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Vraylar

Pronunciation: VRAY-lar
Generic name: cariprazine
Dosage form: capsules (1.5mg, 3mg, 4.5mg, 6mg)
Drug class: Atypical antipsychotics

Medically reviewed by Melisa Puckey, BPharm. Last updated on Mar 19, 2024.

What is Vraylar?

Vraylar (cariprazine) is used to treat types of bipolar I disorder, major depressive disorder (MDD), and schizophrenia. Vraylar works to improve depression symptoms in bipolar depression and major depressive disorder and to improve psychiatric signs and symptoms in schizophrenia. Vraylar capsules are taken once a day. 

Vraylar is thought to work by managing serotonin and dopamine levels, which are chemical messengers in the brain. Vraylar is thought to have this effect (mechanism of action) by having a combination of partial agonist activity at central dopamine Dâ‚‚ and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors. Vraylar is from the drug class of medications called atypical antipsychotics.

Vraylar originally became an FDA-approved medicine on September 17, 2015. Vraylar has FDA approval to treat adults with: 

Vraylar side effects

Common Vraylar side effects may include sleepiness, nausea, vomiting, indigestion, constipation, feeling tired, trouble sleeping, increased appetite, dizziness, involuntary muscle movements, feeling restless, upset stomach, difficulty moving, or slow movements. 

Vraylar may cause weight gain. You and your healthcare provider should check your weight before you start and often during treatment. 

Serious Vraylar side effects

Get emergency medical help if you have signs of an allergic reaction to Vraylar, including hives, difficulty breathing, and swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

Vraylar can have long-lasting effects on your body. Some side effects could occur for several weeks after you stop using this medicine. You may also have new side effects whenever your dose is changed.

This is not a complete list of side effects, and others may occur. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Warnings

Vraylar is not approved for use in older adults with dementia-related psychosis.

Vraylar may disrupt the body’s ability to reduce core body temperature. Strenuous exercise, exposure to extreme heat, dehydration, and anticholinergic medications may cause an increase in body temperature. Use this medicine with caution in these circumstances.

Vraylar and antidepressant medicines may increase suicidal thoughts or actions in some children and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

Before taking this medicine

You should not use Vraylar if you are allergic to cariprazine.

Vraylar is not approved for use by anyone younger than 18 years old.

Cariprazine may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Vraylar is safe for you, tell your doctor if you have:

Taking antipsychotic medicine in the last 3 months of pregnancy may cause withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles in the newborn. If you get pregnant, tell your doctor right away. Do not stop taking Vraylar without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of cariprazine on the baby.

It may not be safe to breastfeed while using this medicine. Ask your doctor about any risks.

How should I take Vraylar?

Take Vraylar once a day, with or without food.

General Vraylar dose information.

It may take several weeks before your symptoms improve. Keep using the medication as directed, and tell your doctor if your symptoms do not improve.

Take Vraylar exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

High doses or long-term use of Vraylar can cause a serious movement disorder that may not be reversible. The longer you use this medicine, the more likely you are to develop this disorder, especially if you are an older adult. Symptoms of this disorder include tremors or other uncontrollable muscle movements.

Tell your doctor if you have any changes in weight while taking this medicine.

Your blood pressure and heart rate will need to be checked often. You may also need frequent blood tests.

Vraylar capsules are available as 1.5 mg, 3 mg, 4.5 mg, and 6 mg.

What happens if I miss a dose?

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What to avoid

Avoid drinking alcohol. Dangerous side effects could occur.

Avoid driving or hazardous activity until you know how this medicine will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

While you are taking Vraylar, you may be more sensitive to temperature extremes such as very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

What other drugs will affect Vraylar?

Sometimes it is not safe to use certain medications at the same time. Some drugs can affect your blood levels of other drugs you take, which may increase side effects or make the medications less effective.

Taking Vraylar with other drugs that make you sleepy or slow your breathing can cause dangerous side effects or death. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Many drugs can interact with cariprazine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.

Ingredients

Active ingredient: cariprazine

Inactive ingredients: gelatin, magnesium stearate, pregelatinized starch, shellac, and titanium dioxide.

Colorants include: black iron oxide, FD&C Blue 1, FD&C Red 3, FD&C Red 40, or yellow iron oxide.

Storage

Store Vraylar at room temperature, between 68°F to 77°F (20°C to 25°C).

Company

Manufactured by: Forest Laboratories Ireland Limited, Dublin, IE.

Distributed by: Allergan USA, Inc. Madison, NJ 07940.

Popular FAQ

Abilify (aripiprazole) and Vraylar (cariprazine) are both classified as atypical antipsychotic medications. They help treat mental health conditions such as schizophrenia, bipolar disorder and as additive treatment for depression. Abilify comes as a long-acting injection and oral form (tablet, solution), and Vraylar comes as an oral capsule. Continue reading

Common side effects of Vraylar include movement disorders (extrapyramidal symptoms); stomach problems (such as indigestion, nausea, vomiting, or constipation); sleep problems such as drowsiness, dizziness, feeling sleepy all the time, fatigue, or trouble sleeping; and increased appetite and weight gain. For most people, these side effects lessen or go away after a few weeks of treatment. Continue reading

Vraylar may be taken either in the morning or at night, depending on your preference. Some people may find changing the time of day that you take Vraylar helps with certain side effects.For example, people who experience restlessness or restless legs as a side effect of Vraylar may find taking it in the morning helps. Up to 10% of people taking Vraylar report sleepiness or drowsiness as a side effect of Vraylar, and these people may prefer taking Vraylar at night. Continue reading

Vraylar and Seroquel are both oral prescription medicines in a drug class called atypical antipsychotic medications. They are used to treat the mental health conditions schizophrenia and bipolar disorder. Vraylar is also approved for depression. They work by changing the actions of chemicals in your brain to help stabilize thoughts, actions and moods. Vraylar is more expensive than generic Seroquel. Continue reading

Vraylar (cariprazine) takes time to work and patients often see a gradual reduction in symptoms over several weeks. Symptoms tend to continue to improve the longer the medication is taken.

Patients with schizophrenia may start to notice an improvement in their symptoms within 1-2 weeks of starting treatment with Vraylar, while those with bipolar I disorder are likely to notice some improvement in symptoms after 3 weeks. Patients who are taking Vraylar as an add on therapy for major depressive disorder should see an improvement in their overall depression symptoms in 6-8 weeks. Continue reading

Most side effects with Vraylar will subside with time after your body has become used to the medicine. However, some side effects can be serious, have long-lasting effects or be irreversible. Speak to your doctor for medical advice if you have side effects that concern you with Vraylar or any other medication. Continue reading

Caffeine is not listed as having a drug interaction with the atypical antipsychotic medicine Vraylar (generic name: cariprazine). However, Vraylar may lead to restlessness, the feeling of the need to move around (akathisia), or trouble with sleeping (insomnia) in some patients. Call a health care provider right away if you or your family member has any of these symptoms while receiving Vraylar. Continue reading

Vraylar (cariprazine), like other atypical antipsychotic drugs, can cause metabolic changes that cause weight gain. However, weight gain is less of a troublesome side effect of Vraylar than it is of some other antipsychotics. Continue reading

Yes, sleepiness or drowsiness can be a common side effect with Vraylar in about 6% to 7% of patients compared to 4% receiving a placebo (inactive) medicine. Continue reading

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Further information

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Vraylar only for the indication prescribed.

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.