From the FDA Drug Label
The most common adverse reactions occurring in greater than 8% of AUSTEDO-treated patients were somnolence, diarrhea, dry mouth, and fatigue. Adverse reactions occurring in 4% or more of patients treated with AUSTEDO, and with a greater incidence than in patients on placebo, are summarized in Table 3 The most common adverse reactions occurring in greater than 3% of AUSTEDO-treated patients and greater than placebo were nasopharyngitis and insomnia The adverse reactions occurring in >2% or more patients treated with AUSTEDO (12-48 mg per day) and greater than in placebo patients in two double-blind, placebo-controlled studies in patients with tardive dyskinesia (Study 1 and Study 2) are summarized in Table 4 The following adverse reactions were reported in frequencies of at least 5% of pediatric patients treated with AUSTEDO and with a greater incidence than in pediatric patients receiving placebo (AUSTEDO vs placebo): headache, somnolence, fatigue, increased appetite, and increased weight.
The side effects of deutetrabenazine include:
- Somnolence
- Diarrhea
- Dry mouth
- Fatigue
- Nasopharyngitis
- Insomnia
- Headache
- Increased appetite
- Increased weight 1
From the Research
Deutetrabenazine can cause several side effects, including common adverse reactions such as nasopharyngitis and insomnia, as well as more serious side effects like depression, anxiety, and parkinsonism. The most recent and highest quality study, published in 2024 2, provides an integrated safety analysis of deutetrabenazine in patients with tardive dyskinesia and chorea associated with Huntington disease, showing that deutetrabenazine has a favorable safety profile and is well tolerated across indications. Some key points to consider when prescribing deutetrabenazine include:
- Starting at a low dose (6 mg daily) and gradually increasing to minimize side effects, with most patients requiring 12-48 mg daily divided into two doses
- Regular monitoring for depression, suicidality, and movement disorders is essential during treatment
- Patients should avoid alcohol and other CNS depressants while taking this medication as they can worsen side effects
- Common adverse reactions include headache, somnolence, nausea, anxiety, fatigue, dry mouth, and diarrhea
- Serious side effects that require immediate medical attention include QT prolongation, neuroleptic malignant syndrome, and tardive dyskinesia. It is also important to note that deutetrabenazine carries a black box warning for depression and suicidality, particularly in patients with Huntington's disease. Overall, deutetrabenazine can be an effective treatment for tardive dyskinesia, but it is essential to carefully weigh the potential benefits and risks and to closely monitor patients for any adverse reactions.