Safety Profile of Abilify.

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What common side effects should I know about?

In 3-week clinical studies of adults with Bipolar Disorder comparing ABILIFY with placebo, some people experienced side effects. The most commonly observed adverse events associated with ABILIFY (reported by 5% or more of ABILIFY patients and more than twice as often as placebo patients) 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).

In a 4-week clinical study of pediatric patients (10 to 17 years) with Bipolar Disorder comparing ABILIFY with placebo, some people experienced side effects. The most commonly observed adverse events associated with ABILIFY (reported by 5% or more of ABILIFY patients and more than twice as often as placebo patients) were an inner sense of restlessness or need to move (akathisia), sleepiness, extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), fatigue, nausea, blurred vision, drooling, and dizziness.

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Will ABILIFY make me feel sleepy or tired?

If you're like many people with Bipolar I Disorder, you may worry that medication will make you feel sleepy or “flat.” In clinical studies, 13% of adults on ABILIFY felt sleepy or tired vs. 6% of adults on placebo (sugar pill). In clinical studies of pediatric patients (10 to 17 years), 25% on ABILIFY felt sleepy or tired vs. 3% on placebo. You may not feel tired, but you should not drive or operate hazardous machinery until you know how ABILIFY affects you.

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Will ABILIFY make me gain weight?

Weight gain has been reported in patients taking medicines like ABILIFY, so you and your healthcare provider 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 (ages 10 to 17).

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Does ABILIFY affect sexual function?

In 3-week clinical studies of adults with Bipolar Disorder, the incidence of patient-reported sexual-related adverse reactions was similar in the ABILIFY and placebo groups.

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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 blood sugar levels were not significantly different among patients taking ABILIFY and 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 (ages 10 to 17).

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Are there additional important safety considerations I should know about?

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, are at an increased risk of death compared to placebo. ABILIFY is not approved for the treatment of people with dementia-related psychosis.

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 is not approved for use in pediatric patients with depression.

Contraindication: Patients should not use ABILIFY if they are allergic to aripiprazole or any of the ingredients in ABILIFY. Allergic reactions have ranged from rash, hives and itching to anaphylaxis, which may include difficulty breathing, tightness in the chest, and swelling of the mouth, face, lips, or tongue.

Serious side effects may include:

• An increased risk of stroke and ministroke have been reported in clinical studies of elderly people with dementia-related psychosis
• High fever, stiff muscles, confusion, sweating, changes in pulse, heart rate and blood pressure may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare and serious condition that can lead to death
• 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
• Changes in cholesterol and triglyceride (fat, also called lipids) levels in the blood have been seen in patients taking medicines like ABILIFY
• Weight gain has been reported in patients taking medicines like ABILIFY so your weight should be checked regularly. Weight gain in children (ages 6 to 17) should be compared against that expected with normal growth
• ABILIFY and medicines like it have been associated with difficulty swallowing which may lead to aspiration or choking
• Uncontrollable movements of face, tongue, or other parts of body, as these may be signs of a serious condition called tardive dyskinesia (TD). TD may not go away, even if you stop taking ABILIFY. TD may also start after you stop taking ABILIFY
• Orthostatic hypotension (decreased blood pressure) or lightheadedness or fainting when rising too quickly from a sitting or lying position has been reported with ABILIFY
• Decreases in white blood cells (WBC; infection fighting cells) have been reported in some patients taking ABILIFY. Patients with a history of a significant decrease in WBC count or who have experienced a low WBC count due to drug therapy should have their blood tested and monitored during the first few months of therapy
• Seizures (convulsions) have been reported with ABILIFY. Tell your healthcare provider if you have a history of or are at risk for seizures
• ABILIFY and medicines like it can affect your judgment, thinking, or motor skills. You should not drive or operate hazardous machinery until you know how ABILIFY affects you
• Medicines like ABILIFY can impact your body’s ability to reduce body temperature; you should avoid overheating and dehydration
• Tell your healthcare provider if you are pregnant or intend to become pregnant. Also tell your healthcare provider about any other medical conditions you have and about all prescription and non-prescription medicines you are taking or plan to take since there are some risks for drug interactions

Find out information about pediatric patients with Bipolar I Disorder (ages 10 to 17).

If you have any questions about your health or medicines, talk to your healthcare provider.

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide, for ABILIFY.