IMPORTANT SAFETY INFORMATION and INDICATION for ABILIFY:
U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

Antidepressants may increase suicidal thoughts or behaviors in some children, teenagers, and young adults, especially within the first few months of treatment or when the dose is changed. Depression and other serious mental illnesses are themselves associated with an increase in the risk of suicide. Patients on antidepressants and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior, or thoughts of suicide. Such symptoms should be reported to the patient's healthcare provider right away, especially if they are severe or occur suddenly. ABILIFY®(aripiprazole) is not approved for use in pediatric patients with depression. See More Safety Information

INDICATION: ABILIFY (aripiprazole) is indicated for the treatment of schizophrenia in adults and adolescents 13 to 17 years of age.

Side Effects FAQs

Here you'll find frequently asked questions
about some of the possible side effects of ABILIFY (aripiprazole) in teenagers 13 to 17 years
of age. Select a question to see the answer below.

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What common side effects should I know about?

In a 6-week clinical study of teenage patients 13 to 17 years of age with schizophrenia, the most commonly observed side effects associated with ABILIFY were extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), somnolence (feeling sleepy), and tremors (shakiness). These side effects were reported by at least 5% of ABILIFY patients and more than twice as often as by placebo patients.

These are not all the possible side effects of ABILIFY. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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What should I do if my teen has side effects with ABILIFY?

Everyone responds differently to medication. Take note of any side effects your teen experiences, and report them to the doctor. This will help the doctor understand how to manage side effects.

Your teen should not stop taking ABILIFY without first talking to the doctor.

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Do many patients have to discontinue ABILIFY due to side effects?

Five percent of teenage patients 13 to 17 years of age taking ABILIFY discontinued treatment because of side effects, compared with 2% of patients taking a placebo.

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Will ABILIFY cause my teen to have movement problems?

In a short-term trial of teenage patients 13 to 17 years of age with schizophrenia, 17% of patients taking ABILIFY (compared with 5% of those taking a placebo) reported one or more of the following: muscle stiffness, tremors, shakes or ticks, or other involuntary movements (extrapyramidal disorder). In addition, 8% of patients taking ABILIFY (compared with 5% of those taking a placebo) reported a feeling of inner restlessness or urge to move (akathisia).

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Will ABILIFY make my teen feel sleepy?

In a short-term clinical trial of teenage patients 13 to 17 years of age, 17% taking ABILIFY felt sleepy compared with 6% of those taking a placebo.

Even if your teen does not feel tired, you should not allow him or her to drive or operate hazardous machinery until you know how ABILIFY affects him or her.

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Will ABILIFY make my teen gain weight?

Weight gain has been reported in patients taking medicines like ABILIFY, so your teenager’s weight should be checked regularly. Weight gain in teenagers should be compared against what is expected as they grow up.

In clinical studies that included teenage patients 13 to 17 years of age with schizophrenia, patients taking ABILIFY gained an average of 3.5 pounds after 6 weeks (compared with 0.66 pounds in patients taking a placebo). Among patients followed up at 24 weeks, patients taking ABILIFY gained an average of 12.8 pounds (compared with 3.1 pounds in patients taking placebo).

Some of these patients experienced significant weight gain after 4 to 6 weeks. The percentage of patients who gained significant weight (based on gaining 7% or more of body weight) was 5.2% for ABILIFY compared with 1.6% for patients treated with placebo. After 26 weeks, the percentage of ABILIFY patients who gained significant weight was 32.8%, which is not clinically significant when adjusted for normal growth.

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Will ABILIFY affect my teen’s blood sugar?

Increases in blood sugar levels called (hyperglycemia) can happen in some patients who take ABILIFY. Extremely high blood sugar can lead to coma or death. If your child has diabetes, or risk factors (for example, obesity, family history of diabetes), or has the following symptoms: increases in thirst, urination, or hunger, feel weak or tired, sick to their stomach, or confused (or breath smells fruity), his or her blood sugar should be monitored.

In clinical studies that included teenage patients 13 to 17 years of age with schizophrenia, the average change in fasting blood sugar levels was not significantly different among patients treated with ABILIFY compared with patients treated with placebo.

The percentage of patients who changed from borderline to high blood sugar levels was 4.5% among patients taking ABILIFY compared with 0% among patients taking placebo.

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  • Side Effects Checklist

    Here you'll find a checklist to help
    you discuss the side effects of your
    teen's treatment with the doctor.

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  • Resources and Support

    There may be resources available in your community: for example, schools, healthcare professionals, hospitals, and local and national organizations.

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