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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 used for the treatment of manic and mixed episodes associated with bipolar I disorder in adults and in pediatric patients 10 to 17 years of age. It can be used either by itself or as an add-on treatment to lithium or valproate.

The individuals who appear on this page are for illustrative
purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.

Side Effects FAQs

Here you'll find frequently asked questions
about some of the possible side effects of
ABILIFY (aripiprazole) for pediatric patients
10 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 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I disorder, manic or mixed, the most commonly observed side effects associated with ABILIFY were an inner sense of restlessness or need to move (akathisia), sleepiness, and extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), fatigue, nausea, blurred vision, drooling, and dizziness. 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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Do many patients have to discontinue ABILIFY due to side effects?

The percentage of pediatric patients discontinuing ABILIFY because of side effects was 7% compared with 2% of patients treated with placebo.

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Will ABILIFY cause my child to have movement problems?

In a 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I disorder, 20% of patients on ABILIFY (compared with 3% for placebo) reported one or more of the following: muscle stiffness, tremors, shakes or ticks, or other involuntary movements (extrapyramidal disorder). In addition, 10% on ABILIFY (compared with 2% for placebo) reported a feeling of inner restlessness or urge to move (akathisia).

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Will ABILIFY make my child feel sleepy?

In a 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I disorder, 23% taking ABILIFY felt sleepy compared with 3% of patients on placebo.

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

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Will ABILIFY make my child gain weight?

Weight gain has been reported in patients taking medicines like ABILIFY, so your child's weight should be checked regularly. Weight gain in pediatric patients should be compared against that expected with normal growth.

In clinical studies that included pediatric patients 10 to 17 years of age with bipolar I disorder, after 6 weeks, patients taking ABILIFY gained an average of 3.5 pounds compared with an average gain of 0.66 pounds among patients taking 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.

In clinical studies that included pediatric patients with bipolar I disorder taking ABILIFY, some 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 taking 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 child's blood sugar?

Increases in blood sugar levels (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), their blood sugar should be monitored.

In clinical studies that included pediatric patients 10 to 17 years of age with bipolar I disorder, the average change in fasting blood sugar level 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
    child's treatment with the doctor.

    Get started
  • 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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