Side Effects of Vraylar: What You Need to Know

Vraylar is a prescription drug that’s used to treat certain mental health conditions, such as bipolar I disorder. Vraylar can cause side effects that range from mild to serious. Examples include weight gain and akathisia (feeling restless and like you need to move around).

Vraylar is used in adults to treat:

• short-term mixed or manic episodes related to bipolar I disorder
• episodes of bipolar depression related to bipolar I disorder
• major depressive disorder (depression), when taken together with an antidepressant
• schizophrenia

The active ingredient in Vraylar is cariprazine. (An active ingredient is what makes a drug work.) The drug comes as a capsule that you swallow.

Keep reading to learn about the common, mild, and serious side effects that Vraylar can cause. For a general overview of the drug, including details about its uses, see this article.

Some people may experience mild or serious side effects when taking Vraylar. The list below includes a few of the more common side effects reported by people who took Vraylar in studies.

Side effects may differ slightly depending on the condition the drug is being used to treat.

Examples of Vraylar’s more commonly reported side effects include:

• trouble moving or slow movements
• tremors
• tardive dyskinesia (uncontrolled movements)*
• akathisia (feeling restless and like you need to move around)*
• sleepiness

* To learn more about this side effect, see the “Side effects explained” section below.

Vraylar may cause mild side effects in some people. The list below includes some of the mild side effects reported by people who took Vraylar in studies.

Mild side effects may differ slightly depending on the condition the drug is being used to treat.

Examples of mild side effects that have been reported with Vraylar include:

• akathisia (feeling restless and like you need to move around)*
• muscle stiffness
• headache
• dizziness
• indigestion (upset stomach)
• constipation
• weight gain
• increased saliva (drool) production
• nausea and vomiting
• sleepiness
• trouble moving or slow movements
• tremors

* To learn more about this side effect, see the “Side effects explained” section below.

For most people, these side effects should be temporary. Some may be easily managed, too. But if you have any symptoms that are ongoing or that bother you, talk with your doctor or pharmacist. Don’t stop using Vraylar unless your doctor recommends it.

Vraylar may cause mild side effects other than the ones listed above. For more information, see the Vraylar prescribing information.

Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you would like to notify the FDA about a side effect you’ve had with Vraylar, visit MedWatch.

Although they’re less common, serious side effects have been reported with Vraylar. These include:

• suicidal thoughts and behaviors in children and young adults*†
• increased risk of death in older adults with psychosis due to dementia*†
• tardive dyskinesia (uncontrolled movements)†
• neuroleptic malignant syndrome (a rare, severe reaction to certain antipsychotic drugs, such as Vraylar)
• hyperglycemia (high blood sugar), which may lead to diabetes
• changes in blood fat levels, including cholesterol or triglycerides
• low white blood cell count
• orthostatic hypotension (drop in blood pressure when getting 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
• allergic reaction†‡

If you develop serious side effects while taking Vraylar, call your doctor right away. If the side effects seem life threatening, or if you think you’re having a medical emergency, immediately call 911 or your local emergency number.

* Vraylar has a boxed warning for this side effect. This is the most serious warning from the Food and Drug Administration (FDA). To learn more, see the “Side effects explained” section below.
† To learn more about this side effect, see the “Side effects explained” section below.
‡ An allergic reaction is possible after using Vraylar. But it’s not clear how often allergic reactions occurred in studies.

Get answers to some frequently asked questions about Vraylar’s side effects.

Do Vraylar side effects go away, or are they long-term?

Vraylar can cause both short-term and long-term side effects.

Some side effects are temporary and tend to go away after your body gets used to the medication. Examples of short-term side effects include:

• headache
• indigestion (upset stomach)
• sleepiness

Other side effects of Vraylar, such as tardive dyskinesia (uncontrolled movements), may last long term.

Tardive dyskinesia is a common side effect of Vraylar. This side effect usually doesn’t occur until you’ve taken the medication for a long time. But it’s possible that these uncontrolled body movements could start after you’ve stopped taking Vraylar. And they sometimes don’t go away once you’ve stopped taking the drug.

