Most side effects due to Vraylar (generic name: cariprazine), will usually go away over a few weeks as your body gets used to the medicine. Some side effects, like uncontrolled body movements, can be long-lasting or permanent. Talk to your doctor about side effects with Vraylar and how they could impact your treatment plan.

Take Vraylar exactly as prescribed by your doctor. Do not change your dose or stop treatment on your own. Always speak to your doctor about any side effects that concern you.

Some side effects may not appear until several weeks after you have started taking Vraylar. This is because the levels of medicine slowly increase in your body over time. Your doctor should monitor you for several weeks after starting Vraylar and any time your dose is increased.

Your doctor may decide to change your dose or stop your treatment, if needed, due to certain side effects. Your doctor may also be able to tell you about ways to prevent or reduce some side effects.

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

How long does it take Vraylar to get out of your system?

• If you and your doctor decide to stop your Vraylar (cariprazine) treatment, it may take from a few days to several weeks for any side effects to go away.
• This is because cariprazine and its two active metabolites may stay in your body for a longer period of time after treatment is stopped. It takes about one week to eliminate most of the drug, but one metabolite may take up to 4 weeks or longer.
• Even though your blood levels of the drug may decline, you may still feel certain side effects.

The therapeutic action of Vraylar is thought to be due to three compounds: cariprazine (the parent compound), and two major active metabolites, desmethylcariprazine (DCAR) and didesmethylcariprazine (DDCAR). Vraylar's metabolites are active by-products of the parent compound cariprazine. All of these compound have equal potencies.

The half-lives reported for Vraylar are 2 to 4 days for cariprazine, about 1 to 2 days for DCAR, and approximately 1 to 3 weeks (7 to 21 days) for DDCAR.

In studies, drug levels of DDCAR decreased by about 50% one week after the last dose. Cariprazine and DCAR levels dropped by about 50% in about one day. There was about a 90% decline in drug plasma exposure within one week for cariprazine and DCAR, and at about four weeks for DDCAR. However, the decrease in blood levels of Vraylar may not be immediately reflected in your clinical symptoms.

Your doctor also will monitor you for side effects and how well you respond for several weeks after starting the medicine and with each dosage change, as drug levels slowly build as well.

Do not change your dose or stop taking Vraylar without first talking to your healthcare provider.

What are the side effects with Vraylar?

The most common side effects of Vraylar, some of which may be serious, include:

• difficulty moving or slow movements
• tremors
• dizziness
• uncontrolled body movements
• restlessness, feeling like you need to move around
• sleepiness, fatigue
• increased appetite
• nausea, vomiting
• indigestion
• constipation
• trouble sleeping

Side effects can also be the result of a drug interaction, so be sure to have your doctor and pharmacist review all of the medications you are taking, including prescription drugs, over-the-counter (OTC) medicines, vitamins, herbals, and dietary supplements.

Learn More: Side Effects with Vraylar (in more detail)

What side effects can be long-lasting with Vraylar?

Some side effects of Vraylar that can be long-lasting, or have long-lasting effects, include:

• tardive dyskinesia, a serious movement disorder that can be permanent and irreversible
• neuroleptic malignant syndrome, that can be fatal
• increased risk of death in elderly people with dementia related psychosis
• increased risk of suicidal thoughts or actions
• allergic reactions
• metabolic changes and weight gain
• effects during pregnancy or breast-feeding
• injury, fall or broken bone due to drowsiness or sedation.

Tardive dyskinesia

Vraylar may cause tardive dyskinesia, which is movement that you cannot control in your face, tongue, or other body parts. These movements may include tongue thrusting, repetitive chewing, jaw swinging and facial grimacing.

• If you or someone you care for develops any abnormal movement while taking Vraylar, contact your health care provider immediately.
• Tardive dyskinesia may not go away or might get worse, even if you stop taking Vraylar. Tardive dyskinesia may also start after you stop taking the medicine.
• Older patients, especially older women, may be at a greater risk for this side effect. However, it is not possible to predict which patients are likely to develop this side effect.

The risk of tardive dyskinesia and the likelihood that it will become permanent increase with the length of time you take the medicine and the total dose over time. The syndrome can develop after a relatively brief treatment period, even at low doses. Whether one antipsychotic is more likely to cause tardive dyskinesia than another is not known.

Neuroleptic malignant syndrome (NMS)

Neuroleptic malignant syndrome can be a serious and fatal side effect of some drugs, including antipsychotic drugs. Call your doctor, get emergency help or go to the nearest hospital emergency room right away if you have some or all of the following signs and symptoms of NMS:

• high fever
• confusion
• changes in your breathing, heart rate, and blood pressure
• stiff muscles
• increased sweating

Increased risk of death in elderly with dementia-related psychosis

Antipsychotic medications like Vraylar can raise the risk of stroke and death in elderly patients who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). Vraylar is not approved for the treatment of patients with dementia-related psychosis.

