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 Austedo (Deutetrabenazine) include:
- Common adverse reactions: somnolence, diarrhea, dry mouth, fatigue, nasopharyngitis, and insomnia
- Adverse reactions in patients with Huntington's disease: somnolence, diarrhea, dry mouth, fatigue, urinary tract infection, insomnia, anxiety, constipation, contusion
- Adverse reactions in patients with tardive dyskinesia: nasopharyngitis, insomnia, depression, akathisia, agitation, restlessness
- Adverse reactions in pediatric patients: headache, somnolence, fatigue, increased appetite, increased weight
- Serious adverse reactions: depression and suicidality, QTc prolongation, neuroleptic malignant syndrome, akathisia, agitation, restlessness, parkinsonism, sedation, somnolence, hyperprolactinemia, binding to melanin-containing tissues 1
From the Research
Austedo (deutetrabenazine) can cause several side effects, with the most common being nasopharyngitis and insomnia, as reported in a systematic review of its efficacy and safety profile 2.
Side Effects of Austedo (Deutetrabenazine)
The side effects of Austedo (deutetrabenazine) are primarily related to its mechanism of action as a reversible inhibitor of vesicular monoamine transporter type 2 (VMAT2).
- Common side effects include:
- Nasopharyngitis
- Insomnia
- Less common but more serious side effects include:
- Parkinsonism (stiffness, tremor, slow movement)
- Akathisia (inner restlessness)
- Tardive dyskinesia (involuntary movements)
Management of Side Effects
It is essential to monitor patients for side effects, especially during the initial treatment period or with dose increases.
- Patients should report any concerning side effects to their healthcare provider immediately, especially mood changes or unusual movements.
- Regular follow-up appointments are crucial to monitor for side effects and adjust dosing as needed.
Recent Studies
A recent systematic review and comparative analysis of deutetrabenazine and valbenazine as VMAT2 inhibitors for tardive dyskinesia found that both medications demonstrated significant improvements in Abnormal Involuntary Movement Scale (AIMS) scores and exhibited favorable safety profiles 3. Another study characterized the pharmacokinetic and pharmacologic profiles of the dihydrotetrabenazine isomers of deutetrabenazine and valbenazine, highlighting the importance of considering the effects of intrinsic/extrinsic variables on deutetrabenazine's safety/efficacy profile 4. However, the most recent and highest quality study, a comparative analysis of deutetrabenazine and valbenazine, found that deutetrabenazine demonstrated significant improvements in AIMS scores with a favorable safety profile 3. Based on the most recent evidence, deutetrabenazine is a safe and effective treatment option for tardive dyskinesia, with a favorable side effect profile compared to other VMAT2 inhibitors 3.