Important Risk Information and Indications
What is the most important information I should know about VRAYLAR?

Elderly people with dementia-related psychosis (having lost touch with reality due to confusion and memory loss) taking antipsychotic drugs are at an increased risk of death. VRAYLAR is not approved for treating people with dementia-related psychosis.

VRAYLAR may cause serious side effects, including:
Who should not take VRAYLAR?

Do not take VRAYLAR if you are allergic to any of its ingredients. Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat).

What should I tell my healthcare provider before taking VRAYLAR?

Tell your healthcare provider about any medical conditions and if you have or have had:

Tell your healthcare provider if you are pregnant, or if you plan to become pregnant. Using VRAYLAR in the third trimester may cause uncontrolled movements of the body and face, muscle stiffness, or feelings of restlessness and/or withdrawal symptoms in newborn babies. A special program (National Pregnancy Registry for Atypical Antipsychotics) collects information on the safety of antipsychotic drugs, including VRAYLAR, during pregnancy. For information, contact the program at 1-866-961-2388 or

Tell your healthcare provider about all medicines that you take or have recently taken, including prescriptions, over-the-counter medicines, and supplements. VRAYLAR may affect the way other medicines work, and other medicines may affect how VRAYLAR works.

What are the most common side effects of VRAYLAR?

Tell your healthcare provider if you have any side effect that bothers you or that does not go away. These are not all possible side effects of VRAYLAR.

Indications and Usage

VRAYLAR (cariprazine) is indicated in adults for the acute treatment of manic or mixed episodes associated with bipolar I disorder and the treatment of schizophrenia.

Please see the Prescription Drug Facts and full Prescribing Information, including Boxed Warning.