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It is not known if VRAYLAR passes into breast milk.

are breastfeeding or plan to breastfeed.

If you become pregnant or think you are pregnant during treatment, talk to your healthcare provider about registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-86 or Talk to your healthcare provider about the risk to your unborn baby if you take VRAYLAR during pregnancy.

are pregnant or plan to become pregnant.

have or have had low white blood cell count.

have or have had kidney or liver problems.

have or have had seizures (convulsions).

have or have had high levels of total cholesterol, LDL-cholesterol, or triglycerides or low levels of HDL-cholesterol.

have or have had diabetes or high blood sugar in you or your family.

have or have had low or high blood pressure.

have or have had heart problems or a stroke.

Tell your healthcare provider about any medical conditions and if you: What should I tell my healthcare provider before taking VRAYLAR?

Get emergency medical help if you are having an allergic reaction (eg, rash, itching, hives, swelling of the tongue, lip, face or throat). Difficulty swallowing that can cause food or liquid to get into your lungsĭo not take VRAYLAR if you are allergic to any of its ingredients.Do not wear too much clothing or heavy clothing. In hot weather, stay inside in a cool place if possible. Increased body temperature: Do not become too hot or dehydrated during VRAYLAR treatment.Impaired judgment, thinking, and motor skills: Do NOT drive, operate machinery, or do other dangerous activities until you know how VRAYLAR affects you.Falls: VRAYLAR may make you sleepy or dizzy, may cause a decrease in blood pressure when changing position (orthostatic hypotension), and can slow thinking and motor skills, which may lead to falls that can cause fractures or other injuries.Decreased blood pressure (orthostatic hypotension): You may feel lightheaded or faint when you rise too quickly from a sitting or lying position.Your healthcare provider may do blood tests during the first few months of treatment with VRAYLAR Very low white blood cell counts, which can be fatal, have been reported with other antipsychotics. This may increase your risk of infection. Low white blood cell count: Low white blood cell counts have been reported with antipsychotic drugs, including VRAYLAR.You and your healthcare provider should check your weight before and regularly during treatment Weight gain: Weight gain has been reported with VRAYLAR.Increased fat levels (cholesterol and triglycerides) in your blood: Your healthcare provider should check fat levels in your blood before or soon after starting VRAYLAR and during treatment.Tell your healthcare provider if you have symptoms such as feeling very thirsty, very hungry, or sick to your stomach, urinating more than usual, feeling weak, tired, confused, or your breath smells fruity Your healthcare provider should check your blood sugar before or soon after starting VRAYLAR and regularly during treatment. Extremely high blood sugar can lead to coma or death. High blood sugar and diabetes: Increases in blood sugar can happen in some people who take VRAYLAR.Problems with your metabolism, such as:.Your healthcare provider should monitor you for side effects for several weeks after starting or increasing dose of VRAYLAR Some side effects may not happen right away and can start a few weeks after starting VRAYLAR, or if your dose increases. Late-occurring side effects: VRAYLAR stays in your body for a long time.Tardive dyskinesia may also start after you stop taking VRAYLAR Tardive dyskinesia may not go away, even if you stop taking VRAYLAR. Uncontrolled body movements (tardive dyskinesia or TD): VRAYLAR may cause movements that you cannot control in your face, tongue, or other body parts.VRAYLAR should be stopped if you have NMS These can be symptoms of a rare but potentially fatal side effect called NMS. Neuroleptic malignant syndrome (NMS): Call your healthcare provider or go to the nearest hospital emergency room right away if you have high fever, stiff muscles, confusion, increased sweating, or changes in breathing, heart rate, and blood pressure.

Stroke (cerebrovascular problems) in elderly people with dementia-related psychosis that can lead to death.VRAYLAR may cause serious side effects, including: