Abilify Maintena and Abilify Asimtufii are used in adults to treat schizophrenia and bipolar disorder.

Aristada is used in adults to treat schizophrenia.

Aristada Initio is used together with oral aripiprazole to start or restart Aristada.

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

You should not be treated with aripiprazole if you are allergic to it.

Tell your doctor if you have never taken aripiprazole.

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 or have ever had:

• a problem in receiving an injection in the arm or buttocks;
• heart disease, a heart attack or stroke;
• high or low blood pressure;
• high blood sugar, diabetes (in you or family member);
• a seizure;
• high cholesterol or triglycerides;
• dehydration; or
• low white blood cell (WBC) counts.

Using 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 Aristada Initio (Intramuscular) 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.

High doses or long-term use of aripiprazole can cause a serious movement disorder that may not be reversible. The longer you use aripiprazole, the more likely you are to develop this disorder, especially if you are a woman or an older adult.

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

Call your doctor at once if you have:

• uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);
• feeling unusually hot or cold;
• trouble swallowing;
• a seizure;
• feeling like you might pass out (even while lying down);
• 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, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath;
• signs of infection--fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects may include:

• feeling restless;
• pain where the medicine was injected;
• weight gain; or
• drowsiness.

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 getting up too fast from a sitting or lying position, or you may feel dizzy. Avoid driving or hazardous activity until you know how this medicine will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Do not drink alcohol. Dangerous side effects could occur.

Avoid becoming overheated or dehydrated during exercise, in hot weather, or by not drinking enough fluids. Drink plenty of liquids while you are receiving aripiprazole.

Avoid sunlight or tanning beds. Wear protective clothing and use sunscreen (SPF 30 or higher) when you are outdoors.