tiagabine Side Effects
Also known as: Gabitril
Analysis of 81 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
81
Death-Related
7
8.6% of reports
Hospitalizations
32
39.5% of reports
Top Indication
Multiple Sclerosis
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 7 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| COMPLETED SUICIDE | 3 |
| DEATH | 2 |
| CARDIAC ARREST | 1 |
| CONVULSION | 1 |
| OVERDOSE | 1 |
| RESPIRATORY ARREST | 1 |
| UNEVALUABLE EVENT | 1 |
| WEIGHT INCREASED | 1 |
Reactions in Hospitalization Reports
Top reactions in 32 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| ENCEPHALOPATHY | 14 |
| MYOCLONUS | 14 |
| OFF LABEL USE | 11 |
| DRUG INEFFECTIVE | 7 |
| FATIGUE | 3 |
| INSOMNIA | 3 |
| TOXICITY TO VARIOUS AGENTS | 3 |
| ANXIETY | 2 |
| DRUG INTERACTION | 2 |
| DYSARTHRIA | 2 |
| DYSKINESIA | 2 |
| HAEMOGLOBIN DECREASED | 2 |
| MUSCLE TWITCHING | 2 |
| PNEUMONIA | 2 |
| SEDATION | 2 |
| SOMNOLENCE | 2 |
| STATUS EPILEPTICUS | 2 |
| TREMOR | 2 |
| ABDOMINAL INJURY | 1 |
| ABDOMINAL PAIN | 1 |
Nearby — Related Medications
What the FAERS Data Reveals About tiagabine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 81 voluntary reports linked to tiagabine and its brand equivalents (Gabitril), spanning 2004 through 2025. Of those, 7 (8.6%) listed death as an outcome and 32 (39.5%) involved hospitalization. The most common indication reported alongside adverse events was Multiple Sclerosis.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 76% were female and 24% male; age distribution skews toward 45-64, with 26 reports in that bracket. The single most reported reaction is encephalopathy with 16 submissions, followed by myoclonus 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.