Drug · FAERS side-effect profile with label screen
Brivaracetam side effects: what 8,938 FDA adverse event reports show
Drug class
Epoxide Hydrolase Inhibitors
FDA label (mechanism-of-action class)
Who reports
8,938 reports · 80% serious · 446 with death outcome · 54% 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 2Labeled (related wording) 3Likely indication confounding 8Reporting / coding artifact 6Lab value / disease marker 1Not 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.
- 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. 962 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 |
|---|---|---|---|---|---|---|
| Epilepsy surgery | 12 | 2,135.6 974.7–4,679.2ROR 2,138.5 · χ² 12,227 / p <1e-300 | 400.2 EB05 243.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| New onset refractory status epilepticus | 33 | 1,060.4 702.7–1,600.3ROR 1,064.3 · χ² 23,229 / p <1e-300 | 510.9 EB05 380.6 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=33 · ♀ 19% (drug 54%) · 100% clinician | no trial data cached |
| Intestinal atresia | 14 | 352.1 200.7–617.5ROR 352.6 · χ² 3,954 / p <1e-300 | 216.0 EB05 136.7 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Vagal nerve stimulator implantation | 33 | 293.7 204.5–421.6ROR 294.7 · χ² 8,283 / p <1e-300 | 226.6 EB05 168.8 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=31 | no trial data cached |
| Postictal paralysis | 21 | 222.9 142.5–348.6ROR 223.4 · χ² 4,031 / p <1e-300 | 171.8 EB05 118.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Partial seizures with secondary generalisation | 37 | 200.9 143.7–281.0ROR 201.8 · χ² 6,590 / p <1e-300 | 169.0 EB05 128.0 · IC025 +5.2 3/3 methods agree | Labeled (related wording) related wording | serious n=37 · 92% clinician | no trial data cached |
| Seizure cluster | 62 | 196.0 151.3–253.7ROR 197.3 · χ² 10,908 / p <1e-300 | 171.3 EB05 138.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=60 | no trial data cached |
| Postictal psychosis | 11 | 179.2 97.1–330.9ROR 179.4 · χ² 1,648 / p <1e-300 | 129.6 EB05 77.2 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Multiple-drug resistance | 218 | 177.8 155.2–203.8ROR 182.3 · χ² 35,440 / p <1e-300 | 162.9 EB05 145.5 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=188 · 92% clinician | no trial data cached |
| Change in seizure presentation | 43 | 164.4 120.8–223.9ROR 165.2 · χ² 6,370 / p <1e-300 | 143.9 EB05 111.3 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=41 | no trial data cached |
| Focal dyscognitive seizures | 72 | 157.7 124.4–200.1ROR 159.0 · χ² 10,353 / p <1e-300 | 142.2 EB05 116.7 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=67 | no trial data cached |
| Sudden unexplained death in epilepsy | 34 | 157.3 111.2–222.5ROR 157.9 · χ² 4,800 / p <1e-300 | 136.2 EB05 102.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=34 | no trial data cached |
| Atonic seizures | 40 | 123.9 90.2–170.2ROR 124.4 · χ² 4,512 / p <1e-300 | 111.5 EB05 85.4 · IC025 +5.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=36 | no trial data cached |
| Aura | 73 | 95.8 75.9–121.0ROR 96.6 · χ² 6,486 / p <1e-300 | 89.9 EB05 73.9 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 30% (drug 54%) | no trial data cached |
| Partial seizures | 199 | 94.1 81.8–108.3ROR 96.2 · χ² 17,531 / p <1e-300 | 89.7 EB05 79.7 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious n=193 | no trial data cached |
| Tonic convulsion | 45 | 77.8 57.8–104.6ROR 78.1 · χ² 3,225 / p <1e-300 | 73.0 EB05 56.8 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=43 | no trial data cached |
| Brain operation | 70 | 75.1 59.3–95.2ROR 75.7 · χ² 4,887 / p <1e-300 | 71.4 EB05 58.5 · IC025 +5.2 3/3 methods agree | Reporting / coding artifact | serious n=70 · 79% consumer | no trial data cached |
