Medication Fact Sheets
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November 25, 2024

Vraylar Side Effects: A Comprehensive Guide

Medically Reviewed by
Updated On
November 26, 2024

Vraylar (Cariprazine) is a powerful antipsychotic medication used to treat mental health conditions like schizophrenia and bipolar disorder, offering relief from symptoms like mood swings, hallucinations, and manic episodes. However, like any medication, it has potential side effects that patients and healthcare providers must understand and monitor.  This article provides a comprehensive guide to the common and serious side effects of Vraylar.

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What is Vraylar (Cariprazine)?

Vraylar, known by its generic name Cariprazine, is a prescription medication used primarily to treat mental health conditions such as bipolar disorder and schizophrenia. It helps manage symptoms like mood swings, depressive episodes, and psychotic symptoms like hallucinations or delusions. Doctors also prescribe Vraylar to address manic and mixed episodes in individuals with bipolar I disorder. Its use can improve mood stability.

How It Works

Vraylar works by affecting the balance of chemicals in the brain, specifically dopamine and serotonin, two key neurotransmitters responsible for regulating mood, behavior, and cognition. Vraylar is a partial agonist (binds to receptors and causes a reaction) at dopamine D2 and D3 receptors and serotonin receptors. This means that Vraylar activates these receptors, providing just enough stimulation to help balance mood without overstimulating the brain, which can lead to side effects or worsening symptoms.

Who Is Prescribed Vraylar?

Doctors typically prescribe Vraylar to adults diagnosed with bipolar I disorder or schizophrenia. It is suitable for patients who experience intense mood swings, periods of mania, or depressive episodes that impact daily life. 

Individuals with schizophrenia who may struggle with disorganized thinking, delusions, or hallucinations also benefit from Vraylar’s mood-stabilizing effects. It helps reduce the severity of these symptoms and improve overall mental functioning.

Common Side Effects of Vraylar

The following side effects are common:

Gastrointestinal Side Effects

  • Symptoms: Patients commonly report nausea, constipation, and vomiting when taking Vraylar. These symptoms may occur more frequently at the beginning of treatment but can lessen over time as the body adjusts.
  • Management Tips:
    • Stay hydrated to help with constipation.
    • Eat smaller meals to reduce nausea.

Nervous System Reactions

  • Vraylar may cause headaches, dizziness, and restlessness.
    • Headaches: Range from mild to moderate and may occur throughout the day.
    • Dizziness: Can affect coordination and balance, especially when standing up quickly.
    • Restlessness: Some patients report feeling unusually agitated or fidgety or unable to keep their legs still.
  • Impact on Daily Life: These side effects can interfere with normal daily activities, such as working, driving, or concentrating. If these symptoms are bothersome, talk to your doctor about adjustments.

Metabolic Effects

  • Weight Gain: Vraylar may cause weight gain. In clinical studies, patients taking Vraylar for major depressive disorder gained an average of 3.7 lbs after about 6 months.
  • Increased Blood Sugar (hyperglycemia): Vraylar can raise blood sugar levels, causing increased thirst and/or urination, fatigue, and blurry vision.  
  • Management Tips:
    • Regular monitoring of weight and blood sugar levels is essential.
    • Follow a balanced diet and maintain physical activity to mitigate these effects.

Sleep-Related Issues

  • Insomnia: Difficulty falling or staying asleep is a common side effect of Vraylar.
  • Drowsiness: Conversely, some patients may feel unusually sleepy during the day.
  • Management Tips:
    • Establish a consistent sleep schedule.
    • Limit caffeine and screen time before bed.
    • If drowsiness persists, avoid activities requiring full attention, like driving, until your body adjusts to the medication.

Serious Side Effects of Vraylar

The following side effects are more serious. Seek medical attention immediately if you experience any of the following:

Extrapyramidal Symptoms (EPS) and Tardive Dyskinesia

Vraylar may cause: 

  • Extrapyramidal symptoms (EPS) include involuntary movements, muscle stiffness, and tremors. These side effects resemble those of Parkinson’s disease and can affect daily functioning.
  • Tardive Dyskinesia, is a condition condition involving uncontrollable facial or body movements. This condition can be permanent, especially with long-term use of antipsychotic medications.

Older adults, those with pre-existing movement disorders, and individuals on long-term treatment are at higher risk. Detecting these symptoms early can help prevent long-term damage. Regular neurological assessments by a healthcare provider are critical.

