Vraylar (cariprazine) is a prescription brand-name medication. It’s approved by the Food and Drug Administration (FDA) to treat the following mental health conditions in adults:
- manic or mixed episodes of bipolar I disorder
- depressive episodes of bipolar I disorder, which are also called bipolar depression
Vraylar is typically prescribed as a long-term treatment, if you and your doctor determine the drug is working well for you.
Here are some fast facts on Vraylar:
- Active ingredient: cariprazine
- Drug class: atypical antipsychotic
- Drug form: oral tablet
As with other medications, Vraylar can cause side effects. Read on to learn about possible common, mild, and serious side effects. For a general overview of Vraylar, including details about its uses, see this article.
Certain side effects have been reported when taking Vraylar, some of which were more common than others. These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are a few of the more common side effects reported by people who took Vraylar in clinical trials:
- difficulty moving or slowed movements
- uncontrolled body movements
Mild side effects can occur with Vraylar use. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Vraylar’s medication guide.
Mild side effects that have been reported with Vraylar use can include:
- weight gain*
- difficulty moving or slowed movements
- indigestion (upset stomach)
- fatigue (lack of energy)
These side effects may be temporary, lasting a few days or weeks. But if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Vraylar and want to tell the FDA about it, visit MedWatch.
* To learn more about this side effect, see the “Vraylar and weight gain” section below.
† For more about this side effect, refer to the “Side effect specifics” section below.
Vraylar may cause serious side effects. The list below may not include all possible serious side effects of the drug. For more information, you can refer to Vraylar’s medication guide.
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 can include:
- Neuroleptic malignant syndrome (a serious reaction to certain drugs that requires immediate medical attention). Symptoms can include:
- very high fever (a temperature higher than 106°F (41.1°C)
- muscle stiffness
- Type 2 diabetes and high blood sugar.* Symptoms can include:
- feeling very thirsty or very hungry
- feeling weak, confused, or tired
- needing to urinate more often than usual
- Orthostatic hypotension (drop in blood pressure when you rise from sitting or lying down). Symptoms can include:
- feeling lightheaded
- blurry vision
- Falls due to other side effects, such as dizziness or orthostatic hypotension.
- Seizures. Symptoms can include:
- uncontrollable muscle spasms
- loss of consciousness followed by confusion
- Leukopenia (low levels of white blood cells). Symptoms can include:
- mouth ulcers (sores)
- sore throat, mouth, and gums
- Difficulty swallowing, which could cause aspiration (food or liquid entering your airway).
- Problems controlling your body temperature, particularly when exercising or in hot weather. Symptoms can include:
- hot, dry skin
- Increased levels of triglycerides and cholesterol in your blood, which typically doesn’t cause symptoms other than abnormal lab test results.
- Uncontrolled body movements.*
- Increased risk of death when used to treat psychosis related to dementia in older adults.†
- Risk of suicidal thoughts and behaviors.†
- Allergic reaction.*‡
* For more about this side effect, refer to the “Side effect specifics” section below.
† Vraylar has a
‡ An allergic reaction is possible after using Vraylar. But it’s not clear whether this side effect occurred in clinical studies.
Weight gain is a possible side effect from treatment with drugs classified as atypical antipsychotics, including Vraylar.
However, weight gain wasn’t common in clinical trials of Vraylar. And it was usually mild when it did occur.
Your doctor will typically measure your body weight before you start taking Vraylar. They’ll also monitor your weight during treatment. If your doctor determines that Vraylar could be causing weight gain, they may have you switch to a different medication.
If you have concerns about your weight while taking Vraylar, talk with your doctor. They can recommend ways to help maintain a moderate weight.
Vraylar may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Do Vraylar side effects go away?
Most side effects from Vraylar go away, either after a few days or once you stop taking the drug.
However, uncontrolled body movements caused by Vraylar may not disappear, even if you stop taking the medication. (Uncontrolled body movements may also be known as tardive dyskinesia.)
Vraylar may also cause type 2 diabetes, which may not go away, even if you stop using the drug.
If you’re experiencing side effects from Vraylar, especially ones that don’t disappear after a few days, talk with your doctor. They may suggest switching to a different medication.
Are sexual side effects possible with Vraylar use?
Sexual side effects weren’t reported by people using Vraylar in clinical trials. Sexual problems, such as changes in sex drive, are known side effects of some other antipsychotic drugs. But Vraylar isn’t known to cause them. (Vraylar is a type of antipsychotic drug.)
If you have sexual problems that concern you, talk with your doctor. They can help advise you on the proper treatment.
Is weight loss a side effect of Vraylar?
No, weight loss isn’t a side effect of Vraylar. People taking Vraylar have sometimes reported weight gain* as a side effect, but not weight loss.
If you’re concerned about your weight, talk with your doctor. They can recommend ways to help maintain a moderate weight.
