Substance / Medication

Deutetrabenazine

Overview

Active Ingredient
deutetrabenazine
RxNorm CUI
1876905

Indications

® ® AUSTEDO XRand AUSTEDOare indicated in adults for the treatment of: 14.1 [see Clinical Studies ()] chorea associated with Huntington’s disease 14.2 [see Clinical Studies ()] tardive dyskinesia

Labeler: Teva Neuroscience, Inc.Updated: 2025-02-28T00:00:00.000ZFull label on DailyMed

Boxed Warning

FDA Black Box Warning

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.

Contraindications

When this intervention should not be used

AUSTEDO XR and AUSTEDO are contraindicated in patients: 5.1 [see Warnings and Precautions ()] With Huntington’s disease who are suicidal, or have untreated or inadequately treated depression. 8.6 12.3 [see Use in Specific Populations (), Clinical Pharmacology ()] With hepatic impairment. 7.2 [see Dr

Indications & Related Conditions

Conditions associated via SNOMED clinical relationships

Administration & Protocol

Dosing, route, and treatment protocol

Detailed dosage and administration information is available in the full FDA drug label.

View full prescribing information on DailyMed

Monitoring & Follow-Up

Biomarkers relevant to this intervention via related conditions

No monitoring biomarkers have been mapped yet. Biomarker-intervention linkages are derived through related conditions and will expand as the knowledge graph grows.

Research Evidence

Published studies and systematic reviews

Sort:
Evaluation of Deutetrabenazine's Potential to Delay Cardiac Repolarization Using Concentration-QTc Analysis.
Schneider Frank, Darpo Borje, Loupe Pippa S et al. · Clin Pharmacol Drug Dev · 2023
PMID: 36098670RCTFull text (PMC)
Minimal clinically important change in Abnormal Involuntary Movement Scale score in tardive dyskinesia as assessed in pivotal trials of deutetrabenazine.
Hauser Robert A, Barkay Hadas, Wilhelm Amanda et al. · Parkinsonism Relat Disord · 2022
PMID: 35299070RCT
Safety and Efficacy of Flexible-Dose Deutetrabenazine in Children and Adolescents With Tourette Syndrome: A Randomized Clinical Trial.
Jankovic Joseph, Coffey Barbara, Claassen Daniel O et al. · JAMA Netw Open · 2021
PMID: 34609495RCTFull text (PMC)
An Open-Label Pilot Study to Examine the Safety, Tolerability and Efficacy of Deutetrabenazine in Isolated Dystonia.
Deik Andres, Aamodt Whitley, Cadet Christina et al. · Mov Disord Clin Pract · 2025
PMID: 39754397TrialFull text (PMC)
The effect of potent CYP2D6 inhibition on the pharmacokinetics and safety of deutetrabenazine in healthy volunteers.
Schneider F, Stamler D, Bradbury M J et al. · Eur J Clin Pharmacol · 2022
PMID: 34491372TrialFull text (PMC)
Long-term safety and efficacy of deutetrabenazine for the treatment of tardive dyskinesia.
Fernandez Hubert H, Stamler David, Davis Mat D et al. · J Neurol Neurosurg Psychiatry · 2019
PMID: 31296586TrialFull text (PMC)
Randomized controlled trial of deutetrabenazine for tardive dyskinesia: The ARM-TD study.
Fernandez Hubert H, Factor Stewart A, Hauser Robert A et al. · Neurology · 2017
PMID: 28446646TrialFull text (PMC)

Research data from MEDLINE/PubMed

Benefits & Expected Outcomes

Benefits, expected outcomes, efficacy data, and NNT (Number Needed to Treat) are pending physician authorship and evidence review.

Risks & Side Effects

Adverse reaction and safety data for this drug is sourced from the FDA-approved label.

View adverse reactions & drug interactions on DailyMed

Related Symptoms

Symptoms associated with conditions this intervention addresses

No related symptoms have been mapped yet. Symptom linkages are derived through associated conditions.

Alternatives & Comparisons

Alternative treatments, comparison data, and clinical decision support are pending physician authorship.

Medical Disclaimer

This information is for educational purposes only and does not constitute medical advice, diagnosis, or treatment. Always consult with a qualified healthcare provider regarding any medical condition or treatment plan.

Do not start, stop, or change any treatment without consulting your healthcare provider.

Quick Facts

Type
Substance / Medication
Fully Specified Name
Deutetrabenazine (substance)
SNOMED CT
733658007
UMLS CUI
C4277781
RxNorm CUI
1876905
Labeler
Teva Neuroscience, Inc.

Clinical Data

This intervention maps to 1 entities in the Ltrl knowledge graph.

1
Conditions
0
Biomarkers
0
Specialists
0
Symptoms

Data is sourced from SNOMED CT, UMLS, and the Ltrl clinical knowledge graph. Content sections marked as pending require physician authorship. Consult a healthcare provider before starting any treatment.