Drug · FAERS side-effect profile with label screen
Stiripentol side effects: what 2,140 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Diacomit
openFDA label
Who reports
2,140 reports · 85% serious · 108 with death outcome · 51% female
openFDA FAERS counts, all years, deduplication not applied
Used for
DIACOMIT is indicated for the treatment of seizures associated with Dravet syndrome (DS) in patients taking clobazam who are 6 months of age and older and weighing 7 kg or more. There are no clinical data to support the use of DIACOMIT as monotherapy in Dravet syndrome.
FDA label, Indications and Usage
What it is
Table 4. Description Proprietary Name DIACOMIT Established Name Stiripentol Route of Administration Oral
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 40 strongest signals
Labeled adverse reaction 9Likely indication confounding 2Reporting / coding artifact 9Not in label — unassessed 20
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.
- 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.
- 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. 19 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Seizure | 854 | 73.4 69.7–77.4ROR 121.5 · χ² 60,809 / p <1e-300 | 72.8 EB05 68.8 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 50.4 | no trial data cached |
| Status epilepticus | 78 | 68.0 54.6–84.6ROR 70.5 · χ² 5,047 / p <1e-300 | 66.5 EB05 55.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.8 | no trial data cached |
| Generalised tonic-clonic seizure | 76 | 45.7 36.6–57.0ROR 47.3 · χ² 3,265 / p <1e-300 | 45.0 EB05 37.1 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.0 | no trial data cached |
| Epilepsy | 81 | 26.1 21.0–32.3ROR 27.0 · χ² 1,925 / p <1e-300 | 25.9 EB05 21.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 · 92% clinician | no trial data cached |
| Prescribed underdose | 50 | 24.6 18.7–32.4ROR 25.2 · χ² 1,107 / p 4e-243 | 24.4 EB05 19.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · 100% clinician | no trial data cached |
| Hypotonia | 24 | 23.5 15.8–35.0ROR 23.7 · χ² 494 / p 1e-109 | 23.1 EB05 16.3 · IC025 +3.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.4 | no trial data cached |
| Myoclonus | 23 | 18.9 12.6–28.4ROR 19.1 · χ² 372 / p 3e-83 | 18.6 EB05 12.9 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 12.9 | no trial data cached |
| Product use in unapproved indication | 350 | 14.1 12.8–15.5ROR 16.6 · χ² 4,273 / p <1e-300 | 14.0 EB05 12.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 | no trial data cached |
| Ataxia | 17 | 14.0 8.7–22.5ROR 14.1 · χ² 192 / p 6e-44 | 13.1 EB05 8.1 · IC025 +2.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.0 | no trial data cached |
| Psychomotor hyperactivity | 22 | 12.9 8.5–19.6ROR 13.1 · χ² 230 / p 2e-52 | 12.3 EB05 8.1 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 10.6 | no trial data cached |
| Aggression | 66 | 12.9 10.2–16.4ROR 13.3 · χ² 714 / p 2e-157 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Mitral valve incompetence | 14 | 12.1 7.2–20.4ROR 12.2 · χ² 132 / p 8e-31 | 10.8 EB05 6.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Eating disorder | 26 | 11.9 8.1–17.5ROR 12.1 · χ² 249 / p 2e-56 | 11.3 EB05 7.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 88% consumer | no trial data cached |
| Somnolence (drowsiness) | 230 | 11.2 9.9–12.7ROR 12.4 · χ² 2,148 / p <1e-300 | 11.1 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Decreased appetite (loss of appetite) | 254 | 10.8 9.6–12.1ROR 12.1 · χ² 2,259 / p <1e-300 | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Drug level increased | 18 | 10.7 6.7–16.9ROR 10.7 · χ² 148 / p 3e-34 | 9.5 EB05 6.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 | no trial data cached |
