Version July 2025
Hypoglycemia, hyperinsulinemic (eg, congenital hyperinsulinism [HI], perinatal stress-induced HI):
Note: Pulmonary hypertension has been observed in neonates while on diazoxide therapy; most frequently reported at doses ≥10 mg/kg/day; monitor neonates closely while on therapy; prior to initiation, all patients should have a thorough cardiac evaluation and consideration of baseline and periodic echocardiogram (Ref).
Preterm and term neonates: Oral: 3 to 15 mg/kg/day in divided doses every 8 to 12 hours; initiate at the low end of dose range to minimize adverse effects, especially in patients with underlying cardiac disease or if perinatal stress-induced HI is suspected. In patients with perinatal stress-induced HI, consider avoiding the use of diazoxide until after 7 to 10 days of life if euglycemia can be maintained by other means (Ref). Gradually titrate dose as needed to maintain serum glucose concentrations >70 mg/dL; use the lowest effective dose to minimize adverse effects; doses >15 mg/kg/day should be avoided (Ref). Due to the long half-life, it may take at least 5 days to assess dose response (Ref). The manufacturer recommends discontinuing if no effect is seen after 2 to 3 weeks. If transient HI is suspected, the dose of diazoxide may be reduced every 2 to 4 weeks if glucose levels are stable (>70 mg/dL) (Ref). Note: Strongly consider use in combination with a thiazide diuretic to minimize fluid retention (Ref).
Dosing: Altered Kidney Function: Neonatal: There are no dosage adjustments provided in the manufacturer's labeling. Half-life may be prolonged with renal impairment; a reduced dose may be necessary. Use with caution and monitor blood glucose and fluid status closely.
Hypoglycemia, hyperinsulinemic: Note: May be used in combination with a thiazide diuretic to minimize fluid retention (Ref). Pulmonary hypertension has been observed in infants while on diazoxide therapy; most frequently reported at doses ≥10 mg/kg/day; monitor closely while on therapy; consider baseline and periodic echocardiogram (Ref).
Infants: Oral: Initial: 5 to 10 mg/kg/day in divided doses every 8 to 12 hours; after 3 to 5 days, may titrate by 2.5 to 5 mg/kg/day as needed to maintain serum glucose concentrations; due to the long half-life, it may take at least 5 days to assess dose response; usual range: 5 to 15 mg/kg/day in divided doses every 8 to 12 hours (Ref).
Children and Adolescents: Oral: Initial: 5 mg/kg/day in divided doses every 8 to 12 hours; usual range: 3 to 15 mg/kg/day in divided doses every 8 to 12 hours (Ref).
All patients: Half-life may be prolonged with renal impairment; a reduced dose should be considered.
There are no dosage adjustments provided in the manufacturer's labeling.
(For additional information see "Diazoxide: Drug information")
Dosage guidance:
Clinical considerations: For use when other specific medical therapy or surgical management for hypoglycemia is unsuccessful or is not feasible.
Hypoglycemia, hyperinsulinemic: Oral: Initial: 3 mg/kg/day divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours; adjust dose until the desired clinical and laboratory effects are produced. Maximum dosage: 8 mg/kg/day. Note: Patients with refractory hypoglycemia may require higher doses. Discontinue if no effect after 2 to 3 weeks.
There are no dosage adjustments provided in the manufacturer's labeling; consider a dosage reduction (half-life may be prolonged).
There are no dosage adjustments provided in the manufacturer’s labeling.
The following adverse drug reactions are derived from product labeling unless otherwise specified.
