What are the side effects of Vraylar (cariprazine)?

Side Effects of Vraylar (Cariprazine)

Vraylar (cariprazine) has several important side effects including extrapyramidal symptoms, akathisia, metabolic effects, and tardive dyskinesia, with the most common being movement disorders, sleepiness, and gastrointestinal symptoms. 1

Common Side Effects

The most frequently reported side effects of Vraylar include:

• Movement disorders:

  • Difficulty moving or slow movements
  • Tremors
  • Uncontrolled body movements
  • Restlessness and feeling like you need to move around (akathisia)
  • Extrapyramidal symptoms (NNH 15 for 1.5-3 mg/d and NNH 10 for 4.5-6 mg/d) 2
  • Akathisia (NNH 20 for 1.5-3 mg/d and NNH 12 for 4.5-6 mg/d) 2

• Neurological effects:

  • Sleepiness/drowsiness
  • Dizziness
  • Trouble sleeping

• Gastrointestinal effects:

  • Nausea
  • Vomiting
  • Indigestion
  • Constipation

• Other common effects:

  • Fatigue/feeling tired
  • Increased appetite 1

Serious Side Effects

Vraylar can cause several serious adverse effects that require immediate medical attention:

1. Tardive dyskinesia: Involuntary movements of the face, tongue, or other body parts that may not go away even after stopping the medication 1

2. Neuroleptic malignant syndrome (NMS): A potentially fatal condition characterized by:

   • High fever
   • Stiff muscles
   • Confusion
   • Increased sweating
   • Changes in breathing, heart rate, and blood pressure 1

3. Metabolic effects:

   • High blood sugar (hyperglycemia) and risk of diabetes
   • Increased cholesterol and triglyceride levels
   • Weight gain (approximately 8% of patients gain ≥7% body weight, NNH 34) 2

4. Orthostatic hypotension: Feeling lightheaded or faint when rising quickly from sitting or lying position 1

5. Low white blood cell count 1

6. Seizures 1

7. Problems controlling body temperature 1

8. Difficulty swallowing that can cause food or liquid to get into lungs 1

9. Falls due to sleepiness, dizziness, or orthostatic hypotension 1

Unique Characteristics

Unlike some other antipsychotics, Vraylar:

• Has a very long half-life (2-5 days for cariprazine and 2-3 weeks for its active metabolite didesmethyl-cariprazine) 3
• Shows preferential binding to dopamine D3 receptors over D2 receptors 2
• Is associated with minimal weight gain compared to some other antipsychotics 2
• Does not cause significant metabolic abnormalities, prolactin increases, or QT prolongation 3

Monitoring Recommendations

When taking Vraylar, patients should be monitored for:

• Movement disorders, particularly within the first few weeks of treatment
• Blood sugar levels before starting treatment and regularly thereafter
• Cholesterol and triglyceride levels
• Weight changes
• Blood pressure changes
• Signs of infection due to potential low white blood cell count
• Temperature regulation issues

Risk Factors and Precautions

Cariprazine should be used with caution in:

• Elderly patients with dementia-related psychosis (increased risk of death)
• Patients with cardiovascular disease (risk of orthostatic hypotension)
• Patients with diabetes or at risk for diabetes
• Patients with a history of seizures
• Patients taking other medications that affect the CYP3A4 enzyme system 4

Timing of Side Effects

Some side effects may not appear immediately and can start several weeks after beginning treatment or after a dose increase, due to the medication's long half-life and accumulation of active metabolites 1, 3.

If side effects become severe or concerning, patients should contact their healthcare provider immediately rather than stopping the medication abruptly.

Comparison to Other Antipsychotics

Compared to other atypical antipsychotics, Vraylar has:

• Higher risk of akathisia and extrapyramidal symptoms
• Lower risk of significant weight gain
• Minimal impact on metabolic parameters
• No significant effect on prolactin levels or QT interval 2, 3

The unique pharmacological profile of cariprazine as a D3-preferring partial agonist distinguishes it from most other antipsychotics, which may explain its different side effect profile 5.