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Deutetrabenazine

Published: July 26, 2026Updated: July 26, 2026

Deutetrabenazine is a medication used to treat movement disorders characterized by involuntary movements. It works by reversibly depleting dopamine and other monoamines from nerve terminals in the brain, which helps reduce hyperkinetic movements. This medication is primarily prescribed for tardive dyskinesia and for chorea associated with Huntington's disease.

Quick summary

Deutetrabenazine is a VMAT2 inhibitor that depletes dopamine to reduce involuntary movements in tardive dyskinesia and Huntington's disease chorea.

Medically reviewed by WellAlly Editorial TeamLast reviewed July 26, 2026Editorial policy
BOXED WARNING

This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.

Key facts at a glance

ATC
N07XX16
RxNorm
1876905
Generic
Deutetrabenazine
Class
atc-n07
Brands
Austedo
Availability
rx
Lactation
unknown
Routes
oral
Forms
tablet
Regions
US, EU, CN, JP
Monitoring
—

This page is for informational purposes only.

Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.

Dosage and administration

adult (standard)tablet
Usual dose
6-48 mg daily
Maximum
consult physician
Frequency
twice daily with food
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
pediatric (not established)tablet
Usual dose
use not established
Maximum
consult physician
Frequency
N/A
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard
geriatric (standard)tablet
Usual dose
6-48 mg daily
Maximum
consult physician
Frequency
twice daily with food
Instructions
Follow physician instructions
Duration limits
as prescribed
Monitoring
standard

Overdose information

Important overdose information
Toxic dose: Single dose exceeding 200mg may cause serious toxicity (approximately 4-5 times maximum daily dose)
Chronic overdose: Cumulative dosing above 48mg daily may lead to severe CNS depression and QT prolongation
Immediate actions
Ensure airway patency, provide supportive care, monitor cardiac rhythm, administer intravenous fluids for hypotension
Antidote
No specific antidote exists(Treatment is supportive; no antidote available)
Poison Control: 1-800-222-1222

Special Populations

10 groups
⚠

pregnancy

first trimester
caution
FDA Category
C
Dose Adjustment

use lowest effective dose if benefits outweigh risks

Key Recommendations

avoid use during pregnancy unless potential benefits justify potential risks to fetus

Monitor

regular fetal monitoring, assess risk versus benefit

Use with caution and monitor for adverse effects.

⚠

pregnancy

second trimester
caution
FDA Category
C
Dose Adjustment

use lowest effective dose if benefits outweigh risks

Key Recommendations

avoid use during pregnancy unless potential benefits justify potential risks to fetus

Monitor

regular fetal monitoring, assess risk versus benefit

Use with caution and monitor for adverse effects.

⚠

pregnancy

third trimester
caution
FDA Category
C
Dose Adjustment

use lowest effective dose if benefits outweigh risks

Key Recommendations

avoid use during pregnancy unless potential benefits justify potential risks to fetus; consider discontinuation prior to delivery

Monitor

regular fetal monitoring, assess risk versus benefit, monitor for neonatal sedation

Use with caution and monitor for adverse effects.

✗

lactation

breastfeeding
unsafe
FDA Category
N
Dose Adjustment

discontinue breastfeeding or discontinue drug

Key Recommendations

deutetrabenazine and its metabolites are excreted in breast milk; breastfeeding is not recommended during treatment

Monitor

monitor infant for excessive sleepiness, feeding difficulties

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

geriatric

elderly
caution
FDA Category
N
Dose Adjustment

no specific dosage adjustment required

Key Recommendations

use with caution; monitor for depression, suicidality, and sedation; start at lower end of dosing range

Monitor

regular monitoring for depression, suicidality, falls, sedation, and parkinsonism

Use with caution and monitor for adverse effects.

✗

pediatric_age

adolescents
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

safety and efficacy not established in patients under 18 years of age; use is not recommended

Monitor

not applicable for pediatric use

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

renal_impairment

mild moderate
caution
FDA Category
N
Dose Adjustment

no dosage adjustment required

Key Recommendations

no dose adjustment needed for mild to moderate renal impairment; use with caution

Monitor

monitor renal function periodically

Use with caution and monitor for adverse effects.

⚠

renal_impairment

severe
caution
FDA Category
N
Dose Adjustment

use with caution, consider lower doses

Key Recommendations

use with caution in severe renal impairment; not studied in end-stage renal disease

Monitor

monitor renal function closely, consider dose adjustment

Use with caution and monitor for adverse effects.

✗

hepatic_impairment

moderate
unsafe
FDA Category
N
Dose Adjustment

not recommended

Key Recommendations

contraindicated in patients with hepatic impairment; do not use

Use of this medication in this population requires careful consideration of risks and benefits.

⚠

alcohol_users

concurrent use
caution
FDA Category
N
Dose Adjustment

avoid alcohol

Key Recommendations

avoid concurrent alcohol consumption; may exacerbate sedation and CNS depression

Monitor

monitor for increased sedation, dizziness, and orthostatic hypotension

Use with caution and monitor for adverse effects.

Statistics and clinical data

prescribingFDA
2023

FDA Approval Year

Value:2017

Initial FDA approval date for Austedo (Deutetrabenazine)

drug_classFDA
2023

Drug class

Value:VMAT-2 inhibitor

Mechanism of action classification

usageMedical guidelines
2023

Common uses

Value:Huntington's disease chorea, Tardive dyskinesia

Approved therapeutic indications

formulationFDA
2023

Available formulations

Value:Oral tablets (6mg, 9mg, 12mg)

Dosage forms and strengths

Deutetrabenazine is FDA-approved for the treatment of tardive dyskinesia (involuntary, repetitive movements caused by long-term use of certain medications) and for the treatment of chorea associated with Huntington's disease (inherited disorder causing progressive movement, cognitive, and psychiatric symptoms).

Deutetrabenazine works by reversibly inhibiting vesicular monoamine transporter 2 (VMAT2), which is responsible for packaging dopamine, serotonin, and norepinephrine into vesicles for release. By inhibiting this transporter, the medication depletes these monoamines from nerve terminals in the brain, thereby reducing the excessive dopaminergic activity that contributes to involuntary movements.

Deutetrabenazine may increase the risk of depression and suicidal thoughts; patients should be monitored closely, especially those with a history of depression. Common side effects include somnolence, fatigue, and akathisia. The medication may cause parkinsonism-like symptoms. Dose adjustment is required for patients with hepatic impairment. Women of childbearing potential should use effective contraception during treatment.

Contraindications

Conditions and patient states where this medication should be avoided or used with caution.

Do not use (1)

ABSOLUTEhypersensitivity

Known allergy to this medication or its components

Use caution (1)

RELATIVEpregnancy

Consult healthcare provider for benefits vs risks assessment

Official drug label

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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.

Medical Disclaimer

This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.

If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.

Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy