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Deutetrabenazine

Austedo · ATC code N07XX16

Key facts
Active substance
Deutetrabenazine
ATC code
N07XX16
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Austedo 12 mg prolonged-release tablets / Austedo 24 mg prolonged-release tablets / Austedo 30 mg prolonged-release tablets
Marketing authorisation holder
Teva GmbH
Information as of
2026-10-27

Key facts

Deutetrabenazine (Austedo) is a VMAT2 inhibitor used to treat moderate to severe tardive dyskinesia in adults.

What it is used for

  • Moderate to severe tardive dyskinesia in adults

Dosing

  • Start at 12 mg once daily for one week, then 24 mg once daily for another week
  • Then titrate at weekly intervals in increments of 6 mg based on response and tolerability
  • Efficacious range 24 mg to 48 mg; maximum daily dose 48 mg
  • Strong CYP2D6 inhibitors or poor CYP2D6 metabolisers: no more than 36 mg daily
  • Doses missed for more than one week: restart at 12 mg once daily
  • Can be stopped without tapering; not for use in hepatic impairment

Contraindications

  • Hypersensitivity to the active substance or any excipient
  • Hepatic impairment
  • Concomitant reserpine, MAOIs or other VMAT2 inhibitors

Important warnings

  • May cause or worsen depression; close monitoring
  • May prolong the QTc interval; caution with QT-prolonging medicines and risk factors
  • Potential risk of neuroleptic malignant syndrome; discontinue immediately if suspected
  • Akathisia, agitation and restlessness

Side effects

  • Most common: somnolence (very common), diarrhoea, dry mouth, fatigue
  • Common: depression, anxiety, insomnia, akathisia, constipation, urinary tract infection
  • Most serious: depression and dysthymic disorder; uncommon: parkinsonism

Interactions

  • Reserpine: contraindicated; at least 20 days after stopping it
  • MAOIs: contraindicated; at least 14 days after stopping
  • Strong CYP2D6 inhibitors: dose cap
  • QT-prolonging and dopamine-reducing medicines: caution

Pregnancy and breastfeeding

  • Not recommended during pregnancy or in women of childbearing potential not using contraception
  • Breast-feeding: risk to the infant cannot be excluded; benefit-risk decision

Summary of the official product information, written with AI (Claude, Anthropic) on 2026-10-28. 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

Package leaflet, verbatim

Package leaflet for patients →

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.

EU – centrally authorised (all member states)

  • AustedoTeva GmbH · EMEA/H/C/006371

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Austedo
Liechtenstein
Austedo
Norway
Austedo

EMA – Article 57 product data (EU/EEA), 2026-10-28

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

Other substances in the same group

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Sources

  1. European Medicines Agency. Austedo – EPAR, Product Information (OF THE TEXT Detailed information on this medicinal product i). 2026-10-27. https://www.ema.europa.eu/en/documents/product-information/austedo-epar-product-information_en.pdf

Editorial: Medelix editorial team · last updated 2026-10-27 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.