Some side effects of Vraylar don’t go away on their own, but they can be treated. For example, if your cholesterol levels become high, your doctor may prescribe medications to treat it.

It’s also important to note that Vraylar takes a long time to build up in and be cleared from your body. This means that side effects may not occur until weeks after starting treatment or a dose increase. Even if your doctor ends your Vraylar treatment, the drug remains in your body for several weeks after your last dose. So it could still cause side effects during that time.

Do side effects from Vraylar vary by capsule strength (1.5 mg, 3 mg, 4.5 mg, or 6 mg)?

It’s possible. In studies, certain side effects from Vraylar varied in how often they occurred, depending on the dose. Some side effects occurred less often in people taking lower doses of Vraylar than in those taking higher doses.

However, this wasn’t true for all side effects. With some side effects, your risk stays about the same whether you use a lower or higher dose.

If you have questions about how your Vraylar dose may affect your risk for side effects, talk with your doctor. And for information about Vraylar’s dosages, see this article.

Could using Vraylar cause sexual side effects?

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.

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

Does Vraylar cause insomnia, fatigue, or anxiety?

Yes, it’s possible that Vraylar could cause these side effects. Some people who took Vraylar in studies reported insomnia (trouble sleeping), fatigue (low energy), and anxiety.

It’s important to note that these may also be symptoms of the conditions Vraylar is used to treat, such as bipolar depression in people with bipolar I disorder. If you’ve noticed new or worsened sleep problems, fatigue, or anxiety since starting Vraylar, talk with your doctor.

Will I experience weight loss during my Vraylar treatment?

No, Vraylar shouldn’t cause weight loss. People taking Vraylar in studies did not report this side effect.

If you’re concerned about weight loss while using Vraylar, talk with your doctor.

Does Vraylar cause hair loss?

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.

Learn more about some of the side effects Vraylar may cause.

Increased risk of death in older adults with psychosis due to dementia

Vraylar has a boxed warning for the increased risk of death in older adults with psychosis (loss of awareness of reality) due to dementia. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

What might help

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

If you’re age 65 or older and develop dementia while taking Vraylar, your doctor will likely have you switch to a different medication.

Suicidal thoughts and behaviors in children and young adults

Vraylar has a boxed warning for suicidal thoughts and behaviors in children and young adults. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

If children or adults ages 24 and younger use antidepressant drugs, it can raise their risk for suicidal thoughts and behaviors. Vraylar is an antipsychotic drug. But it can have antidepressant effects when used to treat bipolar depression related to bipolar I disorder or major depressive disorder (depression).

It’s important to note that Vraylar is only FDA-approved for use in adults.

What might help

If you’re a young adult, your doctor may closely monitor you 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 the 988 Suicide and Crisis Lifeline at 988.
• Text HOME to the Crisis Textline at 741741.
• 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 are not in the same household, stay on the phone with them until help arrives.

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Weight gain

Some people may gain weight while using 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.

To learn about how much weight people taking Vraylar gained in studies, see the drug’s prescribing information.

What might help

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

The following tips may help you reach or maintain a moderate 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’re concerned about weight gain while taking Vraylar, talk with your doctor.

Allergic reaction

Like most drugs, Vraylar can cause an allergic reaction in some people. Although it seemed to be rare, it’s not clear how often allergic reactions occurred in studies of the drug.

Symptoms can be mild or serious and can include:

• skin rash
• itchiness
• flushing (temporary warmth, redness, or deepening of skin color)
• swelling under your skin, typically in your eyelids, lips, hands, or feet
• swelling of your mouth, tongue, or throat, which can make it hard to breathe

What might help

If you have mild symptoms of an allergic reaction, such as a mild rash, call your doctor right away. To manage your symptoms, they may suggest an over-the-counter antihistamine that you swallow, such as diphenhydramine (Benadryl). Or they may recommend a product you apply to your skin, such as hydrocortisone cream.

