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Uses

What is Vraylar used for?

Vraylar (cariprazine) is commonly used for the following conditions.

Learn more about Vraylar for major depressive disorder (MDD) and bipolar 1 disorder.

Vraylar may also be used for other conditions as determined by your healthcare provider.

How does Vraylar work (mechanism of action)?

Vraylar belongs to a group of medicines called second-generation (atypical) antipsychotics. It is thought to work by balancing brain chemicals called serotonin and dopamine. These chemicals are known to affect thoughts and mood.

How is Vraylar supplied (dosage forms)?

Vraylar is available in the following dosage forms that are taken by mouth.

  • 1.5 mg, 3 mg, 4.5 mg, 6 mg oral capsules

How should I store Vraylar?

Vraylar should be stored at room temperature, between 68 F to 77 F (20 C to 25 C). It can be exposed to temperatures between 59 F to 86 F (15 C to 30 C) for shorter periods of time, such as when transporting it. Store in a cool, dry place. Protect from light.

Side Effects

What are the most common side effects of Vraylar?

The most common side effects of Vraylar are listed below. Tell your healthcare provider if you have any of these side effects that bother you.

  • Movement problems
  • Tremor
  • Restlessness
  • Upset stomach
  • Nausea or vomiting
  • Drowsiness, sleepiness, or tiredness
  • Constipation
  • Trouble sleeping
  • Increased appetite
  • Dizziness

There may be other side effects of Vraylar that are not listed here. Contact your healthcare provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088. In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.

What are the serious side effects of Vraylar?

While less common, the most serious side effects of Vraylar are described below, along with what to do if they happen.

Severe Allergic Reactions. Vraylar may cause allergic reactions, which can be serious. Stop taking Vraylar and get help right away if you have any of the following symptoms of a serious allergic reaction.

  • Breathing problems or wheezing
  • Racing heart
  • Fever or general ill feeling
  • Swollen lymph nodes
  • Swelling of the face, lips, mouth, tongue, or throat
  • Trouble swallowing or throat tightness
  • Itching, skin rash, or pale red bumps on the skin called hives
  • Nausea or vomiting
  • Dizziness, feeling lightheaded, or fainting
  • Stomach cramps
  • Joint pain

Suicidal Thoughts or Actions. Vraylar or other antidepressants may increase the risk of suicidal thoughts or actions in a small number of children, teenagers, or young adults. The risk is higher in the first few months of taking the medicine or when the dose is changed. Depression or other serious mental health conditions are the most important causes of suicidal thoughts or actions. If you or your child is about to harm themselves, call 911 or call or text 988, the Suicide & Crisis Lifeline. Call your healthcare provider right away if you have any of the following symptoms.

  • New or increased thoughts of suicide or death
  • Suicide attempt
  • New or increased feelings of anxiety, depression, or other unusual changes in your mood or behavior

Metabolism Changes. Vraylar can cause changes to your metabolism, including an increase in blood sugar levels, diabetes, increase in cholesterol levels, or weight gain. Keep all appointments with your healthcare provider to check your blood work and weight. Call your healthcare provider if you gain weight or develop the following symptoms of high blood sugar.

  •  Thirsty more than usual
  •  Peeing more than usual
  • Increase in hunger
  •  Tiredness
  • Feeling sick to your stomach
  • Confusion
  • Your breath smelling fruity

Uncontrolled Movements. Vraylar can cause some people to have movements that they cannot control.  This condition, called tardive dyskinesia (TD), can cause jerky movements of your face, tongue, or body.  TD can be permanent. Call your healthcare provider right away if you have any symptoms of TD.

  • Tongue sticking out
  • Lip smacking or puckering
  • Grimacing
  • Rapid eye blinking
  • Jerking or twisting motion of the arms, legs, or trunk

Low Blood Pressure Upon Standing (Orthostatic Hypotension) and Falls. Vraylar may cause a sudden drop in blood pressure when standing up from a seated or lying position. To help prevent this, be careful not to get up too quickly. If you feel dizzy, sit or lie down right away until the dizziness stops, then take your time getting up again. Tell your healthcare provider right away if you have any of the following symptoms of orthostatic hypotension.

  • Dizziness, feeling lightheaded, or fainting upon standing
  • Blurred vision
  • Confusion
  • Feeling weak

Seizures. Some people who have taken Vraylar have reported having seizures. There are many different types of seizures and some of them are not easy to recognize. Stop taking Vraylar and call your healthcare provider if you have any of the following signs that a seizure is happening or could happen.

  • Muscle twitching, jerking, spasms, tremors, or other uncontrolled movements
  • Stiffening of your arms and legs
  • Feeling anxious, nervous, confused, or a sense of dread
  • Feeling dizzy or lightheaded
  • Falling or losing consciousness

Blood Disorders. Vraylar can cause blood disorders, such as low white blood cell levels (leukopenia,  neutropenia, or agranulocytosis). Keep all appointments to have your blood checked. Stop taking Vraylar and get help right away if you have any of the following symptoms of blood disorders.

  • Fever
  • Frequent infection
  • Unusual weakness or tiredness
  • Headache

Neuroleptic Malignant Syndrome (NMS). Vraylar may cause a rare but serious condition called neuroleptic malignant syndrome, which may cause muscle stiffness and a high fever. Stop taking Vraylar and contact your healthcare provider right away if you have any of the following symptoms.

