Tetrabenazine

Pronunciation: tet-ra-BEN-a-zeen.

Generic name
tetrabenazine
Drug class
VMAT2 (vesicular monoamine transporter 2) inhibitor; monoamine-depleting agent
Form
Tablet (12.5 mg and 25 mg strengths, depending on market)
Route
Oral
Legal status
Prescription-only

Availability and supply rules vary by country

Trade names by country: United States · United Kingdom · Canada · Australia · New Zealand

Australia: Tetrabenazine (iNova); Tetrabenazine (Sun); Tetrabenazine (Orphan/Valeant) (5) · Full directory

What tetrabenazine is and how it works

Tetrabenazine is a prescription-only oral tablet that reduces involuntary, jerky movements (chorea) by lowering the levels of dopamine and related brain chemicals at nerve endings. It is best known as a treatment for the chorea of Huntington's disease. (1)

Tetrabenazine is started at a low dose and increased slowly, under close medical supervision, to find the dose that controls movement symptoms while keeping side effects manageable. Because it carries a real risk of causing or worsening depression and suicidal thoughts, your prescriber will monitor your mood closely throughout treatment, and it is important to tell your prescriber, caregiver, or family immediately about any changes in mood or thoughts of self-harm.

Mechanism of action: how tetrabenazine works

Tetrabenazine reversibly inhibits the vesicular monoamine transporter 2 (VMAT2), depleting presynaptic stores of dopamine, serotonin, and noradrenaline in the central nervous system, thereby reducing hyperkinetic movements such as chorea. Its central pharmacology closely resembles reserpine but with a shorter duration of action and less peripheral activity. (1) (4)

What tetrabenazine is used for

Chorea associated with Huntington's disease

Used to treat the involuntary, jerky movements (chorea) caused by Huntington's disease. This is the only indication in the current US label. (1)

Other hyperkinetic movement disorders (some countries)

In the UK, EU, Canada, and New Zealand, tetrabenazine is also used more broadly for hyperkinetic movement disorders such as hemiballismus (violent, flinging limb movements) and senile chorea. (2) (4) (6)

Tics and Tourette syndrome (Canada)

In Canada, tetrabenazine is also approved for tics and Gilles de la Tourette's syndrome -- an indication not currently included in the US label. (4)

Tardive dyskinesia (New Zealand)

In New Zealand, tetrabenazine is also indicated for moderate to severe tardive dyskinesia (a movement disorder that can develop after long-term antipsychotic use) that is disabling and/or socially embarrassing and persists despite stopping antipsychotic treatment, or where stopping is not realistic. (6)

Before taking tetrabenazine

Do not take / not appropriate for

  • Do not take tetrabenazine if you are currently suicidal, or if your depression is untreated or not adequately treated. (all countries) (1) (2) (4) (6)
  • Do not take tetrabenazine if you are taking, or have taken in the last 14 days, a monoamine oxidase inhibitor (MAOI). (all countries) (1) (2) (4) (6)
  • Do not take tetrabenazine together with reserpine -- allow at least 20 days after stopping reserpine before starting tetrabenazine. (all countries) (1) (2) (4) (6)
  • Do not take tetrabenazine if you have liver problems (hepatic impairment) -- it is contraindicated in this setting in the US and Canadian labels, and in severe hepatic impairment in the UK label. (United States, Canada, United Kingdom) (1) (2) (4)
  • Do not take tetrabenazine together with deutetrabenazine or valbenazine (other VMAT2 inhibitors). (United States) (1)
  • Do not take tetrabenazine if you have a congenital long QT syndrome. (United States) (1)
  • Do not take tetrabenazine if you have untreated parkinsonism/a hypokinetic-rigid syndrome, phaeochromocytoma, or a prolactin-dependent tumour, or if you are breast-feeding. (United Kingdom) (2)

Tell your clinician about

  • Any personal or family history of depression, suicidal thoughts, or suicide attempts.
  • Any history of heart rhythm problems, congenital long QT syndrome, or slow heart rate.
  • Any history of liver disease.
  • Any history of Parkinson's disease or other movement disorders.
  • All other medicines you take, especially antidepressants, MAOIs, reserpine, antipsychotics, or any medicine known to affect heart rhythm (QT interval).
  • Pregnancy, plans for pregnancy, or breastfeeding.
(1) (2) (4)

How to take tetrabenazine

  • Take tetrabenazine exactly as prescribed -- the dose is individually titrated (adjusted step by step) by your prescriber to find the level that controls your movements while keeping side effects manageable.
  • Treatment is usually supervised by a doctor experienced in movement disorders, and starts at a low dose that is increased gradually over several weeks.
  • Do not change your dose on your own, and do not stop suddenly without talking to your prescriber.
(1) (2)

Procedures and treatment changes

Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2) (3) (4) (5) (6)

Missed dose

If you miss a dose, contact your prescriber for guidance rather than doubling your next dose -- tetrabenazine's dosing is individually titrated, and self-adjusting can increase the risk of side effects.

