What the label lists and what reports show
Deutetrabenazine side effects
Deutetrabenazine's FDA label: “Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue ( 6.1 ) Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with …” FAERS holds 7,234 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is depression (521 reports).
- No generic listed
- Boxed warning
Check it at the source: the deutetrabenazine FDA label on DailyMed (effective February 28, 2025, Teva Neuroscience, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of AUSTEDO XR and AUSTEDO?AUSTEDO XR and AUSTEDO can cause serious side effects, including: Depression and suicidal thoughts or actions in people with Huntington’s disease. See “ What is the most important information I should know about AUSTEDO XR and AUSTEDO? ” Irregular heartbeat (QT prolongation). AUSTEDO XR and AUSTEDO increases your chance of having certain changes in the electrical activity in your heart. These changes can lead to a dangerous abnormal heartbeat. Taking AUSTEDO XR or AUSTEDO with certain medicines may increase this chance. Neuroleptic Malignant Syndrome (NMS). Call your healthcare provider right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: high fever problems thinking increased sweating stiff muscles very fast or uneven heartbeat Restlessness. You may get a condition where you feel a strong urge to move. […]
Source: FDA drug label, Teva Neuroscience, Inc., effective February 28, 2025 (SPL set 7ea3c60a-45c7-44cc-afc2-d87fa53993c0), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue ( 6.1 ) Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Adverse Reaction | AUSTEDO (N = 45) % | Placebo (N = 45) % |
|---|---|---|
| Somnolence | 11 | 4 |
| Diarrhea | 9 | 0 |
| Dry mouth | 9 | 7 |
| Fatigue | 9 | 4 |
| Urinary tract infection | 7 | 2 |
| Insomnia | 7 | 4 |
| Anxiety | 4 | 2 |
| Constipation | 4 | 2 |
| Contusion | 4 | 2 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Suicidality in Patients with Huntington’s disease [see Warnings and Precautions ( 5.1 )] QTc Prolongation [see Warnings and Precautions ( 5.3 )] Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions ( 5.4 )] Akathisia, Agitation, and Restlessness [see Warnings and Precautions ( 5.5 )] Parkinsonism [see Warnings and Precautions ( 5.6 )] Sedation and Somnolence [see Warnings and Precautions ( 5.7 )] Hyperprolactinemia [see Warnings and Precautions ( 5.8 )] Binding to Melanin-Containing Tissues [see Warnings and Precautions ( 5.9 )] Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue ( 6.1 ) Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva Pharmaceuticals at 1-888-483-8279 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Teva Neuroscience, Inc., effective February 28, 2025 (SPL set 7ea3c60a-45c7-44cc-afc2-d87fa53993c0), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,234 reports list deutetrabenazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 581 are coded as a death and 937 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 16 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Deutetrabenazine: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions