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brivaracetam Side Effects

Also known as: Briviact

Analysis of 4,286 adverse event reports submitted to the FDA from 2010 to 2025.

Total Reports

4,286

Death-Related

236

5.5% of reports

Hospitalizations

1,362

31.8% of reports

Top Indication

Seizure

Most Reported Adverse Reactions

SEIZURE
1,810
DRUG INEFFECTIVE
568
OFF LABEL USE
552
THERAPY INTERRUPTED
280
OVERDOSE
233
FATIGUE
230
SOMNOLENCE
216
DIZZINESS
213
PRODUCT AVAILABILITY ISSUE
211
FALL
199
PRODUCT USE ISSUE
168
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
DRUG INEFFECTIVE 25
SEIZURE 25
OFF LABEL USE 23
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
PRODUCT USE ISSUE 7
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
DRUG INEFFECTIVE 188
OFF LABEL USE 159
FALL 99
THERAPY INTERRUPTED 82
OVERDOSE 76
DIZZINESS 74
HOSPITALISATION 69
STATUS EPILEPTICUS 68
GENERALISED TONIC-CLONIC SEIZURE 65
SOMNOLENCE 65
FATIGUE 59
PRODUCT USE ISSUE 53
VOMITING 52
EPILEPSY 49
PRODUCT AVAILABILITY ISSUE 48
DEPRESSION 47
MEMORY IMPAIRMENT 46
CONDITION AGGRAVATED 45
PNEUMONIA 43

Nearby — Related Medications

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 drug ineffective and off label use.

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.