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 irritability associated with autistic disorder in pediatric patients 6 to 17 years of age, as part of a total treatment plan.

Side Effects FAQs

Here you'll find frequently asked questions about some of the possible side effects of ABILIFY (aripiprazole) for children 6 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 clinical studies of children 6 to 17 years of age who have irritability associated with autistic disorder, the most commonly observed side effects were sedation, fatigue, vomiting, sleepiness, tremors, fever, drooling, decreased appetite, increased saliva, extrapyramidal disorder (eg, shakes, muscle stiffness, or other involuntary movements), and lethargy. These side effects were reported in at least 5% of patients taking ABILIFY and at least twice the rate of patients taking a placebo.

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Do many patients have to stop taking ABILIFY due to side effects?

In clinical studies of children 6 to 17 years of age who have irritability associated with autistic disorder, the percentage of patients who stopped taking ABILIFY due to side effects was 10% compared with 8% of those taking a placebo.

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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 children should be compared against that expected with normal growth.

In clinical studies of children 6 to 17 years of age who have irritability associated with autistic disorder, patients taking ABILIFY gained an average of 3.5 pounds after 8 weeks compared with 0.9 pounds among patients taking placebo. The percentage of patients who significantly gained weight (7% or more of body weight) was 26.3% for patients taking ABILIFY compared with 7.1% of those taking a placebo.

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Will ABILIFY affect my child's blood sugar?

Increases in blood sugar levels (or hyperglycemia) can happen in some people 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 if your child has certain symptoms (specifically, increases in thirst, urination, or hunger; weakness or tiredness; feeling sick to the stomach; confusion; or breath that smells fruity), his or her blood sugar should be monitored.

In clinical studies of children 6 to 17 years of age who have irritability associated with autistic disorder, patients taking ABILIFY did not experience a significantly different change in fasting blood sugar levels.

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  • Treating With ABILIFY

    Treating With ABILIFY

    ABILIFY may be an option to help manage your
    child's irritability associated with autistic disorder.

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  • Family Support

    Therapy, parent education, and community support may help
    you care for a child who has irritability associated with autistic disorder.

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