Overdose

Seek urgent medical attention if too much tetrabenazine may have been taken, especially if there are signs of severe sedation, confusion, low blood pressure, abnormal heart rhythm, or worsening mood/suicidal thoughts. (1)

Side effects

Side effects and their urgency vary; report severe, persistent, or concerning symptoms.

Drowsiness/sedation -- the most common dose-limiting effect; avoid driving or operating machinery until you know how tetrabenazine affects you.

What to notice: Drowsiness/sedation -- the most common dose-limiting effect; avoid driving or operating machinery until you know how tetrabenazine affects you.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Parkinson-like symptoms (slowness, stiffness, tremor).

What to notice: Parkinson-like symptoms (slowness, stiffness, tremor).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Akathisia and restlessness.

What to notice: Akathisia and restlessness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Depression and anxiety (see the boxed warning above for the serious form of this risk).

What to notice: Depression and anxiety (see the boxed warning above for the serious form of this risk).

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1) (2)

Insomnia, confusion, agitation, decreased appetite.

What to notice: Insomnia, confusion, agitation, decreased appetite.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Nausea, vomiting, diarrhoea, constipation, dry mouth, excessive salivation.

What to notice: Nausea, vomiting, diarrhoea, constipation, dry mouth, excessive salivation.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Low blood pressure on standing up (postural hypotension), which can cause dizziness.

What to notice: Low blood pressure on standing up (postural hypotension), which can cause dizziness.

What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (2)

Serious warnings

New or worsening depression, or thoughts of suicide — boxed_warning

Symptoms: Persistent low mood, loss of interest in activities, hopelessness, talking about wanting to die or hurt yourself, or sudden changes in behaviour.

Action: Tell your prescriber, caregiver, or family immediately, and seek emergency help if there is any thought of self-harm. Tetrabenazine can increase the risk of depression and suicidality in people with Huntington's disease; your prescriber may reduce your dose, pause treatment, or start antidepressant treatment. (1) (4)

Signs of neuroleptic malignant syndrome (NMS) — emergency

Symptoms: High fever, severe muscle stiffness, confusion or altered consciousness, irregular heartbeat, or sweating.

Action: Seek emergency medical care immediately -- NMS is rare but can be fatal, and tetrabenazine should be stopped right away if it is suspected. (1) (2) (6)

Signs of an abnormal heart rhythm (QT prolongation) — high caution

Symptoms: Palpitations, fainting, or severe dizziness.

Action: Contact your prescriber promptly -- tetrabenazine can slightly prolong the QT interval, and the risk is higher if you take other QT-prolonging medicines or have a history of heart rhythm problems. (1) (4) (6)

Worsening parkinsonism or new restlessness (akathisia) — high caution

Symptoms: New or worsening slowness, stiffness, tremor, or an inability to sit still.

Action: Tell your prescriber -- your dose may need to be adjusted. (1) (2)

Severe sedation affecting daily activities — high caution

Symptoms: Excessive drowsiness that interferes with daily tasks, driving, or operating machinery.

Action: Do not drive or use machinery until you know how tetrabenazine affects you, and tell your prescriber if sedation is severe -- your dose may need to be adjusted. (1) (2)

Interactions

  • Monoamine oxidase inhibitors (MAOIs) must not be combined with tetrabenazine -- allow at least 14 days between stopping one and starting the other, in either direction, because of the risk of a serious reaction (including hypertensive crisis). (1) (2) (4)
  • Reserpine must not be combined with tetrabenazine -- allow at least 20 days after stopping reserpine before starting tetrabenazine, because reserpine binds irreversibly and effects can persist. (1) (2) (4) (6)
  • Strong CYP2D6-inhibiting medicines (such as fluoxetine, paroxetine, or bupropion) can raise tetrabenazine levels in the body -- your prescriber may need to cap your dose lower. (1) (2)
  • Other medicines that prolong the QT interval (certain antipsychotics, some antibiotics, and certain heart-rhythm medicines) can add to tetrabenazine's own small QT effect -- combination requires caution. (1) (2) (4)
  • Dopamine-blocking medicines (antipsychotics) may increase the risk of neuroleptic malignant syndrome and movement side effects (parkinsonism, akathisia) when combined with tetrabenazine. (2) (4)
  • Alcohol and other sedating medicines can add to tetrabenazine's drowsiness. (1) (2)