* For information on weight gain, see the “Vraylar and weight gain” section above.
Can Vraylar cause brain fog?
Vraylar wasn’t reported to specifically cause brain fog. But it’s possible that the drug could cause side effects that would be considered to be brain fog. Another name for brain fog is mental fatigue.
Brain fog isn’t a medical condition. But it can be a symptom of other conditions or a side effect of certain medications.
If you experience brain fog while taking Vraylar, talk with your doctor. They may recommend ways to help ease it. They may also recommend a different medication for your condition.
Are any side effects specific to Vraylar strengths?
The different strengths of Vraylar aren’t known to cause different side effects. The drug is available in four strengths: 1.5 milligrams (mg), 3 mg, 4.5 mg, and 6 mg.
Some side effects were more or less common in people taking certain doses of Vraylar in clinical trials. However, the rates of side effects may be slightly different, depending on your Vraylar dose.
If you have questions about the various strengths of Vraylar and possible side effects, talk with your doctor or pharmacist.
Learn more about some of the side effects that Vraylar may cause.
Nausea is a potential mild side effect from taking Vraylar. Nausea was among the more common side effects reported by people using the drug in clinical studies. But most people taking Vraylar didn’t experience it.
For most people who experience nausea from Vraylar, this side effect goes away on its own after a few days.
What you can do
If you experience nausea that doesn’t go away after a few days while taking Vraylar, talk with your doctor. They’ll typically want to see you for an appointment so they can see if anything else could be causing the nausea. If your doctor determines that the nausea is a side effect of Vraylar, they may suggest ways to ease it. But if the nausea is affecting your daily life, your doctor will typically recommend a different medication for your condition.
Insomnia is a possible side effect of taking Vraylar. Insomnia is a condition in which you have difficulty sleeping. People who took Vraylar reported symptoms such as:
- difficulty falling asleep or staying asleep
- trouble falling asleep after waking in the middle of the night or very early in the morning
What you can do
If you experience insomnia while taking Vraylar, talk with your doctor. They may recommend different options. One is treatment for this side effect, such as a medication to help you sleep. Your doctor may recommend changes to your sleep hygiene, such as avoiding TV and phones before bed. Another option they may also suggest is switching to a different drug for your condition.
Uncontrolled body movements
Although rare, taking Vraylar can cause a serious side effect called tardive dyskinesia. It refers to uncontrolled body movements that are repetitive.
Symptoms of tardive dyskinesia can include:
- chewing motions
- jerky movements of your arms, legs, or torso
- lip smacking
- puffing air into your cheeks
- tongue twisting
Sometimes, tardive dyskinesia symptoms go away after you stop taking Vraylar. But this side effect can sometimes be permanent.
It isn’t possible to predict who develops tardive dyskinesia with Vraylar. But it’s believed that older adults, particularly older females,* are at a higher risk. Both your risk for developing tardive dyskinesia and having it be permanent rise the longer you use Vraylar.
Taking a higher dose can also increase your risk, but in rare cases, tardive dyskinesia has occurred in people taking low doses. In addition, it’s possible to develop tardive dyskinesia after stopping Vraylar treatment because the drug stays in your body for a long time.
* Sex and gender exist on spectrums. Use of the term “female” in this article refers to sex assigned at birth.
What you can do
Your doctor will monitor you while you’re taking Vraylar to see whether the drug is effective and whether you have any side effects. They’ll try to prescribe the lowest dose that works for you.
While taking Vraylar, watch for symptoms of tardive dyskinesia and talk with your doctor if you develop any of them. They’ll likely want to discuss with you the pros and cons of continuing to take the drug. For some people, Vraylar is the best long-term treatment for their condition, even when tardive dyskinesia occurs. For other people, tardive dyskinesia may be a reason to stop taking Vraylar and switch to a different medication.
Increased risk of death in older adults who have psychosis due to dementia
Vraylar has a
Psychosis refers to a changed sense of reality. And with dementia, people have problems with memory, thinking, and communication.
Older adults with psychosis related to dementia have a higher risk for death when treated with antipsychotic medications, including Vraylar.
What you can do
Vraylar is not FDA-approved for treating psychosis caused by dementia in older adults. If an older adult has psychosis due to dementia and you’re interested in treatments for them, talk with their doctor.
Suicidal thoughts and behaviors
Vraylar has a boxed warning for the risk of suicidal thoughts and behaviors in children and young adults. A boxed warning is the strongest warning that the FDA requires. Boxed warnings alert patients and doctors about potentially dangerous drug effects.
Antidepressants may increase the risk of suicidal thoughts and behaviors in children and young adults. Vraylar is a type of antipsychotic drug. But when Vraylar is used to treat depressive episodes in bipolar I disorder, it may act similarly to antidepressants.
Vraylar is not approved for use in people younger than age 18 years. However, whatever your age, your doctor will typically monitor you while you take drugs such as Vraylar. They’ll watch for changes in thinking, including suicidal thoughts or behaviors.
