Deutetrabenazine: Uses, Side Effects, Dosage - Drugvu

ℹ️ Compiled from public regulatory records · Last regulator revision: March 23, 2026🚩 Report this page

Deutetrabenazine

Other Nervous System Drugs

Sold as Austedo

GB MHRAEU EMA

Drug class: Other Nervous System Drugs
Availability: See label
Markets covered: 2
Products on record: 7

Overview

Deutetrabenazine is an active pharmaceutical ingredient in the Other Nervous System Drugs group (N07XX). The information below is compiled per regulator from the product labels on record, with direct links to the original documents.

Regulatory status by market

Market	Regulator	Products	Last revision
GB United Kingdom	MHRA	6	March 23, 2026
EU European Union	EMA	1	January 23, 2026

GBUnited Kingdom· MHRA

6 products

Uses

GBOfficial regulatory label· revised March 23, 2026[1]

Austedo is indicated for the treatment of moderate to severe tardive dyskinesia in adults.

How to take

EUEuropean Union· EMA

1 product

Uses

EUOfficial regulatory label· revised January 23, 2026[2]

Austedo is indicated for the treatment of moderate to severe tardive dyskinesia in adults.

How to take

Drug interactions

Known interactions involving Deutetrabenazine. Select one for details. This list is informational and not a complete interaction checker.

Amiodarone Amisulpride Amoxapine Anagrelide Aripiprazole Arsenic Trioxide Asenapine Bedaquiline Bepridil Brexpiprazole Bupropion Cabozantinib Ceritinib Chloroquine Chlorpromazine Cinacalcet Cisapride Citalopram Clozapine Crizotinib Dacomitinib Disopyramide Dofetilide Dolasetron Dronedarone Droperidol Efavirenz Escitalopram Fingolimod Fluoxetine Fluphenazine Gatifloxacin Grepafloxacin Halofantrine Haloperidol Hydroxychloroquine Ibutilide Iloperidone Isocarboxazid Ivabradine Ivosidenib Lefamulin Linezolid Loxapine Lumefantrine Lurasidone Macimorelin Mesoridazine Methadone Methdilazine Methotrimeprazine Methylene Blue Metoclopramide Mifepristone Molindone Moxifloxacin Nilotinib Olanzapine Osimertinib Ozanimod Paliperidone Panobinostat Papaverine Paroxetine Pasireotide Perphenazine Phenelzine Pimozide Procainamide Procarbazine Prochlorperazine Promazine Promethazine Propiomazine Quetiapine Quinidine Rasagiline Reserpine Ribociclib Risperidone Safinamide Saquinavir Selegiline Siponimod Sotalol Sparfloxacin Tetrabenazine Thiethylperazine Thioridazine Thiothixene Toremifene Tranylcypromine Trifluoperazine Triflupromazine Trimeprazine Vandetanib Vemurafenib Ziprasidone Abarelix Abiraterone Adenosine Albuterol Alfentanil Alfuzosin Alprazolam Amitriptyline Amobarbital Apalutamide Apomorphine Astemizole Atomoxetine Azatadine Azelastine Azithromycin Baclofen Bicalutamide Biperiden Bisacodyl Bosutinib Brivaracetam Bromocriptine Brompheniramine Buprenorphine Buspirone Butabarbital Butalbital Butorphanol Cannabidiol Carbamazepine Carbinoxamine Cariprazine Carisoprodol Castor Oil Cetirizine Chlorcyclizine Chlordiazepoxide Chlormezanone Chlorphenesin Chlorpheniramine Chlorzoxazone Cilostazol Ciprofloxacin Clarithromycin Clemastine Clobazam Clofazimine Clomipramine Clonazepam Clonidine Clorazepate Codeine Cyclizine Cyclobenzaprine Cyproheptadine Dantrolene Dasatinib Daunorubicin Degarelix Desipramine Desvenlafaxine Dexbrompheniramine Dexmedetomidine Dextromethorphan Dezocine Diazepam Dichloralphenazone Difenoxin Dihydrocodeine Diphenhydramine Diphenoxylate Donepezil Doxepin Doxorubicin Doxylamine Dronabinol Duloxetine Encorafenib Entacapone Entrectinib Enzalutamide Epirubicin Eribulin Erythromycin Eslicarbazepine Estazolam Eszopiclone Ethanol Ethchlorvynol Ethosuximide Ethotoin Ezogabine Famotidine Fedratinib Felbamate Fentanyl Flavoxate Flecainide Flibanserin Fluconazole Flurazepam Flutamide Fluvoxamine Formoterol Foscarnet Fosphenytoin Gabapentin Galantamine Gemifloxacin Gilteritinib Glasdegib Glycerin Glycerol Phenylbutyrate Goserelin Granisetron Halazepam Halothane Histrelin Hydrocodone Hydromorphone Hydroxyzine Idarubicin Imipramine Indacaterol Inotuzumab Ozogamicin Isoproterenol Ketamine Ketoconazole Lactitol Lactulose Lamotrigine Lapatinib Lenvatinib Leuprolide Levetiracetam Levocetirizine Levofloxacin Lisdexamfetamine Lofexidine Lomefloxacin Loperamide