| Petit mal epilepsy | 153 | 72.7 62.0–85.3ROR 74.0 · χ² 10,429 / p <1e-300 | 70.0 EB05 61.1 · IC025 +5.6 3/3 methods agree | Labeled (related wording) related wording | serious n=148 | no trial data cached |
| Psychogenic seizure | 27 | 70.7 48.2–103.6ROR 70.9 · χ² 1,732 / p <1e-300 | 65.6 EB05 47.3 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 | no trial data cached |
| Seizure | 3,218 | 67.7 65.8–69.6ROR 105.2 · χ² 206,405 / p <1e-300 | 65.7 EB05 63.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 47.4 | no trial data cached |
| Myoclonic epilepsy | 41 | 67.1 49.2–91.5ROR 67.4 · χ² 2,532 / p <1e-300 | 63.4 EB05 48.7 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=41 · ♀ 29% (drug 54%) | no trial data cached |
| Simple partial seizures | 19 | 55.9 35.5–88.0ROR 56.0 · χ² 947 / p 4e-208 | 51.9 EB05 35.1 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious n=18 | no trial data cached |
| Behaviour disorder | 118 | 53.3 44.5–63.9ROR 54.0 · χ² 5,873 / p <1e-300 | 51.7 EB05 44.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=97 | no trial data cached |
| Generalised tonic-clonic seizure | 341 | 49.9 44.9–55.4ROR 51.8 · χ² 15,963 / p <1e-300 | 48.8 EB05 44.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 35.4 | no trial data cached |
| Drug level fluctuating | 18 | 49.0 30.7–78.1ROR 49.1 · χ² 782 / p 2e-172 | 45.8 EB05 30.7 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious n=18 | no trial data cached |
| Status epilepticus | 221 | 46.7 41.0–53.3ROR 47.9 · χ² 9,650 / p <1e-300 | 45.6 EB05 40.8 · IC025 +5.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 32.9 | no trial data cached |
| Product availability issue | 392 | 41.7 37.8–46.0ROR 43.6 · χ² 15,285 / p <1e-300 | 40.9 EB05 37.6 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 51.9 · 85% consumer | no trial data cached |
| Anticonvulsant drug level increased | 28 | 41.1 28.3–59.6ROR 41.2 · χ² 1,036 / p 1e-227 | 39.4 EB05 28.6 · IC025 +3.9 3/3 methods agree | Lab value / disease marker | serious n=25 · ♀ 87% (drug 54%) | no trial data cached |
| Sleep deficit | 31 | 35.7 25.1–50.9ROR 35.9 · χ² 997 / p 4e-219 | 34.5 EB05 25.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=30 · ♀ 75% (drug 54%) · 74% consumer | no trial data cached |
| Hyperammonaemic encephalopathy | 23 | 31.9 21.2–48.1ROR 32.0 · χ² 649 / p 2e-143 | 30.8 EB05 21.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 54%) · 100% clinician | no trial data cached |
| Covid-19 immunisation | 11 | 30.9 17.0–56.0ROR 30.9 · χ² 285 / p 3e-64 | 29.1 EB05 17.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=11 | no trial data cached |
| Gaze palsy | 22 | 30.7 20.2–46.8ROR 30.8 · χ² 595 / p 9e-132 | 29.6 EB05 20.6 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=22 · 91% clinician | no trial data cached |
| Product dispensing issue | 45 | 29.9 22.3–40.0ROR 30.0 · χ² 1,211 / p 1e-265 | 29.2 EB05 22.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=44 · 100% consumer | no trial data cached |
| Inability to afford medication | 118 | 28.5 23.8–34.1ROR 28.8 · χ² 3,065 / p <1e-300 | 28.0 EB05 24.0 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=96 · 82% consumer | no trial data cached |
| Lip injury | 15 | 27.2 16.3–45.2ROR 27.2 · χ² 348 / p 5e-78 | 26.1 EB05 16.7 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Maternal exposure before pregnancy | 75 | 26.2 20.9–32.8ROR 26.4 · χ² 1,771 / p <1e-300 | 25.7 EB05 21.2 · IC025 +4.1 3/3 methods agree | Reporting / coding artifact | serious n=66 · ♀ 89% (drug 54%) | no trial data cached |
| Epilepsy | 332 | 25.8 23.2–28.7ROR 26.7 · χ² 7,811 / p <1e-300 | 25.5 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 | no trial data cached |
| Insurance issue | 143 | 22.8 19.4–26.8ROR 23.1 · χ² 2,931 / p <1e-300 | 22.5 EB05 19.6 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 26.1 · 83% consumer | no trial data cached |
