Diazoxide Choline side effects: what 530 FDA adverse event reports show

Diazoxide Choline · Vykat Xr · 10 reaction terms · 380 drug–reaction co-reports · data 2026-09-14

Drug class

Not stated in label

Brand names

Vykat Xr

openFDA label

Who reports

530 reports · 18% serious · 7 with death outcome · 48% female

openFDA FAERS counts, all years, deduplication not applied

Used for

VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). VYKAT XR is indicated for the treatment of hyperphagia in adults and pediatric patients 4 years of age and older with Prader-Willi syndrome (PWS). ( 1 )

FDA label, Indications and Usage

What it is

VYKAT XR contains diazoxide choline. Diazoxide choline is very slightly soluble to soluble in solvents dichloromethane, tetrahydrofuran, acetonitrile, and methanol and practically insoluble in solvents methyl tert -butyl ether.

FDA label, Description section

Boxed warning

None in the current label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 9 strongest signals

Labeled adverse reaction 5Labeled (related wording) 2Lab value / disease marker 1Not in label — unassessed 1

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.
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. 1 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Fluid retention	54	42.1 32.7–54.2ROR 46.7 · χ² 2,127 / p <1e-300	41.5 EB05 33.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.3 · 76% consumer	no trial data cached
Oedema	53	38.8 30.0–50.1ROR 43.0 · χ² 1,916 / p <1e-300	38.2 EB05 30.4 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.0	no trial data cached
Hyperglycaemia (high blood sugar)	32	34.9 24.9–48.8ROR 37.1 · χ² 1,020 / p 3e-224	34.2 EB05 25.4 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.4 · ♀ 27% (drug 48%)	no trial data cached
Abnormal behaviour	34	33.8 24.4–46.7ROR 36.0 · χ² 1,049 / p 2e-230	33.2 EB05 24.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 43.6 · 76% consumer	no trial data cached
Oedema peripheral (swelling of legs/feet)	96	31.1 25.9–37.2ROR 37.7 · χ² 2,778 / p <1e-300	30.9 EB05 26.0 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.2	no trial data cached
Aggression	26	20.5 14.1–29.9ROR 21.5 · χ² 464 / p 3e-103	20.2 EB05 14.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.9 · 73% consumer	no trial data cached
Glycosylated haemoglobin increased	13	20.4 11.9–34.9ROR 20.9 · χ² 221 / p 2e-50	19.6 EB05 11.8 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 45.3	no trial data cached
Thirst	7	15.5 7.4–32.4ROR 15.7 · χ² 81 / p 1e-19	12.7 EB05 5.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Blood glucose increased	61	12.8 10.1–16.2ROR 14.3 · χ² 655 / p 8e-145	12.6 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.1 · 79% consumer	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Oedema peripheral (swelling of legs/feet)	96	31.1 25.9–37.2ROR 37.7 · χ² 2,778 / p <1e-300	30.9 EB05 26.0 · IC025 +4.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 26.2	no trial data cached
Blood glucose increased	61	12.8 10.1–16.2ROR 14.3 · χ² 655 / p 8e-145	12.6 EB05 10.0 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.1 · 79% consumer	no trial data cached
Fluid retention	54	42.1 32.7–54.2ROR 46.7 · χ² 2,127 / p <1e-300	41.5 EB05 33.0 · IC025 +4.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 41.3 · 76% consumer	no trial data cached
Oedema	53	38.8 30.0–50.1ROR 43.0 · χ² 1,916 / p <1e-300	38.2 EB05 30.4 · IC025 +4.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 35.0	no trial data cached
Abnormal behaviour	34	33.8 24.4–46.7ROR 36.0 · χ² 1,049 / p 2e-230	33.2 EB05 24.8 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 43.6 · 76% consumer	no trial data cached
Hyperglycaemia (high blood sugar)	32	34.9 24.9–48.8ROR 37.1 · χ² 1,020 / p 3e-224	34.2 EB05 25.4 · IC025 +3.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 27.4 · ♀ 27% (drug 48%)	no trial data cached
Aggression	26	20.5 14.1–29.9ROR 21.5 · χ² 464 / p 3e-103	20.2 EB05 14.4 · IC025 +3.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 21.9 · 73% consumer	no trial data cached
Glycosylated haemoglobin increased	13	20.4 11.9–34.9ROR 20.9 · χ² 221 / p 2e-50	19.6 EB05 11.8 · IC025 +2.6 3/3 methods agree	Lab value / disease marker	serious PRR 45.3	no trial data cached
Thirst	7	15.5 7.4–32.4ROR 15.7 · χ² 81 / p 1e-19	12.7 EB05 5.2 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	–	no trial data cached
Blood glucose fluctuation	4	14.4 5.4–38.2ROR 14.5 · χ² 37 / p 5e-10	8.8 EB05 2.9 · IC025 +0.8 3/3 methods agree	Lab value / disease marker	serious n=1	no trial data cached

Unlabeled candidate signals

These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.

Abnormal behaviour — n=34, PRR 33.8

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 Choline?

In FDA FAERS, the most frequently co-reported reaction terms for Diazoxide Choline are oedema peripheral, blood glucose increased, fluid retention, oedema, abnormal behaviour, hyperglycaemia. 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 Choline have an FDA boxed warning?

No. The FDA label retrieved for Diazoxide Choline has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Diazoxide Choline 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 0e745e85-9512-e360-e063-6394a90aebf1, effective 20250326; matched on openfda.generic_name.exact:"DIAZOXIDE CHOLINE")
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, field patient.drug.openfda.generic_name.exact, 10 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.