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09/17/2024 | Press release | Distributed by Public on 09/17/2024 15:27

10 Vraylar Side Effects You Should Know About

Key takeaways:

  • Vraylar (cariprazine) is an atypical antipsychotic that treats schizophrenia and bipolar disorder.

  • Common Vraylar side effects include headache, sleeping changes, and stomach problems. Changes to your metabolism, such as weight gain, are also possible.

  • Rare but serious Vraylar side effects include tardive dyskinesia, neuroleptic malignant syndrome, and suicidal thoughts. Seek medical help right away if you have severe or life-threatening symptoms.

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Vraylar (cariprazine) is an atypical antipsychotic that's prescribed to treat schizophrenia and bipolar disorder. You can also take Vraylar along with other medications to help treat major depressive disorder.

While it can be an effective medication, Vraylar can cause side effects. It's important to know what side effects you may experience and when to contact a healthcare professional for guidance.

Vraylar side effects at a glance

Vraylar shares many of the same side effects as other atypical antipsychotics. Some side effects are mild and can often be managed at home. Others are serious and can be life-threatening in severe cases. Knowing the difference between them is key to safely taking Vraylar.

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Common Vraylar side effects include:

  • Headache

  • Trouble sleeping

  • Drowsiness

  • Constipation

  • Diarrhea

  • Nausea

  • Vomiting

  • Heartburn

  • Stomach pain

  • Toothache

  • Restlessness

  • Uncontrollable muscle movements

  • Agitation

  • Nervousness

  • Dizziness

  • Decreased appetite

  • Weight gain

Rare but serious Vraylar side effects include:

  • Neuroleptic malignant syndrome (NMS)

  • Raised cholesterol

  • Raised blood glucose (sugar)

  • Low blood pressure

  • Fainting

  • Trouble swallowing

  • Tardive dyskinesia (involuntary movements)

  • Mood changes

  • Thoughts of suicide

  • Trouble controlling your body temperature

  • Low numbers of white blood cells (immune cells that fight infections)

  • Seizures

  • Higher risk of falls

  • Higher risk of stroke and death in older adults with dementia-related psychosis

Keep in mind that you may not experience some side effects until several weeks after you start taking Vraylar. This isn't a complete list of all potential Vraylar side effects. Before starting Vraylar, talk with your healthcare team about your risk for side effects and any other concerns you have.

Here, we'll discuss eight Vraylar side effects in greater detail and what to do if they occur.

1. Headache

Headache is a fairly common Vraylar side effect. You may notice this side effect more when you're first starting the medication or after a dose increase. Headaches tend to get better or go away as your body adjusts to Vraylar.

Staying hydrated and getting extra rest can help keep headaches to a minimum. If these steps don't help, ask your healthcare team about over-the-counter (OTC) headache medications. They can recommend a safe option for occasional headache relief.

If you continue to experience headaches or they get worse, let your prescriber know. A sudden, intense headache that won't go away can be a symptom of something more serious, like a stroke. If you have a headache like this, don't wait - seek emergency help immediately.

2. Sleep changes

Some people who take Vraylar find they have trouble sleeping at night (insomnia). Others experience the opposite - they feel drowsy. In clinical trials, slightly more people reported insomnia. Taking Vraylar with other medications that cause trouble sleeping or drowsiness can make these side effects worse.

There are several lifestyle changes you can make that may improve your quality of sleep. Examples include sticking to a consistent sleep schedule, keeping your bedroom cool, and avoiding caffeine and alcohol in the evenings.

Let your prescriber know if you're experiencing bothersome sleep changes. Most people take Vraylar once a day. Changing the time of day you take your dose may help alleviate this side effect.

3. Stomach-related side effects

Stomach issues are also common Vraylar side effects. Constipation, nausea, and stomach pain are some of the most frequently reported. Diarrhea, heartburn, and vomiting are also possible. Stomach-related side effects are often worse when you first start Vraylar. They tend to lessen or resolve the longer you take it.

Taking Vraylar with food can help prevent an upset stomach. Increasing your fiber intake can help with constipation. But avoiding high-fiber foods is helpful if you have diarrhea. And drinking more water or fluids can also help keep many stomach-related side effects in check.

Let your prescriber know if stomach-related side effects continue or get worse with Vraylar. They may want to evaluate you for other potential causes of your symptoms.

4. Uncontrollable muscle movements

Repetitive or uncontrollable muscle movements can happen while taking Vraylar. These are called extrapyramidal symptoms (EPS), and they're possible with all antipsychotics. EPS can affect different body parts, such as your arms, legs, or face.

Commonly, people taking Vraylar experience a feeling of restlessness or an inability to sit still. This usually affects your legs. To other people, it may look like you're constantly bouncing or swinging your legs. This form of EPS isn't usually harmful, but it can be frustrating and interfere with your daily routine.

It's a good idea to let your prescriber know if involuntary movements appear while you're taking Vraylar. They can keep an eye on them and prescribe treatment if necessary.

5. Tardive dyskinesia (TD)

More rarely, some people taking Vraylar may develop a form of EPS called tardive dyskinesia (TD). TD can cause uncontrollable movements of the face, mouth, or upper trunk. It can also cause problems with talking or eating, and it can become permanent.

Early treatment is key to lowering the risk of permanent issues from TD. So be sure to let your prescriber know about any unusual body movements that occur while taking Vraylar.