Increased risk of suicide

Vraylar may increase the risk for suicidal thoughts or actions in patients who are depressed. The risk may be higher in patients with a history of depression, a family history of depression, bipolar illness (also called manic-depressive illness), or a history of suicidal thoughts or actions.

Vraylar is not approved for use by anyone younger than 18 years old. Antidepressant medicines may increase suicidal thoughts or actions in some children and young adults within the first few months of treatment and when the dose is changed.

Call a health care provider right away if you or your family member has any of the following symptoms, especially if they are new, worsen, or worry you:

• thoughts about suicide or dying
• new or worse depression
• feeling very agitated or restless
• trouble sleeping (insomnia)
• acting aggressive, being angry, or violent
• an extreme increase in activity and talking (mania)
• attempts to commit suicide
• new or worse anxiety
• panic attacks
• new or worse irritability
• acting on dangerous impulses
• other unusual changes in behavior or mood.

Allergies

Do not use Vraylar (cariprazine) if you are allergic to any ingredients in the product.

Signs of an allergic reaction can include hives, difficult breathing, and swelling of your face, lips, tongue, or throat. Call for emergency medical help if you think you are having an allergic reaction.

Metabolic changes

Vraylar can cause high blood sugar (hyperglycemia) and diabetes, changes in cholesterol and triglycerides in your blood, and weight gain. Your doctor should check your blood sugar and blood lipids on a regular basis.

• In bipolar depression studies, patients who took Vraylar experienced an average weight gain of 1.2 lb (0.54 kg), compared to those on placebo who lost 0.2 lb (0.1 kg).
• In bipolar mania studies, patients experienced an average weight gain of 1.1 lb (0.5 kg), compared to those on placebo who gained 0.4 pounds (0.18 kg).
• In some studies, up to 17% of patients had a weight gain.

Pregnancy and breastfeeding

Vraylar can harm an unborn baby. If you are planning a pregnancy, speak with your doctor before starting treatment. If you become pregnant, or think you are pregnant while taking Vraylar, notify your doctor immediately. Your doctor may ask you to join a National Pregnancy Registry for Atypical Antipsychotics to monitor your outcome.

It is not known if Vraylar passes into breast milk. Talk with your doctor about the best way to feed your baby.

Falls and injuries

Vraylar can cause drowsiness or may make you faint or dizzy upon standing (orthostatic hypotension). This can lead to dangerous falls, broken bones or other injuries. Avoid alcohol while taking Vraylar.

Do not drive, operate machinery, or do other dangerous activities until you know how this medicine affects you.

Dehydration

Atypical antipsychotics like Vraylar may increase your risk of becoming too hot or dehydrated during treatment.

• Avoid exercising too much, and stay inside and out of the sun and in a cool place when possible.
• Wear lightweight clothing and drink plenty of fluids.
• Some drugs with anticholinergic properties may increase this risk. Have your doctor or pharmacist review your medications for possible drugs with anticholinergic properties.

Other side effects with Vraylar can include low white blood cell counts, seizures, and difficulty swallowing.

Related questions

• Vraylar vs Abilify - How do they compare?
• What are 6 Vraylar side effects you need to be aware of?
• Should you take Vraylar in the morning or at night?

Bottom Line

• Most side effects with Vraylar will decrease or go away after your body has become used to the medicine. However, some side effects can be serious, have long-lasting effects or be irreversible.
• Your health care provider will monitor you for side effects after starting or adjusting your dose of Vraylar. If your doctor should stop your Vraylar treatment, it may take a week or longer for any side effects to go away.
• Do not stop taking Vraylar unless your doctor has recommended that you stop treatment. Speak to your doctor for medical advice if you have side effects that concern you with Vraylar or any other medications.

This is not all the information you need to know about Vraylar (cariprazine) for safe and effective use and does not take the place of your doctor’s directions. Review the full product information and discuss this information and any questions you have with your doctor or other health care provider.

References

• Vraylar (cariprazine) Prescribing Information. Allergan. Madison, NJ. Revised 12/2022. Accessed Oct 3, 2023 at https://www.rxabbvie.com/pdf/vraylar_pi.pdf
• Vraylar Product Monograph. Drugs.com. Accessed Oct 3, 2023 at https://www.drugs.com/vraylar.html
• Vraylar.com. Pharmacokinetics. Allergan. Accessed Oct 4, 2023 at https://www.vraylarhcp.com/pharmacokinetics

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