Vraylar (Cariprazine) - Oral

Warning:

Antipsychotic medicines like Vraylar may increase the risk of death in older adults with dementia-related psychosis. The Food and Drug Administration (FDA) has not approved Vraylar to treat behavior disorders in older adults with dementia.


Antidepressants may increase the risk of suicidal thinking and behavior (suicidality). If you’re considering using Vraylar or any other antidepressant, it’s important to balance this possible risk with your current medical needs. When on antidepressant therapy, your healthcare provider will work with you to help look for any symptoms over time that may mean that your condition is worsening (e.g., suicidality, unusual behavior). It’s important that the individual on the medication, family members, and/or caregivers thoughtfully and carefully observe any changes and keep communication open with each other and the prescriber.

What Is Vraylar?

Vraylar is an oral prescription medication used to treat schizophrenia and certain forms of bipolar disorder in adults. Vraylar belongs to a group of drugs called second-generation or atypical antipsychotics. It works by affecting the activity of natural brain chemicals, including dopamine and serotonin.

The FDA has boxed warnings for Vrayalar. Talk with your healthcare provider about these risks before starting treatment.

Drug Facts

Generic Name: Cariprazine

Brand Name(s): Vraylar

Drug Availability: Prescription

Therapeutic Classification: Second-generation or atypical antipsychotic

Available Generically: No

Controlled Substance: No

Administration Route: Oral

Active Ingredient: Cariprazine

Dosage Form(s): Oral capsule

What Is Vraylar Used For?

The FDA has approved Vraylar to treat schizophrenia and certain forms of bipolar disorder in adults.

Schizophrenia is estimated to occur in up to 0.64% of people in the United States. Schizophrenia is a mental illness that can affect how people with the illness think, behave, and perceive reality. Symptoms may include:

  • Hallucinations
  • Delusions
  • Unusual, disorganized speech
  • Reduced emotional expression
  • Lack of motivation
  • Difficulty with social relationships

Bipolar disorder (sometimes called manic-depressive disorder) is estimated to affect 2.8% of adults in the United States. People with bipolar disorder experience extreme changes in mood, energy, and activity levels that make it challenging to keep up with day-to-day responsibilities. During manic episodes, people affected by bipolar disorder may feel "up," elated, or irritable. Depressive episodes can cause those affected to feel "down," sad, hopeless, or worried. While we all experience changes in mood, these shifts are much more extreme for someone with bipolar disorder.

How to Take Vraylar

Vraylar is an oral capsule that you take once daily, with or without food. Do not change your dose or stop taking Vraylar without talking to your healthcare provider first.

Storage

Store your Vraylar prescription at room temperature. Keep Vraylar and all of your medicines in a safe location, out of the reach of children and pets.

How Long Does Vraylar Take to Work?

Vraylar takes time to work. In clinical studies, participants saw improvements in their symptoms within three to six weeks, but you may notice changes earlier. Talk with your healthcare provider about what to expect and when a dose adjustment might be necessary.

Off-Label Uses

Healthcare providers may prescribe medications for conditions not approved by the FDA. This is called off-label use. Vraylar may be prescribed off-label to treat major depressive disorder in people not receiving adequate relief from antidepressants alone.

What Are the Side Effects of Vraylar?

This is not a complete list of side effects and others may occur. A healthcare provider can advise you on side effects. If you experience other effects, contact your pharmacist or a healthcare provider. You may report side effects to the FDA at fda.gov/medwatch or 800-FDA-1088.

Common Side Effects

You may experience side effects while taking Vraylar. Some side effects may not happen right away and can take several weeks to appear. Contact your healthcare provider if you develop any side effects that bother you or don't go away.

Common side effects include:

  • Difficulty moving or slowed movements
  • Tremors (shaking)
  • Uncontrollable body movements
  • Restlessness or feeling like you need to move
  • Sleepiness
  • Nausea or vomiting
  • Upset stomach

Severe Side Effects

Contact your healthcare provider immediately if you develop any signs of a severe reaction. Call 911 if your symptoms feel life-threatening.

Serious side effects and their symptoms include:

  • Increased risk of death and stroke in older adults with dementia-related psychosis
  • Suicidal thoughts or actions. Contact your healthcare provider immediately if you notice any new or sudden changes in mood, behaviors, or thoughts.
  • The severe, sometimes deadly condition neuroleptic malignant syndrome (NMS). Seek emergency medical care if you have a high fever, confusion, changes in your breathing, increased heart rate, low or high blood pressure, stiff muscles, or increased sweating.
  • Uncontrollable body movements (tardive dyskinesia) in your face, tongue, or other body parts.
  • High blood sugar (hyperglycemia) and diabetes. Contact your healthcare provider if you need to urinate more than usual, feel very thirsty or hungry, nauseous, weak, tired, confused, or your breath smells fruity.
  • Increased cholesterol or triglyceride levels in your blood
  • Weight gain
  • Low white blood cells levels
  • Decreased blood pressure when rising from a sitting or lying position (orthostatic hypotension). Let your healthcare provider know if you feel lightheaded or faint.
  • Falls that may lead to injuries.
  • Seizures
  • Difficulty controlling your body temperature, which can cause you to become overheated
  • Difficulty swallowing

Long-Term Side Effects

Vraylar may cause a potentially irreversible movement disorder called tardive dyskinesia, involving uncontrollable movements in your face, tongue, or other body parts. Tardive dyskinesia may occur shortly after starting Vraylar or after you've been on it for a while. It can even happen after stopping Vraylar. Let your healthcare provider know if you develop any body movements that you can't control.

