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Drug side effects

brivaracetam Side Effects

The reactions most often reported to the FDA for brivaracetam (also sold as Briviact), with demographics, serious outcomes, and reporting trends.

Data updated 2026-05-15

4,286
FAERS reports

Data from the FDA Adverse Event Reporting System (FAERS), 2010 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.

The most commonly reported side effects of brivaracetam come from 4,286 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.

This page analyzes 4,286 reports to the FDA Adverse Event Reporting System (FAERS) for brivaracetam (Briviact): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.

Total Reports

4,286

Reports Mentioning Death

236

5.5% of reports — not proof the medicine caused the death

Hospitalizations

1,362

31.8% of reports

Top Indication

Seizure

Most Reported Adverse Reactions

SEIZURE
1,810
THERAPY INTERRUPTED
280
OVERDOSE
233
FATIGUE
230
SOMNOLENCE
216
DIZZINESS
213
PRODUCT AVAILABILITY ISSUE
211
FALL
199
MULTIPLE-DRUG RESISTANCE
165
GENERALISED TONIC-CLONIC SEIZURE
162
EPILEPSY
151
AGGRESSION
148
HEADACHE
144
MEMORY IMPAIRMENT
128
DEPRESSION
127
ANXIETY
120
STATUS EPILEPTICUS
120

Who Reports Side Effects

Gender Distribution

Female 1,929 (53%)
Male 1,721 (47%)
Unknown 2

Age Distribution

0-17 314 (12%)
18-44 1,264 (47%)
45-64 662 (25%)
65-74 255 (9%)
75+ 207 (8%)

Reporting Trend by Year

10
12
14
15
16
17
18
19
20
21
22
23
24
25

Reactions in Death Reports

Top reactions reported in 236 reports where death was an outcome. These are voluntarily reported and do not establish causation.

Reaction Reports
DEATH 81
SEIZURE 25
SUDDEN UNEXPLAINED DEATH IN EPILEPSY 19
CARDIAC ARREST 15
COMPLETED SUICIDE 14
OVERDOSE 13
CARDIO-RESPIRATORY ARREST 9
RESPIRATORY FAILURE 9
CEREBROVASCULAR ACCIDENT 8
MATERNAL DEATH 8
PARTIAL SEIZURES 8
GENERALISED TONIC-CLONIC SEIZURE 6
STATUS EPILEPTICUS 6
ANGER 5
BALANCE DISORDER 5
CONFUSIONAL STATE 5
EPILEPSY 5

Reactions in Hospitalization Reports

Top reactions in 1,362 reports where hospitalization was an outcome.

Reaction Reports
SEIZURE 492
FALL 99
THERAPY INTERRUPTED 82
OVERDOSE 76
DIZZINESS 74
HOSPITALISATION 69
STATUS EPILEPTICUS 68
GENERALISED TONIC-CLONIC SEIZURE 65
SOMNOLENCE 65
FATIGUE 59
VOMITING 52
EPILEPSY 49
PRODUCT AVAILABILITY ISSUE 48
DEPRESSION 47
MEMORY IMPAIRMENT 46
CONDITION AGGRAVATED 45
PNEUMONIA 43

Compare brivaracetam vs cannabidiol →

What the FAERS Data Reveals About brivaracetam Side Effects

The FDA Adverse Event Reporting System (FAERS) contains 4,286 voluntary reports linked to brivaracetam and its brand equivalents (Briviact), spanning 2010 through 2025. Of those, 236 (5.5%) listed death as an outcome and 1,362 (31.8%) involved hospitalization. The most common indication reported alongside adverse events was Seizure.

Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 53% were female and 47% male; age distribution skews toward 18-44, with 1,264 reports in that bracket. The single most reported reaction is seizure with 1,810 submissions, followed by therapy interrupted and overdose.

How to read these numbers

FAERS is a signal-detection tool, not a scorecard. Reports are voluntary, and a single case may list multiple suspect drugs, so numbers above should not be read as incidence rates or per-patient risk. Widely prescribed drugs naturally accumulate more reports than niche therapies even when individual risk is low. These aggregates are useful for spotting patterns that merit further pharmacovigilance, not for choosing between medications. This page is for educational reference only and is not medical advice, speak with a licensed clinician about any side-effect concerns.

Drugs With a Similar FAERS Report Volume

Other medications with a total FDA adverse-event report count closest to brivaracetam's 4,286.