Pregnancy, breastfeeding, kidney/liver function, age

Pregnancy

Tetrabenazine is not recommended during pregnancy. There are no adequate, well-controlled studies in pregnant women. Animal studies at clinically relevant exposures showed increased stillbirths, neonatal mortality, and neurobehavioural impairment. Discuss the balance of risks and benefits with your prescriber if you are pregnant or planning pregnancy. (1) (2) (3) (4) (5) (6)

Breastfeeding

There is no reliable data on whether tetrabenazine passes into human breast milk. The UK label states breastfeeding is contraindicated during treatment; other labels advise weighing the benefits of breastfeeding against the mother's clinical need. Discuss with your prescriber. (1) (2) (3) (4) (5) (6)

Children

Tetrabenazine is not recommended in children in the UK/EU label due to inadequate controlled studies; Canadian labelling includes tic/Tourette syndrome use, but paediatric treatment should only occur under specialist supervision. (1) (2) (3) (4) (5) (6)

Elderly

No specific dose adjustment based on age alone is described, but Parkinson-like side effects may be more dose-limiting in older adults. (1) (2) (3) (4) (5) (6)

Hepatic_impairment

Tetrabenazine is contraindicated in patients with hepatic impairment in the US and Canadian labels (and in severe hepatic impairment in the UK label), because metabolite exposure and safety in this setting are not established. (1) (2) (3) (4) (5) (6)

Renal_impairment

Dose adjustment may be recommended in renal impairment in some markets (e.g. Australia); discuss with your prescriber if you have kidney disease. (1) (2) (3) (4) (5) (6)

Source_ids

US-DAILYMED-XENAZINE-2026,UK-EMC-TETRABENAZINE-2026,CA-HC-NITOMAN-2026,AU-TGA-TETRABENAZINE-2026 (1) (2) (3) (4) (5) (6)

Monitoring

Before starting

  • Assessment of current mood, depression history, and suicide risk
  • Baseline ECG in patients with cardiac risk factors, given the QT-prolongation effect
  • Review of all current medicines for MAOIs, reserpine, or other interacting drugs
  • Liver function assessment

During treatment

  • Regular monitoring for new or worsening depression, suicidal thoughts, or unusual behaviour change throughout treatment, especially during dose titration.
  • Monitoring for signs of neuroleptic malignant syndrome (fever, rigidity, altered consciousness).
  • Monitoring for parkinsonism, akathisia, and excessive sedation, with dose adjustment as needed.
  • Periodic reassessment of the need for continued treatment and the balance of benefit versus depression/suicidality risk.
(1) (4)

Storage

Store tetrabenazine tablets at room temperature, away from moisture and light, as directed on the product labelling. Keep out of reach of children.

Professional information

Clinician-facing context only, sourced from the current US FDA prescribing information and Health Canada product monograph; verify against the current full label in the relevant jurisdiction before prescribing.

United States

Indication: Chorea associated with Huntington's disease

Dose summary: Start 12.5 mg once daily; increase to 25 mg/day (divided) in week 2; then titrate weekly by 12.5 mg increments. Maximum total daily dose and single dose are capped according to CYP2D6 metaboliser status (up to 50 mg/day for poor metabolisers; up to 100 mg/day, 37.5 mg single dose, for extensive/intermediate metabolisers able to tolerate more) and further capped with strong CYP2D6 inhibitors.

Renal context: Not specifically addressed with a dedicated adjustment in the source reviewed for this dossier. (1)

Canada

Indication: Huntington's chorea, hemiballismus, senile chorea, tic and Gilles de la Tourette's syndrome

Dose summary: Individualised titration; depression/suicidality safety data specifically documented: 19% depression/worsening depression at 12 weeks vs. 0% placebo, rising to 35% in open-label extensions to 48-80 weeks; 1 suicide, 1 suicide attempt, 6 suicidal ideation cases among 187 HD chorea patients in the safety database.

Renal context: Not specifically addressed with a dedicated adjustment in the source reviewed for this dossier. (4)

Mechanism of action

Hepatic guidance

Contraindicated in hepatic impairment (US/Canada); severe hepatic impairment contraindicated in the UK label. Active metabolite exposure and safety have not been adequately studied in this population.

Overdose note

Overdose experience is limited; manage supportively with monitoring for excessive sedation, hypotension, cardiac arrhythmia (given the QT effect), and worsening mood/suicidality. (1) (4)

Frequently asked questions

Is tetrabenazine available in the US, UK, Europe, Canada, Australia, and New Zealand?