Frequency not defined:
Cardiovascular: Hypertension (transient), hypotension, palpitations, tachycardia
Dermatologic: Cutaneous candidiasis, loss of scalp hair, pruritus, skin rash
Endocrine & metabolic: Albuminuria, diabetes mellitus with hyperosmolar coma (nonketotic), diabetic ketoacidosis, fluid retention, galactorrhea not associated with childbirth, hirsutism, hyperglycemia, increased uric acid, sodium retention
Gastrointestinal: Abdominal pain, acute pancreatitis, ageusia (transient), anorexia, diarrhea, intestinal obstruction, nausea, pancreatic necrosis, vomiting
Genitourinary: Azotemia, decreased urine output, glycosuria, hematuria, lump in breast (enlargement)
Hematologic & oncologic: Decreased hematocrit, decreased hemoglobin, decreased serum immunoglobulins (IgG), eosinophilia, hemorrhage (excessive), lymphadenopathy, neutropenia (transient)
Hepatic: Increased serum alkaline phosphatase, increased serum aspartate aminotransferase
Infection: Herpes virus infection
Nervous system: Anxiety, asthenia, dizziness, extrapyramidal reaction, headache, insomnia, malaise, paresthesia, peripheral neuritis (poly)
Neuromuscular & skeletal: Accelerated bone maturation, gout
Ophthalmic: Blurred vision, cataract (transient), diplopia, lacrimation, scotoma (ring), subconjunctival hemorrhage
Renal: Decreased creatinine clearance, nephrotic syndrome (reversible)
Miscellaneous: Fever
Postmarketing:
Cardiovascular: Chest pain, pericardial effusion (Avatapalle 2012)
Dermatologic: Hypertrichosis (Salido 2013)
Gastrointestinal: Necrotizing enterocolitis
Hematologic & oncologic: Hemolysis (Best 1975), immune thrombocytopenia (Thus 2019), thrombocytopenia (Adachi 2014)
Respiratory: Pulmonary hypertension (infants and neonates) (Ohnishi 2020)
Hypersensitivity to diazoxide, other thiazides, or any component of the formulation; functional hypoglycemia
Concerns related to adverse effects:
• Abnormal facial features: Development of abnormal facial features was reported in children treated >4 years for hypoglycemia hyperinsulinism.
• Hyperglycemic crises: Ketoacidosis or hyperosmolar coma may occur during treatment; usually in patients with concomitant illness; prompt recognition and treatment are essential.
Disease-related concerns:
• Heart failure: Use may lead to increased fluid retention due to antidiuretic properties and may precipitate heart failure in patients with compromised cardiac reserve.
• Gout: Use with caution in patients with hyperuricemia or a history of gout.
• Renal impairment: Use with caution in patients with renal impairment.
Special populations:
• Pediatric: May displace bilirubin from albumin; use caution in newborns with hyperbilirubinemia. Pulmonary hypertension has been reported in newborns and young infants and was reversible upon drug discontinuation; monitor patients (especially patients with risk factors for pulmonary hypertension) for respiratory distress and discontinue diazoxide if pulmonary hypertension is suspected.
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.
• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).
Pulmonary hypertension has been reported in newborns and infants receiving diazoxide for hypoglycemia; since the early 1970s, eleven cases have been reported either to the FDA or within the literature; in the majority of cases, the neonate/infant had other ongoing serious medical conditions and were at high risk for development of pulmonary hypertension; reported onset was within a day to a few months after diazoxide therapy initiation and in all cases, the pulmonary hypertension resolved or improved with discontinuation of the diazoxide. Pulmonary hypertension may be dose dependent; a review of published cases reported that circulatory effects were observed most frequently at doses ≥10 mg/kg/day. Monitor neonates and infants closely for signs of respiratory distress (tachypnea, flaring nostrils, grunting, chest wall retractions), cyanosis, or feeding intolerance, particularly those neonates and infants with risk factors for pulmonary hypertension (eg, meconium aspiration syndrome, respiratory distress syndrome, transient tachypnea of the newborn, pneumonia, sepsis, congenital diaphragmatic hernia, congenital heart disease); discontinue if pulmonary hypertension is identified (FDA 2015; Timlin 2017).
Transient cataracts have been reported in an infant in association with hyperosmolar coma; cataracts subsided following correction of hyperosmolarity. Abnormal facial features have been reported in 4 children who received diazoxide for >4 years for the treatment of hypoglycemia hyperinsulinism.
