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.

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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?

In a 3-week clinical study of adults 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% for ABILIFY compared with 3% for patients treated with placebo.

In a 4-week clinical study, the rate of pediatric patients (10 to 17 years) who gained significant weight (based on gaining 7% or more of body weight) was 3.2% for ABILIFY 10 mg/day and 9.4% for ABILIFY 30 mg/day, compared with 3.3% for placebo.

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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 cholesterol?

In clinical trials of adults with Bipolar Disorder, cholesterol levels were similar among patients taking ABILIFY and those taking placebo.

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Will ABILIFY affect my blood sugar?

In clinical studies of adults with Bipolar Disorder, blood sugar levels were similar among patients taking ABILIFY and those taking placebo.

Tell your healthcare professional right away if you have any conditions or side effects, including the following:

• Diabetes, risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger
• Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it
• Ask your healthcare professional about the need to monitor your blood sugar level before and during treatment

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Are there additional important safety considerations I should know about?

Elderly patients, diagnosed with psychosis as a result of dementia (for example, an inability to perform daily activities as a result of increased memory loss), and who are treated with antipsychotic medicines including ABILIFY, are at an increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for these patients.

Some medicines can increase suicidal thoughts and behaviors in children, teens, and young adults. Serious mental illnesses are themselves associated with an increase in the risk of suicide. When taking ABILIFY call your doctor right away if you have new or worsening mood symptoms, unusual changes in behavior, or thoughts of suicide. Patients and their caregivers should be especially observant for such symptoms within the first few months of treatment or after a change in dose.

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, or 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
• Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure. These may be signs of a condition called neuroleptic malignant syndrome (NMS), a rare but serious side effect which could be fatal
• 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 become permanent and the risk of TD may increase with the length of treatment and the overall dose. While TD can develop after taking the medicine at low doses for short periods, this is much less common. There is no known treatment for TD, but it may go away partially or completely if the medicine is stopped
• If you have diabetes, or risk factors for diabetes (for example, obesity, family history of diabetes), or unexpected increases in thirst, urination, or hunger, your blood sugar should be monitored. Increases in blood sugar levels (hyperglycemia), in some cases serious and associated with coma or death, have been reported in patients taking ABILIFY and medicines like it

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

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

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