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

Elderly people with psychosis related to dementia (for example, an inability to perform daily activities as a result of increased memory loss), treated with antipsychotic medicines including ABILIFY®(aripiprazole), are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis. 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). Select a question to
see the answer below.

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What common side effects should I know about?

In 3-week clinical studies of adults with bipolar I disorder, the most commonly observed side effects associated with ABILIFY were an inner sense of restlessness or need to move (akathisia), sleepiness, tremors, restlessness, and extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements). These side effects were reported by at least 5% of ABILIFY patients and more than twice as often as by placebo patients.

In clinical studies, there was little difference between ABILIFY (11%) and placebo (10%) in the percentage of patients who stopped due to side effects.

Find out information about pediatric patients with bipolar I disorder 10 to 17 years of age.

See More Safety Information

Will ABILIFY make me feel sleepy or tired?

In clinical studies, 8% of adults on ABILIFY felt sleepy or tired compared with 3% of adults on placebo (sugar pill). You should not drive or operate hazardous machinery until you know how ABILIFY affects you.

Find out information about pediatric patients with bipolar I disorder 10 to 17 years of age.

See More Safety Information

Will ABILIFY make me gain weight?

Weight gain has been reported in patients taking medicines like ABILIFY, so you and your doctor should check your weight regularly.

In clinical studies that included adults with bipolar I disorder, after approximately 3 weeks, patients taking ABILIFY gained an average of 0.7 pounds compared with placebo-treated patients, who lost an average of 0.2 pounds. Among patients followed up at 24 weeks, those taking ABILIFY lost an average of 3.3 pounds compared with patients taking placebo, who lost an average of 0.4 pounds.

In a 3-week clinical study of adults with bipolar I disorder on ABILIFY, some people experienced significant weight gain. The percentage of patients who gained significant weight (based on gaining 7% or more of body weight) was 2.2% for ABILIFY compared with 2.7% for patients treated with placebo.

Find out information about pediatric patients with bipolar I disorder 10 to 17 years of age.

See More Safety Information

Will ABILIFY affect my blood sugar?

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

In clinical studies that included adults with bipolar I disorder, changes in fasting blood sugar levels were not significantly different among patients taking ABILIFY compared with those taking placebo. Some patients taking ABILIFY who had borderline blood sugar levels at the start of clinical studies experienced a change to high blood sugar levels during treatment.

The percentage of patients who changed from borderline to high blood sugar levels was 17.6% among patients taking ABILIFY compared with 9.2% among patients taking placebo.

Find out information about pediatric patients with bipolar I disorder 10 to 17 years of age.

See More Safety Information
  • Side effects checklist

    Side Effects Checklist

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

    Get started
  • Real Patient Stories

    Meet real ABILIFY patients who got help treating their
    bipolar I disorder.

    More