Diazoxide side effects: what 724 FDA adverse event reports show
Drug class
Not stated in label
Who reports
724 reports · 88% serious · 97 with death outcome · 53% female
Used for
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.
What it is
DESCRIPTION Diazoxide Oral Suspension, USP is a nondiuretic benzothiadiazine derivative taken orally for the management of symptomatic hypoglycemia. Diazoxide oral suspension contains 50 mg of diazoxide, USP in each milliliter and has a chocolate-mint flavor; alcohol content is approximately 7.29%.
Boxed warning
None in the current label
Causality screen of the 13 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 2 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 99 | 59.2 49.3–71.1ROR 68.4 · χ² 5,607 / p <1e-300 | 58.4 EB05 49.4 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 41.4 · 90% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 46 | 36.7 27.8–48.6ROR 39.1 · χ² 1,564 / p <1e-300 | 36.2 EB05 28.2 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.7 | no trial data cached |
| Pulmonary hypertension | 19 | 26.3 16.9–41.1ROR 27.0 · χ² 438 / p 1e-97 | 25.7 EB05 17.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | no trial data cached |
| Petechiae | 8 | 22.3 11.2–44.4ROR 22.5 · χ² 142 / p 5e-33 | 20.5 EB05 10.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 | no trial data cached |
| Generalised oedema | 9 | 21.2 11.1–40.6ROR 21.4 · χ² 153 / p 2e-35 | 19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 19.8 14.5–26.9ROR 20.8 · χ² 659 / p 1e-145 | 19.6 EB05 14.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.4 · 97% clinician | no trial data cached |
| Body temperature decreased | 6 | 17.5 7.9–38.9ROR 17.6 · χ² 78 / p 6e-19 | 14.1 EB05 5.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 | no trial data cached |
| Metastases to liver | 7 | 11.6 5.5–24.2ROR 11.7 · χ² 57 / p 2e-14 | 8.5 EB05 3.8 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Blood glucose decreased | 17 | 10.2 6.4–16.3ROR 10.4 · χ² 133 / p 6e-31 | 9.0 EB05 5.6 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.4 | no trial data cached |
| Blood glucose abnormal | 6 | 9.4 4.2–20.8ROR 9.5 · χ² 37 / p 6e-10 | 6.4 EB05 2.9 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 13.2 | no trial data cached |
| Malignant neoplasm progression | 23 | 6.5 4.4–9.8ROR 6.7 · χ² 103 / p 2e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · ♀ 74% (drug 53%) · 100% clinician | no trial data cached |
| Needle issue | 5 | 5.1 2.1–12.1ROR 5.1 · χ² 13 / p 2e-4 | 3.7 EB05 1.8 · IC025 +0.3 | Not in label — unassessed | serious n=5 | no trial data cached |
| Myelosuppression | 5 | 4.3 1.8–10.2ROR 4.3 · χ² 9 / p 0.001 | 3.2 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Hypoglycaemia (low blood sugar) | 99 | 59.2 49.3–71.1ROR 68.4 · χ² 5,607 / p <1e-300 | 58.4 EB05 49.4 · IC025 +5.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 41.4 · 90% clinician | no trial data cached |
| Hyperglycaemia (high blood sugar) | 46 | 36.7 27.8–48.6ROR 39.1 · χ² 1,564 / p <1e-300 | 36.2 EB05 28.2 · IC025 +4.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 26.7 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 19.8 14.5–26.9ROR 20.8 · χ² 659 / p 1e-145 | 19.6 EB05 14.8 · IC025 +3.4 3/3 methods agree | Reporting / coding artifact | serious PRR 24.4 · 97% clinician | no trial data cached |
| Malignant neoplasm progression | 23 | 6.5 4.4–9.8ROR 6.7 · χ² 103 / p 2e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 4.4 · ♀ 74% (drug 53%) · 100% clinician | no trial data cached |
| Pulmonary hypertension | 19 | 26.3 16.9–41.1ROR 27.0 · χ² 438 / p 1e-97 | 25.7 EB05 17.4 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.5 | no trial data cached |
| Blood glucose decreased | 17 | 10.2 6.4–16.3ROR 10.4 · χ² 133 / p 6e-31 | 9.0 EB05 5.6 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.4 | no trial data cached |
| Generalised oedema | 9 | 21.2 11.1–40.6ROR 21.4 · χ² 153 / p 2e-35 | 19.7 EB05 10.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 15.4 | no trial data cached |
| Petechiae | 8 | 22.3 11.2–44.4ROR 22.5 · χ² 142 / p 5e-33 | 20.5 EB05 10.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 17.7 | no trial data cached |
| Metastases to liver | 7 | 11.6 5.5–24.2ROR 11.7 · χ² 57 / p 2e-14 | 8.5 EB05 3.8 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Blood glucose abnormal | 6 | 9.4 4.2–20.8ROR 9.5 · χ² 37 / p 6e-10 | 6.4 EB05 2.9 · IC025 +1.1 3/3 methods agree | Lab value / disease marker | serious PRR 13.2 | no trial data cached |
| Body temperature decreased | 6 | 17.5 7.9–38.9ROR 17.6 · χ² 78 / p 6e-19 | 14.1 EB05 5.2 · IC025 +1.5 3/3 methods agree | Lab value / disease marker | serious PRR 12.8 | no trial data cached |
| Myelosuppression | 5 | 4.3 1.8–10.2ROR 4.3 · χ² 9 / p 0.001 | 3.2 EB05 1.6 · IC025 +0.2 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Needle issue | 5 | 5.1 2.1–12.1ROR 5.1 · χ² 13 / p 2e-4 | 3.7 EB05 1.8 · IC025 +0.3 | Not in label — unassessed | serious n=5 | no trial data cached |
| Drug exposure during pregnancy | 3 | 2.5 0.8–7.8ROR 2.5 · χ² 1 / p 0.115 | 2.1 EB05 0.9 · IC025 -1.0 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.8 | no trial data cached |
| Posterior reversible encephalopathy syndrome | 3 | 9.1 3.0–28.2ROR 9.2 · χ² 14 / p 8e-5 | 4.7 EB05 1.7 · IC025 +0.0 | Not in label — unassessed | serious PRR 6.0 | no trial data cached |
Unlabeled candidate signals
Every screened signal with n ≥ 20 was either labeled, an indication term, or an artifact pattern — no unlabeled candidate stood out in the top signals.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Diazoxide?
In FDA FAERS, the most frequently co-reported reaction terms for Diazoxide are hypoglycaemia, hyperglycaemia, pulmonary hypertension, blood glucose decreased, generalised oedema, petechiae. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Diazoxide have an FDA boxed warning?
No. The FDA label retrieved for Diazoxide has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Diazoxide causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID abe317a5-6c63-469c-89c8-9fedfe859c3d, effective 20260807; matched on
openfda.generic_name.exact:"DIAZOXIDE") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 15 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.