Drug side effects
deutetrabenazine Side Effects
The reactions most often reported to the FDA for deutetrabenazine (also sold as Austedo), with demographics, serious outcomes, and reporting trends.
Data updated 2026-05-15
- 6,445
- FAERS reports
Data from the FDA Adverse Event Reporting System (FAERS), 2016 to 2025. A FAERS report records a temporal association, not proof of cause. See our methodology for how figures are compiled and de-duplicated.
The most commonly reported side effects of deutetrabenazine come from 6,445 reports to the FDA, broken down here by frequency, patient demographics, and serious outcomes.
This page analyzes 6,445 reports to the FDA Adverse Event Reporting System (FAERS) for deutetrabenazine (Austedo): the reactions reported most often, who reported them, serious outcomes such as hospitalization, and year-over-year trends. A FAERS report does not prove the drug caused the effect, and report volume tracks how widely a drug is used, not how likely an effect is for any one person. Educational information, not medical advice.
Total Reports
6,445
Reports Mentioning Death
464
7.2% of reports — not proof the medicine caused the death
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 |
| FALL | 7 |
| PNEUMONIA | 7 |
| DISEASE PROGRESSION | 6 |
| HOSPITALISATION | 6 |
| TOXICITY TO VARIOUS AGENTS | 6 |
| HOSPICE CARE | 5 |
| INAPPROPRIATE SCHEDULE OF PRODUCT ADMINISTRATION | 5 |
| CARDIAC ARREST | 4 |
| DEPRESSION | 4 |
| DYSPHAGIA | 4 |
| HUNTINGTON^S DISEASE | 4 |
| INCORRECT DOSE ADMINISTERED | 4 |
| MYOCARDIAL INFARCTION | 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 |
| DIZZINESS | 35 |
| PNEUMONIA | 35 |
| URINARY TRACT INFECTION | 33 |
| TARDIVE DYSKINESIA | 31 |
| DYSKINESIA | 30 |
| FATIGUE | 30 |
| ASTHENIA | 28 |
| 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 depression with 463 submissions, followed by dyskinesia and death.
How to read these numbers
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.
Drugs With a Similar FAERS Report Volume
Other medications with a total FDA adverse-event report count closest to deutetrabenazine's 6,445.
Read our methodology - how this data is sourced, computed, and verified.