Aripiprazole is an antipsychotic medicine that is used to treat adults with schizophrenia.

Aripiprazole is used alone or with a mood stabilizer medicine to treat adults with bipolar I disorder (manic depression).

Aripiprazole is used with antidepressant medication to treat major depressive disorder in adults.

Aripiprazole may also be used for purposes not listed in this medication guide.

Aripiprazole is not approved for use in older adults with dementia-related psychosis.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Tell your doctor right away if you have any sudden changes in mood or behavior, or thoughts about suicide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Abilify MyCite is a drug and device system that has 4 parts:

• A MyCite tablet with a sensor inside it.

• A MyCite Patch (to wear on your skin) that detects a signal from the sensor in the tablet after you take it, and sends this information to a smartphone.

• A Mycite App (a smartphone app) that records when you took the tablet, and tracks information about your activity, sleep, and mood.

• An online portal to share information from the MyCite App with your healthcare providers.

The Mycite Patch usually detects a tablet within 30 minutes after you take it. If the tablet is not detected, do not repeat the dose.

It may take up to 2 hours or longer for the smartphone app and online portal to detect that you've taken a tablet.

You may take aripiprazole with or without food.

Your doctor will need to check your progress on a regular basis.

Swallow the tablet whole and do not crush, chew, or break it.

Store at room temperature away from moisture and heat.

You should not use aripiprazole if you are allergic to it.

Aripiprazole may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

Tell your doctor if you have ever had:

• heart problems or a stroke;

• high or low blood pressure;

• diabetes (in you or a family member);

• low white blood cell (WBC) counts;

• seizures; or

• trouble swallowing.

People with depression or mental illness may have thoughts about suicide. Some young people may have increased suicidal thoughts when first starting a medicine to treat depression. Stay alert to changes in your mood or symptoms. Your family or caregivers should also watch for sudden changes in your behavior.

Aripiprazole can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels carefully.

Taking antipsychotic medicine in the last 3 months of pregnancy may cause serious problems in the newborn. Tell your doctor right away if you get pregnant. Do not stop the medicine without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of aripiprazole on the baby.

Ask a doctor if it is safe to breastfeed while using aripiprazole.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, vomiting, aggression, confusion, tremors, fast or slow heart rate, seizure (convulsions), weak or shallow breathing, fainting, or coma.

Avoid driving or hazardous activity until you know how aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

While you are taking aripiprazole, you may be more sensitive to very hot conditions. Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Aripiprazole may cause serious side effects. Call your doctor at once if you have:

• severe agitation, distress, or restless feeling;

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• mask-like appearance of the face, trouble swallowing, problems with speech;

• seizure (convulsions);

• severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• low blood cell counts--fever, chills, sore throat, weakness, easy bruising, unusual bleeding, purple or red spots under your skin; or

• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking aripiprazole. Talk with your doctor if this occurs.

Common side effects of aripiprazole may include:

• feeling shaky, anxious, or restless;

• nausea, constipation;

• dizziness, drowsiness; or

• sleep problems (insomnia).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Other drugs may affect aripiprazole, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.