felbamate Side Effects
Also known as: Felbatol
Analysis of 1,714 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
1,714
Death-Related
86
5.0% of reports
Hospitalizations
529
30.9% 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 86 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| CARDIAC ARREST | 22 |
| DEATH | 20 |
| TACHYCARDIA | 18 |
| TOXICITY TO VARIOUS AGENTS | 18 |
| CIRCULATORY COLLAPSE | 14 |
| ELECTROCARDIOGRAM QRS COMPLEX PROLONGED | 14 |
| ATRIOVENTRICULAR BLOCK FIRST DEGREE | 13 |
| CARDIOTOXICITY | 13 |
| ELECTROCARDIOGRAM ST SEGMENT ELEVATION | 13 |
| ELECTROCARDIOGRAM REPOLARISATION ABNORMALITY | 12 |
| SINUS BRADYCARDIA | 12 |
| SYSTOLIC DYSFUNCTION | 12 |
| VENTRICULAR HYPOKINESIA | 12 |
| UNMASKING OF PREVIOUSLY UNIDENTIFIED DISEASE | 11 |
| VENTRICULAR EXTRASYSTOLES | 11 |
| SEIZURE | 7 |
| SUDDEN UNEXPLAINED DEATH IN EPILEPSY | 7 |
| HYPOTENSION | 6 |
| METABOLIC ACIDOSIS | 6 |
| RESPIRATORY FAILURE | 6 |
Reactions in Hospitalization Reports
Top reactions in 529 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| SEIZURE | 109 |
| DRUG INEFFECTIVE | 83 |
| CONVULSION | 41 |
| OFF LABEL USE | 41 |
| TOXICITY TO VARIOUS AGENTS | 40 |
| PNEUMONIA | 39 |
| VOMITING | 36 |
| TACHYCARDIA | 35 |
| SOMNOLENCE | 33 |
| CONDITION AGGRAVATED | 30 |
| DRUG INTERACTION | 29 |
| HOSPITALISATION | 29 |
| FATIGUE | 27 |
| FALL | 25 |
| STATUS EPILEPTICUS | 22 |
| CARDIAC ARREST | 20 |
| DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS | 20 |
| PYREXIA | 19 |
| ASTHENIA | 18 |
| EPILEPSY | 18 |
Nearby — Related Medications
What the FAERS Data Reveals About felbamate Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 1,714 voluntary reports linked to felbamate and its brand equivalents (Felbatol), spanning 2004 through 2025. Of those, 86 (5.0%) listed death as an outcome and 529 (30.9%) 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, 52% were female and 48% male; age distribution skews toward 0-17, with 405 reports in that bracket. The single most reported reaction is seizure with 345 submissions, followed by drug ineffective and convulsion.
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.