6. Weight gain and increased cholesterol and blood glucose

Vraylar and other antipsychotics can change how well your body's metabolism works. These changes can lead to weight gain, raised cholesterol, and raised blood glucose (sugar) levels. In some cases, people can even develop Type 2 diabetes. The good news is that Vraylar has a lower risk of these side effects than most other antipsychotics.

From time to time, your prescriber should check your body weight, cholesterol levels, and blood glucose. If they notice metabolic changes, they may recommend lifestyle changes or medications to help limit these effects. If you experience weight gain that you're uncomfortable with while taking Vraylar, reach out to your prescriber.

7. Overheating

Vraylar may make it harder for some people to regulate their body temperature. This can cause you to overheat more easily than usual, especially after intense exercise or if you're dehydrated. In rare cases, it can lead to heat stroke.

To reduce your risk of this side effect, avoid extreme heat while you're taking Vraylar when possible. And be sure to stay hydrated and use caution when exercising.

If you feel nauseated or dizzy or like you can't cool down after activity or exposure to heat, seek medical care right away.

8. Neuroleptic malignant syndrome

Neuroleptic malignant syndrome (NMS) is a rare but life-threatening condition that can happen when you take antipsychotics, including Vraylar. It's important to know how to recognize it, so you can get help as soon as possible.

Symptoms of NMS include:

  • High fever

  • Sweating

  • Confusion

  • Muscle stiffness

  • Uncontrollable changes in breathing, heart rate, or blood pressure

NMS is a medical emergency that requires care in a hospital setting. Call 991 or seek immediate care if you believe you're experiencing symptoms of NMS.

9. Mood changes

While taking Vraylar, it's important to watch for any new or unusual mood changes. Vraylar can sometimes cause new or worse anxiety or agitation. This is more common during the first few months after you start taking Vraylar or after your dose is increased. These symptoms are common, but it's still important to let your prescriber know if you notice them.

Very rarely, people taking Vraylar have experienced suicidal thoughts or actions. The risk for this may be higher in people younger than 25 years old. If you or a loved one taking Vraylar starts to experience worsening mood, concerning behaviors, or talk of hurting themselves or others, seek help immediately.

If you or someone you know is having thoughts of suicide, you're not alone, and help is available. Call the National Suicide Prevention Lifeline at 988, or text HOME to 741-741 to reach the Crisis Text Line.

10. Higher risk of death for older adults with dementia

All antipsychotics can raise the risk of death in older adults with dementia-related psychosis. They can also raise the risk of strokes in this group, which may be fatal. Experts aren't sure why antipsychotics raise these risks. But because of this, Vraylar shouldn't be prescribed to treat dementia-related psychosis.

Frequently asked questions

When should Vraylar side effects go away?
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Some Vraylar side effects will go away over the first few weeks or months as your body adjusts to the medication. But others may not appear until you've been taking the medication for a while. It's a good idea to keep your prescriber in the loop as to how you're feeling as Vraylar treatment continues. They can keep an eye out for any concerning side effects and address them if they occur.

Can you drink alcohol while taking Vraylar?
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No, you shouldn't drink alcohol while taking Vraylar or any atypical antipsychotic medication. Alcohol can make Vraylar side effects worse. It can also worsen the symptoms of the condition you're taking Vraylar for. Talk to your prescriber about the risks of drinking alcohol with Vraylar. Even an occasional drink or two may not be worth the risk.

The bottom line

Common Vraylar (cariprazine) side effects include headaches, stomach issues, and sleeping changes. These side effects can often be managed at home, and some may resolve on their own over time. Metabolic side effects, such as weight gain and raised blood glucose, are also possible.

Rare but serious Vraylar side effects include tardive dyskinesia, neuroleptic malignant syndrome, and suicidal thoughts. It can also raise your risk of heat stroke. Vraylar isn't FDA approved to treat older adults with dementia-related psychosis because it can raise the risk of strokes and death in this group.

Why trust our experts?

Kristine Foley is a licensed pharmacist with over 13 years of community pharmacy experience. She earned her Doctor of Pharmacy degree from Rutgers University.
Stacia Woodcock, PharmD, is a pharmacy editor for GoodRx. She earned her Doctor of Pharmacy degree from the University of Kentucky and is licensed in New York and Massachusetts.
Austin Ulrich, PharmD, BCACP, is a board-certified ambulatory care clinical pharmacist. In his early career, he provided direct patient care in a variety of settings, including hospital and community pharmacies, and in a primary care clinic as a clinical pharmacist.

References

D'Souza, R. S., et al. (2023). Extrapyramidal syndromes. StatPearls.

Horseman, M., et al. (2022). Drug-induced hyperthermia review. Cureus.

View All References (5)
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Koponen, M., et al. (2022). Antipsychotic use and risk of stroke among community-dwelling people with Alzheimer's disease. The Journal of Post-Acute and Long-Term Care Medicine.

National Institute of Neurological Disorders and Stroke. (2024). Neuroleptic malignant syndrome. National Institutes of Health.

Patel, J., et al. (2023). Akathisia. StatPearls.

Pillinger, T., et al. (2019). Comparative effects of 18 antipsychotics on metabolic function in patients with schizophrenia, predictors of metabolic dysregulation, and association with psychopathology: A systematic review and network meta-analysis. The Lancet Psychiatry.

Remedyrepack, Inc. (2024). Vraylar-cariprazine capsule, gelatin coated [package insert].

GoodRx Health has strict sourcing policies and relies on primary sources such as medical organizations, governmental agencies, academic institutions, and peer-reviewed scientific journals. Learn more about how we ensure our content is accurate, thorough, and unbiased by reading our editorial guidelines.

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