| Intellectual disability | 13 | 21.7 12.6–37.5ROR 21.7 · χ² 234 / p 4e-53 | 20.7 EB05 12.6 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Gastrostomy | 13 | 20.0 11.6–34.5ROR 20.0 · χ² 214 / p 8e-49 | 19.1 EB05 11.4 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious n=13 | 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 | 3,218 | 67.7 65.8–69.6ROR 105.2 · χ² 206,405 / p <1e-300 | 65.7 EB05 63.9 · IC025 +6.0 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 47.4 | no trial data cached |
| Off label use (used outside approved label) | 1,137 | 3.1 2.9–3.2ROR 3.4 · χ² 1,657 / p <1e-300 | 3.1 EB05 2.9 · IC025 +1.5 3/3 methods agree | Reporting / coding artifact | serious PRR 3.5 | no trial data cached |
| Drug ineffective (drug did not work) | 996 | 1.8 1.7–1.9ROR 1.9 · χ² 358 / p 3e-80 | 1.8 EB05 1.7 · IC025 +0.7 | Reporting / coding artifact | serious PRR 3.1 | no trial data cached |
| Fatigue (tiredness) | 576 | 1.7 1.6–1.9ROR 1.8 · χ² 187 / p 6e-43 | 1.7 EB05 1.6 · IC025 +0.7 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Therapy interrupted | 518 | 17.7 16.3–19.3ROR 18.8 · χ² 8,129 / p <1e-300 | 17.6 EB05 16.4 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 25.7 · 86% consumer | no trial data cached |
| Somnolence (drowsiness) | 513 | 6.0 5.5–6.5ROR 6.3 · χ² 2,147 / p <1e-300 | 6.0 EB05 5.5 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.6 | no trial data cached |
| Overdose | 496 | 5.4 4.9–5.9ROR 5.6 · χ² 1,779 / p <1e-300 | 5.3 EB05 5.0 · IC025 +2.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.2 | no trial data cached |
| Dizziness | 464 | 2.2 2.0–2.4ROR 2.3 · χ² 305 / p 2e-68 | 2.2 EB05 2.0 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.2 | no trial data cached |
| Product availability issue | 392 | 41.7 37.8–46.0ROR 43.6 · χ² 15,285 / p <1e-300 | 40.9 EB05 37.6 · IC025 +5.1 3/3 methods agree | Reporting / coding artifact | serious PRR 51.9 · 85% consumer | no trial data cached |
| Fall | 369 | 2.6 2.4–2.9ROR 2.7 · χ² 369 / p 2e-82 | 2.6 EB05 2.4 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Generalised tonic-clonic seizure | 341 | 49.9 44.9–55.4ROR 51.8 · χ² 15,963 / p <1e-300 | 48.8 EB05 44.6 · IC025 +5.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 35.4 | no trial data cached |
| Product dose omission issue | 333 | 2.7 2.5–3.1ROR 2.8 · χ² 372 / p 3e-83 | 2.7 EB05 2.5 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 4.6 · 77% consumer | no trial data cached |
| Epilepsy | 332 | 25.8 23.2–28.7ROR 26.7 · χ² 7,811 / p <1e-300 | 25.5 EB05 23.3 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 18.5 | no trial data cached |
| Product use issue | 309 | 3.9 3.5–4.3ROR 4.0 · χ² 663 / p 2e-146 | 3.9 EB05 3.5 · IC025 +1.8 3/3 methods agree | Reporting / coding artifact | serious PRR 5.4 · 73% consumer | no trial data cached |
| Headache | 305 | 1.1 1.0–1.3ROR 1.1 · χ² 5 / p 0.010 | 1.1 EB05 1.0 · IC025 +0.0 | Not in label — unassessed | serious PRR 1.4 | 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.
- New onset refractory status epilepticus — n=33, PRR 1,060.4
- Vagal nerve stimulator implantation — n=33, PRR 293.7
- Postictal paralysis — n=21, PRR 222.9
- Sudden unexplained death in epilepsy — n=34, PRR 157.3
- Aura — n=73, PRR 95.8
- Tonic convulsion — n=45, PRR 77.8
- Myoclonic epilepsy — n=41, PRR 67.1
- Behaviour disorder — n=118, PRR 53.3
- Sleep deficit — n=31, PRR 35.7
- Hyperammonaemic encephalopathy — n=23, PRR 31.9
✓ 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, fatigue, somnolence, dizziness, fall, 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 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, 1,002 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.