Aripiprazole is an antipsychotic medicine that is used to treat schizophrenia in adults and children at least 13 years old.

Aripiprazole is also used in children 6 years or older who have Tourette's disorder, or symptoms of autistic disorder (irritability, aggression, mood swings, temper tantrums, and self-injury).

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

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

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.

Do not stop using aripiprazole suddenly, or you could have unpleasant withdrawal symptoms.

Avoid driving and doing other tasks or actions that call for you to be alert or have clear eyesight until you see how aripiprazole affects you.

High blood sugar or diabetes, high cholesterol, and weight gain have happened with drugs like this one. These may raise the chance of heart and brain blood vessel disease.

Low white blood cell counts have happened with drugs like this one. This may lead to a higher chance of infection. Rarely, infections have been deadly. Tell your doctor if you have ever had a low white blood cell count. Call your doctor right away if you have signs of infection like fever, chills, or sore throat.

Aripiprazole comes as a tablet, a solution (liquid), an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Apriprazole also comes as a tablet that contains a sensor device to take by mouth to be used in adults to provide information about how the medication is taken. Take aripiprazole at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take aripiprazole exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not try to push the orally disintegrating tablet through the foil. Instead, use dry hands to peel back the foil packaging. Immediately take out the tablet and place the entire tablet on your tongue. Do not try to split the tablet. The tablet will quickly dissolve and can be swallowed without liquid. If necessary, liquid can be used to take the orally disintegrating tablet.

Swallow the tablets and the tablet with a sensor whole; do not divide, crush, or chew.

The tablets that contain a small sensor come with a patch (a wearable sensor) that detects a signal from the tablet and a smartphone application (app) to display information about how you are taking the medication. The app must be downloaded onto your smartphone before you start the medication. Apply your patch to the left side of the body above the lower edge of the rib cage only when prompted by the smartphone app instructions. Do not place the patch in areas where the skin is scraped, cracked, inflamed, or irritated or in a location that overlaps the area of the most recently removed patch. Change the patch weekly or sooner, if needed. The app reminds you to change the patch and explains how to apply and remove the patch correctly. Keep the patch on when showering, swimming, or exercising. If undergoing a magnetic resonance imaging (MRI; a medical test that uses powerful magnets to take pictures of the inside of the body), remove the patch and replace it with a new one as soon as possible. If the patch causes skin irritation, remove it and tell your doctor. After you take the medication, the tablets can be detected in the body by the app within 30 minutes to 2 hours. If the tablet is not detected after ingestion, do not take another dose. Talk to your doctor if you have any questions about how to take the tablets and use the patch or smartphone app.

Your doctor may start you on a low dose of aripiprazole and gradually increase or decrease your dose depending on how well the medication works for you and the side effects you experience.

Aripiprazole may help control your symptoms but will not cure your condition. It may take 2 weeks or longer before you feel the full benefit of aripiprazole. Continue to take aripiprazole even if you feel well. Do not stop taking aripiprazole without talking to your doctor.

Take aripiprazole 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.

Aripiprazole 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. Aripiprazole 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 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.

To make sure aripiprazole 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 aripiprazole 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 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.

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.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store the tablets, the solution, and the orally disintegrating tablets at room temperature and away from excess heat and moisture (not in the bathroom). Store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Store the tablets with a sensor at room temperature; do not store in places with high humidity. Dispose of any unused aripiprazole solution 6 months after you open the bottle or when the expiration date marked on the bottle has passed, whichever is sooner.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

Talk to your doctor about drinking grapefruit juice while taking this medicine.

Be sure to drink plenty of water every day while you are taking this medication.

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 aripiprazole will affect you. Dizziness or drowsiness can cause falls, accidents, or severe injuries.

Avoid drinking alcohol. Dangerous side effects could occur.

While 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 to aripiprazole: 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 aripiprazole 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 aripiprazole 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.

Keep all appointments with your doctor and the laboratory. Your doctor may order laboratory tests before and during your treatment with aripiprazole.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.