Drug · FAERS side-effect profile with label screen
Brivaracetam side effects: what 4,653 FDA adverse event reports show
Drug class
Epoxide Hydrolase Inhibitors
FDA label (mechanism-of-action class)
Who reports
4,653 reports · 94% serious · 245 with death outcome · 53% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Brivaracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. Brivaracetam injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
FDA label, Indications and Usage
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 12Labeled (related wording) 3Likely indication confounding 2Reporting / coding artifact 5Not in label — unassessed 18
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.
- 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. 136 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 | 1,962 | 78.4 75.8–81.1ROR 134.8 · χ² 148,024 / p <1e-300 | 77.0 EB05 74.2 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 49.3 | no trial data cached |
| Status epilepticus | 136 | 54.8 46.4–64.8ROR 56.4 · χ² 7,048 / p <1e-300 | 53.8 EB05 46.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.2 · 92% clinician | no trial data cached |
| Generalised tonic-clonic seizure | 187 | 52.1 45.2–60.0ROR 54.2 · χ² 9,218 / p <1e-300 | 51.2 EB05 45.4 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 31.9 | no trial data cached |
| Product availability issue | 237 | 48.1 42.5–54.5ROR 50.7 · χ² 10,789 / p <1e-300 | 47.5 EB05 42.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 60.3 · 87% consumer | no trial data cached |
| Inability to afford medication | 66 | 30.4 23.9–38.7ROR 30.9 · χ² 1,839 / p <1e-300 | 30.0 EB05 24.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=65 · 82% consumer | no trial data cached |
| Epilepsy | 183 | 27.2 23.6–31.3ROR 28.3 · χ² 4,568 / p <1e-300 | 27.0 EB05 23.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 | no trial data cached |
| Insurance issue | 84 | 25.6 20.7–31.7ROR 26.1 · χ² 1,953 / p <1e-300 | 25.4 EB05 21.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 31.8 · 87% consumer | no trial data cached |
| Ataxia | 67 | 25.5 20.1–32.3ROR 25.8 · χ² 1,543 / p <1e-300 | 25.2 EB05 20.5 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.0 | no trial data cached |
| Therapy interrupted | 334 | 21.9 19.8–24.3ROR 23.5 · χ² 6,637 / p <1e-300 | 21.8 EB05 19.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 30.4 · 89% consumer | no trial data cached |
| Myoclonus | 47 | 17.8 13.4–23.7ROR 18.0 · χ² 727 / p 2e-160 | 17.6 EB05 13.7 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 10.5 · ♀ 14% (drug 53%) · 100% clinician | no trial data cached |
| Salivary hypersecretion | 33 | 14.9 10.6–21.0ROR 15.0 · χ² 414 / p 3e-92 | 14.6 EB05 10.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 · ♀ 11% (drug 53%) | no trial data cached |
| Prescribed overdose | 63 | 14.7 11.5–18.8ROR 14.9 · χ² 790 / p 5e-174 | 14.5 EB05 11.7 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 14.1 | no trial data cached |
| Aggression | 154 | 13.9 11.9–16.2ROR 14.3 · χ² 1,826 / p <1e-300 | 13.8 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 | no trial data cached |
| Mood swings | 67 | 9.5 7.5–12.0ROR 9.6 · χ² 500 / p 6e-111 | 9.2 EB05 7.4 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 · ♀ 85% (drug 53%) | no trial data cached |
| Brain neoplasm | 19 | 9.3 6.0–14.6ROR 9.4 · χ² 133 / p 5e-31 | 8.2 EB05 5.3 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Drug resistance | 51 | 9.0 6.8–11.8ROR 9.1 · χ² 353 / p 6e-79 | 8.5 EB05 6.7 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · 98% clinician | no trial data cached |