Cardiovascular Risks

  • Increased Heart Rate: Vraylar can cause an increased heart rate and may contribute to a heightened risk of stroke, especially in elderly patients with dementia-related psychosis.
  • Monitoring Strategies: High-risk patients, such as those with a history of heart disease, should undergo regular heart rate monitoring and blood pressure checks. Doctors may also advise lifestyle adjustments to minimize cardiovascular risks.

Neuroleptic Malignant Syndrome (NMS)

  • What It Is: Neuroleptic Malignant Syndrome (NMS) is a rare but potentially life-threatening condition associated with antipsychotic medications like Vraylar.
  • Symptoms: Signs include high fever, muscle rigidity, confusion, and rapid heart rate.
  • Treatment and Intervention: NMS requires immediate medical attention. Treatment often involves stopping the medication and providing supportive care in a hospital setting. Early recognition and timely intervention are critical to preventing severe complications.

Understanding these serious side effects can help patients and caregivers monitor and manage potential risks more effectively.

Vraylar Side Effects in Special Populations

The following side effects are specific to certain groups of people:

Elderly Patients

Elderly patients, particularly those with dementia-related psychosis, are at higher risk for serious side effects from Vraylar. This includes increased cardiovascular risks such as heart attack or stroke and a heightened chance of metabolic issues like weight gain and blood sugar spikes.

Doctors often start elderly patients on lower doses of Vraylar and carefully monitor their heart rate, blood pressure, and blood sugar levels. Regular check-ups help detect potential side effects early, and adjustments can be made to the treatment plan.

Pregnancy and Lactation

Pregnancy: The safety of Vraylar during pregnancy is not well established, but it may pose risks to fetal development, particularly if taken during the third trimester. Babies born to mothers who used antipsychotics during pregnancy may experience withdrawal symptoms, including muscle stiffness, tremors, or breathing difficulties.

Breastfeeding Risks: It is unclear if Vraylar passes into breast milk, but due to the potential for adverse effects in the nursing infant, breastfeeding is generally not recommended while on this medication.

Women who are pregnant or planning to become pregnant should thoroughly discuss the risks and benefits of continuing Vraylar during pregnancy and lactation with their healthcare provider.

Comorbid Conditions

Patients with existing conditions like diabetes or heart disease face an elevated risk of metabolic side effects such as weight gain and increased blood sugar, as well as cardiovascular complications like heart attacks or strokes.

Doctors may recommend a more cautious and tailored dosing strategy and regular monitoring of blood sugar, cholesterol, and cardiovascular health. To minimize these risks, patients should also follow a healthy diet and exercise routine.

How to Manage and Mitigate Side Effects

  • Regular checkup visits allow healthcare providers to monitor health markers like weight, blood pressure, and blood sugar levels, which are particularly important due to the risk of metabolic side effects. 
  • Patients at risk for diabetes or cardiovascular disease should undergo frequent monitoring to detect any early signs of complications. 
  • Routine assessments also help catch more serious side effects, such as extrapyramidal symptoms (EPS) or the onset of tardive dyskinesia.

Lifestyle Adjustments

  • Managing side effects such as weight gain and increased blood sugar requires a proactive lifestyle approach. A balanced diet rich in fruits, vegetables, lean proteins, and whole grains can help manage weight and maintain stable blood sugar levels. 
  • Regular exercise is equally important for improving metabolism and cardiovascular health, with activities like walking, swimming, or yoga recommended.
  • Sleep Hygiene: For patients experiencing insomnia or drowsiness, practicing good sleep hygiene can improve sleep quality. This includes maintaining a consistent sleep schedule, reducing caffeine intake, and avoiding electronic screens before bedtime. 

Medication Adjustments

If side effects become too challenging to manage, consult with a healthcare provider. Dose adjustments may be necessary to reduce side effects, or the doctor may suggest switching to a different medication. 

Each patient’s response to Vraylar is different, and healthcare providers can tailor medication plans to suit individual needs better, ensuring effective management of the condition and its side effects.

Patient Education and Communication Tips for Healthcare Providers

Effective communication is essential for helping patients understand the common and serious side effects of Vraylar. Healthcare providers should explain potential side effects clearly, ensuring patients know what to expect and which symptoms warrant immediate attention. 

Patients are more likely to recognize side effects early by providing detailed information upfront, improving overall treatment outcomes. Additionally, healthcare providers should emphasize the importance of reporting side effects promptly. 