| Sedation | 24 | 9.0 6.1–13.4ROR 9.1 · χ² 163 / p 1e-37 | 8.1 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 7.0 | no trial data cached |
| Pneumonia aspiration | 22 | 8.7 5.7–13.1ROR 8.7 · χ² 141 / p 7e-33 | 7.7 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.9 | no trial data cached |
| Abnormal behaviour | 34 | 8.4 6.0–11.7ROR 8.5 · χ² 213 / p 1e-48 | 7.7 EB05 5.7 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Hypersomnia | 22 | 7.5 5.0–11.4ROR 7.6 · χ² 118 / p 8e-28 | 6.7 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 · 77% consumer | no trial data cached |
| Product use complaint | 11 | 7.0 3.9–12.5ROR 7.0 · χ² 50 / p 7e-13 | 5.6 EB05 3.3 · IC025 +1.4 3/3 methods agree | Reporting / coding artifact | serious n=10 | no trial data cached |
| Prescribed overdose | 13 | 6.6 3.8–11.3ROR 6.6 · χ² 56 / p 3e-14 | 5.5 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 | no trial data cached |
| Sleep disorder | 46 | 6.4 4.8–8.6ROR 6.6 · χ² 207 / p 4e-47 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Encephalopathy | 16 | 6.4 3.9–10.4ROR 6.4 · χ² 68 / p 1e-16 | 5.5 EB05 3.6 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Irritability | 39 | 6.3 4.6–8.7ROR 6.4 · χ² 171 / p 3e-39 | 5.9 EB05 4.5 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · ♀ 73% (drug 51%) | no trial data cached |
| Anger | 21 | 6.1 4.0–9.3ROR 6.1 · χ² 84 / p 3e-20 | 5.4 EB05 3.7 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Hospitalisation | 94 | 6.0 5.0–7.4ROR 6.3 · χ² 393 / p 8e-88 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Product dose omission issue | 172 | 5.9 5.1–6.8ROR 6.3 · χ² 707 / p 4e-156 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 · 85% consumer | no trial data cached |
| Hepatitis (liver inflammation) | 15 | 5.7 3.5–9.5ROR 5.8 · χ² 54 / p 9e-14 | 4.9 EB05 3.2 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 4.0 | no trial data cached |
| Lethargy | 33 | 5.6 4.0–7.9ROR 5.7 · χ² 121 / p 2e-28 | 5.2 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 4.4 | no trial data cached |
| Altered state of consciousness | 12 | 5.5 3.1–9.6ROR 5.5 · χ² 39 / p 2e-10 | 4.6 EB05 2.8 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Feeding disorder | 11 | 5.4 3.0–9.7ROR 5.4 · χ² 35 / p 1e-9 | 4.5 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 4.7 | no trial data cached |
| Agitation | 38 | 5.1 3.7–6.9ROR 5.1 · χ² 120 / p 3e-28 | 4.8 EB05 3.6 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.2 | no trial data cached |
| Drug ineffective for unapproved indication | 28 | 4.9 3.4–7.1ROR 5.0 · χ² 84 / p 3e-20 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 6.7 | no trial data cached |
| Liver injury | 12 | 4.9 2.8–8.5ROR 4.9 · χ² 33 / p 4e-9 | 4.2 EB05 2.6 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Head injury | 14 | 4.3 2.6–7.3ROR 4.4 · χ² 33 / p 5e-9 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.9 | no trial data cached |
| Illness | 39 | 3.8 2.8–5.2ROR 3.9 · χ² 78 / p 5e-19 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 97% consumer | no trial data cached |
| Surgery | 20 | 3.4 2.2–5.2ROR 3.4 · χ² 31 / p 1e-8 | 3.2 EB05 2.2 · IC025 +0.9 3/3 methods agree | Reporting / coding artifact | serious PRR 2.5 · 95% consumer | no trial data cached |
| Crying | 12 | 3.2 1.8–5.7ROR 3.2 · χ² 16 / p 3e-5 | 2.9 EB05 1.8 · IC025 +0.6 | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| No adverse event | 45 | 2.5 1.9–3.3ROR 2.5 · χ² 39 / p 2e-10 | 2.4 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 4.9 · 84% 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 |
|---|---|---|---|---|---|---|