| Anger | 58 | 7.7 6.0–10.0ROR 7.8 · χ² 332 / p 2e-74 | 7.3 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.4 | no trial data cached |
| Irritability | 102 | 7.6 6.3–9.3ROR 7.8 · χ² 583 / p 4e-129 | 7.4 EB05 6.3 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 | no trial data cached |
| Head injury | 52 | 7.4 5.7–9.7ROR 7.5 · χ² 283 / p 8e-64 | 7.0 EB05 5.6 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · 75% consumer | no trial data cached |
| Diplopia (double vision) | 42 | 7.3 5.4–9.9ROR 7.4 · χ² 222 / p 2e-50 | 6.8 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 · 98% clinician | no trial data cached |
| Maternal exposure during pregnancy | 140 | 7.2 6.1–8.4ROR 7.4 · χ² 738 / p 8e-163 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · ♀ 93% (drug 53%) | no trial data cached |
| Vitamin d deficiency | 15 | 6.9 4.2–11.5ROR 7.0 · χ² 70 / p 2e-17 | 5.9 EB05 3.7 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 5.1 | no trial data cached |
| Premature delivery | 24 | 6.8 4.5–10.1ROR 6.8 · χ² 112 / p 2e-26 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 4.2 · ♀ 100% (drug 53%) | no trial data cached |
| Parkinsonism | 14 | 6.5 3.8–10.9ROR 6.5 · χ² 59 / p 6e-15 | 5.4 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.6 | no trial data cached |
| Cognitive disorder | 66 | 6.4 5.0–8.1ROR 6.5 · χ² 296 / p 1e-66 | 6.1 EB05 5.0 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 5.2 · ♀ 78% (drug 53%) | no trial data cached |
| Abnormal behaviour | 53 | 6.0 4.6–7.8ROR 6.1 · χ² 216 / p 4e-49 | 5.7 EB05 4.5 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Mood altered | 35 | 5.8 4.2–8.1ROR 5.8 · χ² 135 / p 2e-31 | 5.4 EB05 4.1 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.2 | no trial data cached |
| Overdose | 272 | 5.7 5.0–6.4ROR 6.0 · χ² 1,050 / p 1e-230 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Somnolence (drowsiness) | 250 | 5.6 5.0–6.3ROR 5.9 · χ² 950 / p 6e-209 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Suicidal ideation (thoughts of suicide) | 107 | 5.3 4.4–6.4ROR 5.4 · χ² 367 / p 5e-82 | 5.1 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Affect lability | 11 | 5.1 2.8–9.3ROR 5.1 · χ² 33 / p 6e-9 | 4.3 EB05 2.6 · IC025 +1.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Hallucination, auditory | 18 | 5.1 3.2–8.1ROR 5.1 · χ² 55 / p 5e-14 | 4.5 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | no trial data cached |
| Thinking abnormal | 21 | 5.1 3.3–7.7ROR 5.1 · χ² 64 / p 5e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.8 | no trial data cached |
| Sedation | 29 | 5.0 3.5–7.2ROR 5.0 · χ² 89 / p 2e-21 | 4.7 EB05 3.4 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.4 | no trial data cached |
| Encephalopathy | 27 | 5.0 3.4–7.2ROR 5.0 · χ² 82 / p 8e-20 | 4.6 EB05 3.3 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 · ♀ 86% (drug 53%) · 100% clinician | no trial data cached |
| Apathy | 16 | 5.0 3.0–8.1ROR 5.0 · χ² 47 / p 4e-12 | 4.4 EB05 2.9 · IC025 +1.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.4 | no trial data cached |
| Mental disorder | 48 | 5.0 3.7–6.6ROR 5.0 · χ² 148 / p 2e-34 | 4.7 EB05 3.7 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Nephropathy | 10 | 4.8 2.6–8.9ROR 4.8 · χ² 26 / p 1e-7 | 4.0 EB05 2.4 · IC025 +0.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.1 | no trial data cached |
| Hypersomnia | 29 | 4.6 3.2–6.6ROR 4.6 · χ² 77 / p 7e-19 | 4.3 EB05 3.1 · IC025 +1.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.7 | no trial data cached |
| Memory impairment | 137 | 4.5 3.8–5.3ROR 4.6 · χ² 370 / p 7e-83 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | 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 | 1,962 | 78.4 75.8–81.1ROR 134.8 · χ² 148,024 / p <1e-300 | 77.0 EB05 74.2 · IC025 +6.2 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 49.3 | no trial data cached |
