Note: This document contains side effect information about deutetrabenazine. Some dosage forms listed on this page may not apply to the brand name Austedo XR.
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
Side effects include:
Adverse effects in patients with Huntington's disease (>8%): somnolence, diarrhea, dry mouth, fatigue.
Adverse effects in patients with tardive dyskinesia (>4%): nasopharyngitis, insomnia.
For Healthcare Professionals
Applies to deutetrabenazine: oral tablet, oral tablet extended release.
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]
