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.
Before taking this medicine
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.
