Prescription medicine
Tetrabenazine Brand names: Xenazine
Tetrabenazine (Xenazine) is a prescription medicine with an FDA approval on record since 2008. FDA's NDC Directory lists it from 10 generic labelers, and pharmacies paid $0.702 per tetrabenazine 12.5 mg tablet in the October 7, 2026 NADAC survey.
- Generic listed
- Boxed warning
Check it at the source: the tetrabenazine FDA label on DailyMed (effective November 29, 2019, Oceanside Pharmaceuticals); the NDA 21894 record on Drugs@FDA; every tetrabenazine label on DailyMed.
Highlights of the record
FDA label of November 29, 2019; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
DEPRESSION AND SUICIDALITY.
Tetrabenazine tablets can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington's disease. Anyone considering the use of tetrabenazine tablets must balance the risks of depression and suicidality with the clinical need for control of chorea. Close observation of patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior should accompany therapy. Patients, their caregivers, and families should be informed of the risk of depression and suicidality and should be instructed to report behaviors of concern promptly to the treating physician. Particular caution should be exercised in treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease. Tetrabenazine tablets are contraindicated in patients who are actively suicidal, and in patients with untreated or inadequately treated depression [see Contraindications (4), ]. WARNING: DEPRESSION AND SUICIDALITY See full prescribing information for complete boxed warning. […]
Used for
From the label: indications and usageTetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease.
Forms and strengths
- 12.5 mg
- 25 mg
Tablet; coated tablet.
On the market
- Earliest approval on file
- August 15, 2008 Xenazine, Bausch; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 11 first August 17, 2015; 8 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 12 of which 10 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- $0.702 per tablet Tetrabenazine 12.5 mg tablet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 7,301 through July 30, 2026
What is tetrabenazine used for?
From the label: indications and usageTetrabenazine tablets are indicated for the treatment of chorea associated with Huntington's disease. Tetrabenazine tablets are a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington's disease.
FDA pharmacologic class: Vesicular Monoamine Transporter 2 Inhibitor.
Source: FDA drug label (tetrabenazine), 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 patient leaflet for tetrabenazine say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about tetrabenazine tablets?Tetrabenazine tablets can cause serious side effects, including: o depression o suicidal thoughts o suicidal actions • You should not start taking tetrabenazine tablets if you are depressed (have untreated depression or depression that is not well controlled by medicine) or have suicidal thoughts. • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts or feelings. This is especially important when tetrabenazine tablets are started and when the dose is changed. Call the doctor right away if you become depressed or have any of the following symptoms, especially if they are new, worse, or worry you: • feel sad or have crying spells • lose interest in seeing your friends or doing things you used to enjoy • sleep a lot more or a lot less than usual • feel unimportant • feel guilty • feel hopeless or helpless • more irritable, angry or aggressive than usual • more or less hungry than usual or notice a big change in your body weight • have trouble paying attention • feel tired or sleepy all the time • have thoughts about hurting yourself or ending your life
From the patient leaflet: What should I avoid while taking tetrabenazine tablets?Sleepiness (sedation) is a common side effect of tetrabenazine tablets. While taking tetrabenazine tablets, do not drive a car or operate dangerous machinery until you know how tetrabenazine tablets affect you. Drinking alcohol and taking other drugs that may also cause sleepiness while you are taking tetrabenazine tablets may increase any sleepiness caused by tetrabenazine tablets.
Source: FDA drug label (tetrabenazine), 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
Is there a generic for tetrabenazine (Xenazine)?
The FDA approved the first generic tetrabenazine on August 17, 2015. 11 generic applications are approved; 8 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists tetrabenazine from 10 labelers under a generic (ANDA) application and from 1 brand labeler. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
- 2008 earliest approval on file
- 2015 first generic approved
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for tetrabenazine (Xenazine)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $0.702 per Tetrabenazine 12.5 mg tablet, down 8% from $0.764 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Tetrabenazine 12.5 mg tablet (generic)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Tetrabenazine 12.5 mg tablet | Generic | $0.702 per tablet | $21.06 | -8% |
| Tetrabenazine 25 mg tablet | Generic | $1.34 per tablet | $40.09 | -1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
What does the tetrabenazine label say about other medicines?
The tetrabenazine label names 15 other medicines in its interaction, contraindication or warning sections. The labels of 3 other medicines name tetrabenazine. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Amiodarone | drug interactions | … ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval. |
| Chlorpromazine | drug interactions | Tetrabenazine tablets cause a small prolongation of QTc (about 8 msec), concomitant use with other drugs that are known to cause QTc prolongation should be avoided, these including antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A … |
| Deutetrabenazine | contraindications | Taking monoamine oxidase inhibitors (MAOIs) or reserpine Taking deutetrabenazine or valbenazine |
| Fluoxetine | drug interactions | Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) markedly increase exposure to these metabolites. |
| Haloperidol | drug interactions | Tetrabenazine tablets cause a small prolongation of QTc (about 8 msec), concomitant use with other drugs that are known to cause QTc prolongation should be avoided, these including antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A … |
| Moxifloxacin | drug interactions | … antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval. |
| Olanzapine | drug interactions | The risk for Parkinsonism, NMS, and akathisia may be increased by concomitant use of tetrabenazine tablets and dopamine antagonists or antipsychotics (e.g., chlorpromazine, haloperidol, olanzapine, risperidone, thioridazine, ziprasidone) [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 )]. |
| Paroxetine | drug interactions | Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) markedly increase exposure to these metabolites. |
| Procainamide | drug interactions | … chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval. |
| Quinidine | drug interactions | Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) markedly increase exposure to these metabolites. |
| Risperidone | drug interactions | The risk for Parkinsonism, NMS, and akathisia may be increased by concomitant use of tetrabenazine tablets and dopamine antagonists or antipsychotics (e.g., chlorpromazine, haloperidol, olanzapine, risperidone, thioridazine, ziprasidone) [see Warnings and Precautions ( 5.4 , 5.5 , 5.6 )]. |
| Sotalol | drug interactions | … antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone, sotalol) antiarrhythmic medications or any other medications known to prolong the QTc interval. |
| Thioridazine | drug interactions | Tetrabenazine tablets cause a small prolongation of QTc (about 8 msec), concomitant use with other drugs that are known to cause QTc prolongation should be avoided, these including antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A … |
| Valbenazine | contraindications | Taking monoamine oxidase inhibitors (MAOIs) or reserpine Taking deutetrabenazine or valbenazine |
Every other medicine the tetrabenazine label names
| Medicine named | Section | What the label says |
|---|---|---|
| Ziprasidone | drug interactions | … antipsychotic medications (e.g., chlorpromazine, haloperidol, thioridazine, ziprasidone), antibiotics (e.g., moxifloxacin), Class 1A (e.g., quinidine, procainamide) and Class III (e.g., amiodarone … |
Other labels that name tetrabenazine
Source: FDA drug label (tetrabenazine), 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 for tetrabenazine?
The FDA Adverse Event Reporting System holds 7,301 reports that list tetrabenazine among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other vesicular monoamine transporter 2 inhibitors
- the pharmacologic class, with prices and generics
- Tetrabenazine side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other