Deutetrabenazine is a prescription medicine indicated in adults for the treatment of chorea associated with Huntington’s disease tardive dyskinesia AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of. MedsAcross supplies Deutetrabenazine 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.
AUSTEDO XR ® and AUSTEDO ® are indicated in adults for the treatment of: chorea associated with Huntington’s disease tardive dyskinesia AUSTEDO XR and AUSTEDO are vesicular monoamine transporter 2 (VMAT2) inhibitors indicated in adults for the treatment of: Chorea associated with Huntington’s disease. Tardive dyskinesia
Source: US FDA prescribing information
The precise mechanism by which deutetrabenazine exerts its effects in the treatment of tardive dyskinesia and chorea in patients with Huntington’s disease 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. The major circulating metabolites (α-dihydrotetrabenazine [HTBZ] and β-HTBZ) of deutetrabenazine, are reversible inhibitors of VMAT2, resulting in decreased uptake of monoamines into synaptic vesicles and depletion of monoamine stores.
Source: US FDA prescribing information
AUSTEDO XR AUSTEDO Recommended Starting Dosage 12 mg once daily (12 mg per day) 6 mg twice daily (12 mg per day) Titrate at weekly intervals by 6 mg per day based on reduction of chorea or tardive dyskinesia, and tolerability, up to a maximum recommended daily dosage of 48 mg. Administer AUSTEDO XR with or without food in once-daily doses. Administer AUSTEDO with food and administer total daily dosages of 12 mg or above in two divided doses. Swallow tablets whole, do not chew, crush, or break. If switching patients from tetrabenazine, discontinue tetrabenazine and initiate AUSTEDO XR or AUSTEDO the following day. See full prescribing information for recommended conversion table. Maximum recommended dosage of AUSTEDO XR or AUSTEDO in poor CYP2D6 metabolizers is 36 mg per day
Source: US FDA prescribing information
AUSTEDO XR and AUSTEDO are contraindicated in patients: With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. With hepatic impairment. Taking reserpine. At least 20 days should elapse after stopping reserpine before starting AUSTEDO XR or AUSTEDO. Taking monoamine oxidase inhibitors (MAOIs). AUSTEDO XR and AUSTEDO should not be used in combination with an MAOI, or within 14 days of discontinuing therapy with an MAOI. Taking tetrabenazine or valbenazine. Suicidal, or untreated/inadequately treated depression in patients with Huntington’s disease. Hepatic impairment. Taking reserpine, MAOIs, tetrabenazine, or valbenazine
Source: US FDA prescribing information
Boxed warning (depression and suicidality in patients with huntington’s disease austedo xr and austedo): can increase the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease. Anyone considering the use of AUSTEDO XR or AUSTEDO must balance the risks of depression and suicidality with the clinical need for treatment of chorea. QT Prolongation: Avoid use in patients with congenital long QT syndrome or with arrhythmias associated with a prolonged QT interval. Neuroleptic Malignant Syndrome (NMS): Discontinue if this occurs. Akathisia, agitation, restlessness, and parkinsonism: Reduce dose or discontinue if this occurs. Sedation/somnolence: May impair the patient’s ability to drive or operate complex machinery
Source: US FDA prescribing information
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: Depression and Suicidality in Patients with Huntington’s disease QTc Prolongation Neuroleptic Malignant Syndrome (NMS) Akathisia, Agitation, and Restlessness Parkinsonism Sedation and Somnolence Hyperprolactinemia Binding to Melanin-Containing Tissues Most common adverse reactions (>8% of AUSTEDO-treated patients with Huntington’s disease and greater than placebo): somnolence, diarrhea, dry mouth, and fatigue. Most common adverse reactions (that occurred in 4% of AUSTEDO-treated patients with tardive dyskinesia and greater than placebo): nasopharyngitis and insomnia
Source: US FDA prescribing information
Concomitant use of strong CYP2D6 inhibitors: Maximum recommended dose of AUSTEDO XR or AUSTEDO is 36 mg per day. Alcohol or other sedating drugs: May have additive sedation and somnolence
Source: US FDA prescribing information
Storage Store at 25°C (77°F), excursions permitted to 15°C to 30°C (59°F to 86°F). Protect from light and moisture.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
13 presentations of Deutetrabenazine, sorted by availability.
2 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.
Yes, on request. MedsAcross lists 13 presentations of Deutetrabenazine and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 2 brand names for Deutetrabenazine, including Austedo, Austedo XR.
Yes. The US FDA first approved Deutetrabenazine on 3 April 2017, according to Drugs@FDA.
Yes. Deutetrabenazine has a central EU marketing authorisation (status: authorised), according to European Medicines Agency data.
No listed presentation of Deutetrabenazine is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Deutetrabenazine is classified under ATC code N07XX16 (Deutetrabenazine).
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