Key takeaways

  • Vraylar (cariprazine) is used to treat schizophrenia, bipolar I disorder, and major depressive disorder (MDD) in adults. It’s also approved to treat schizophrenia and manic episodes in some children.
  • The most common side effects of Vraylar are nausea, sleepiness, vomiting, and indigestion. Many mild side effects are often temporary and tend to improve within a few days or weeks as your body adjusts to the medication.
  • Because Vraylar stays in the body for a long time, some side effects may not appear until weeks after starting treatment.

Keep reading to learn about the common, mild, and serious side effects Vraylar can cause, including Vraylar’s boxed warnings.

Vraylar’s more commonly reported side effects include:

  • extrapyramidal symptoms (also called drug-induced movement disorders), which can include:
    • restlessness and feeling unable to sit still
    • involuntary muscle contractions
    • Parkinsonism, including muscle stiffness
    • tremors
  • sleepiness
  • nausea

In clinical trials, the side effects of Vraylar were similar for both adults and children. But it’s important to note that some side effects might be more common than others, depending on the condition you’re taking Vraylar to treat.

Vraylar can cause side effects that range from mild to serious. The following table may not include all possible serious side effects of the drug. For more information, you can refer to Vraylar’s prescribing information.

Mild side effectsSerious side effects
• muscle stiffness

• headache

• dizziness

• indigestion (upset stomach)

• constipation

• weight gain

• nausea and vomiting

• sleepiness

• trouble moving or slow movements

• tremors

• restlessness and feeling like you need to move around

• mild allergic reaction		• high blood sugar, which may lead to diabetes

• high cholesterol or triglycerides (fats in the blood)

• low white blood cell count

• orthostatic hypotension (dizziness when standing up)

• increased risk of falling (due to other side effects, such as movement problems and dizziness)

• seizures

• trouble regulating your body temperature (especially in hot weather or when exercising)

• trouble swallowing

• high fever, which may be followed by chills

• tardive dyskinesia (uncontrolled movements)

• serious allergic reaction

• suicidal thoughts and behaviors in children and young adults

• increased risk of death in older adults with dementia-related psychosis

Most mild side effects should go away on their own within a few days or weeks. Other side effects of Vraylar may not go away on their own, but they can be treated.

It’s important to note that Vraylar takes a long time to build up in and be cleared from your body. This means that some side effects may not appear for weeks after starting treatment or increasing your dose.

Even if you stop taking Vraylar, the drug remains in your body for several weeks after your last dose. So it could still cause side effects during that time.

Experiencing side effects? After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. If you develop a side effect while taking this drug and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.

In addition to these side effects, Vraylar has boxed warnings. A boxed warning is the most serious type of warning from the Food and Drug Administration (FDA). It alerts doctors and patients to drug effects that may be dangerous.

Increased risk of death in older adults with dementia-related psychosis

Older adults with dementia can sometimes develop psychosis (loss of awareness of reality). Antipsychotic medications like Vraylar can increase the risk of death in older adults with this condition.

Other treatment options besides Vraylar may be a better fit for an older adult with dementia-related psychosis.

Suicidal thoughts and behaviors in children and young adults

In children and adults younger than 25 years old, antidepressants can increase the risk of suicidal thoughts and behaviors.

Vraylar is an antipsychotic medication, but it also has an antidepressant effect when used for bipolar depression or MDD.

What might help

If you’re 25 years old or younger, your doctor will closely monitor your condition for signs of depression, thoughts of harming yourself, or other suicidal behaviors during your Vraylar treatment.

Based on data from studies, these side effects may be more likely to occur soon after starting treatment or soon after any dose increases. Your doctor may monitor you more closely during these times.

If you have any questions or concerns about suicidal thoughts or behaviors with Vraylar, talk with your doctor. If you have a history of severe depression or have attempted suicide, your doctor may discuss other treatment options with you.

