rispolet | Risricot | Riss | Riswrd | Risynth | Sai rest | Sperid | Sycocar | Sycon | Sycorest | Vepridone | Wake up | Wenoris | Wizen | Zargus | Zedone;
  • (PL) Poland: Apo Risperid | Doresol | Galperinon | Lioxam | Mepharis | Nodir | Orizon | Ranperidon | Rileptid | Rispen | Risperatio | Risperdal | Risperdal consta | Risperidon Vipharm | Risperidone Bmm Pharma | Risperidone farmax | Risperiwin | Risperon | Rispofren | Rispolept | Rispolux | Risset | Ryspolit | Speridan | Torendo q | Ziperid;
  • (PR) Puerto Rico: Perseris | Risperdal | Risperdal consta;
  • (PT) Portugal: Azirosama | Doprifane | Okedi | Perdin | Risperdal | Risperdal consta | Risperidona accord | Risperidona Aurobindo | Risperidona Baldacci | Risperidona ciclum | Risperidona Decafarma | Risperidona Dhira | Risperidona generis | Risperidona Germed | Risperidona Ratiopharm | Risperidona Sandoz | Risperidona wynn | Risperidone Mylan;
  • (PY) Paraguay: Levo prom | Risperdal | Risperidona whelp | Risperix | Rsp;
  • (QA) Qatar: Raxidone | Respal | Ridon | Risperdal | Risperdal Consta | Rispons;
  • (RO) Romania: Essens | Essens OD | Rison | Risperidone teva | Rispolept consta | Rispolux | Torendo | Xenoma;
  • (RU) Russian Federation: Leptinorm | Rezalen | Ridonex | Rilept | Risdonal | Rispaksole | Rispaxol | Rispen | Risperidone krka | Risperidone Organika | Risperidone tl | Rispolept | Rispolept consta | Rispolept quicklet | Rispolux | Risset | Torendo | Torendo q | Torendo q tab;
  • (SA) Saudi Arabia: Apo risperidone | Calmtrol | Pms risperidone | Respal | Ridon | Risidone | Risperdal | Risperdal consta | Rispitab | Saxid;
  • (SE) Sweden: Abriact | Rispemyl | Risperdal | Risperdal consta | Risperidon | Risperidon abacus medicine | Risperidon actavis | Risperidon arrow | Risperidon bluefish | Risperidon bmm pharma | Risperidon copyfarm | Risperidon ebb | Risperidon krka | Risperidon medartuum | Risperidon mylan | Risperidon orifarm | Risperidon orion | Risperidon ratiopharm | Risperidon sandoz | Risperidon stada | Risperidon teva | Risperidone teva gmbh | Rispolept consta;
  • (SG) Singapore: Apo risperidone | Eperon | Ridkline | Risperdal | Risperdal consta | Risperidex;
  • (SI) Slovenia: Risperdal | Risperdal consta | Risperidon Alkaloid | Risperidon teva | Rispolux | Rispons | Risset | Torendo;
  • (SK) Slovakia: Medorisper | Rispen | Risperdal | Risperdal consta | Risperidon | Risperidon +Pharma | Risperidon farmax | Risperidon orion | Risperidon sandoz | Risperidon teva | Rispolux | Risset | Torendo;
  • (TH) Thailand: Neuris | Risdal | Rispel | Risperdal | Risperdal consta | Risperidone GPO;
  • (TN) Tunisia: Raxidone | Respirox | Risdone | Risperdal | Risperdalconsta lp | Risperidone teriak;
  • (TR) Turkey: Perilife | Restela | Ricus | Ripesil | Riplidon | Risperdal | Risperdal consta | Rixol | Rixper;
  • (TW) Taiwan: Anxilet | Apo risperidone | Blue Up | Perisdone | Respor | Riper | Risdal | Risdon | Risdone | Risperdal | Risperdal consta | Spiterin;
  • (UA) Ukraine: Eridon | Rispaxol | Rispen | Risperidon apo | Risperidon sandoz | Risperon | Rispetril | Rispolept | Rispolept quicklet | Rispon | Risset | Rosemide | Rosemide odt | Rostalept rota | Sizodon | Torendo;
  • (UG) Uganda: Respiwel | Risdone | Rispitas;
  • (UY) Uruguay: Goval | Narval 3 | Restelea | Risperdal | Risperidona | Risperix | Rsp;
  • (VE) Venezuela, Bolivarian Republic of: Ridal | Ripevil | Risperdal | Risperid | Risperidona | Rispolux;
  • (VN) Viet Nam: Agirisdon;
  • (ZA) South Africa: Aspen risperidone | Auroperdal | Auropidone | Drl Risperidone | Perida | Perizal | Risnia | Rispacor | Risperdal | Risperidone Hexal | Risperidone Mylan | Risperlet | Rispevon | Rispide | Risponz | Rutra | Schizorol | Zoxadon | Zoxadon odt;
  • (ZM) Zambia: Risdone;
  • (ZW) Zimbabwe: Risperdal
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