Report Side Effects

Vraylar may cause other side effects. Call your healthcare provider if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your healthcare provider may send a report to the FDA's MedWatch Adverse Event Reporting Program or by phone (800-332-1088).

Dosage: How Much Vraylar Should I Take?

Drug Content Provided and Reviewed by IBM Micromedex®

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

  • For oral dosage form (capsules):
    • For bipolar disorder and manic episodes related with schizophrenia:
      • Adults—At first, 1.5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 6 mg per day.
      • Children—Use and dose must be determined by your doctor.
    • For depressive episodes related with schizophrenia:
      • Adults—At first, 1.5 milligrams (mg) once a day. Your doctor will adjust your dose as needed and tolerated. However, the dose is usually not more than 3 mg per day.
      • Children—Use and dose must be determined by your doctor.

Modifications

The following modifications (changes) should be kept in mind when using Vraylar:

Severe allergic reaction: Avoid using Vraylar if you have a known allergy to it or its ingredients. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

Pregnancy: Taking Vraylar during the third trimester of pregnancy may cause uncontrollable movements or withdrawal reactions in your baby after delivery. These reactions may last hours to days and require hospitalization. Talk with your healthcare provider if you are pregnant or plan to become pregnant about the benefits and risks of taking Vraylar during your pregnancy.

Breastfeeding: In animal studies, Vraylar was present in rat breastmilk. We don't know enough about the safety of Vraylar in human breastmilk and nursing babies. Talk with your healthcare provider if you plan to breastfeed about the benefits and risks of taking Vraylar while nursing and the different ways to feed your baby.

Adults over 65: Clinical studies haven't included a large enough number of people in this age group to see whether they respond differently from younger adults.

Children: The safety and effectiveness of using Vraylar in children have not been established.

Kidney and liver problems: Individuals with kidney or liver problems may not be able to clear medication from their bodies as easily. This means the medicine stays in the body longer and can have increased side effects. For this reason, if you have severe kidney or liver impairment, your healthcare provider will likely not prescribe Vraylar.

Missed Dose

If you accidentally forgot your Vraylar dose, take it as soon as you remember. If it's already close to your next scheduled dose, skip the missed dose and take the following dose at your next scheduled dosing time. Don't try to double up to make up for the missed dose.

Try to find ways to help yourself remember to routinely keep your appointments and take your medication. If you miss too many doses, Vraylar might be less effective at controlling your symptoms.

Overdose: What Happens If I Take Too Much Vraylar?

The symptoms of a suspected Vraylar overdose include:

  • Sedation
  • Feeling dizzy, lightheaded, or faint after rising from a lying or seated position

If you think you're experiencing an overdose or life-threatening symptoms, seek immediate medical attention.

What Happens If I Overdose on Vraylar?

If you think you or someone else may have overdosed on Vraylar, call a healthcare provider or the Poison Control Center (800-222-1222).

If someone collapses or isn't breathing after taking Vraylar, call 911 immediately.

Precautions

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It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood tests may be needed to check for unwanted effects.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed. Make sure the doctor knows if you have trouble sleeping, get upset easily, have a big increase in energy, or start to act reckless. Also tell the doctor if you have sudden or strong feelings, such as feeling nervous, angry, restless, violent, or scared. If you or your caregiver notice any of these side effects, tell your doctor right away.

Check with your doctor right away if you have convulsions (seizures), difficulty with breathing, a fast heartbeat, a high fever, high or low blood pressure, increased sweating, loss of bladder control, severe muscle stiffness, unusually pale skin, or tiredness. These could be symptoms of a serious condition called neuroleptic malignant syndrome (NMS).

This medicine may cause tardive dyskinesia (a movement disorder). Check with your doctor right away if you have lip smacking or puckering, puffing of the cheeks, rapid or worm-like movements of the tongue, uncontrolled chewing movements, or uncontrolled movements of the arms and legs.

For diabetic patients: This medicine may cause high blood sugar levels (hyperglycemia). Check with your doctor right away if you have increased thirst or increased urination. If you notice a change in the results of your urine or blood sugar tests, or if you have any questions, check with your doctor.

