Can Vraylar Cause Symptoms?
Yes, Vraylar (cariprazine) can cause a wide range of symptoms as side effects, some of which may be serious and require immediate medical attention. 1
Common Side Effects
The FDA-approved labeling for Vraylar identifies several frequently occurring adverse effects that patients should anticipate:
- Extrapyramidal symptoms (EPS) and akathisia are among the most common side effects, occurring with mild to moderate intensity in clinical trials 1, 2
- Gastrointestinal symptoms including nausea are frequently reported 1, 3
- Restlessness is a commonly documented adverse effect 1
- Sedation and drowsiness can occur, potentially interfering with cognitive and motor performance 1
The incidence of these symptoms is dose-dependent, with patients receiving 3.0 mg/day experiencing more adverse events compared to those on 1.5 mg/day 3
Serious and Life-Threatening Side Effects
Black Box Warnings
The FDA mandates several critical warnings for Vraylar:
- Increased risk of death in elderly patients with dementia-related psychosis - Vraylar is not approved for this population 1
- Increased risk of suicidal thoughts and actions, particularly in children and young adults during the first few months of treatment or when doses are changed 1
Other Serious Adverse Reactions
- Neuroleptic Malignant Syndrome (NMS) - a potentially fatal reaction requiring immediate emergency care 1
- Tardive dyskinesia - abnormal involuntary movements that may be irreversible 1
- Metabolic changes including hyperglycemia, diabetes mellitus, dyslipidemia, and weight gain 1
- Leukopenia/neutropenia - particularly concerning in patients with pre-existing low white blood cell counts 1
- Orthostatic hypotension and syncope, especially early in treatment or with dose increases 1
- Hypersensitivity reactions ranging from rash and urticaria to angioedema (swollen tongue, lip swelling, face edema, pharyngeal edema) 1
Important Clinical Considerations
Late-Occurring Adverse Reactions
A critical pitfall to avoid: adverse reactions may not appear until several weeks after initiating Vraylar treatment due to the extremely long half-life of its active metabolite didesmethyl-cariprazine (DDCAR), which ranges from 1-3 weeks 1, 3. This delayed onset means patients and providers must maintain vigilance well beyond the initial treatment period.
Discontinuation Rates
In pooled clinical trial data for bipolar depression, discontinuation rates due to adverse events were 6.7% for cariprazine versus 4.8% for placebo (number needed to harm = 51, not statistically significant) 3. This suggests that while side effects occur, they are generally tolerable for most patients.
Risk-Benefit Profile
The likelihood of experiencing therapeutic benefit (response or remission) substantially exceeds the likelihood of discontinuation due to adverse events 3. However, this must be weighed against the potential for serious adverse effects, particularly in vulnerable populations.
Monitoring Requirements
Patients taking Vraylar require monitoring for:
- Blood glucose and lipids to detect metabolic changes 1
- Complete blood count (CBC) in patients with pre-existing low WBC or history of drug-induced leukopenia/neutropenia 1
- Weight changes at regular intervals 1
- Emergence of suicidal thoughts, especially during dose adjustments 1
- Signs of NMS (fever, muscle rigidity, altered mental status, autonomic instability) 1
- Abnormal involuntary movements suggestive of tardive dyskinesia 1
Special Precautions
- Avoid overheating and dehydration as Vraylar can impair body temperature regulation 1
- Caution with activities requiring mental alertness (driving, operating machinery) until individual response is established 1
- Third trimester pregnancy use may cause extrapyramidal and/or withdrawal symptoms in neonates 1