deutetrabenazine Side Effects
Also known as: Austedo
Analysis of 6,445 adverse event reports submitted to the FDA from 2016 to 2025.
Total Reports
6,445
Death-Related
464
7.2% of reports
Hospitalizations
802
12.4% of reports
Top Indication
Tardive Dyskinesia
Most Reported Adverse Reactions
Who Reports Side Effects
Gender Distribution
Age Distribution
Reporting Trend by Year
Reactions in Death Reports
Top reactions reported in 464 reports where death was an outcome. These are voluntarily reported and do not establish causation.
| Reaction | Reports |
|---|---|
| DEATH | 400 |
| COMPLETED SUICIDE | 19 |
| PRODUCT USE IN UNAPPROVED INDICATION | 10 |
| FALL | 7 |
| PNEUMONIA | 7 |
| DISEASE PROGRESSION | 6 |
| HOSPITALISATION | 6 |
| PRODUCT USE ISSUE | 6 |
| TOXICITY TO VARIOUS AGENTS | 6 |
| HOSPICE CARE | 5 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 5 |
| CARDIAC ARREST | 4 |
| DEPRESSION | 4 |
| DRUG INEFFECTIVE | 4 |
| DYSPHAGIA | 4 |
| HUNTINGTON^S DISEASE | 4 |
| INCORRECT DOSE ADMINISTERED | 4 |
| MYOCARDIAL INFARCTION | 4 |
| OFF LABEL USE | 4 |
| ASTHENIA | 3 |
Reactions in Hospitalization Reports
Top reactions in 802 reports where hospitalization was an outcome.
| Reaction | Reports |
|---|---|
| HOSPITALISATION | 113 |
| FALL | 82 |
| DEPRESSION | 59 |
| TREMOR | 48 |
| SUICIDAL IDEATION | 40 |
| CONFUSIONAL STATE | 39 |
| DRUG INEFFECTIVE | 38 |
| DIZZINESS | 35 |
| PNEUMONIA | 35 |
| URINARY TRACT INFECTION | 33 |
| TARDIVE DYSKINESIA | 31 |
| DYSKINESIA | 30 |
| FATIGUE | 30 |
| PRODUCT DOSE OMISSION ISSUE | 30 |
| ASTHENIA | 28 |
| PRODUCT USE ISSUE | 27 |
| GAIT DISTURBANCE | 24 |
| LOSS OF PERSONAL INDEPENDENCE IN DAILY ACTIVITIES | 24 |
| INSOMNIA | 23 |
| SPEECH DISORDER | 23 |
Nearby — Related Medications
What the FAERS Data Reveals About deutetrabenazine Side Effects
The FDA Adverse Event Reporting System (FAERS) contains 6,445 voluntary reports linked to deutetrabenazine and its brand equivalents (Austedo), spanning 2016 through 2025. Of those, 464 (7.2%) listed death as an outcome and 802 (12.4%) involved hospitalization. The most common indication reported alongside adverse events was Tardive Dyskinesia.
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 45-64, with 1,505 reports in that bracket. The single most reported reaction is drug ineffective with 924 submissions, followed by depression and dyskinesia.
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.