Help is out there

If you or someone you know is in crisis and considering suicide or self-harm, please seek support:

  • Call or text the 988 Suicide and Crisis Lifeline at 988 or chat at 988lifeline.org. Caring counselors are available to listen and provide free and confidential support 24/7.
  • Text HOME to the Crisis Text Line at 741741 to connect with a volunteer crisis counselor for free and confidential support 24/7.
  • Not in the United States? Find a helpline in your country with Befrienders Worldwide.
  • Call 911 or your local emergency services number if you feel safe to do so.

If you’re calling on behalf of someone else, stay with them until help arrives. You may remove weapons or substances that can cause harm if you can do so safely.

If you’re not in the same household, stay on the phone with them until help arrives.

Some people may gain weight while taking Vraylar. The amount of weight you might gain depends on several factors, including your dosage and the condition you’re using the drug to treat.

During your Vraylar treatment, your doctor will monitor your weight regularly.

The following tips may help you reach or maintain a healthy weight while you’re taking Vraylar:

  • Focus on nutrition: Aim for a balanced diet, and consider using a calorie-tracking app or a journal to log your calories. Keeping track of your foods and portion sizes can help prevent you from consuming too many calories. Your doctor may also be able to refer you to a registered dietitian or certified nutritionist. They can provide customized nutritional counseling for your specific needs.
  • Exercise regularly: Staying active on a regular basis (to the best of your ability) can help you burn calories and manage your weight. If you’re beginning a new fitness routine, try starting small and setting realistic goals. And talk with your doctor before starting a new exercise routine.

If you have concerns about weight gain while taking Vraylar, talk with your doctor.

Here are answers to some commonly asked questions about Vraylar’s side effects.

No, Vraylar doesn’t usually cause hair loss. This side effect wasn’t reported in studies of Vraylar.

If you’re concerned about hair loss during your Vraylar treatment, talk with your doctor.

» FindCare: Find a hair loss doctor in your area today.

It isn’t likely. Vraylar isn’t known to cause sexual side effects, such as low libido (sex drive). Sexual side effects weren’t reported in studies of Vraylar. But treatment with Vraylar may cause changes in your mood, which may affect your sex drive.

And Vraylar is sometimes prescribed in combination with an antidepressant, which is known to cause sexual side effects. If you experience changes in your libido, it could be due to the antidepressant, rather than Vraylar.

If you’re concerned about sexual side effects during your Vraylar treatment, talk with your doctor.

» Learn more: Managing Antidepressant Sexual Side Effects

Before taking Vraylar, discuss your health history with your doctor. Vraylar may not be right for you if you have certain medical conditions or other factors affecting your health. Be sure to talk with your doctor if any of the following apply to you:

  • age 65 years or older
  • type 2 diabetes
  • kidney or liver problems
  • low white blood cell counts
  • lipid disorders
  • heart problems, such as a previous stroke
  • increased risk of dehydration
  • seizures
  • high or low blood pressure
  • previous allergic reaction to Vraylar or any of its ingredients
  • pregnancy or breastfeeding

Common side effects of Vraylar include nausea, sleepiness, and restlessness. Many of these mild side effects are temporary and typically improve within a few weeks as your body adjusts to the medication.

It’s possible for some side effects to appear shortly after starting treatment. But because Vraylar stays in your system for a long time, side effects can also take weeks to develop.

More serious risks, like uncontrollable muscle movements, may need treatment to resolve. It’s important to let your doctor know how you feel throughout treatment so they can help manage any side effects effectively.

Disclaimer: While Healthline strives for factual, comprehensive, and current information, this article is not a substitute for a licensed healthcare professional’s expertise. Always consult a doctor before taking or discontinuing any medication. Drug information is subject to change and may not cover all uses, directions, precautions, warnings, interactions, reactions, or adverse effects. The lack of a warning does not guarantee a drug’s safety, effectiveness, or appropriateness for all patients or specific uses. Learn more about our approach to content integrity.