What the label lists and what reports show
Tetrabenazine side effects
Tetrabenazine's FDA label: “Most common adverse reactions (greater than 10% and at least 5% greater than placebo) were: sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, nausea.” FAERS holds 7,301 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 (476 reports).
- Generic listed
- Boxed warning
Check it at the source: the tetrabenazine FDA label on DailyMed (effective November 29, 2019, Oceanside Pharmaceuticals); 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 tetrabenazine tablets?Tetrabenazine tablets can cause serious side effects, including: • Depression, suicidal thoughts, or actions. See “ What is the most important information I should know about tetrabenazine tablets?” • Neuroleptic Malignant Syndrome (NMS). Call your doctor right away and go to the nearest emergency room if you develop these signs and symptoms that do not have another obvious cause: o high fever o stiff muscles o problems thinking o very fast or uneven heartbeat o increased sweating • Parkinsonism. Symptoms of Parkinsonism include: slight shaking, body stiffness, trouble moving or keeping your balance. • Restlessness. You may get a condition where you feel a strong urge to move. This is called akathisia. • Irregular heartbeat. Tetrabenazine tablets increase your chance of having certain changes in the electrical activity in your heart which can be seen on an electrocardiogram (EKG). […]
Source: FDA drug label, NDA021894 (Bausch), as published by Oceanside Pharmaceuticals, effective November 29, 2019 (SPL set 5867189c-17bd-4e70-a079-c4730f9950d1), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (greater than 10% and at least 5% greater than placebo) were: sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, nausea.
Table 1: Adverse Reactions in a 12-Week, Double-Blind, Placebo-Controlled Trial in Patients with Huntington’s Disease
| Adverse Reaction | Tetrabenazine Tablets n=54 % | Placebo n=30 % |
|---|---|---|
| Sedation/somnolence | 31 | 3 |
| Insomnia | 22 | 0 |
| Fatigue | 22 | 13 |
| Depression | 19 | 0 |
| Akathisia | 19 | 0 |
| Anxiety/anxiety aggravated | 15 | 3 |
| Fall | 15 | 13 |
| Nausea | 13 | 7 |
| Upper respiratory tract infection | 11 | 7 |
| Irritability | 9 | 3 |
| Balance difficulty | 9 | 0 |
| Parkinsonism/bradykinesia | 9 | 0 |
| Vomiting | 6 | 3 |
| Laceration (head) | 6 | 0 |
| Ecchymosis | 6 | 0 |
| Decreased appetite | 4 | 0 |
| Obsessive reaction | 4 | 0 |
| Dizziness | 4 | 0 |
| Dysarthria | 4 | 0 |
| Unsteady gait | 4 | 0 |
| Headache | 4 | 3 |
| Shortness of breath | 4 | 0 |
| Bronchitis | 4 | 0 |
| Dysuria | 4 | 0 |
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 described below and elsewhere in the labeling: • Depression and Suicidality [see Warnings and Precautions (5.1) ] • Neuroleptic Malignant Syndrome (NMS) [see Warnings and Precautions (5.4) ] • Akathisia, Restlessness, and Agitation [see Warnings and Precautions (5.5) ] • Parkinsonism [see Warnings and Precautions (5.6) ] • Sedation and Somnolence [see Warnings and Precautions (5.7) ] • QTc Prolongation [see Warnings and Precautions (5.8) ] • Hypotension and Orthostatic Hypotension [see Warnings and Precautions (5.9) ] • Hyperprolactinemia [see Warnings and Precautions (5.10) ] • Binding to Melanin-Containing Tissues [see Warnings and Precautions (5.11) ] Most common adverse reactions (greater than 10% and at least 5% greater than placebo) were: sedation/somnolence, fatigue, insomnia, depression, akathisia, anxiety/anxiety aggravated, nausea. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Oceanside Pharmaceuticals at 1-800-321-4576 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. …
Source: FDA drug label, NDA021894 (Bausch), as published by Oceanside Pharmaceuticals, effective November 29, 2019 (SPL set 5867189c-17bd-4e70-a079-c4730f9950d1), via openFDA; the full label on DailyMed
What do FAERS reports show?
7,301 reports list tetrabenazine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1,531 are coded as a death and 1,498 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 17 reactions below, 8 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?
- Tetrabenazine: 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