Vraylar (Cariprazine) Side Effects
Most Common Side Effects
The most frequently reported side effects of Vraylar include extrapyramidal symptoms (EPS), akathisia (restlessness), sleepiness, nausea, vomiting, indigestion, constipation, difficulty moving or slow movements, tremors, uncontrolled body movements, feeling tired, trouble sleeping, increased appetite, and dizziness. 1
Movement-Related Side Effects (Most Prominent)
Extrapyramidal symptoms (EPS) occur with a number needed to harm (NNH) of 15 for doses of 1.5-3 mg/day and NNH of 10 for doses of 4.5-6 mg/day compared to placebo, making this one of the most common adverse effects. 2
Akathisia (restlessness and feeling like you need to move around) has an NNH of 20 for lower doses (1.5-3 mg/day) and NNH of 12 for higher doses (4.5-6 mg/day) versus placebo. 2
These movement side effects are typically mild to moderate in intensity but are more common than with placebo. 3, 4
Gastrointestinal Side Effects
- Nausea, vomiting, indigestion, and constipation are commonly reported. 1
Neuropsychiatric Side Effects
Sleepiness, drowsiness, feeling tired, and difficulty thinking are frequent complaints that may impair normal activities. 1
Trouble sleeping (insomnia) can occur despite the sedating effects in some patients. 1
Serious Side Effects (Less Common but Important)
Tardive Dyskinesia
- Uncontrolled body movements (tardive dyskinesia) may develop and potentially not resolve even after stopping Vraylar, representing a serious long-term risk. 1
Neuroleptic Malignant Syndrome (NMS)
- NMS is a potentially fatal condition characterized by high fever, stiff muscles, confusion, increased sweating, and changes in breathing, heart rate, and blood pressure—requiring immediate emergency care. 1
Metabolic Effects
Weight gain appears minimal in short-term studies, with approximately 8% of patients on cariprazine 1.5-6 mg/day gaining ≥7% body weight versus 5% on placebo (NNH of 34). 2
High blood sugar (hyperglycemia) and diabetes can occur, requiring monitoring before starting treatment and regularly during long-term use. 1
Increased cholesterol and triglyceride levels may develop, necessitating periodic lipid monitoring. 1
Metabolic changes are generally not clinically significant compared to other antipsychotics. 2, 4
Cardiovascular Effects
Decreased blood pressure upon standing (orthostatic hypotension) may cause lightheadedness or fainting when rising from sitting or lying positions. 1
No clinically meaningful ECG QT interval prolongation has been observed. 2
Hematologic Effects
- Low white blood cell count may occur, potentially requiring blood tests during the first few months of treatment. 1
Other Serious Risks
Falls due to sleepiness, dizziness, orthostatic hypotension, or slowed thinking and motor skills. 1
Seizures (convulsions) can occur. 1
Difficulty swallowing that may lead to aspiration of food or liquid into the lungs. 1
Problems controlling body temperature, potentially causing overheating. 1
Critical Timing Consideration: Delayed Side Effects
A unique and critical feature of Vraylar is that side effects may not appear immediately and can start several weeks after initiating treatment or after dose increases, due to the drug's extremely long half-life. 1
Cariprazine has an elimination half-life of 2-5 days, but its active metabolite didesmethyl-cariprazine has a half-life of 2-3 weeks. 5
Healthcare providers should monitor patients for side effects for several weeks after starting or increasing the dose. 1
This prolonged half-life means the drug stays in your body for an extended period, and effects persist long after discontinuation. 1