If your doctor confirms you had a mild allergic reaction to Vraylar, they’ll decide if you should continue using it.

If you have symptoms of a severe allergic reaction, such as swelling or trouble breathing, call 911 or your local emergency number right away. These symptoms could be life threatening and require immediate medical care.

If your doctor confirms you had a serious allergic reaction to Vraylar, they may have you switch to a different treatment.

• what dose of drug you were taking when you had the side effect
• how soon after starting that dose you had the side effect
• what your symptoms were from the side effect
• how it affected your daily activities
• what other medications you were also taking
• any other information you feel is important

Vraylar comes with several warnings.

Boxed warnings

Vraylar has two boxed warnings . These are the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings for Vraylar include:

• Increased risk of death in older adults with psychosis due to dementia. Older adults with dementia can sometimes develop psychosis (loss of awareness of reality). Antipsychotic medications such as Vraylar can raise the risk of death in older adults with this condition.

• Suicidal thoughts and behaviors in children and young adults. In children and adults younger than age 25 years, antidepressant medications 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 related to bipolar I disorder or major depressive disorder (depression).

To learn more, see the “Side effects explained” section above.

Other warnings

Vraylar may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Vraylar. The list below includes factors to consider.

Age 65 years or older. Older adults may have an increased risk for some of Vraylar’s side effects. These include dizziness, orthostatic hypotension, falling, trouble regulating body temperature, and tardive dyskinesia. If you’re age 65 years or older and your doctor recommends that you take Vraylar, they’ll likely prescribe a lower dose for you. They may also monitor you more closely for side effects during your treatment.

Allergic reaction. If you’ve had an allergic reaction to Vraylar or any of its ingredients, you shouldn’t take Vraylar. Ask your doctor what other medications could be a better option for you.

Diabetes. Vraylar may cause hyperglycemia (high blood sugar). If you already have diabetes, taking this drug may worsen your condition. Before you start taking Vraylar, talk with your doctor about a plan for managing your blood sugar. This may include checking your blood sugar more often, changing your diet, or adjusting your diabetes medications.

Kidney or liver problems. Vraylar hasn’t been studied in people with severe kidney or liver problems. Talk with your doctor about whether other treatment options would be better for you.

Low white blood cell count. Vraylar can cause a low level of white blood cells (WBCs). If you already have a condition that lowers your WBC count, it may be harmful to you to take Vraylar. This is because you could develop serious infections. If you are able to take Vraylar, talk with your doctor about a plan for checking your WBC count regularly.

Lipid disorder. If you currently have a lipid disorder or have had this disorder in the past, taking Vraylar could worsen your condition. If you use Vraylar, your doctor will need to check your cholesterol levels regularly. They may also prescribe or increase your dose of cholesterol-lowering medications.

Heart problems or stroke. Vraylar can cause orthostatic hypotension. If you’ve had heart problems or a stroke, you could have a higher risk for this side effect. Before using Vraylar, tell your doctor if you’ve had a stroke or have had heart problems. They’ll help you decide if another medication is a better option for you.

Dehydration. If you have certain health conditions or factors that make you become dehydrated easily, this can raise your risk for certain side effects with Vraylar. Examples of these side effects include trouble regulating your body temperature, especially when exercising or in hot weather. Be sure to drink plenty of water while taking Vraylar.

Seizures. Vraylar may cause seizures in some people. You could have a higher risk for this side effect if you’ve had seizures in the past. If you’ve had or currently have epilepsy, talk with your doctor before taking Vraylar.

High or low blood pressure. Vraylar may cause changes in your blood pressure, including high blood pressure and drop in blood pressure when getting up. Sudden changes to your blood pressure may cause or worsen these blood pressure conditions. If you have a history of blood pressure problems, talk with your doctor. They’ll discuss with you whether Vraylar is right for you.

Alcohol use and Vraylar

Alcohol isn’t known to interact with Vraylar. But drinking alcohol during your Vraylar treatment could raise your risk for certain side effects of the drug.

