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.
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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
| Condition Treated | Common Side Effects |
| Schizophrenia | Extrapyramidal symptoms (involuntary movements), akathisia (restlessness) |
| Bipolar Depression | Nausea, akathisia, restlessness, extrapyramidal symptoms |
| Bipolar Mania | Extrapyramidal symptoms, akathisia, dyspepsia (indigestion), vomiting, drowsiness, restlessness |
| Major Depressive Disorder (Add-On Treatment) | Akathisia, restlessness, fatigue, constipation, nausea, insomnia, increased appetite, dizziness, extrapyramidal symptoms |
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.
References
- Food and Drug Administration. VRAYLAR Product Label. Available at https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf [Accessed December 22, 2022]
Read next
How long does it take for Vraylar (cariprazine) to work?
Vraylar (cariprazine) takes time to work and patients often see a gradual reduction in symptoms over several weeks. Symptoms tend to continue to improve the longer the medication is taken. Continue reading
How does Vraylar compare with Seroquel?
Vraylar and Seroquel are both oral prescription medicines known as atypical antipsychotics. They treat the mental health conditions schizophrenia and bipolar disorder. Vraylar is also approved to treat Major Depressive Disorder (MDD). They work by changing the actions of chemicals in your brain to help stabilize thoughts, actions and moods. Continue reading
Do Vraylar (cariprazine) side effects go away?
Most side effects with Vraylar will subside with time after your body has become used to the medicine. However, some side effects can be serious, have long-lasting effects or be irreversible. Speak to your doctor for medical advice if you have side effects that concern you with Vraylar or any other medication. Continue reading
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Drug information
- Vraylar Information for Consumers
- Vraylar prescribing info & package insert (for Health Professionals)
- Side Effects of Vraylar (detailed)
- Vraylar user reviews (525)
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