Yes, tetrabenazine is authorised in all of these regions, though under different brand names: Xenazine (US), Tetrabenazine/historically Nitoman (UK), Tetmodis and other brands (EU, via national/decentralised procedures rather than one single EU-wide approval), Nitoman (Canada), several ARTG-registered brands (Australia), and Motetis (New Zealand). (1) (2) (3) (4) (5) (6)

Why does tetrabenazine carry a boxed warning about depression and suicide?

In clinical trials, depression occurred in about 19% of people with Huntington's disease taking tetrabenazine, compared with 0% on placebo, and rose to around 35% in longer open-label follow-up. Across the safety database, there was one suicide, one suicide attempt, and six cases of suicidal ideation. Because depression and suicidal thoughts already occur more often in people with Huntington's disease, and tetrabenazine can add to that risk, the FDA requires this to be its highest-level warning. Anyone taking it needs close monitoring for mood changes. (1) (4)

Can I take tetrabenazine with antidepressants or other psychiatric medicines?

It depends on the specific medicine. MAOIs must never be combined with tetrabenazine (a 14-day washout is required in either direction). Some other antidepressants can raise tetrabenazine levels in the body (if they strongly inhibit an enzyme called CYP2D6), which may require a lower tetrabenazine dose. Always tell your prescriber about every medicine you take so they can check for interactions. (1) (2)

What is the mechanism of action of tetrabenazine?

Tetrabenazine reversibly inhibits the vesicular monoamine transporter 2 (VMAT2), depleting presynaptic stores of dopamine, serotonin, and noradrenaline in the central nervous system, thereby reducing hyperkinetic movements such as chorea. Its central pharmacology closely resembles reserpine but with a shorter duration of action and less peripheral activity. (1) (4)

What is the generic name of Tetrabenazine?

The generic name is tetrabenazine. (1)

What class of drug is tetrabenazine?

Tetrabenazine is classed as: VMAT2 (vesicular monoamine transporter 2) inhibitor; monoamine-depleting agent. (1)

References

  1. XENAZINE (tetrabenazine) tablets -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Lundbeck Pharmaceuticals LLC · United States · accessed 2026-07-30 · source 1
  2. Tetrabenazine 25 mg Tablets -- Summary of Product Characteristicselectronic medicines compendium (emc), United Kingdom -- Sun Pharmaceutical Industries Europe B.V. (Ranbaxy (UK) Limited, a Sun Pharmaceutical company) · United Kingdom · accessed 2026-07-30 · source 2
  3. Tetmodis 25 mg tablets (tetrabenazine) -- Public Assessment Report, Decentralised Procedure UK/H/1816/001/DCEU decentralised procedure Public Assessment Report (Netherlands MEB / geneesmiddeleninformatiebank), Reference Member State: United Kingdom · European Union · accessed 2026-07-30 · source 3
  4. NITOMAN (tetrabenazine) Tablets 25 mg -- Product MonographHealth Canada product monograph, Bausch Health, Canada Inc. · Canada · accessed 2026-07-30 · source 4
  5. Australian Product Information -- Tetrabenazine Tablets (iNova)Therapeutic Goods Administration (TGA), Australia -- Australian Product Information, sponsor iNova Pharmaceuticals · Australia · accessed 2026-07-30 · source 5
  6. Motetis 25 mg tablet -- New Zealand Data SheetMedsafe (New Zealand regulator), sponsor Douglas Pharmaceuticals Ltd · New Zealand · accessed 2026-07-30 · source 6

Brand names by country

Single-ingredient tetrabenazine names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.

Priority countries

United States

  • Xenazine25 mg, 12.5 mg · lundbeck pharmaceuticals llc

United Kingdom

  • Tetrabenazine (Sun/Ranbaxy); Nitoman (historical Roche-originated brand) (2)MHRA licensed emc smpc confirmed · 25 mg tablet · Sun Pharmaceutical Industries Europe B.V. (Ranbaxy (UK) Limited)

Canada

  • NITOMAN

Australia

  • Tetrabenazine (iNova); Tetrabenazine (Sun); Tetrabenazine (Orphan/Valeant) (5)TGA ARTG registered PBS listed confirmed · 25 mg tablet · iNova Pharmaceuticals (and other ARTG-registered sponsors)

New Zealand

  • Motetis (6)Medsafe approved confirmed via data sheet · 25 mg tablet · Douglas Pharmaceuticals Ltd
View brands in additional countries.

European Union

Tetmodis (3)