| Drug ineffective (drug did not work) | 627 | 2.1 2.0–2.3ROR 2.3 · χ² 408 / p 4e-91 | 2.1 EB05 2.0 · IC025 +1.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Off label use (used outside approved label) | 599 | 3.1 2.9–3.4ROR 3.4 · χ² 893 / p 2e-196 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.3 | no trial data cached |
| Therapy interrupted | 334 | 21.9 19.8–24.3ROR 23.5 · χ² 6,637 / p <1e-300 | 21.8 EB05 19.9 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious PRR 30.4 · 89% consumer | no trial data cached |
| Overdose | 272 | 5.7 5.0–6.4ROR 6.0 · χ² 1,050 / p 1e-230 | 5.6 EB05 5.1 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Somnolence (drowsiness) | 250 | 5.6 5.0–6.3ROR 5.9 · χ² 950 / p 6e-209 | 5.5 EB05 5.0 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Product availability issue | 237 | 48.1 42.5–54.5ROR 50.7 · χ² 10,789 / p <1e-300 | 47.5 EB05 42.6 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious PRR 60.3 · 87% consumer | no trial data cached |
| Fall | 229 | 3.1 2.7–3.5ROR 3.2 · χ² 330 / p 5e-74 | 3.1 EB05 2.8 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 2.2 | no trial data cached |
| Generalised tonic-clonic seizure | 187 | 52.1 45.2–60.0ROR 54.2 · χ² 9,218 / p <1e-300 | 51.2 EB05 45.4 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 31.9 | no trial data cached |
| Epilepsy | 183 | 27.2 23.6–31.3ROR 28.3 · χ² 4,568 / p <1e-300 | 27.0 EB05 23.8 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.6 | no trial data cached |
| Product use issue | 182 | 4.4 3.8–5.1ROR 4.5 · χ² 477 / p 5e-106 | 4.3 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.8 · 76% consumer | no trial data cached |
| Aggression | 154 | 13.9 11.9–16.2ROR 14.3 · χ² 1,826 / p <1e-300 | 13.8 EB05 12.0 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 10.2 | no trial data cached |
| Maternal exposure during pregnancy | 140 | 7.2 6.1–8.4ROR 7.4 · χ² 738 / p 8e-163 | 7.0 EB05 6.1 · IC025 +2.5 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · ♀ 93% (drug 53%) | no trial data cached |
| Memory impairment | 137 | 4.5 3.8–5.3ROR 4.6 · χ² 370 / p 7e-83 | 4.4 EB05 3.8 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Status epilepticus | 136 | 54.8 46.4–64.8ROR 56.4 · χ² 7,048 / p <1e-300 | 53.8 EB05 46.6 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 33.2 · 92% clinician | 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.
- Inability to afford medication — n=66, PRR 30.4
- Insurance issue — n=84, PRR 25.6
- Myoclonus — n=47, PRR 17.8
- Salivary hypersecretion — n=33, PRR 14.9
- Prescribed overdose — n=63, PRR 14.7
- Head injury — n=52, PRR 7.4
- Diplopia — n=42, PRR 7.3
- Premature delivery — n=24, PRR 6.8
- Cognitive disorder — n=66, PRR 6.4
- Abnormal behaviour — n=53, PRR 6.0
✓ A hand-written Bradford Hill causality assessment exists for this drug: Brivaracetam ↔ Aggression.
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 Brivaracetam?
In FDA FAERS, the most frequently co-reported reaction terms for Brivaracetam are seizure, somnolence, fall, generalised tonic-clonic seizure, epilepsy, aggression. 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 Brivaracetam have an FDA boxed warning?
No. The FDA label retrieved for Brivaracetam has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Brivaracetam 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 2c6af271-3222-4602-98a6-14754f0a29ba, effective 20260223; matched on
openfda.generic_name.exact:"BRIVARACETAM") - 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, 176 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.