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.

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 this medicine.

Use Abilify Mycite Starter Kit (Oral) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

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

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 this medicine. Talk with your doctor if this occurs.

Common side effects 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.

Avoid driving or hazardous activity until you know how this medicine 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.