Vraylar (cariprazine) is an antipsychotic medication used to treat mental health or mood disorders including schizophrenia, specific types of bipolar I disorder, and as an add-on treatment for major depressive disorder (MDD).

Vraylar is a once a day capsule that is thought to work by managing chemicals in the brain (neurotransmitters) such as serotonin and dopamine. Although the mechanism of action of Vraylar is unknown, it may have an effect from a combination of partial agonist activity at central dopamine D₂ and serotonin 5-HT1A receptors and antagonist activity at serotonin 5-HT2A receptors.

Vraylar is specifically indicated to treat adults with:

• schizophrenia
• acute manic or mixed episodes associated with bipolar I
• depressive episodes associated with bipolar I disorder (bipolar depression) 
• adjunctive treatment with an antidepressant therapy (ADT) for major depressive disorder (MDD).

Vraylar originally became a FDA approved medicine on September 17, 2015.

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 body temperature. Use this medicine with caution in these circumstances.

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.

You may take Vraylar with or without food.

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.

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.

Store this medicine in its original packaging at room temperature, away from moisture, heat, and light.

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:

• heart disease, high blood pressure;

• a stroke or blood clot;

• high cholesterol or triglycerides (a type of fat in the blood);

• liver or kidney disease;

• diabetes; or

• if you are dehydrated.

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 breast-feed while using this medicine. Ask your doctor about any risk.

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.

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

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.

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

Call your doctor at once if you have:

• sudden numbness or weakness (especially on one side of the body);

• problems with vision or speech,

• a light-headed feeling, like you might pass out;

• severe distress or agitation;

• a seizure;

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

• trouble swallowing, or accidentally inhaling food or drink;

• low white blood cell counts - fever, chills, sore throat, mouth sores, skin sores, sore throat, cough, trouble breathing, feeling light-headed;

• high blood sugar - increased thirst, increased urination, dry mouth, fruity breath odor; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

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.

Common Vraylar side effects may include:

• involuntary muscle movements;

• upset stomach, vomiting;

• drowsiness; or

• feeling restless.

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 FDA at 1-800-FDA-1088.

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.