Key takeaways

Vraylar (cariprazine) is an atypical antipsychotic medication used to treat bipolar disorder.
Common side effects of Vraylar include insomnia, stomach problems, weight gain, movement disorders, and others. Serious side effects may include suicidal thoughts, neuroleptic malignant syndrome, tardive dyskinesia, and significant changes in blood sugar and cholesterol levels.
Vraylar has a black box warning. The warning states that this medicaiton is not safe for use in older adults with dementia-related psychosis due to an increased risk of death.
To minimize side effects, it is advised to take Vraylar as directed, avoid abrupt cessation, manage heat exposure and dehydration, disclose all medical conditions and medications to healthcare providers, and avoid grapefruit due to its interaction with the medication.

Vraylar is the brand name for cariprazine, a prescription drug that treats bipolar disorder. This atypical antipsychotic is used to treat bipolar depression and for short-term treatment of manic episodes in bipolar I disorder. Vraylar works to reduce the severity of bipolar disorder by balancing the chemicals in the brain responsible for mood, like serotonin and dopamine. Side effects and drug interactions are possible when taking Vraylar, and it may not be right for everyone.

RELATED: More Vraylar details

Common side effects of Vraylar

The most common side effects of Vraylar are:

Trouble sleeping
Extrapyramidal symptoms (tremor, shaking, involuntary movements, drooling)
An uncontrollable urge to move (akathisia)
Nausea and vomiting
Constipation
Fatigue and sleepiness
Muscle stiffness
Restlessness
Dizziness
Indigestion
Blurred vision
Increased blood pressure
Back pain
Weight gain
Increased heart rate (tachycardia)
Dry mouth

Weight changes

Weight gain is a side effect of taking Vraylar. In clinical studies that followed patients with schizophrenia over a six-week period, 8% of patients taking 1.5 to 3 mg of Vraylar daily experienced weight gain compared to 5% in the placebo group. A 48-week uncontrolled trial found an estimated average weight gain of 5.5 pounds when taking Vraylar. While weight gain during treatment is possible, the amount gained will vary by person.

Insomnia

The same six-week clinical trial of Vraylar in people with schizophrenia found that 12% of participants taking 1.5 to 3 mg daily experienced insomnia. It’s important to speak with a healthcare provider about new or worsening insomnia while taking Vraylar.

Serious side effects of Vraylar

Serious side effects of Vraylar include:

Suicidal thoughts
Neuroleptic malignant syndrome (fever, rigid muscles, and mental status changes)
Severe extrapyramidal symptoms (tremor, shaking, involuntary movements, drooling)
Involuntary movements of the jaw, lip, and tongue (tardive dyskinesia)
Uncontrollable muscle contraction (dystonia)
Type 2 diabetes or high blood sugar
Transient ischemic attack (mini-stroke) or stroke
Sudden drop in blood pressure (hypotension)
Seizures
Low blood sugar
Severe trouble swallowing
Aspiration
Excessive body temperature (hyperthermia)
Stevens-Johnson syndrome (medication-induced syndrome causing flu-like symptoms and painful rash)
Low white blood cells

Seizures

Antipsychotic medications increase the risk of seizures. Anyone with a history of seizures or seizure disorders should take special caution with taking Vraylar. Be sure to consult your healthcare provider about your history of seizures before taking Vraylar.

Diabetes

Vraylar may increase your blood sugar. People with a history of high blood sugar, diabetes, or with a family history of diabetes should have their blood sugar levels monitored before and during treatment with Vraylar.

Low white blood cell count

Medications like Vraylar have been reported to increase the risk for leukopenia, neutropenia, and agranulocytosis. Any history of low white blood cell counts should be discussed with your healthcare provider. A lab test known as a complete blood count (CBC) should be done before and during treatment to ensure white blood cell counts are in a healthy range while taking Vraylar. Users should be monitored for signs of infection, like a high fever. If your white blood cell count drops to a dangerous level, your healthcare provider may discontinue it.

Abnormal cholesterol levels

Vraylar may affect cholesterol levels. If you have had a history of high total cholesterol, LDL cholesterol, or triglycerides, your healthcare provider should check your levels before and during treatment. People experiencing low HDL cholesterol before treatment should also have their cholesterol levels monitored.

How long do Vraylar side effects last?

The most common side effects of Vraylar are temporary and will improve over time, usually within the first few months of treatment. Late-onset side effects are possible even after the first few weeks of treatment or when the dosing of Vraylar is increased. If serious side effects occur, contact your healthcare provider about discontinuing the use of Vraylar.

Some severe side effects may require you to stop taking Vraylar. These include involuntary movements of the jaw, lip, and tongue (tardive dyskinesia), neuroleptic malignant syndrome, and a lowering of white blood cells. A healthcare professional will determine whether your side effects are serious enough to discontinue use.

Vraylar contraindications & warnings

Restrictions

Vraylar has an FDA black-box warning and is not approved for elderly patients with dementia-related psychosis because of the increased risk of death. There is an increased risk of suicidal thoughts in children and young adults taking Vraylar. It should also not be taken by people with a history of hypersensitivity to cariprazine. Symptoms of hypersensitivity include rash, itching, hives, swelling of the face, lips, tongue, or airway.

Children

Antidepressants, including Vraylar, may increase the risk of suicidal thoughts in children and young adults. This is more common within the first months of treatment or when altering the dose. Further studies are needed to determine the safety and effectiveness of Vraylar in children.