Showing 240 of 376. Type above to find a specific drug.

Interaction data compiled from DDInter (academic, CC-BY). Severity classification only - this is not a complete interaction checker and not medical advice.

Sources & citations

[1]MHRA (UK) · PL002892641 · revised March 23, 2026
[2]European Medicines Agency · EMEA/H/C/006371 · revised January 23, 2026

Information on this page is compiled from public regulatory records. Drugvu is not affiliated with any regulator or pharmaceutical manufacturer. This is not medical advice. Always consult a qualified healthcare professional.

The initiation and titration of Austedo treatment should be supervised by a physician with experience in drug-induced movement disorders. Posology Austedo dosing should be determined individually for each patient, based on adequate reduction of tardive dyskinesia symptoms and tolerability.
Therapy should be initiated at 12 mg once daily for one week. The dose should then be increased to 24 mg once daily for another week. After the second week, it is recommended that the dose be titrated at weekly intervals in increments of 6 mg once daily, based on reduction of tardive dyskinesia symptoms and tolerability.
The efficacious dose range is considered to be 24 mg to 48 mg. The maximum recommended daily dose is 48 mg. 2). A decision to continue treatment with deutetrabenazine should be taken on an individual patient basis. Treatment can be continued for as long as a therapeutic benefit is observed, and the patient tolerates treatment.
Treatment with deutetrabenazine can be discontinued without the need for tapering off. Missed doses If a patient misses doses for less than one week, treatment can be resumed at the current dose. If the patient misses doses for more than one week, Austedo therapy should be restarted at 12 mg once daily.
Special populations Elderly There is limited data available on the use of deutetrabenazine in patients ≥ 65 years of age. 2). 2). 2). Paediatric population There is no relevant use of Austedo in the paediatric population for the indication of tardive dyskinesia.
Method of administration For oral use. The prolonged-release tablets can be taken with or without food. To preserve the prolonged-release properties, the tablets must be swallowed whole with water, not chewed, crushed or divided. The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate.
The tablet shell is eliminated from the body. Patients should be advised that they may occasionally notice in their stool something that looks like a tablet.

Side effects & warnings

GBOfficial regulatory label· Adverse reactions· revised March 23, 2026[1]

