tetrabenazine Side Effects
Also known as: Xenazine
Analysis of 7,235 adverse event reports submitted to the FDA from 2004 to 2025.
Total Reports
7,235
Death-Related
1,527
21.1% of reports
Hospitalizations
1,469
20.3% of reports
Top Indication
Huntington^S Disease
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 1,527 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 1,210 |
| OFF LABEL USE | 110 |
| PRESCRIBED OVERDOSE | 56 |
| PNEUMONIA | 47 |
| HUNTINGTON^S DISEASE | 40 |
| HOSPITALISATION | 34 |
| DYSPHAGIA | 33 |
| FALL | 32 |
| PNEUMONIA ASPIRATION | 28 |
| DISEASE PROGRESSION | 21 |
| SOMNOLENCE | 21 |
| INTENTIONAL PRODUCT USE ISSUE | 20 |
| DYSKINESIA | 17 |
| CARDIAC ARREST | 16 |
| DRUG ADMINISTRATION ERROR | 16 |
| HUNTINGTON'S DISEASE | 16 |
| ASPIRATION | 13 |
| COMPLETED SUICIDE | 13 |
| HOSPICE CARE | 13 |
| DECREASED APPETITE | 12 |
Reactions in Hospitalization Reports
Top reactions in 1,469 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 293 |
| OFF LABEL USE | 216 |
| FALL | 124 |
| PNEUMONIA | 85 |
| DRUG INEFFECTIVE | 80 |
| DEPRESSION | 79 |
| DEATH | 74 |
| ANXIETY | 60 |
| DYSPHAGIA | 56 |
| TARDIVE DYSKINESIA | 53 |
| URINARY TRACT INFECTION | 53 |
| SOMNOLENCE | 52 |
| INVESTIGATION | 49 |
| DYSKINESIA | 48 |
| CONDITION AGGRAVATED | 47 |
| DEHYDRATION | 45 |
| VOMITING | 45 |
| NAUSEA | 44 |
| PRESCRIBED OVERDOSE | 43 |
| DYSTONIA | 42 |
Nearby — Related Medications
What the FAERS Data Reveals About tetrabenazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 7,235 voluntary reports linked to tetrabenazine and its brand equivalents (Xenazine), spanning 2004 through 2025. Of those, 1,527 (21.1%) listed death as an outcome and 1,469 (20.3%) involved hospitalization. The most common indication reported alongside adverse events was Huntington^S Disease.
Demographic breakdowns help contextualize who is being exposed to the drug. Of reports with known sex, 58% were female and 42% male; age distribution skews toward 45-64, with 1,496 reports in that bracket. The single most reported reaction is death with 1,216 submissions, followed by off label use and drug ineffective.
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.