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Serious and common adverse effects of pharmacotherapeutic agents used for symptom management in children and adolescents with autism spectrum disorders

Serious and common adverse effects of pharmacotherapeutic agents used for symptom management in children and adolescents with autism spectrum disorders
Medication or medication class Rare serious adverse effects Other common side effects
Alpha-2-adrenergic agonists (eg, guanfacine, clonidine)
  • Cardiovascular effects (eg, bradycardia, hypotension)
  • Rebound hypertension if discontinued abruptly
  • Increased aggression and self-injury
  • Gastrointestinal – Abdominal pain, constipation, decreased appetite, dry mouth
  • Genitourinary – Nocturnal enuresis
  • Neurologic – Dizziness, fatigue, headache, irritability, sedation, sleep disturbances
Atomoxetine
  • Suicidal ideation*
  • Severe cardiovascular events, including sudden death
  • Severe psychiatric symptoms (eg, aggressive behavior, hostility, psychosis, mania, or hypomania)
  • Priapism
  • Hepatotoxicity
  • Cardiovascular – Elevated blood pressure, tachycardia
  • Gastrointestinal – Abdominal pain, decreased appetite, nausea, vomiting, dry mouth
  • Neurologic – Dizziness, drowsiness, fatigue, headache, insomnia, irritability
  • Other – Erectile dysfunction
Atypical antipsychoticsΔ (eg, risperidone, aripiprazole)
  • Cardiac conduction effects (eg, QTc prolongation)
  • Neuroleptic malignant syndrome
  • Tardive dyskinesia
  • Cardiovascular – Tachycardia
  • Endocrine and metabolic – Dyslipidemia, glucose abnormalities, increase in prolactin (may cause gynecomastia), weight gain
  • Gastrointestinal – Increased appetite
  • Neurologic – Dizziness, extrapyramidal symptoms (eg, akathisia, bradykinesia, dystonia, and tremor), fatigue, headache, sedation
  • Other – Drooling
Melatonin  
  • Generally well tolerated; possible adverse effects may include daytime sleepiness, difficulty waking, dizziness, headache, nocturnal enuresis
Selective serotonin reuptake inhibitors (eg, fluoxetine, fluvoxamine, sertraline, paroxetine)
  • Suicidal ideation*
  • Serotonin syndrome
  • Withdrawal syndrome
  • Activation of mania or hypomania in patients with bipolar disorder
  • QTc prolongation (dose-dependent and agent-specific)
  • Gastrointestinal – Abdominal pain, anorexia, diarrhea, nausea
  • Neurologic – Akathisia, behavioral activation (eg, agitation, disinhibition, impulsivity), anxiety, headache, irritability, sleep disturbance
  • Other – Sexual dysfunction and decreased libido
Stimulants (eg, methylphenidate, dexmethylphenidate, amphetamines)
  • Serious cardiovascular events, including sudden death
  • Lowering of seizure threshold◊
  • Priapism (with methylphenidate, dexmethylphenidate)
  • Growth suppression with long-term use
  • Severe psychiatric symptoms (eg, suicidality, hallucinations, increased aggression)
  • Serotonin syndrome (with amphetamines)
  • Gastrointestinal – Abdominal pain, decreased appetite, nausea, dry mouth
  • Neurologic – Emotional lability, dizziness, headache, insomnia/nightmares, irritability, tics
  • Other – Rebound (ie, symptoms that occur as the medication is wearing off), social withdrawal
This table lists examples of serious and common adverse effects of agents used to treat impairing behavioral concerns in children and adolescents with autism spectrum disorder. This is not a complete list of adverse effects, and adverse effect profiles may differ among medications within each class. Additional information can be found in related UpToDate clinical topic reviews and the drug monographs included within UpToDate.

QTc: corrected QT interval.

* Antidepressants and atomoxetine are associated with an increased risk of suicidal ideation in pediatric and young adult patients. Children and adolescents who are treated with these agents should be closely monitored by clinicians and families for suicidal thoughts and behaviors.

¶ Serious cardiac events occur primarily in patients with underlying structural cardiac defects; drugs with stimulatory effects on the sympathetic nervous system (eg, stimulants, atomoxetine) should generally be avoided in these patients.

Δ This table includes adverse effects common to many of the atypical (second-generation) antipsychotics. Severity of adverse effects varies among agents; some agents may cause other adverse effects. Refer to the clinical topic review of atypical antipsychotic use in pediatric patients for more details.

◊ Seizures occur primarily in patients with underlying seizure disorder.
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