Abilify is an antipsychotic medication. It works by changing the actions of chemicals in the brain.

Abilify is used to treat the symptoms of psychotic conditions including schizophrenia in adults and children at least 13 years old.

Abilify is also used alone or with a mood stabilizer medicine to treat bipolar I disorder (manic depression) in adults and children at least 10 years old.

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

Abilify is also used in children at least 6 years old to treat Tourette's disorder and to treat symptoms related to autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

Abilify 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.

Stop using Abilify and call your doctor at once if you have the following symptoms: fever with stiff muscles and rapid heart rate; uncontrolled muscle movements; symptoms that come on suddenly such as numbness or weakness, severe headache, and problems with vision, speech, or balance.

If you also use antidepressant medicine, do not stop using it suddenly.

Before taking this medicine

You should not take Abilify if you are allergic to aripiprazole.

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

To make sure this medicine is safe for you, tell your doctor if you have:

• heart problems or a stroke;

• high or low blood pressure;

• diabetes (in you or a family member);

• seizures; or

• low white blood cell (WBC) counts.

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.

The liquid form (oral solution) of this medication contains sugar. Before taking Abilify oral solution, tell your doctor if you have diabetes.

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

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria (PKU).

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.

Take Abilify exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

Abilify can be taken with or without food.

Swallow the regular tablet whole and do not crush, chew, or break it. Do not split the orally disintegrating tablet.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Remove an orally disintegrating tablet from the package only when you are ready to take the medicine. Place the tablet in your mouth and allow it to dissolve, without chewing. Swallow several times as the tablet dissolves. If needed, you may drink liquid to help swallow the dissolved tablet.

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

If you also use antidepressant medicine, do not stop using it suddenly or you could have unpleasant symptoms. Ask your doctor before stopping the antidepressant.

Store at room temperature away from moisture and heat. Abilify liquid may be used for up to 6 months after opening, but not after the expiration date on the medicine label.

You should not take Abilify if you are allergic to aripiprazole.

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

To make sure this medicine is safe for you, tell your doctor if you have:

• heart problems or a stroke;

• high or low blood pressure;

• diabetes (in you or a family member);

• seizures; or

• low white blood cell (WBC) counts.

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.

The liquid form (oral solution) of this medication contains sugar. Before taking Abilify oral solution, tell your doctor if you have diabetes.

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

The orally disintegrating tablet form of this medication may contain over 3 milligrams of phenylalanine per tablet. Before taking Abilify Discmelt, tell your doctor if you have phenylketonuria (PKU).

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.

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.

Get your prescription refilled before you run out of medicine completely.

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 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.

Avoid drinking alcohol. Dangerous side effects could occur.

While taking Abilify, 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 to Abilify: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Tell your doctor right away if you have new or sudden changes in mood or behavior, including new or worse depression or anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, more active or talkative, or have thoughts about suicide or hurting yourself.

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 Abilify side effects may include:

• blurred vision;

• increased saliva or drooling;

• muscle stiffness;

• uncontrolled muscle movements, shaking, anxiety, feeling restless;

• weight gain;

• nausea, vomiting, constipation;

• increased or decreased appetite;

• headache, dizziness, drowsiness, feeling tired;

• sleep problems (insomnia); or

• cold symptoms such as stuffy nose, sneezing, sore throat;

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.

Taking Abilify with other drugs that make you drowsy or slow your breathing can cause dangerous side effects or death.

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.

Many drugs can interact with aripiprazole. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all other medicines you use.