Vraylar (cariprazine) can cause side effects that range from mild to serious. More common side effects include nausea and restlessness. If side effects from Vraylar become difficult to tolerate, talk with your doctor.
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.) Vraylar comes as a capsule that you swallow.
Keep reading to learn about the common, mild, and serious side effects Vraylar can cause. To learn more about Vraylar, including its uses, dosage, and cost, read this Vraylar overview article.
Vraylar has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). For details, see the “Tips for managing side effects” section.
Vraylar can cause certain side effects, some more common than others. These side effects may be temporary, lasting a few days to weeks. Talk with your doctor if side effects do not go away, get worse, or become too difficult for you to tolerate.
Vraylar’s more commonly reported side effects include:
- extrapyramidal symptoms (also called drug-induced movement disorders), which can include:
- akathisia (feeling restless and like you need to move around)
- dystonia (involuntary muscle contractions)
- Parkinsonism, including muscle stiffness
- tremors
- sleepiness
- nausea
To learn more about some of these side effects, see the “Tips for managing side effects” section.
Mild side effects have been reported with Vraylar. These include:
- muscle stiffness
- headache
- dizziness
- indigestion (upset stomach)
- constipation
- weight gain
- nausea and vomiting
- sleepiness
- trouble moving or slow movements
- tremors
- akathisia (feeling restless and like you need to move around)
In most cases, these side effects should be temporary, and some may be easily managed. But if you have symptoms that are ongoing or bothersome, talk with your doctor or pharmacist. Do not stop taking Vraylar unless your doctor recommends it.
Vraylar may cause mild side effects other than those listed above. See the Vraylar prescribing information for details.
To learn more about some of these side effects, see the “Tips for managing side effects” section.
Vraylar may cause serious side effects. The following list may not include all possible serious side effects of the drug. For more information, you can refer to Vraylar’s prescribing information.
If you develop serious side effects while taking Vraylar, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- neuroleptic malignant syndrome
- high blood sugar, which may lead to diabetes
- changes in blood fat levels, including cholesterol or triglycerides
- low white blood cell count
- orthostatic hypotension
- 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
- suicidal thoughts and behaviors in children and young adults
- increased risk of death in older adults with psychosis due to dementia
For more information about some of these side effects, see the “Boxed warnings for Vraylar” and the “Tips for managing side effects” sections.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks and reviews side effects of the medication. Sharing your experience helps make medication safer for everyone by giving doctors and researchers more information about how the drug works in real life. If you develop a side effect while taking Vraylar and want to tell the FDA about it, visit MedWatch or call 800-FDA-1088.
Allergic reaction
For some people, Vraylar can cause an allergic reaction.
But it’s not clear how often this side effect occurred in the drug’s studies.
In general, symptoms of allergic reaction can be mild or serious.
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 a treatment to manage your symptoms and can determine whether you should keep taking Vraylar.
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’ve had a serious allergic reaction to Vraylar, they may have you switch to a different treatment.
Vraylar has boxed warnings. A boxed warning is the most serious warning from the Food and Drug Administration (FDA).
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.
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
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).
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 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.
While taking Vraylar, you may be able to take steps to make side effects easier to manage.
If you have problems with side effects, they do not go away, or they become worse, talk with your doctor or pharmacist. They can discuss options for managing side effects or other available treatment options.
Sleepiness
Sleepiness is a common side effect of Vraylar. You may be more likely to have this side effect if you take higher doses of the drug.
What might help
Until you know whether Vraylar makes you sleepy, do not perform potentially dangerous tasks that require you to be alert. This includes driving.
Make sure you get adequate sleep while taking Vraylar. If sleepiness while taking Vraylar is bothersome and difficult to manage, talk with your doctor. They may recommend changing your Vraylar dosage or suggest taking a different medication.
Vraylar weight gain
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. Read more about Vraylar and weight gain.
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.
Here are answers to some commonly 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 possible 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.
Learn more about Vraylar’s dosages. 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?
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.
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.
Consider the following important information before starting Vraylar.
Vraylar has boxed warnings. A boxed warning is the most serious warning from the FDA. For details, see the “Boxed warnings for Vraylar” section.
Other precautions
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: 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 high blood sugar. If you already have diabetes, high blood sugar, or a family history of either, 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 a 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 consumption: 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. If you drink alcohol and have questions about alcohol use during your Vraylar treatment, talk with your doctor.
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. Do 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.
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.
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.