Vraylar - What are some of the important warnings?

Vraylar (cariprazine) is an atypical antipsychotic used to treat schizophrenia, bipolar disorder, and major depressive disorder. While effective, it carries important warnings, including an increased risk of death in elderly patients with dementia-related psychosis and a higher risk of suicidal thoughts or behaviors in children and young adults.

What Is Vraylar Used For?

Vraylar is FDA-approved to treat:

• Schizophrenia in adults.
• Bipolar I disorder: Acute treatment of manic, mixed, and depressive episodes in adults.
• Major depressive disorder (MDD): As an add-on therapy to antidepressants in adults.

Serious Warnings and Precautions

1. Increased Risk of Death in Elderly Patients with Dementia-Related Psychosis

Antipsychotic medications, including Vraylar, are not approved for treating dementia-related psychosis due to an increased risk of stroke and death in this population.

2. Increased Risk of Suicidal Thoughts and Behaviors

Children and young adults taking Vraylar may have a higher risk of suicidal thoughts or actions, especially when starting treatment or adjusting the dose. Any new or sudden changes in mood, behaviors, thoughts, or feelings should be reported to a healthcare provider right away.

Symptoms of concern include:

• Suicidal thoughts or behaviors
• Worsening depression or anxiety
• Agitation, aggression, or panic attacks
• Trouble sleeping (insomnia)
• Acting on dangerous impulses

3. Neurological and Movement Disorders

Vraylar carries a warning for developing conditions that affect the nervous system and muscles. These side effects may not appear until several weeks after starting Vraylar, since it takes time for the medication to build up in the body. Watch for the following serious side effects during the first several weeks of starting treatment and beyond:

• Neuroleptic Malignant Syndrome (NMS): A life-threatening condition with symptoms such as fever, muscle stiffness, confusion, irregular heartbeat, and sweating.
• Tardive Dyskinesia (TD): Uncontrolled body movements, especially in the face, tongue, or limbs.

Related questions

• Vraylar vs Abilify - How do they compare?
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4. Metabolic Changes

Similar to other atypical antipsychotics, Vraylar can cause metabolic changes such as:

• High blood sugar and diabetes
• Weight gain
• Elevated cholesterol and triglycerides

5. Blood and Circulatory Risks

Low white blood cell count (leukopenia, neutropenia, agranulocytosis), which may increase infection risk, is possible with Vraylar. It can also cause low blood pressure and dizziness when changing from a sitting or lying to a standing position (orthostatic hypotension). This can lead to falls and serious injury. The risk is highest when you first start treatment or when the dose is increased.

6. Other Risks

In addition to the risks listed above, Vraylar can cause:

• Seizures
• Cognitive and motor impairment (drowsiness, dizziness, difficulty thinking)
• Body temperature dysregulation (overheating or feeling too warm)
• Difficulty swallowing (dysphagia), increasing the risk of choking or pneumonia

Common Side Effects

When to Call Your Doctor

Contact your healthcare provider immediately if you experience:

• Suicidal thoughts, aggression, or severe mood changes.
• Uncontrolled movements, fever, or muscle stiffness.
• Severe dizziness, fainting, or difficulty breathing.