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Deutetrabenazine Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Apr 27, 2022.

Summary

Commonly reported side effects of deutetrabenazine include: drowsiness. Other side effects include: depression, agitation, akathisia, fatigue, and restlessness. See below for a comprehensive list of adverse effects.

For the Consumer

Applies to deutetrabenazine: oral tablets

Warning

    Depression and Suicidality in Patients with Huntington's Disease
  • Deutetrabenazine increases the risk of depression and suicidal thoughts and behavior (suicidality) in patients with Huntington’s disease; balance this risk with clinical need for treatment of chorea.1

  • Closely monitor patients for the emergence or worsening of depression, suicidality, or unusual changes in behavior.1

  • Inform patients, caregivers, and families of risk of depression and suicidality and instruct them to promptly report any behaviors of concern to the treating clinician.1

  • Exercise particular caution when treating patients with a history of depression or prior suicide attempts or ideation, which are increased in frequency in Huntington's disease.1

  • Deutetrabenazine is contraindicated in patients with Huntington's disease who are suicidal or have untreated or inadequately treated depression.1 (See Depression and Suicidality in Patients with Huntington's Disease under Cautions.)

Side effects include:

Huntington's disease: Somnolence, diarrhea, dry mouth, fatigue, urinary tract infection, insomnia, anxiety, constipation, contusion.

Tardive dyskinesia: Nasopharyngitis, insomnia, somnolence, fatigue, depression/dysthymic disorder, anxiety, diarrhea, dry mouth, akathisia/agitation/restlessness.

For Healthcare Professionals

Applies to deutetrabenazine: oral tablet

General

The most common adverse reactions occurring in greater than 8% were somnolence, diarrhea, dry mouth, and fatigue.[Ref]

Nervous system

Very common (10% or more): Sedation/somnolence (11%)

Common (1% to 10%): Dizziness[Ref]

Dermatologic

Common (1% to 10%): Contusion[Ref]

Gastrointestinal

Common (1% to 10%): Diarrhea, dry mouth, constipation[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Other

Common (1% to 10%): Fatigue[Ref]

Psychiatric

Common (1% to 10%): Insomnia, anxiety, depression, suicidal ideation, akathisia/agitation/restlessness[Ref]

Frequently asked questions

References

1. "Product Information. Austedo (deutetrabenazine)." Teva Pharmaceuticals USA (2017):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.