oxcarbazepine Side Effects
Also known as: Trileptal
Analysis of 31,347 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
31,347
Death-Related
2,109
6.7% of reports
Hospitalizations
9,541
30.4% 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 2,109 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 537 |
| DEATH | 470 |
| TOXICITY TO VARIOUS AGENTS | 200 |
| CARDIAC ARREST | 162 |
| CARDIO-RESPIRATORY ARREST | 141 |
| SEIZURE | 100 |
| RESPIRATORY ARREST | 92 |
| OFF LABEL USE | 82 |
| PNEUMONIA | 81 |
| CONVULSION | 71 |
| DRUG INEFFECTIVE | 58 |
| METABOLIC ACIDOSIS | 56 |
| PYREXIA | 54 |
| RESPIRATORY FAILURE | 54 |
| SUDDEN UNEXPLAINED DEATH IN EPILEPSY | 53 |
| ARRHYTHMIA | 52 |
| FALL | 50 |
| ELECTROCARDIOGRAM QT PROLONGED | 48 |
| STATUS EPILEPTICUS | 48 |
| SEPTIC SHOCK | 47 |
Reactions in Hospitalization Reports
Top reactions in 9,541 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| SEIZURE | 848 |
| HYPONATRAEMIA | 751 |
| DRUG INEFFECTIVE | 723 |
| FALL | 648 |
| OFF LABEL USE | 586 |
| DIZZINESS | 534 |
| DRUG INTERACTION | 529 |
| CONVULSION | 521 |
| VOMITING | 513 |
| PYREXIA | 478 |
| NAUSEA | 441 |
| FATIGUE | 440 |
| HEADACHE | 432 |
| SOMNOLENCE | 425 |
| DYSPNOEA | 415 |
| PAIN | 376 |
| ASTHENIA | 374 |
| TOXICITY TO VARIOUS AGENTS | 357 |
| DEPRESSION | 349 |
| RASH | 335 |
Nearby — Related Medications
What the FAERS Data Reveals About oxcarbazepine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 31,347 voluntary reports linked to oxcarbazepine and its brand equivalents (Trileptal), spanning 2001 through 2025. Of those, 2,109 (6.7%) listed death as an outcome and 9,541 (30.4%) 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, 59% were female and 41% male; age distribution skews toward 18-44, with 7,102 reports in that bracket. The single most reported reaction is drug ineffective with 2,867 submissions, followed by seizure 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.
Read our methodology — how this data is sourced, computed, and verified.