Side effects can occur with any medication for Bipolar Disorder. Here are some commonly asked questions about the safety profile and side effects for ABILIFY.
What common side effects should I know about?
In a 4-week clinical study of pediatric patients (10 to 17 years) with Bipolar I Disorder (manic or mixed) 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, and extrapyramidal disorder (such as shakes, muscle stiffness, or other involuntary movements), fatigue, nausea, blurred vision, drooling, and dizziness.
Do many patients have to discontinue ABILIFY due to side effects?
The percentage of pediatric patients discontinuing ABILIFY because of side effects was 7% compared to 2% treated with placebo.
Will ABILIFY cause my child age 10 to 17 to have movement problems?
In a 4-week clinical study of pediatric patients (10 to 17 years) with Bipolar Disorder, 20% of patients on ABILIFY (compared with 3% for placebo) reported one or more of the following: muscle stiffness, tremors, shakes or ticks, or other involuntary movements (extrapyramidal disorder). In addition, 10% on ABILIFY (vs. 2% for placebo) reported a feeling of inner restlessness or urge to move (akathisia).
Will ABILIFY make my child age 10 to 17 feel sleepy or tired?
In a 4-week clinical study of pediatric patients (10 to 17 years) with Bipolar Disorder, 25% taking ABILIFY felt sleepy or tired vs. 3% on placebo. Even if your child does not feel tired, you should not allow him or her to drive or operate hazardous machinery until you know how ABILIFY affects them. Sleepiness is a dose-dependent side effect.
Will ABILIFY make my child age 10 to 17 gain weight?
In a 4-week clinical study the percentage of pediatric patients age 10 to 17 with Bipolar Disorder who gained significant weight (based on gaining 7% or more of body weight) was 3.2% ABILIFY
10 mg/day; 9.4% ABILIFY 30 mg/day compared with 3.3% for placebo. The mean weight gain was 1.3 lbs with ABILIFY 10mg/day, and 2.0 lbs with ABILIFY 30 mg/day compared with
1.1 lbs with placebo.
Will ABILIFY affect my 10 to 17 year old child's cholesterol levels?
In a 4-week clinical study of pediatric patients (10-17) with Bipolar I Disorder, there were no medically important changes observed among patients taking ABILIFY and those taking placebo in the following metabolic parameters:
Will ABILIFY affect my 10 to 17 year old child's blood sugar?
In a 4-week clinical study of pediatric patients (10-17 years) with Bipolar Disorder, there were no medically important changes observed among patients taking ABILIFY and those taking placebo in the fasting blood glucose.
Tell your child'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 child's healthcare professional if they need to monitor their blood sugar level before and during treatment
Will ABILIFY affect my 10 to 17 year old child's prolactin levels?
In a 4-week clinical study, there were no medically important differences in prolactin levels among pediatric patients (10 to 17) with Bipolar Disorder.
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.
Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.
If you have any questions about your child's health or medicines, talk to your healthcare professional.
