Vraylar Side Effects
Vraylar (cariprazine) carries serious risks including neuroleptic malignant syndrome, tardive dyskinesia, and metabolic problems, with the most common side effects being akathisia, nausea, and extrapyramidal symptoms. 1
Serious and Life-Threatening Side Effects
Neuroleptic Malignant Syndrome (NMS)
This potentially fatal reaction requires immediate emergency care. Watch for the tetrad of:
- High fever
- Severe muscle rigidity/stiffness
- Confusion and altered mental status
- Autonomic instability (changes in breathing, heart rate, blood pressure, increased sweating)
Stop Vraylar immediately and go to the emergency room if these symptoms develop. 1
Tardive Dyskinesia (TD)
Vraylar can cause involuntary movements that may be permanent, even after stopping the medication. TD can also begin after discontinuation. Monitor for:
- Uncontrolled movements of face, tongue, or other body parts
- Facial grimacing, tongue movements
- Extremity or truncal movements
Metabolic and Cardiovascular Effects
High Blood Sugar and Diabetes
Vraylar can cause hyperglycemia that may lead to coma or death if severe. Your provider should check blood sugar before starting, soon after initiation, and regularly during treatment. Seek care if you experience:
- Excessive thirst
- Increased urination
- Extreme hunger
- Weakness or fatigue
- Nausea
- Confusion or fruity-smelling breath
Lipid Abnormalities
Increased cholesterol and triglycerides require monitoring before starting and periodically during treatment. 1
Weight Gain
Real-world data shows cariprazine has a relatively favorable weight profile compared to other antipsychotics, with estimated weight gain of approximately +0.91 kg/year during treatment. 2 However, weight should be monitored before starting and regularly during treatment. 1
Orthostatic Hypotension and Falls
You may feel lightheaded or faint when standing up quickly. Vraylar can also cause sleepiness and slowed thinking, increasing fall risk and potential for fractures or injuries. 1
Neurological Side Effects
Extrapyramidal Symptoms (EPS)
The most common neurological effects include:
- Akathisia (severe restlessness, need to move around) - occurs in ≥5% of patients at twice the rate of placebo, with potential dose-dependent increase 3
- Difficulty moving or slow movements
- Tremors
- Uncontrolled body movements
- Muscle stiffness
These effects are generally mild to moderate in intensity. 3, 4
Common Side Effects
The most frequently reported side effects include:
- Akathisia and restlessness (most common, dose-related)
- Nausea (≥5%, twice placebo rate)
- Insomnia (≥5%, twice placebo rate, dose-dependent)
- Vomiting
- Indigestion and constipation
- Sleepiness, drowsiness, feeling tired
- Tremors
- Increased appetite
- Dizziness
Discontinuation due to adverse events is relatively low at 4.3% in pooled studies, with most patients (90%) completing treatment. 3
Other Important Side Effects
- Low white blood cell count - requires blood monitoring during first few months 1
- Seizures (convulsions) 1
- Difficulty swallowing - can cause aspiration of food or liquid into lungs 1
- Temperature regulation problems - difficulty controlling body temperature, feeling too warm 1
- Cognitive effects - difficulty thinking and performing normal activities 1
Critical Timing Consideration
Vraylar has a very long half-life and stays in your body for weeks. Side effects may not appear immediately and can start several weeks after beginning treatment or after dose increases. Your provider should monitor you for several weeks after starting and after any dose adjustment. 1
Hypersensitivity Reactions
Vraylar is contraindicated in patients with prior hypersensitivity reactions, which can include:
- Rash, pruritus, urticaria
- Angioedema (swollen tongue, lip swelling, face edema, pharyngeal edema)
Comparative Safety Profile
Cariprazine demonstrates a relatively favorable metabolic profile compared to other atypical antipsychotics, with minimal impact on BMI and blood pressure in real-world settings. 2 The risk of sedation, metabolic issues, and hypotension is lower than many other antipsychotics. 5 However, akathisia and extrapyramidal symptoms remain notable concerns, particularly at higher doses. 3, 4