From the FDA Drug Label
Weight Gain Weight gain has been observed with use of atypical antipsychotics, including VRAYLAR Monitor weight at baseline and frequently thereafter. Table 4. Change in Body Weight (kg) in 6-Week Schizophrenia Trials VRAYLAR* Placebo(N=573)1. 5 - 3 mg/day(N=512)4.5 - 6mg/day(N=570)9 - 12⸰ mg/day(N=203) Mean Change at Endpoint+0.3+0. 8+1+1 Proportion of Patients with Weight Increase (≥7%)5%8%8%17% In long-term, uncontrolled trials with VRAYLAR in schizophrenia, the mean changes from baseline in weight at 12,24, and 48 weeks were 1.2 kg, 1.7 kg, and 2.5 kg, respectively.
Yes, Vraylar (cariprazine) can cause weight gain, as evidenced by the mean changes in body weight and proportion of patients with weight increase (≥7%) in the clinical trials 1.
- Key findings include:
- Mean weight changes ranging from +0.3 kg to +2.5 kg in different trials and time points
- Proportion of patients with weight increase (≥7%) ranging from 1% to 17% in different trials and doses It is recommended to monitor weight at baseline and frequently thereafter when using Vraylar.
From the Research
Vraylar (cariprazine) is associated with a relatively low risk of weight gain, with an estimated annual weight gain of +0.91 kg/year, according to the most recent and highest quality study 2.
Key Findings
- The study published in the Annals of General Psychiatry in 2025 found that cariprazine had a minimal impact on body weight and blood pressure in patients with bipolar I disorder, schizophrenia, or major depressive disorder 2.
- The estimated annual weight gain of +0.91 kg/year is considered modest compared to other antipsychotic medications.
- The study also found that the weight effects of cariprazine appear to be dose-dependent, with higher doses potentially causing more weight gain.
Clinical Implications
- Patients taking Vraylar should monitor their weight regularly and maintain healthy diet and exercise habits to minimize the risk of weight gain.
- Healthcare providers should discuss any significant weight changes with their patients and consider medication adjustments if weight gain becomes problematic.
- It is essential to note that individual responses to cariprazine may vary, and some patients may experience no weight changes or gain more weight than others.
Comparison to Other Studies
- While other studies have reported varying results regarding the weight gain associated with cariprazine, the most recent and highest quality study 2 provides the most reliable estimate of the medication's effect on weight.
- A study published in 2020 found that cariprazine was associated with weight gain in some patients, particularly those receiving higher doses 3.
- However, the 2025 study 2 provides a more comprehensive and up-to-date analysis of the medication's effects on weight and other health outcomes.