Summary of the safety profile Most commonly reported adverse reactions associated with deutetrabenazine were somnolence (11%), diarrhoea, dry mouth, and fatigue (each 9%). Somnolence may occur more frequently at the beginning of treatment and decrease with treatment continuation.
The most serious adverse reactions were depression and dysthymic disorder (2%). Tabulated list of adverse reactions Adverse reactions from clinical studies and post-marketing reports are presented according to MedDRA system organ classification.
Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness. Frequency categories are based on the following convention: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1 000 to < 1/100), rare (≥ 1/10 000 to < 1/1 000) and not known (cannot be estimated from the available data).
The following adverse reactions have been identified for deutetrabenazine (see Table 1).
Table 1:
List of adverse reactions System Organ Class Frequency Adverse Reaction Urinary tract infectionInfections and infestations Common Nasopharyngitis Depression* Dysthymic disorder* Anxiety Psychiatric disorders Common Insomnia Agitation** Restlessness** Very common Somnolence Common Akathisia** Nervous system disorders Uncommon Parkinsonism Diarrhoea Constipation Gastrointestinal disorders Common Dry mouth General disorders and administration site conditions Common Fatigue Injury, poisoning and procedural complications Common Contusion * Preferred terms depression and dysthymic disorder were grouped for frequency calculation.
** Preferred terms agitation, restlessness and akathisia were grouped for frequency calculation. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.

GBOfficial regulatory label· Warnings and precautions· revised March 23, 2026[1]

8). Patients should be closely monitored for the emergence of such adverse reactions. Patients and their caregivers should be informed of the risks and instructed to report any concerns to their doctor immediately. If depression does not resolve, discontinuing treatment with deutetrabenazine should be considered.
1). 5) and in patients with congenital long QT syndrome, bradycardia, hypokalaemia, hypomagnesaemia or a history of cardiac arrhythmias. 5). Main symptoms of NMS are mental changes, rigidity, hyperthermia, autonomic dysfunction and elevated creatinine phosphokinase levels.
If NMS is suspected, deutetrabenazine should be discontinued immediately and appropriate symptomatic treatment should be initiated. 8). Patients receiving deutetrabenazine should be monitored for signs and symptoms of restlessness and agitation, as these may be indicators of developing akathisia.
If a patient develops akathisia during treatment with deutetrabenazine, the dose should be reduced; some patients may require discontinuation of therapy. 7). 5). 8). If a patient develops parkinsonism, the deutetrabenazine dose should be reduced and discontinuation of treatment should be considered if the event does not resolve.
g. skin and eye), it could accumulate in these tissues over time. This raises the possibility that deutetrabenazine may cause toxicity in these tissues after extended use. The clinical relevance of deutetrabenazine’s binding to melanin-containing tissues is unknown.
e. is essentially ‘sodium-free’. This medicinal product contains sunset yellow FCF and/or allura red AC which may cause allergic reactions (see section 2).

This is not medical advice. Consult a qualified healthcare professional.

The initiation and titration of Austedo treatment should be supervised by a physician with experience in drug-induced movement disorders. Posology Austedo dosing should be determined individually for each patient, based on adequate reduction of tardive dyskinesia symptoms and tolerability.
Therapy should be initiated at 12 mg once daily for one week. The dose should then be increased to 24 mg once daily for another week. After the second week, it is recommended that the dose be titrated at weekly intervals in increments of 6 mg once daily, based on reduction of tardive dyskinesia symptoms and tolerability.
The efficacious dose range is considered to be 24 mg to 48 mg. The maximum recommended daily dose is 48 mg. 2). A decision to continue treatment with deutetrabenazine should be taken on an individual patient basis. Treatment can be continued for as long as a therapeutic benefit is observed, and the patient tolerates treatment.
Treatment with deutetrabenazine can be discontinued without the need for tapering off. 4 Missed doses If a patient misses doses for less than one week, treatment can be resumed at the current dose. If the patient misses doses for more than one week, Austedo therapy should be restarted at 12 mg once daily.
Special populations Elderly There is limited data available on the use of deutetrabenazine in patients ≥ 65 years of age. 2). 2). 2). Paediatric population There is no relevant use of Austedo in the paediatric population for the indication of tardive dyskinesia.
Method of administration For oral use. The prolonged-release tablets can be taken with or without food. To preserve the prolonged-release properties, the tablets must be swallowed whole with water, not chewed, crushed or divided. The active substance is contained within a non-absorbable shell designed to release the active substance at a controlled rate.
The tablet shell is eliminated from the body. Patients should be advised that they may occasionally notice in their stool something that looks like a tablet.