cenobamate Side Effects
Also known as: Xcopri
Analysis of 6,460 adverse event reports submitted to the FDA from 2019 to 2025.
Total Reports
6,460
Death-Related
156
2.4% of reports
Hospitalizations
1,300
20.1% of reports
Top Indication
Product Used For Unknown Indication
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 156 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 64 |
| SEIZURE | 27 |
| CARDIAC ARREST | 13 |
| DRUG INEFFECTIVE | 13 |
| SUDDEN UNEXPLAINED DEATH IN EPILEPSY | 12 |
| COMPLETED SUICIDE | 11 |
| PRODUCT DOSE OMISSION ISSUE | 10 |
| CARDIO-RESPIRATORY ARREST | 9 |
| OFF LABEL USE | 8 |
| FALL | 5 |
| AGITATION | 4 |
| HOSPITALISATION | 4 |
| HYPOTENSION | 4 |
| SOMNOLENCE | 4 |
| TOXICITY TO VARIOUS AGENTS | 4 |
| BRADYCARDIA | 3 |
| CHEST PAIN | 3 |
| DECREASED APPETITE | 3 |
| DIZZINESS | 3 |
| HEAD INJURY | 3 |
Reactions in Hospitalization Reports
Top reactions in 1,300 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| SEIZURE | 486 |
| PRODUCT DOSE OMISSION ISSUE | 194 |
| HOSPITALISATION | 159 |
| FALL | 158 |
| OFF LABEL USE | 150 |
| SOMNOLENCE | 127 |
| DIZZINESS | 121 |
| DRUG INTERACTION | 107 |
| FATIGUE | 105 |
| DRUG INEFFECTIVE | 72 |
| WRONG TECHNIQUE IN PRODUCT USAGE PROCESS | 66 |
| BALANCE DISORDER | 58 |
| GAIT DISTURBANCE | 58 |
| VOMITING | 57 |
| ASTHENIA | 50 |
| PRODUCT USE ISSUE | 49 |
| PNEUMONIA | 47 |
| DECREASED APPETITE | 46 |
| STATUS EPILEPTICUS | 45 |
| DYSARTHRIA | 44 |
Nearby — Related Medications
What the FAERS Data Reveals About cenobamate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,460 voluntary reports linked to cenobamate and its brand equivalents (Xcopri), spanning 2019 through 2025. Of those, 156 (2.4%) listed death as an outcome and 1,300 (20.1%) involved hospitalization. The most common indication reported alongside adverse events was Product Used For Unknown Indication.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 54% were female and 45% male; age distribution skews toward 18-44, with 486 reports in that bracket. The single most reported reaction is seizure with 1,815 submissions, followed by product dose omission issue and fatigue.
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.
Read our methodology — how this data is sourced, computed, and verified.