What is the risk of thromboembolism associated with Vraylar (cariprazine)?

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Last updated: May 28, 2025View editorial policy

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From the Guidelines

Vraylar (cariprazine) is associated with an increased risk of blood clots, and patients should be closely monitored for signs of venous thromboembolism (VTE), particularly during the initial treatment period. The risk of VTE is a significant concern in hospitalized medical patients, with an incidence of up to 14.9% in acutely ill patients, as reported in a systematic review and meta-analysis published in the journal Blood 1. Patients taking Vraylar should be aware of the warning signs of a blood clot, including swelling, pain, warmth, and redness in a limb, sudden shortness of breath, chest pain, or neurological symptoms like sudden headache, vision changes, or weakness on one side of the body.

Key Considerations

  • The risk of blood clots associated with Vraylar is thought to be related to its effects on dopamine receptors and metabolic parameters.
  • Patients with additional risk factors, such as smoking, obesity, immobility, advanced age, or a personal/family history of blood clots, should be closely monitored.
  • Regular follow-up appointments with a healthcare provider are crucial to monitor for any complications while taking Vraylar.
  • The benefits of Vraylar for conditions like bipolar disorder or schizophrenia typically outweigh the potential risk of blood clots, but patients should be informed of this potential side effect.

Management and Prevention

  • Healthcare providers should assess patients' risk factors for VTE and consider using risk assessment models (RAMs) to stratify patients by their risk of having a VTE or clinically significant bleeding event, as discussed in the study published in Blood 1.
  • Pharmacological and nonpharmacological interventions can be used to reduce the risk of hospital-acquired VTE, but these interventions should be carefully considered to minimize potential patient harms.

From the Research

Vraylar and Risk of Blood Clots

  • There is no direct evidence in the provided studies that links Vraylar to the risk of blood clots.
  • However, the studies discuss the risk of blood clots in the context of venous thromboembolism (VTE) and anticoagulation treatment 2, 3, 4, 5, 6.
  • Venous thromboembolism is a condition that affects nearly 10 million people worldwide every year, and it can be caused by various factors, including major surgery, active cancer, and immobility 3, 6.
  • Anticoagulation treatment is the cornerstone of therapy for VTE, but it increases the risk of bleeding, and patients at high risk for major bleeding might benefit from treatment discontinuation 2, 4.
  • The studies discuss different bleeding risk assessment tools, such as the HAS-BLED, RIETE, and VTE-BLEED scores, which can aid in clinical decision-making, but none of these tools has been investigated in clinical trials to provide evidence to withhold anticoagulation treatment based on the score 2.
  • The optimal duration of anticoagulation treatment for VTE is still a topic of debate, and ongoing research is focused on improving diagnostic strategies, comparing different anticoagulants, and developing safer anticoagulants 3, 4, 5.

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Venous thromboembolism.

Lancet (London, England), 2021

Research

Venous thromboembolism: a public health concern.

American journal of preventive medicine, 2010

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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