If you’re considering treatment options for certain mental health conditions, your doctor might suggest Vraylar (cariprazine).

Vraylar is a brand-name prescription medication that’s used to treat the following mental health conditions in adults:

Vraylar comes as a capsule that you swallow, usually once a day. It can be used as a short-term or long-term treatment.

For an overview of Vraylar, including details of its uses, see this in-depth article on the drug.

Like other drugs, Vraylar can cause mild or serious side effects. Keep reading to learn more.

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:

* To learn more about this side effect, see “Side effects explained” 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:

* To learn more about this side effect, see “Side effects explained” 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. See the Vraylar medication guide.

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:

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
  • 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 having your dose increased. Even if your doctor ends your Vraylar treatment, the drug remains in your body for several weeks after your last dose. And it could still cause side effects.

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 used. Some side effects occurred less often in people receiving lower doses of Vraylar compared with those who received higher doses.

However, this wasn’t true for all side effects. With other 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.

Could using Vraylar cause sexual side effects?

No. 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.

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. Insomnia (trouble sleeping), fatigue (lack of energy), and anxiety were reported in some people who took Vraylar in studies.

It’s important to note that these may also be symptoms of the conditions Vraylar is used to treat (bipolar depression or schizophrenia). If you’ve notice 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. This side effect wasn’t reported in people taking Vraylar in studies.

If you’re concerned 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 touch with reality) due to dementia. Vraylar belongs to a class of drugs called antipsychotics. These drugs are known to raise the risk of death in older adults with this condition.

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. 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.

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 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 attempts at suicide, your doctor may discuss other treatment options with you.

Suicide prevention

If you think someone is at immediate risk of self-harm or hurting another person:

  • Call 911 or your local emergency number.
  • Stay with the person until help arrives.
  • Remove any guns, knives, medications, or other things that may cause harm.
  • Listen, but don’t judge, argue, threaten, or yell.

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

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 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 nutritional counseling that’s customized 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.

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. They may suggest an over-the-counter oral antihistamine, such as diphenhydramine (Benadryl), or topical product, like hydrocortisone cream, to manage your symptoms.

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.

Keeping track of side effects

During your Vraylar treatment, consider keeping notes on any side effects you’re having. Then, you can share this information with your doctor. This is especially helpful to do when you first start taking new drugs or using a combination of treatments.

Your side effect notes can include things like:

  • 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

Keeping notes and sharing them with your doctor will help your doctor learn more about how the drug affects you. Your doctor can use this information to adjust your treatment plan if needed.

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 touch with reality). Antipsychotic medications such as Vraylar can raise the risk for 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.

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. 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 for 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.

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
  • upset stomach

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

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. Not much is known about the drug’s safety in humans during pregnancy. Animal studies suggest that Vraylar could cause harm to a fetus when taken during pregnancy. But animal studies don’t always predict what will happen in humans.

If you become pregnant while taking Vraylar, let your doctor know right away. You shouldn’t 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 get worse. 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 if 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. 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?

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Disclaimer: Healthline 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.