The oral suspension contains 7.25% alcohol. Some dosage forms may contain propylene glycol; in neonates large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Suspension, Oral:
Proglycem: 50 mg/mL (30 mL) [chocolate mint flavor]
Generic: 50 mg/mL (30 mL)
Yes
Suspension (Diazoxide Oral)
50 mg/mL (per mL): $12.38 - $12.40
Suspension (Proglycem Oral)
50 mg/mL (per mL): $19.46
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.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Capsule, Oral:
Proglycem: 100 mg
Oral: Shake suspension well before each use; suspension comes with calibrated dropper (to deliver dose of 10 to 50 mg, in 10 mg increments).
Shake suspension well before each use.
Capsules [Canadian product]: Store at 15°C to 30°C (59°F to 86°F).
Suspension: Store at 25°C (77°F); excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light. Store in carton until contents are used.
Management of hypoglycemia related to hyperinsulinism secondary to the following conditions: islet cell adenoma, adenomatosis, or hyperplasia; extrapancreatic malignancy; nesidioblastosis; leucine sensitivity (All indications: FDA approved in neonates, infants, and children).
Management of hypoglycemia related to hyperinsulinism secondary to the following conditions: inoperable islet cell adenoma or carcinoma; extrapancreatic malignancy (FDA approved in adults).
Diazoxide may be confused with diazePAM, Dyazide
None known.
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 drug interactions program by clicking on the “Launch drug interactions program” link above.
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 drug interactions program
Antidiabetic Agents: Hyperglycemia-Associated Agents may decrease therapeutic effects of Antidiabetic Agents. Risk C: Monitor
Blood Pressure Lowering Agents: Diazoxide may increase hypotensive effects of Blood Pressure Lowering Agents. Risk C: Monitor
Fosphenytoin-Phenytoin: Diazoxide may decrease serum concentration of Fosphenytoin-Phenytoin. Total phenytoin concentrations may be affected more than free phenytoin concentrations. Risk C: Monitor
Thiazide and Thiazide-Like Diuretics: May increase adverse/toxic effects of Diazoxide. Risk C: Monitor
Thiopental: May increase hypotensive effects of Diazoxide. Risk C: Monitor
Diazoxide crosses the human placenta and can be detected in the newborn serum (Saito 2022).
Outcome data following maternal use of diazoxide for the treatment of hyperinsulinemic hypoglycemia (Barsi 2022; Benner 2020; Saito 2022) or other indications (Sridharan 2018) during pregnancy are limited. Altered carbohydrate metabolism, hyperbilirubinemia, and thrombocytopenia have been reported in the fetus or neonate. Alopecia and hypertrichosis lanuginosa have also been reported in infants following maternal use of diazoxide during the last 19 to 60 days of pregnancy.
Some liquid formulations may contain alcohol, which should be considered prior to use in pregnant patients.
Blood glucose, electrolytes, renal function (BUN, SCr); AST; CBC with differential and platelets (baseline, 5 to 7 days after initiation, then every 3 to 6 months thereafter) (Brar 2020); serum uric acid (baseline, 5 to 7 days after initiation, then every 6 months thereafter) (Brar 2020); urine glucose and ketones (baseline, during therapy initiation, and then periodically); blood pressure (especially with IV therapy), heart rate; signs of fluid overload, pulmonary hypertension, and respiratory decompensation (neonates/infants [eg, respiratory, cyanosis, feeding intolerance]); consider echocardiogram in neonates and infants (baseline, 5 to 7 days after initiation, and periodically) (Brar 2020; Timlin 2017); signs of feeding intolerance.
Opens ATP-dependent potassium channels on pancreatic beta cells in the presence of ATP and Mg2+, resulting in hyperpolarization of the cell and inhibition of insulin release. Diazoxide binds to a different site on the potassium channel than the sulfonylureas (Doyle 2003).
Onset of action: Hyperglycemic: Oral: Within 1 hour.
Duration: Hyperglycemic: Oral: Normal renal function: ≤8 hours.
Protein binding: >90%.
Half-life elimination: Oral:
Infants, Children, and Adolescents: 5.9 to 27.7 hours (Kizu 2017).
Adults: 24 to 36 hours.
Excretion: Urine (50% as unchanged drug).
Altered kidney function: Plasma half-life is prolonged.