  • High fever
  • Muscle stiffness or rigidity, where it is hard to move
  • Confusion 
  • Changes in your breathing or heart rate
  • Increased sweating

Decreased Alertness or Coordination. Vraylar can affect your alertness or coordination. Do not drive or do other activities that require alertness or coordination until you know how Vraylar affects you.

Trouble Swallowing. Vraylar can cause trouble swallowing (dysphagia), which can increase your risk of choking while eating or drinking. Eat small amounts of food, and chew your food well. Get emergency help if you are choking or have food stuck in your esophagus that is not passing.

Body Temperature Regulation. Vraylar can affect your ability to regulate your body temperature. This could make you become very hot, especially in hot weather or after exercising a lot. You should drink water and avoid overheating and dehydration. Call your healthcare provider right away if you are severely ill and have the following symptoms of dehydration.

  • Excessive or no sweating
  • Dry mouth
  • Feeling very hot
  • Feeling thirsty 
  • Not able to pee

Warnings & Precautions

Who should not use Vraylar?

Allergies to Ingredients. People who are allergic to any of the following should not take Vraylar.

  • Vraylar
  • Cariprazine
  • Any of the ingredients in the specific product dispensed

Your pharmacist can tell you all of the ingredients in Vraylar.

What should I know about Vraylar before using it?

Do not take Vraylar unless it has been prescribed to you by a healthcare provider. Take it as prescribed.

Do not share Vraylar with other people, even if they have the same condition as you. It may harm them.

Keep Vraylar out of the reach of children.

Potential side effects could occur after several weeks of taking the medicine due to how Vraylar works in your body.

Because Vraylar can cause your body temperature to increase, try to avoid becoming too hot or dehydrated. Try to drink plenty of water, and wear light and breathable clothing. Limit your exercise and exposure to the heat and sun.

What should I tell my healthcare provider before using Vraylar?

Tell your healthcare provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them determine if Vraylar is right for you.

In particular, make sure that you discuss any of the following.

Current and Past Health Conditions. In particular, tell your healthcare provider if you have any of the following.

  • High or low blood pressure
  • Diabetes or family history of diabetes
  • High cholesterol or triglyceride levels
  • Heart problems, including a heart attack, heart failure, or abnormal heart rhythm 
  • Kidney or liver problems
  • Suicide attempt
  • Seizures
  • Stroke
  • Low white blood cell counts

Other Medicines and Supplements. Vraylar may interact with other medicines and supplements. Before taking Vraylar, tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. See the Interactions section for more details.

Psychosis Related to Dementia. There is a higher risk of death, stroke, or mini-stroke in older adults who take Vraylar or another antipsychotic and have memory loss or psychosis related to dementia. Vraylar is not approved to treat dementia-related psychosis.

Pregnancy. Vraylar used later in pregnancy may lead to an increased risk of certain problems in your newborn. Tell your healthcare provider if you are or plan to become pregnant while taking Vraylar. Your healthcare provider will advise you if you should take Vraylar while you are pregnant or trying to get pregnant. If you become pregnant while taking  Vraylar, you can register with the National Pregnancy Registry for Atypical Antipsychotics by calling 866-961-2388 or at womensmentalhealth.org/research/pregnancyregistry. This registry collects safety information about the use of psychiatric medicines during pregnancy.

Breastfeeding. It is not known if Vraylar passes into breast milk. Tell your healthcare provider if you are breastfeeding or plan to breastfeed. Your healthcare provider will advise you if you should take Vraylar while breastfeeding.

How can I get more information about Vraylar?

For more information about Vraylar, you can visit the manufacturer’s website at www.vraylar.com or call them at 800-678-1605.

Interactions

Does Vraylar interact with foods or drinks?

There are no known interactions between Vraylar and foods or drinks.

It is unknown if drinking alcohol will affect Vraylar. Drinking alcohol while taking Vraylar could increase your risk of sleepiness, dizziness, feeling lightheaded, or fainting upon standing. It is best to limit the amount of alcohol that you drink.

Does Vraylar interact with other medicines (drug interactions)?

Always tell your healthcare provider about any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.

In particular, make sure that you discuss if you are using any of the following before taking Vraylar.

  • Ketoconazole, itraconazole (Sporanox, Tolsura), or fluconazole (Diflucan), which is a medicine used for fungal infections
  • Carbamazepine (Carbatrol, Tegretol, and others), which is a medicine commonly used to treat seizures or nerve pain
  • Clarithromycin, which is a medicine used for bacterial infections
  • Phenytoin (Dilantin, Phenytek, and others), which is a medicine to control seizures
  • Rifampin (Rifadin), which is a medicine commonly used to treat an infection called tuberculosis
  • St. John’s wort, which is a supplement that may be used to help with depression

Many other medicines may alter the blood levels of Vraylar. Tell your healthcare provider about all medicines that you take or have recently taken.

This may not be a complete list of medicines that can interact with Vraylar. Always check with your healthcare provider.

Does interact with other drugs you are taking?

Enter your medication into the WebMD interaction checker

Overdose/Missed Dose

What should I do if I accidentally use too much Vraylar?

If you or someone else has used too much Vraylar, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.

What should I do if I miss a dose of Vraylar?

If you miss a dose, take it as soon as you remember. If it is almost time for your next dose, skip the missed dose and only take the next dose. Do not take double or extra doses.

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