Tetrabenazine is a vesicular monoamine transporter 2 inhibitor indicated for the treatment of chorea associated with Huntington’s disease. It is available as tablets for oral use. MedsAcross supplies Tetrabenazine for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
XENAZINE is indicated for the treatment of chorea associated with Huntington’s disease. XENAZINE is a vesicular monoamine transporter 2 (VMAT) inhibitor indicated for the treatment of chorea associated with Huntington’s disease.
Source: US FDA prescribing information
The precise mechanism by which XENAZINE (tetrabenazine) exerts its anti-chorea effects is unknown but is believed to be related to its effect as a reversible depletor of monoamines (such as dopamine, serotonin, norepinephrine, and histamine) from nerve terminals. Tetrabenazine reversibly inhibits the human vesicular monoamine transporter type 2 (VMAT2) (K i ≈ 100 nM), resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores. Human VMAT2 is also inhibited by dihydrotetrabenazine (HTBZ), a mixture of α-HTBZ and β-HTBZ. α- and β-HTBZ, major circulating metabolites in humans, exhibit high in vitro binding affinity to bovine VMAT2. Tetrabenazine exhibits weak in vitro binding affinity at the dopamine D2 receptor (K i = 2100 nM).
Source: US FDA prescribing information
• Individualization of dose with careful weekly titration is required. The 1 st week’s starting dose is 12.5 mg daily, 2 nd week, 25 mg (12.5 mg twice daily), then slowly titrate at weekly intervals by 12.5 mg to a tolerated dose that reduces chorea. • Doses of 37.5 mg and up to 50 mg/day should be administered in three divided doses per day with a maximum recommended single dose not to exceed 25 mg. • Patients requiring doses above 50 mg/day should be genotyped for the drug metabolizing enzyme CYP2D6 to determine if the patient is a poor metabolizer (PM) or an extensive metabolizer (EM). • Maximum daily dose in PMs: 50 mg with a maximum single dose of 25 mg. • Maximum daily dose in EMs and intermediate metabolizers (IMs): 100 mg with a maximum single dose of 37.5 mg. • If serious adverse reactions occur, titration should be stopped and the dose should be reduced.
Source: US FDA prescribing information
XENAZINE is contraindicated in patients: • Who are actively suicidal, or in patients with untreated or inadequately treated depression. • With hepatic impairment. • Taking monoamine oxidase inhibitors (MAOIs). XENAZINE should not be used in combination with an MAOI, or within a minimum of 14 days of discontinuing therapy with an MAOI. • Taking reserpine. At least 20 days should elapse after stopping reserpine before starting XENAZINE. • Taking deutetrabenazine or valbenazine. • Actively suicidal, or who have depression which is untreated or undertreated. • Hepatic impairment. • Taking monoamine oxidase inhibitors (MAOIs) or reserpine. • Taking deutetrabenazine or valbenazine
Source: US FDA prescribing information
Boxed warning (depression and suicidality xenazine): can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of XENAZINE must balance the risks of depression and suicidality with the clinical need for control of chorea. • Periodically reevaluate the benefit and potential for adverse effects such as worsening mood, cognition, rigidity, and functional capacity. • Do not exceed 50 mg/day and the maximum single dose should not exceed 25 mg if administered in conjunction with a strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine). • Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs. • Restlessness, agitation, akathisia and parkinsonism: Reduce dose or discontinue if occurs. • Sedation/Somnolence: May impair patient’s ability to drive or operate complex machinery.
Source: US FDA prescribing information
The following serious adverse reactions are described below and elsewhere in the labeling: • Depression and Suicidality • Neuroleptic Malignant Syndrome (NMS) • Akathisia, Restlessness, and Agitation • Parkinsonism • Sedation and Somnolence • QTc Prolongation • Hypotension and Orthostatic Hypotension • Hyperprolactinemia • Binding to Melanin-Containing Tissues 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.
Source: US FDA prescribing information
Strong CYP2D6 Inhibitors In vitro studies indicate that α-HTBZ and β-HTBZ are substrates for CYP2D6. Strong CYP2D6 inhibitors (e.g., paroxetine, fluoxetine, quinidine) markedly increase exposure to these metabolites. A reduction in XENAZINE dose may be necessary when adding a strong CYP2D6 inhibitor (e.g., fluoxetine, paroxetine, quinidine) in patients maintained on a stable dose of XENAZINE. The daily dose of XENAZINE should not exceed 50 mg/day and the maximum single dose of XENAZINE should not exceed 25 mg in patients taking strong CYP2D6 inhibitors.
Source: US FDA prescribing information
Store at 25°C (77°F), excursions permitted to 15° to 30°C (59° to 86°F).
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
4 presentations of Tetrabenazine, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Tetrabenazine 12.5 mg tabletOralGeneric name | — | US FDA | Available on request |
| Tetrabenazine 25 mg tabletOralGeneric name | — | US FDA | Available on request |
| Xenazine 12.5 mg tabletOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
| Xenazine 25 mg tabletOral | Lundbeck Pharmaceuticals | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 15 August 2008 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Tetrabenazine in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 4 presentations of Tetrabenazine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Tetrabenazine, including Xenazine.
Yes. The US FDA first approved Tetrabenazine on 15 August 2008, according to Drugs@FDA.
No listed presentation of Tetrabenazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Tetrabenazine is classified under ATC code N07XX06 (Tetrabenazine).
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