Summary
Commonly reported side effects of tetrabenazine include: drowsiness, sedated state, bradykinesia, hypertonia, muscle rigidity, depression, exacerbation of depression, akathisia, and restlessness. Other side effects include: dysphagia, anxiety, and dizziness. Continue reading for a comprehensive list of adverse effects.
Applies to tetrabenazine: oral tablets.
Warning
-
Tetrabenazine increases 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 observe all patients for emergence or clinical worsening of depression, suicidality, or unusual changes in behavior; involve family members and/or caregivers in this process.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
- Tetrabenazine is contraindicated in patients who are suicidal and in patients with untreated or inadequately treated depression.1
Side effects include:
Adverse effects reported in ≥5% of patients with Huntington’s chorea receiving tetrabenazine and at an incidence greater than that reported with placebo include sedation or somnolence, insomnia, fatigue, depression, anxiety, irritability, balance difficulties, extrapyramidal adverse effects (e.g., akathisia, bradykinesia, parkinsonism, hypertonia), nausea, vomiting, ecchymosis, falls, laceration of the head, and upper respiratory tract infection.
For Healthcare Professionals
Applies to tetrabenazine: oral tablet.
Nervous system
Very common (10% or more): Any extrapyramidal event (33%), sedation/somnolence (31%), akathisia/hyperkinesia/restlessness (19%), parkinsonism (12%)
Common (1% to 10%): Balance difficulty, dizziness, dysarthria, unsteady gait, headache
Uncommon (0.1% to 1%): Altered levels of consciousness
Rare (less than 0.1%): Neuroleptic malignant syndrome
Frequency not reported: Ataxia, dyskinetic seizure, dystonia, memory impairment, amnesia
Postmarketing reports: Tremor[Ref]
Other
Very common (10% or more): Fatigue (22%), fall (15%)
Common (1% to 10%): Head laceration
Uncommon (0.1% to 1%): Hyperthermia
Frequency not reported: Lassitude, hypothermia, weakness, lactation, irregular menstrual cycle[Ref]
Psychiatric
Very common (10% or more): Insomnia (22%), depression (19%), anxiety/aggravated anxiety (15%)
Common (1% to 10%): Irritability, obsessive reaction, agitation, confusion
Frequency not reported: Disorientation, feelings of unreality, nervousness, sleep disorders
Postmarketing reports: Worsening aggression[Ref]
Gastrointestinal
Very common (10% or more): Nausea (13%)
Common (1% to 10%): Vomiting, dysphagia/choking attacks, constipation, diarrhea
Frequency not reported: Dry mouth, epigastric pain, sialorrhea[Ref]
Respiratory
Very common (10% or more): Upper respiratory tract infection (11%)
Common (1% to 10%): Shortness of breath, bronchitis
Frequency not reported: Bronchopneumonia
Postmarketing reports: Pneumonia[Ref]
Cardiovascular
Common (1% to 10%): Hypotension
Frequency not reported: Hypertensive crisis, bradycardia[Ref]
Dermatologic
Common (1% to 10%): Ecchymosis
Frequency not reported: Sweating
Postmarketing reports: Hyperhidrosis, skin rash[Ref]
Genitourinary
Common (1% to 10%): Dysuria[Ref]
Metabolic
Common (1% to 10%): Decreased appetite
Frequency not reported: Anorexia, weight gain[Ref]
Musculoskeletal
Uncommon (0.1% to 1%): Severe extrapyramidal symptoms (e.g., muscular rigidity, autonomic dysfunction)
Very rare (less than 0.01%): Skeletal muscle damage[Ref]
Hematologic
Frequency not reported: Leukopenia[Ref]
Ocular
Frequency not reported: Oculogyric crisis, photophobia[Ref]
