lamotrigine Side Effects
Also known as: Lamictal
Analysis of 127,196 adverse event reports submitted to the FDA from 2002 to 2025.
Total Reports
127,196
Death-Related
10,680
8.4% of reports
Hospitalizations
38,667
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 10,680 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 3,161 |
| TOXICITY TO VARIOUS AGENTS | 1,790 |
| DEATH | 1,531 |
| OFF LABEL USE | 1,001 |
| GENERAL PHYSICAL HEALTH DETERIORATION | 835 |
| MATERNAL EXPOSURE DURING PREGNANCY | 823 |
| RASH | 770 |
| PEMPHIGUS | 741 |
| TYPE 2 DIABETES MELLITUS | 736 |
| SYSTEMIC LUPUS ERYTHEMATOSUS | 733 |
| CONFUSIONAL STATE | 721 |
| PERICARDITIS | 713 |
| CARDIO-RESPIRATORY ARREST | 711 |
| CARDIAC ARREST | 709 |
| SYNOVITIS | 708 |
| DRUG INEFFECTIVE | 694 |
| GLOSSODYNIA | 686 |
| HYPERTENSION | 677 |
| PAIN | 674 |
| EPILEPSY | 672 |
Reactions in Hospitalization Reports
Top reactions in 38,667 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| RASH | 3,158 |
| PYREXIA | 2,977 |
| DRUG INEFFECTIVE | 2,698 |
| OFF LABEL USE | 2,341 |
| VOMITING | 2,296 |
| NAUSEA | 2,232 |
| SEIZURE | 2,209 |
| DIZZINESS | 2,011 |
| TOXICITY TO VARIOUS AGENTS | 1,979 |
| FATIGUE | 1,960 |
| HEADACHE | 1,934 |
| FALL | 1,910 |
| DEPRESSION | 1,866 |
| CONFUSIONAL STATE | 1,798 |
| DRUG INTERACTION | 1,769 |
| DRUG REACTION WITH EOSINOPHILIA AND SYSTEMIC SYMPTOMS | 1,727 |
| STEVENS-JOHNSON SYNDROME | 1,697 |
| INTENTIONAL OVERDOSE | 1,669 |
| OVERDOSE | 1,623 |
| SOMNOLENCE | 1,612 |
Nearby — Related Medications
What the FAERS Data Reveals About lamotrigine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 127,196 voluntary reports linked to lamotrigine and its brand equivalents (Lamictal), spanning 2002 through 2025. Of those, 10,680 (8.4%) listed death as an outcome and 38,667 (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, 68% were female and 32% male; age distribution skews toward 18-44, with 35,619 reports in that bracket. The single most reported reaction is drug ineffective with 9,923 submissions, followed by rash and seizure.
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.