Tell your healthcare professional if you notice new or increased changes in mental health symptoms or behaviors, including:

New or worsening depressive episodes
Increased feelings of agitation
Difficulty sleeping
Aggressive or violent behavior
Panic attacks
Suicide attempts
Signs of increased bipolar mania, like extreme increases in activity or talking
Any new behavior that worries you

Seniors

Elderly patients with dementia-related psychosis have an increased risk of death when taking Vraylar. Heart failure, sudden death, and infections like pneumonia were more common in these people. For this reason, Vraylar should not be used in older adults with dementia-related psychosis.

Further testing needs to be done in seniors taking Vraylar. It’s recommended that people 65 and older begin with lower doses.

Pregnancy and breastfeeding

There is not enough research to suggest whether Vraylar is safe to take during pregnancy. Taking antipsychotic drugs during the third trimester of pregnancy increases the risk for neonatal withdrawal symptoms including agitation, drowsiness, increased or decreased muscle tone, tremors, respiratory distress, and feeding issues. Studies in animals suggest a possible increase in the risk of birth defects. It is important to notify your healthcare provider if you are pregnant, think you may be pregnant, or may become pregnant while taking Vraylar.

Studies on how Vraylar affects the breastfed infant and the mother’s breast milk supply are lacking. However, rat studies found cariprazine (the active ingredient of Vraylar) in rat milk. The healthcare provider should consider whether the need for Vraylar in breastfeeding outweighs the risk to the infant.

Vraylar withdrawal and overdose

Vraylar has not been studied to determine the risk of dependence. The manufacturer reports withdrawal symptoms as possible, but not likely.

Vraylar dosages:

For schizophrenia, the dosage is between 1.5 mg to 6 mg daily, with 6 mg daily being the maximum recommended dosage.
For manic or mixed episodes associated with bipolar I disorder, the recommended dosage is between 3 mg and 6 mg daily.
For bipolar depression, the recommended dosage is between 1.5 mg and 3 mg daily.

If overdose is suspected, contact the Poison Control Center for guidance.

Vraylar interactions

There are several potential drug interactions when taking Vraylar. It’s important to discuss your medications and possible interactions with your healthcare provider.

Vraylar and CYP3A4 inhibitors

Dosing of Vraylar may need to be reduced when taking a CYP3A4 inhibitor. This is because some CYP3A4 inhibitors alter how the body processes and breaks down the active ingredient in Vraylar (cariprazine). Some CYP3A4 inhibitors include:

Antibiotics: clarithromycin and erythromycin
Antifungals: itraconazole and ketoconazole
Antivirals: ritonavir
Calcium channel blockers: verapamil and diltiazem
Goldenseal (a medicinal herb)
Grapefruit

Vraylar and CYP3A4 inducers

Use of Vraylar with a CYP3A4 inducer is not recommended. CYP3A4 inducers speed up the rate at which Vraylar (cariprazine) is broken down in the body. CYP3A4 inducers include:

Anticonvulsants: phenobarbital and phenytoin
Antibiotics: Rifampin
Glucocorticoids: cortisone, prednisone, and dexamethasone
St. John’s wort

How to avoid Vraylar side effects

Vraylar may not be right for everyone. If you experience side effects while taking Vraylar, contact your healthcare provider. He or she can give you medical advice on how to prevent side effects and what to do in the event that side effects occur. While side effects can be discouraging, there are ways to prevent or reduce adverse effects while taking Vraylar, including:

1. Take Vraylar as directed

It’s important to take Vraylar as directed by your healthcare provider. Vraylar is usually taken once a day, with or without food. You should never change your dosage without speaking to your healthcare provider. It’s important to continue taking Vraylar daily, even if you are feeling better. If you’re experiencing side effects that make taking Vraylar difficult, speak to your healthcare provider about ways to prevent these adverse effects. A change in dosage or medication may be necessary if side effects become too severe to tolerate.

2. Avoid becoming too hot or dehydrated when taking Vraylar

Be sure to drink plenty of water when taking Vraylar. Avoid the heat and sun as much as possible. When exercising, pay special attention to your body and take breaks before becoming overheated. Wear lightweight, loose clothing to prevent becoming too hot.

3. Do not stop taking Vraylar suddenly

Avoid stopping Vraylar abruptly. It’s important to take Vraylar as directed, without missing doses. Discontinuing the medication or missing doses increases the chances of experiencing a relapse in symptoms.

4. Discuss all medical conditions before beginning treatment with Vraylar

Before taking Vraylar, tell your healthcare provider if you have had any of the following conditions:

Heart problems or history of stroke
Problems with blood pressure
History of high blood sugar in you or a family member
Problems with cholesterol levels, either high or low
History of seizures
Kidney or liver problems
Low white blood cell count
Are pregnant, breastfeeding, or have plans to become pregnant while taking Vraylar

5. Tell your provider what medications you’re taking

Drug interactions while taking Vraylar are possible. Your healthcare provider should be aware of all the medications you take, including over-the-counter medications and supplements, before starting treatment with Vraylar.

6. Avoid grapefruit while taking Vraylar

Grapefruit is a CYP3A4 inhibitor that can affect the way the body metabolizes Vraylar. This can result in too much of the medication being stored in the body. For this reason, ingesting grapefruit or grapefruit juice while taking Vraylar can be dangerous.