Shared Decision-Making

Shared decision-making is key to ensuring that patients feel involved in their treatment plans. Healthcare providers should discuss the benefits versus risks of staying on Vraylar, especially if side effects become troublesome. This collaborative approach helps patients feel more in control of their health and fosters trust. Involving caregivers in these conversations can also be beneficial, as they can help monitor and manage side effects, particularly in elderly patients or those with cognitive challenges. 

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Key Takeaways

  • Vraylar (Cariprazine) is used to treat bipolar disorder and schizophrenia, helping manage symptoms like mood swings, hallucinations, and manic episodes.
  • Common side effects include gastrointestinal issues (nausea, vomiting), nervous system reactions (dizziness, headaches), metabolic effects (weight gain, increased blood sugar), and sleep-related issues (insomnia or drowsiness).
  • Serious side effects include extrapyramidal symptoms (involuntary movements), cardiovascular risks (increased heart rate, stroke risk), and the rare but dangerous Neuroleptic Malignant Syndrome (NMS).
  • Special populations, such as the elderly, pregnant women, and patients with comorbid conditions like diabetes or heart disease, require extra caution and monitoring due to heightened risks.
  • Managing side effects involves regular checkups, lifestyle adjustments (diet, exercise, and sleep hygiene), and potential medication adjustments based on patient response.
  • Clear communication from healthcare providers is crucial in educating patients about side effects and empowering them to report any concerns promptly.
  • Shared decision-making helps patients weigh the risks and benefits of staying on Vraylar and involves caregivers in monitoring and managing side effects.
The information in this article is designed for educational purposes only and is not intended to be a substitute for informed medical advice or care. This information should not be used to diagnose or treat any health problems or illnesses without consulting a doctor. Consult with a health care practitioner before relying on any information in this article or on this website.

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Achuff, J. (2024, April 2). Unlocking the Genetic Pathways to Psychosis: A Study Reveals Key Insights. Rupa Health. https://www.rupahealth.com/post/unlocking-the-genetic-pathways-to-psychosis-a-study-reveals-key-insights

Cleveland Clinic. (n.d.-a). Cariprazine (VRAYLAR): Uses & Side Effects. Cleveland Clinic. https://my.clevelandclinic.org/health/drugs/20257-cariprazine-capsules

Cleveland Clinic. (n.d.-b). Tardive Dyskinesia: What It Is, Causes, Symptoms & Treatment. Cleveland Clinic. https://my.clevelandclinic.org/health/diseases/6125-tardive-dyskinesia

Cleveland Clinic. (2022, March 14). Neurotransmitters: What they are, functions & types. Cleveland Clinic. https://my.clevelandclinic.org/health/articles/22513-neurotransmitters

Cloyd, J. (2023, August 25). A Root Cause Medicine Protocol For Patients With Insomnia: Testing, Therapeutic Diet, and Supportive Supplements. Rupa Health. https://www.rupahealth.com/post/a-root-cause-medicine-protocol-for-patients-with-insomnia-testing-therapeutic-diet-and-supportive-supplements

D’Souza, R. S., & Hooten, W. M. (2023). Extrapyramidal symptoms (EPS). Nih.gov; StatPearls Publishing. https://www.ncbi.nlm.nih.gov/books/NBK534115/

Kresge, K. (2023, February 21). An Integrative Medicine Approach to Depression. Rupa Health. https://www.rupahealth.com/post/an-integrative-medicine-approach-to-depression

National Institute of Mental Health. (2023). Understanding psychosis. National Institute of Mental Health; U.S. Department of Health and Human Services, National Institutes of Health. https://www.nimh.nih.gov/health/publications/understanding-psychosis

National Institute of Mental Health. (2024). Schizophrenia. National Institute of Mental Health. https://www.nimh.nih.gov/health/topics/schizophrenia

NIH. (2015). These highlights do not include all the information needed to use VRAYLAR safely and effectively. See full prescribing information for VRAYLAR . VRAYLAR ® ( cariprazine ) c apsules , for o ral u se Initial U.S. Approval: 2015. Nih.gov. https://dailymed.nlm.nih.gov/dailymed/medguide.cfm?setid=3435ec73-86ed-46d1-bd1f-ee6c30209123

Tondo, L., Vazquez, G., & Baldessarini, R. (2017). Depression and Mania in Bipolar Disorder. Current Neuropharmacology, 15(3), 353–358. https://doi.org/10.2174/1570159x14666160606210811

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