carbamazepine Side Effects
Also known as: Tegretol
Analysis of 65,260 adverse event reports submitted to the FDA from 2001 to 2025.
Total Reports
65,260
Death-Related
5,503
8.4% of reports
Hospitalizations
25,279
38.7% 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 5,503 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 920 |
| DEATH | 906 |
| TOXICITY TO VARIOUS AGENTS | 742 |
| CARDIAC ARREST | 366 |
| CARDIO-RESPIRATORY ARREST | 270 |
| DRUG INTERACTION | 268 |
| OVERDOSE | 263 |
| PNEUMONIA | 257 |
| DRUG ABUSE | 223 |
| PYREXIA | 207 |
| OFF LABEL USE | 194 |
| DRUG INEFFECTIVE | 173 |
| CONDITION AGGRAVATED | 172 |
| RESPIRATORY FAILURE | 172 |
| RESPIRATORY ARREST | 166 |
| DYSPNOEA | 153 |
| SEPSIS | 142 |
| CONVULSION | 136 |
| MALAISE | 136 |
| MULTI-ORGAN FAILURE | 132 |
Reactions in Hospitalization Reports
Top reactions in 25,279 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| FALL | 1,951 |
| PYREXIA | 1,861 |
| TOXICITY TO VARIOUS AGENTS | 1,661 |
| DRUG INTERACTION | 1,607 |
| VOMITING | 1,572 |
| DRUG INEFFECTIVE | 1,413 |
| NAUSEA | 1,288 |
| PAIN | 1,264 |
| HYPOTENSION | 1,193 |
| RASH | 1,151 |
| DIZZINESS | 1,132 |
| OFF LABEL USE | 1,074 |
| HYPONATRAEMIA | 1,069 |
| BALANCE DISORDER | 1,020 |
| PNEUMONIA | 1,015 |
| SEIZURE | 1,009 |
| SOMNOLENCE | 1,006 |
| CONSTIPATION | 985 |
| OVERDOSE | 950 |
| CONDITION AGGRAVATED | 942 |
Nearby — Related Medications
What the FAERS Data Reveals About carbamazepine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 65,260 voluntary reports linked to carbamazepine and its brand equivalents (Tegretol), spanning 2001 through 2025. Of those, 5,503 (8.4%) listed death as an outcome and 25,279 (38.7%) 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, 58% were female and 41% male; age distribution skews toward 45-64, with 14,484 reports in that bracket. The single most reported reaction is drug ineffective with 4,898 submissions, followed by seizure and drug interaction.
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.