| Seizure | 854 | 73.4 69.7–77.4ROR 121.5 · χ² 60,809 / p <1e-300 | 72.8 EB05 68.8 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 50.4 | no trial data cached |
| Product use in unapproved indication | 350 | 14.1 12.8–15.5ROR 16.6 · χ² 4,273 / p <1e-300 | 14.0 EB05 12.8 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 17.3 | no trial data cached |
| Decreased appetite (loss of appetite) | 254 | 10.8 9.6–12.1ROR 12.1 · χ² 2,259 / p <1e-300 | 10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Somnolence (drowsiness) | 230 | 11.2 9.9–12.7ROR 12.4 · χ² 2,148 / p <1e-300 | 11.1 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.8 | no trial data cached |
| Product dose omission issue | 172 | 5.9 5.1–6.8ROR 6.3 · χ² 707 / p 4e-156 | 5.8 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 11.7 · 85% consumer | no trial data cached |
| Hospitalisation | 94 | 6.0 5.0–7.4ROR 6.3 · χ² 393 / p 8e-88 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Epilepsy | 81 | 26.1 21.0–32.3ROR 27.0 · χ² 1,925 / p <1e-300 | 25.9 EB05 21.5 · IC025 +4.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 17.7 · 92% clinician | no trial data cached |
| Status epilepticus | 78 | 68.0 54.6–84.6ROR 70.5 · χ² 5,047 / p <1e-300 | 66.5 EB05 55.0 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 45.8 | no trial data cached |
| Generalised tonic-clonic seizure | 76 | 45.7 36.6–57.0ROR 47.3 · χ² 3,265 / p <1e-300 | 45.0 EB05 37.1 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 30.0 | no trial data cached |
| Aggression | 66 | 12.9 10.2–16.4ROR 13.3 · χ² 714 / p 2e-157 | 12.7 EB05 10.3 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.4 | no trial data cached |
| Prescribed underdose | 50 | 24.6 18.7–32.4ROR 25.2 · χ² 1,107 / p 4e-243 | 24.4 EB05 19.2 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.5 · 100% clinician | no trial data cached |
| Wrong technique in product usage process | 49 | 2.4 1.8–3.1ROR 2.4 · χ² 38 / p 3e-10 | 2.3 EB05 1.8 · IC025 +0.8 | Reporting / coding artifact | serious PRR 8.6 | no trial data cached |
| Sleep disorder | 46 | 6.4 4.8–8.6ROR 6.6 · χ² 207 / p 4e-47 | 6.1 EB05 4.7 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| No adverse event | 45 | 2.5 1.9–3.3ROR 2.5 · χ² 39 / p 2e-10 | 2.4 EB05 1.9 · IC025 +0.8 | Reporting / coding artifact | serious PRR 4.9 · 84% consumer | no trial data cached |
| Illness | 39 | 3.8 2.8–5.2ROR 3.9 · χ² 78 / p 5e-19 | 3.7 EB05 2.8 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.8 · 97% consumer | 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.
- Prescribed underdose — n=50, PRR 24.6
- Myoclonus — n=23, PRR 18.9
- Psychomotor hyperactivity — n=22, PRR 12.9
- Eating disorder — n=26, PRR 11.9
- Sedation — n=24, PRR 9.0
- Pneumonia aspiration — n=22, PRR 8.7
- Abnormal behaviour — n=34, PRR 8.4
- Hypersomnia — n=22, PRR 7.5
- Sleep disorder — n=46, PRR 6.4
- Irritability — n=39, PRR 6.3
✓ A hand-written Bradford Hill causality assessment exists for this drug: Stiripentol ↔ Somnolence.
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 Stiripentol?
In FDA FAERS, the most frequently co-reported reaction terms for Stiripentol are seizure, decreased appetite, somnolence, epilepsy, status epilepticus, generalised tonic-clonic seizure. 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 Stiripentol have an FDA boxed warning?
No. The FDA label retrieved for Stiripentol has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Stiripentol 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 58304ba8-9779-4658-811e-94ffe08c3f16, effective 20260427; matched on
openfda.generic_name.exact:"STIRIPENTOL") - 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, 59 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.