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What common side effects should I know about?

In a 6-week clinical study among adolescent patients (13 to 17 years) with Schizophrenia comparing ABILIFY with placebo, some people experienced side effects. The most commonly observed adverse events associated with ABILIFY (reported by at least 5% of ABILIFY patients and twice as often as those taking a sugar pill) were: extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), somnolence (feeling sleepy), and tremor (shakiness).

What should I do if my teenager (13 to 17) has side effects with ABILIFY?

Everyone responds differently to medication. Side effects may be related to numerous factors, such as medications they may be taking in addition to ABILIFY. Keep track of any side effects your teenager experiences and talk to the doctor. This will help the doctor understand how to manage side effects.

Your teenager should not stop taking ABILIFY without first talking to your healthcare professional. Always talk to the doctor before making changes in your teenager’s treatment plan.

Do many patients have to discontinue ABILIFY due to side effects?

In a large clinical study of over 300 adolescent patients (13 to 17 years) with Schizophrenia, the percentage of those discontinuing ABILIFY because of side effects was 5% compared to 2% treated with placebo.

Will ABILIFY cause my teenager (13 to 17 years) to have movement problems?

In a short-term trial of Schizophrenia in adolescent patients (13 to 17), 17% of patients on ABILIFY (compared with 5% for placebo) reported one or more of the following: muscle stiffness, tremors, shakes or ticks, or other involuntary movements (extrapyramidal disorder). In addition, 8% on ABILIFY (vs 5% for placebo) reported a feeling of inner restlessness or urge to move (akathisia). Involuntary movements and tremors are dose-dependant side effects.

Will ABILIFY make my teenager (13 to 17 years) feel sleepy or tired?

In a short-term clinical trial of adolescent patients (13 to 17 years), 17% taking ABILIFY felt sleepy or tired vs 6% on placebo. Even if your teen does not feel tired, you should not allow your teenager to drive or operate hazardous machinery until you know how ABILIFY affects them. Sleepiness is a dose-dependent side effect.

Will ABILIFY make my teenager (13 to 17 years) gain weight?

In a 6-week clinical study, the percent of adolescents (13 to 17 years) with Schizophrenia who gained significant weight (based on gaining 7% or more of body weight) was 4.0% ABILIFY 10 mg/day; 5.2% ABILIFY 30 mg/day compared with 1.0% for placebo. The mean weight gain was 0.0 lbs with ABILIFY 10mg/day, and 0.4 lbs with ABILIFY 30 mg/day compared with -1.8 lbs with placebo.

Will ABILIFY affect my teenager’s (13 to 17 years) cholesterol levels?

In a 6-week clinical study of adolescent patients (13 to 17) with Schizophrenia, there were no medically important changes observed among patients taking ABILIFY and those taking placebo in the following metabolic parameters:

Will ABILIFY affect my teenager’s (13 to 17 years) blood sugar?

In a 6-week clinical study of adolescents (13 to 17 years) with Schizophrenia, there were no medically important changes observed among patients taking ABILIFY and those taking placebo in the fasting blood glucose.

Tell your teenager’s healthcare professional right away if they 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

Also, ask your teenager’s healthcare professional if they need to monitor their blood sugar level before and during treatment.

Will ABILIFY affect my teenager’s (13 to 17) prolactin levels?

In a 6-week clinical trial, there were no medically important differences in prolactin levels among adolescent patients with Schizophrenia (13 to 17).

What additional SAFETY INFORMATION should I know about ABILIFY?

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. Call your child’s doctor right away if you notice 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, 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
• Abnormal or uncontrollable movements of face, tongue, or other parts of body. These may be signs of a serious condition called tardive dyskinesia (TD), which could become permanent
• 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

Please see additional IMPORTANT SAFETY INFORMATION including Boxed WARNINGS below.

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