What you can do
During your Vraylar treatment, watch for changes in your thoughts and behaviors. You can also ask friends and loved ones to monitor you. This is especially important when you first start taking the medication and whenever your dose is adjusted. If you or someone else notices any changes, talk with your doctor immediately or get emergency medical attention right away.
Symptoms can be mild or serious and can include:
- flushing (temporary warmth, redness, or deepening of skin color)
- swelling under your skin, typically in your lips, eyelids, feet, or hands
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Vraylar. But if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Below are precautions to consider before you take Vraylar.
This drug has boxed warnings. One is about the increased risk of death in older adults who have psychosis due to dementia. The other boxed warning is about suicidal thoughts and behaviors. These are serious warnings from the Food and Drug Administration (FDA). For details, see the “Side effect specifics” section above.
Be sure to talk with your doctor about your health history before you take Vraylar. This drug may not be the right treatment for you if you have certain medical conditions or other factors that affect your health. The conditions and factors to consider include the following:
Type 2 diabetes. Vraylar may cause type 2 diabetes and high blood sugar as a side effect. If you already have type 2 diabetes, you may find it harder to control your blood sugar while taking Vraylar. Before you take Vraylar, be sure to talk with your doctor about the best way to treat your type 2 diabetes.
High levels of triglycerides or cholesterol. Vraylar may cause high levels of triglycerides or cholesterol as a side effect. If you already have elevated levels of these fats, you may find it harder to manage your condition while using Vraylar. Your doctor will regularly check these levels while you’re taking the drug. They may require treatment if the levels become too high.
Kidney or liver problems. Vraylar hasn’t been studied in people with severe kidney or severe liver problems, such as chronic kidney disease or hepatitis. Talk with your doctor about whether Vraylar is right for you if you have kidney or liver problems.
Low levels of white blood cells. Taking Vraylar may cause leukopenia. If you already have low levels of white blood cells, you may be at a higher risk. Your doctor will monitor your levels of white blood cells while you’re using Vraylar. They may have you stop taking the medication if the levels become too low.
Seizures. Although rare, Vraylar can cause seizures as a side effect. You’re more at risk for this side effect if you have epilepsy or had seizures in the past. Talk with your doctor about whether Vraylar is the right treatment for you.
Allergic reaction. You should not take Vraylar if you’ve ever had an allergic reaction to Vraylar or any of its ingredients. Talk with your doctor about which other treatments are better choices for you.
Alcohol use with Vraylar
There are no known interactions between taking Vraylar and consuming alcohol.
However, drinking alcohol may increase your risk for certain side effects of Vraylar, such as sleepiness and fatigue (lack of energy). Talk with your doctor about how much alcohol is safe for you to consume while you’re taking Vraylar.
Pregnancy and breastfeeding while taking Vraylar
Here’s some information about taking Vraylar while pregnant or breastfeeding.
Pregnancy. It’s not known whether it’s safe to take Vraylar while pregnant. Talk with your doctor about treatment options for your condition if you’re pregnant or planning to become pregnant.
If you do choose to use Vraylar while pregnant, keep in mind that there’s a pregnancy registry available. The registry gathers information on people who take drugs such as Vraylar while pregnant and their babies. The information may help you and your doctor decide if Vraylar is right for you. If you’re interested in joining the pregnancy registry, talk with your doctor or visit the pregnancy registry site.
Breastfeeding. It’s not known whether Vraylar is present in human breast milk. Talk with your doctor about the feeding options available for you and your child while taking Vraylar. Your doctor may also suggest trying a different medication.
Side effects from Vraylar aren’t common. And, when they do occur, they’re usually mild. Most mild side effects of the drug go away with time and don’t require medical attention.
But you should talk with your doctor if you experience symptoms of serious side effects. They could require medical attention. These serious side effects include:
- allergic reaction
- suicidal thoughts and behaviors*
- uncontrolled body movements
- neuroleptic malignant syndrome (a serious reaction to certain drugs that requires immediate medical attention)
- type 2 diabetes and high blood sugar
- orthostatic hypotension (drop in blood pressure when you rise from sitting or lying down)
- falls due to other side effects such as dizziness or orthostatic hypotension
- difficulty swallowing, which could cause aspiration (food or liquid entering your airway)
- leukopenia (low levels of white blood cells)
- problems controlling your body temperature, particularly when exercising or in hot weather
It’s important to note that antipsychotic medications such as Vraylar can increase the risk of death when used to treat psychosis related to dementia in older adults.* Vraylar should not be used to treat this condition.
You should also talk with your doctor if you become pregnant while taking Vraylar.
To learn more
If you’d like to learn more about Vraylar, talk with your doctor or pharmacist. They can help answer any questions you have about side effects from taking the drug.
Disclaimer: Medical News Today 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.