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ABILIFY
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INDICATION: ABILIFY® (aripiprazole) is a prescription medicine used to treat depression in adults as an add-on treatment to an antidepressant when an antidepressant alone is not enough.

IMPORTANT WARNING ON SUICIDALITY AND ANTIDEPRESSANT DRUGS: Children, adolescents, and young adults taking antidepressants for Major Depressive Disorder (MDD) and other psychiatric disorders are at an increased risk of suicidal thinking and behavior. More

U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.

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 prescribed as an add-on treatment for adults with depression when an antidepressant alone is not enough.

About ABILIFY

Side Effects FAQs

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

  • What common side effects should I know about?
  • Will ABILIFY make me feel sleepy or tired?
  • Will ABILIFY make me gain weight?
  • Does ABILIFY affect sexual function?
  • Will ABILIFY affect my blood sugar?
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What common side effects should I know about?

In 6-week clinical studies of adults with Major Depressive Disorder (MDD), the most commonly observed side effects associated with ABILIFY (aripiprazole) plus an antidepressant were an inner sense of restlessness or need to move (akathisia), restlessness, insomnia, fatigue, blurred vision, and constipation. These side effects were reported in at least 5% of patients taking ABILIFY plus an antidepressant and at least twice the rate of patients taking a placebo plus an antidepressant.

In clinical studies, 6% of patients taking ABILIFY (aripiprazole) plus an antidepressant stopped due to side effects, compared with 2% of patients taking a placebo plus an antidepressant.

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Will ABILIFY make me feel sleepy or tired?

In 6-week clinical studies, 6% of patients taking ABILIFY (aripiprazole) plus an antidepressant experienced somnolence (drowsiness), and 4% experienced sedation. In the same trials, 4% of patients taking a placebo plus an antidepressant experienced somnolence, and 2% experienced sedation.

Although you may not feel tired, you should not drive or operate hazardous machinery until you know how ABILIFY (aripiprazole) affects you.

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Will ABILIFY make me gain weight?

Weight gain has been reported in some patients taking medicines like ABILIFY (aripiprazole), so you and your healthcare provider should check your weight regularly.

In 6-week clinical studies of adults with MDD, 5.2% of patients taking ABILIFY (aripiprazole) plus an antidepressant gained at least 7% of their baseline body weight, compared with 0.6% of patients taking a placebo plus an antidepressant. At week 6, the average weight change for patients taking ABILIFY plus an antidepressant was 3.7 lb, compared with 0.9 lb for patients taking a placebo plus an antidepressant.

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Does ABILIFY affect sexual function?

In 6-week clinical studies of adults with MDD, patients taking ABILIFY (aripiprazole) plus an antidepressant were minimally impacted when it came to sexual function as measured by the Sexual Function Inventory (SFI) Questionnaire. In addition, less than 2% of patients taking ABILIFY plus an antidepressant had adverse reactions related to sexual dysfunction.

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Will ABILIFY affect my blood sugar?

Increases in blood sugar levels (hyperglycemia) can happen in some people who take ABILIFY (aripiprazole). 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 6-week clinical studies of adults with MDD, the mean change in fasting glucose in patients taking ABILIFY (aripiprazole) plus an antidepressant was not significantly different compared with patients taking a placebo plus an antidepressant.

The percentage of patients who changed from borderline to high blood sugar levels was 11.8% for patients taking ABILIFY (aripiprazole) plus an antidepressant, compared with 8.1% of patients taking a placebo plus an antidepressant.

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Personal Stories Meet real ABILIFY (aripiprazole) patients who got help treating their unresolved symptoms of depression. More

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