Drinking alcohol with Vraylar can raise your risk for side effects such as:

• nausea
• dizziness
• sleepiness
• indigestion (upset stomach)

Alcohol can also worsen symptoms of certain mental health conditions, such as depression.

If you drink alcohol and have questions about alcohol use during your Vraylar treatment, talk with your doctor.

Pregnancy and breastfeeding while taking Vraylar

Below are details about Vraylar’s use during pregnancy and while breastfeeding.

Pregnancy

Vraylar may not be safe to use during pregnancy. It’s thought that this drug could cause fetal harm when taken during pregnancy.

If you become pregnant while taking Vraylar, let your doctor know right away. You should not suddenly stop taking Vraylar unless your doctor recommends it. Stopping Vraylar without a new treatment plan in place could cause symptoms of your condition to return or worsen.

It’s also important to note that untreated mental health conditions during pregnancy can also have harmful effects on a pregnant female* and their newborn infant.

If you do use Vraylar while pregnant, consider signing up for the National Pregnancy Registry for Atypical Antipsychotics. This registry collects information about the safety of antipsychotic drugs (such as Vraylar) when used during pregnancy. For more information, talk with your doctor or visit the registry’s website.

* In this article, we use the term “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.

Breastfeeding

It’s not known whether Vraylar is safe to use while breastfeeding. There aren’t enough studies that look at the safety of Vraylar while breastfeeding or its effects on a breastfed child.

If you’re breastfeeding or are planning to breastfeed, talk with your doctor about your treatment options.

Vraylar can be an effective treatment for bipolar I disorder and schizophrenia. It can also be an effective treatment for major depressive disorder (depression), when taken together with an antidepressant. But this drug may also cause side effects in some people.

It’s important to talk with your doctor to decide if the potential benefits of Vraylar outweigh your risk for side effects.

Here are some questions to consider asking your doctor about Vraylar:

• With my overall health and medical history, do I have a higher risk for serious side effects from Vraylar?
• Do my other medications increase my risk for side effects from Vraylar?
• If I develop certain side effects from Vraylar, is that a sign that the drug is working?

To learn more about Vraylar, see these articles:

• All About Vraylar
• Vraylar and Cost: What You Need to Know
• Dosage for Vraylar: What You Need to Know

To get information on different conditions and tips for improving your health, subscribe to any of Austra Health’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.

Q:

If I develop diabetes as a side effect of Vraylar, will it go away if my doctor switches me to a different medication

A:

Hyperglycemia (high blood sugar) is a possible side effect of Vraylar. High blood sugar can lead to type 2 diabetes if your blood sugar levels remain high over time.

Type 2 diabetes isn’t usually reversible, but is manageable with a variety of treatments. This means switching from Vraylar to another medication for your condition may help manage your blood sugar levels. But it isn’t likely to reverse your diabetes.

If you’re concerned about hyperglycemia or diabetes from taking Vraylar, talk with your doctor or pharmacist. They can recommend ways to help manage your blood sugar levels.

The Austra Health Pharmacist Team Answers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.

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Disclaimer: Austra Health has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or other healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.

Last medically reviewed on April 6, 2023

How we reviewed this article:

Austra Health has strict sourcing guidelines and relies on peer-reviewed studies, academic research institutions, and medical associations. We avoid using tertiary references. You can learn more about how we ensure our content is accurate and current by reading our editorial policy.

• Dayabandara M, et al. (2017). Antipsychotic-associated weight gain: Management strategies and impact on treatment adherence.
  dovepress.com/antipsychotic-associated-weight-gain-management-strategies-and-impact–peer-reviewed-fulltext-article-NDT
• Vraylar (cariprazine) capsules, for oral use. (2022).
  accessdata.fda.gov/drugsatfda_docs/label/2022/204370s009lbl.pdf

Our experts continually monitor the health and wellness space, and we update our articles when new information becomes available.