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Tetrabenazine

Tetmodis, Tetrabenazin Aristo · ATC code N07XX06

Also known as: Tetrabenazin · Brand names: Tetmodis, Tetrabenazin Aristo, Nitoman, Tetrabenazin Neuraxpharm, Xenazine

Key facts
Active substance
Tetrabenazine
ATC code
N07XX06
Authorisation
authorised nationally; no central EU authorisation
Information as of
2026-10-29

Boxed warning

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), ].

Key facts

Tetrabenazine is, per the US prescribing information, a drug that reduces dopaminergic transmission and is used to treat chorea associated with Huntington's disease.

What it is used for

  • Treatment of chorea associated with Huntington's disease.

Dosing

  • Start with 12.5 mg/day in the morning; after 1 week 25 mg/day as 12.5 mg twice a day; then increase slowly by 12.5 mg daily at weekly intervals.
  • Give 37.5 to 50 mg/day in a three times a day regimen; maximum single dose 25 mg.
  • Above 50 mg/day only after CYP2D6 genotyping: extensive/intermediate metabolizers maximum 100 mg daily and 37.5 mg per dose; poor metabolizers maximum 50 mg daily and 25 mg per dose.
  • With strong CYP2D6 inhibitors (e.g. paroxetine, fluoxetine, quinidine): no more than 50 mg/day and 25 mg per dose.
  • If akathisia, parkinsonism, depression, insomnia, anxiety or sedation occur, stop titration and reduce the dose; may be taken without regard to food.

Contraindications

  • Active suicidality or untreated or inadequately treated depression.
  • Hepatic impairment.
  • MAOIs (until at least 14 days after stopping); reserpine (at least 20 days apart).
  • Concomitant deutetrabenazine or valbenazine.

Important warnings

  • Boxed warning: increased risk of depression and suicidal thoughts and behavior in Huntington's disease; observe closely, with particular caution after prior depression or suicide attempts.
  • Neuroleptic malignant syndrome (potentially fatal).
  • Akathisia, restlessness and agitation; parkinsonism; sedation is the most common dose-limiting adverse reaction (caution with driving).
  • QTc prolongation (about 8 msec); avoid in congenital long QT syndrome or a history of arrhythmias.
  • Orthostatic hypotension, hyperprolactinemia, possible accumulation in melanin-containing tissues.

Side effects

  • In the 12-week trial: sedation/somnolence 31%, insomnia 22%, fatigue 22%, depression 19%, akathisia 19%, anxiety 15%, falls 15%, nausea 13%.
  • Others: irritability, balance difficulty, parkinsonism/bradykinesia, vomiting, dizziness, dysarthria.
  • Postmarketing: tremor, confusion, worsening aggression, pneumonia, skin rash.

Interactions

  • Strong CYP2D6 inhibitors (paroxetine, fluoxetine, quinidine) markedly increase exposure to the active metabolites; limit the dose.
  • Reserpine, MAOIs, deutetrabenazine and valbenazine: contraindicated.
  • Drugs that reduce dopaminergic transmission increase the risk of neuroleptic malignant syndrome; avoid QT-prolonging drugs.

Pregnancy and breastfeeding

  • No adequate data in pregnant women; in rats, stillbirths and offspring deaths increased.
  • There are no data on presence in human milk.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Patient information (US)

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

Austria

  • TetmodisWalter Ritter Gmbh + Co. Kg · 1 register entry
  • Tetrabenazin AristoAristo Pharma Gmbh (Art 57) · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

Germany

  • NitomanBausch Health Ireland Limited · 1 register entry
  • TetmodisWalter Ritter Gmbh + Co. Kg · 1 register entry
  • Tetrabenazin AristoAristo Pharma Gmbh (Art 57) · 1 register entry
  • Tetrabenazin NeuraxpharmNeuraxpharm Arzneimittel Gmbh · 1 register entry

Source: EMA – Article 57 product data (EU/EEA), as of 2026-10-29

USA

  • XenazineLundbeck Pharmaceuticals LLC · 1 register entry

Source: U.S. FDA – Drug labels (openFDA/DailyMed), as of 2026-10-29

Brand names in 23 more European countries
Belgium
Tetrabenazine Walter Ritter
Bulgaria
Тетмодис
Croatia
Tetmodis
Czechia
Tetmodis
Denmark
Nitoman, Tetmodis
Estonia
Tetmodis
Finland
Tetmodis, Xenazine
France
Tetmodis, Xenazine
Greece
Tetmodis, Xenazine
Hungary
Motetis
Ireland
Nitoman, Tetrabenazine Walter Ritter
Italy
Tetrabenazina Aristo, Tetrabenazina Sun, Xenazina
Latvia
Tetmodis
Lithuania
Tetmodis
Netherlands
Tetmodis, Tetrabenazine Sun, Xenazine
Norway
Tetmodis
Poland
Tetmodis
Portugal
Nitoman, Tetmodis
Romania
Tetmodis
Slovakia
Tetmodis
Slovenia
Tetmodis, Xenazine
Spain
Nitoman, Tetmodis, Tetrabenazina Aristo, Tetrabenazina Sun
Sweden
Tetmodis, Xenazine

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. U.S. Food and Drug Administration. tetrabenazine (Oceanside Pharmaceuticals) – Prescribing Information, 2019-11-29. DailyMed (NLM), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5867189c-17bd-4e70-a079-c4730f9950d1
  2. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  3. EMA – Article 57 product data (EU/EEA), 2026-10-29. https://www.ema.europa.eu/en/human-regulatory-overview/post-authorisation/data-medicines-iso-idmp-standards-post-authorisation/public-data-article-57-database
  4. U.S. FDA – Drug labels (openFDA/DailyMed), 2026-10-29. https://dailymed.nlm.nih.gov/dailymed/

Editorial: Medelix editorial team · last updated 2026-10-29 · How these pages are made · Report an error

Source: U.S. Food and Drug Administration (FDA), prescribing information, via DailyMed (NLM); public domain. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.