pharmacopeia
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/api/v1/drug/diazoxide

Mechanism of action

Sourced from openFDA

Mechanism-of-action classes: Carbonic Anhydrase Inhibitors; Potassium Channel Openers.

Carbonic Anhydrase

Indications

Sourced from openFDA
  • & USAGE Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis.

Contraindications

Sourced from openFDA
  • Diazoxide oral suspension is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in diazoxide oral suspension, or other thiazidescontraindicated

Dosage & administration

Sourced from openFDA

DOSAGE & ADMINISTRATION Patients should be under close clinical observation when treatment with diazoxide oral suspension is initiated. Carefully monitor the clinical response and blood glucose until the patient’s condition has stabilized satisfactory; in most instances, this may be accomplished in several days. If administration of diazoxide oral suspension is not effective after 2 or 3 weeks, discontinue diazoxide oral suspension. Individualize the dosage of diazoxide oral suspension based on the severity of the hypoglycemic condition and the blood glucose level and clinical response of the patient. Adjust the dosage until the desired clinical and laboratory effects are produced with the least amount of diazoxide oral suspension. Take special care to ensure the accuracy of the dosage in infants and young children. Adults and children : The recommended starting dosage is 3 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 8 mg/kg/day. Patients with refractory hypoglycemia may require higher dosages. Infants and newborns : The recommended starting dosage is 8 mg/kg/day, administered orally, divided into 3 equal doses every 8 hours or 2 equal doses every 12 hours. The dosage may be titrated to a maximum of 15 mg/kg/day.

Warnings & precautions

Sourced from openFDA

The antidiuretic property of diazoxide may lead to significant fluid retention. In patients with compromised cardiac reserve, fluid retention may precipitate congestive heart failure. If fluid retention develops, manage according to standards of care. Co-administration of diazoxide oral suspension with thiazides may potentiate the hyperglycemic and hyperuricemic actions of diazoxide (see DRUG INTERACTIONS and ANIMAL PHARMACOLOGY AND/OR TOXICOLOGY ). Ketoacidosis and nonketotic hyperosmolar coma have been reported in patients treated with diazoxide oral suspension, usually during intercurrent illness. Prompt recognition and treatment are essential (see OVERDOSAGE), and prolonged surveillance following the acute episode is necessary because of the long drug half-life of approximately 30 hours. Advise patients to monitor urine glucose and ketones and to promptly report abnormal findings and symptoms of ketoacidosis to their healthcare provider. Transient cataracts occurred in association with hyperosmolar coma in an infant, and subsided on correction of the hyper-osmolarity. Cataracts have been observed in several animals receiving daily dosages of intravenous or oral diazoxide. The development of abnormal facial features in four children treated chronically (>4 years) with diazoxide oral suspension for hypoglycemia hyperinsulinism in the same clinic has been reported. Pulmonary Hypertension in Neonates and Infants There have been postmarketing reports of pulmonary hypertension occurring in infants and neonates treated with diazoxide.

Adverse reactions

Sourced from openFDA

Frequent and Serious : Sodium and fluid retention is most common in young infants and in adults and may precipitate congestive heart failure in patients with compromised cardiac reserve. (see DRUG INTERACTIONS ). Infrequent but Serious : Diabetic ketoacidosis and hyperosmolar nonketotic coma may develop very rapidly. Monitor patients for up to 7 days due to the long half-life of diazoxide (see OVERDOSAGE ). Other frequent adverse reactions : Hirsutism of the lanugo type, mainly on the forehead, back and limbs, occurs most commonly in children and women and may be cosmetically unacceptable. It subsides on discontinuation of diazoxide oral suspension. Hyperglycemia or glycosuria may require reduction in dosage in order to avoid progression to ketoacidosis or hyperosmolar coma. Gastrointestinal intolerance may include anorexia, nausea, vomiting, abdominal pain, ileus, diarrhea, transient loss of taste. Tachycardia, palpitations, increased levels of serum uric acid are common. Thrombocytopenia with or without purpura may require discontinuation of diazoxide oral suspension. Neutropenia is transient, is not associated with increased susceptibility to infection, and ordinarily does not require discontinuation of diazoxide oral suspension. Skin rash, headache, weakness, and malaise may also occur. Other adverse reactions : Cardiovascular : Hypotension occurs occasionally, which may be augmented by thiazide diuretics given concurrently. A few cases of transient hypertension, for which no explanation is apparent, have been noted. Chest pain has been reported rarely.

Overdosage

Sourced from openFDA

An overdosage of diazoxide oral suspension causes marked hyperglycemia which may be associated with ketoacidosis. Because of the diazoxide’s long half-life (approximately 30 hours), the symptoms of overdosage require prolonged surveillance for periods up to 7 days until the blood glucose level stabilizes within the normal range. One investigator reported successful lowering of diazoxide blood levels by peritoneal dialysis in one patient and by hemodialysis in another.

Approval history

Sourced from openFDA
  • May 28, 1976NDANDA017453Teva Branded Pharm
  • Dec 20, 2019ANDAANDA211050E5 Pharma Inc
  • Jul 8, 2020ANDAANDA210799Novitium Pharma
  • Mar 26, 2025NDANDA216665Soleno Therap

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
1,035 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective15315%
  2. 2Hypoglycaemia979.4%
  3. 3Oedema Peripheral918.8%
  4. 4Off Label Use696.7%
  5. 5Hyperglycaemia666.4%
  6. 6Oedema656.3%
  7. 7Weight Increased545.2%
  8. 8Blood Glucose Increased504.8%
  9. 9Peripheral Swelling474.5%
  10. 10Fluid Retention464.4%
  11. 11Drug Ineffective For Unapproved Indication383.7%
  12. 12Dyspnoea333.2%
  13. 13Drug Interaction302.9%
  14. 14Hypertrichosis282.7%
  15. 15Product Use In Unapproved Indication282.7%

Literature

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Recent PubMed references pinned to Diazoxide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 38 ClinicalTrials.gov registrations naming Diazoxide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Diazoxide work?
Mechanism-of-action classes: Carbonic Anhydrase Inhibitors; Potassium Channel Openers.
What is Diazoxide used for?
According to FDA labeling, Diazoxide carries indications including: & USAGE Diazoxide oral suspension is indicated for the management of hypoglycemia due to hyperinsulinism associated with the following conditions: Adults: Inoperable islet cell adenoma or carcinoma, or extrapancreatic malignancy. Infants and children: Leucine sensitivity, islet cell hyperplasia, nesidioblastosis, extrapancreatic malignancy, islet cell adenoma, or adenomatosis.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Diazoxide?
Diazoxide is classified as Drugs for treatment of hypoglycemia, Thiazide derivatives, Carbonic Anhydrase Inhibitors, Potassium Channel Openers, Decreased Blood Pressure, Decreased Insulin Secretion, Vasodilation.
What are the brand names for Diazoxide?
Diazoxide is marketed under brand names including Proglycem, Vykat.
What are the contraindications for Diazoxide?
Diazoxide labeling lists contraindications including: Diazoxide oral suspension is contraindicated in patients with: Functional hypoglycemia Hypersensitivity to diazoxide, any of the excipients in diazoxide oral suspension, or other thiazides. Always consult the full prescribing information and a clinician.
Note. Data for diazoxide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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