This medicine may increase your weight. Your doctor may need to check your weight on a regular basis while you are using this medicine. Talk to your doctor about ways to prevent weight gain.

Cariprazine can temporarily lower the number of white blood cells in your blood, increasing the chance of getting an infection. If you can, avoid people with infections. Check with your doctor right away if you think you are getting an infection, or if you have a fever or chills, cough or hoarseness, lower back or side pain, or painful or difficult urination.

Dizziness, lightheadedness, or fainting may occur, especially when you get up suddenly from a lying or sitting position. Getting up slowly may help. If this problem continues or gets worse, check with your doctor.

This medicine may cause dizziness, drowsiness, trouble with thinking, or trouble with controlling body movements, which may lead to falls, fractures, or other injuries. Do not drive or do anything else that could be dangerous until you know how this medicine affects you.

This medicine might reduce how much you sweat and make you feel too hot. You might feel dizzy, weak, tired, or confused, or begin to vomit or have an upset stomach. Do not get too hot while exercising and avoid places with high temperatures. Call your doctor if you become overheated and cannot cool down.

Make sure your doctor knows if you are pregnant. Do not use this medicine during the last 3 months of a pregnancy unless your doctor tells you to.

Some side effects may not happen right away and can start a few weeks after you start using this medicine or if your dose increases. Do not change your dose or stop using your medicine without first checking with your doctor.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

What Are Reasons I Shouldn’t Take Vraylar?

Do not take Vraylar if you are allergic to cariprazine or any other ingredient in Vraylar. Ask your pharmacist or healthcare provider for a complete list of the ingredients if you're unsure.

What Other Medications Interact With Vraylar?

Use caution when taking Vraylar with the following medications:

Many other medications may interact with Vraylar. Be sure to inform your healthcare provider and pharmacist about all the medicines you take, including over-the-counter, nonprescription products, vitamins, or herbal medicines.

What Medications Are Similar?

Vraylar is a second-generation (or atypical) antipsychotic. Other second-generation antipsychotics include:

  • Abilify (aripiprazole)
  • Rexulti (brexpiprazole)
  • Risperdal (risperidone)
  • Seroquel (quetiapine)
  • Zyprexa (olanzapine)

Second-generation antipsychotics differ based on their formulations (oral, long-acting injections, transdermal patches), drug interactions, and side effects. You and your healthcare provider will work together to select the best therapy for you.

Frequently Asked Questions

  • What is Vraylar used for?

    Vraylar is used to help control the symptoms of schizophrenia and certain forms of bipolar disorder.

  • How does Vraylar work?

    Vraylar is a second-generation (or atypical) antipsychotic medication. It works by affecting the activity of certain brain chemicals, including dopamine and serotonin.

  • What are the side effects of Vraylar?

    The most common side effects of Vraylar include difficulty moving or slowed movements, shaking (tremors), uncontrollable movements in the face, tongue, or other body parts, restlessness, sleepiness, nausea, vomiting, and upset stomach.

How Can I Stay Healthy While Taking Vraylar?

Living with or caring for a loved one with schizophrenia or bipolar disorder can have its challenges. Fortunately, medication therapy like Vraylar can help control symptoms and improve your quality of life. Refer below for some general tips to support your health:

  • Take medications as recommended by your healthcare provider.
  • Follow-up with all appointments and lab work to monitor for side effects.
  • Manage your stress.
  • Avoid alcohol and drugs which may worsen symptoms and interact with your medications.
  • Get enough sleep. Regular exercise and avoiding caffeine may help if you're having trouble sleeping.
  • Consider support groups or working with a mental healthcare provider to help you find coping strategies to change the way you think, feel, react, or respond to living with schizophrenia or bipolar disorder.

Medical Disclaimer

Verywell Health's drug information is meant for educational purposes only and is not intended as a replacement for medical advice, diagnosis, or treatment from a healthcare provider. Consult your healthcare provider before taking any new medication(s). IBM Watson Micromedex provides some of the drug content, as indicated on the page.

7 Sources
Verywell Health uses only high-quality sources, including peer-reviewed studies, to support the facts within our articles. Read our editorial process to learn more about how we fact-check and keep our content accurate, reliable, and trustworthy.
  1. DailyMed. Vraylar- cariprazine capsule, gelatin coated.

  2. National Institute of Mental Health. Schizophrenia.

  3. National Institute of Mental Health. Bipolar disorder.

  4. National Institute of Mental Health. Bipolar disorder: signs and symptoms.

  5. Durgam S, Earley W, Guo H, et al. Efficacy and safety of adjunctive cariprazine in inadequate responders to antidepressants: a randomized, double-blind, placebo-controlled study in adult patients with major depressive disorderJ Clin Psychiatry. 2016;77(3):371-378. doi:10.4088/JCP.15m10070

  6. MedlinePlus. Cariprazine.

  7. American Psychiatric Association. Treatment of patients with schizophrenia.