purposes only. Any person depicted here is a model and not an
actual patient unless otherwise noted.
Side Effects FAQs
Here you'll find frequently asked questions
about some of the possible side effects of
ABILIFY (aripiprazole) for pediatric patients
10 to 17 years of age. Select a question to
see the answer below.
What common side effects should I know about?
In a 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I disorder, manic or mixed, the most commonly observed side effects associated with ABILIFY 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. These side effects were reported by at least 5% of ABILIFY patients and more than twice as often as by placebo patients.
These are not all the possible
side effects of ABILIFY. For more
information, ask your healthcare
provider or pharmacist. Call your
doctor for medical advice about side
effects. You may report side effects
to the FDA at
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 with 2% of patients treated with placebo.See More Safety Information
Will ABILIFY cause my child to have movement problems?
In a 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I 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 (compared with 2% for placebo) reported a feeling of inner restlessness or urge to move (akathisia).See More Safety Information
Will ABILIFY make my child feel sleepy?
In a 4-week clinical study of pediatric patients 10 to 17 years of age with bipolar I disorder, 23% taking ABILIFY felt sleepy compared with 3% of patients 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 your child.See More Safety Information
Will ABILIFY make my child gain weight?
Weight gain has been reported in patients taking medicines like ABILIFY, so your child's weight should be checked regularly. Weight gain in pediatric patients should be compared against that expected with normal growth.
In clinical studies that included pediatric patients 10 to 17 years of age with bipolar I disorder, after 6 weeks, patients taking ABILIFY gained an average of 3.5 pounds compared with an average gain of 0.66 pounds among patients taking placebo. Among patients followed up at 24 weeks, patients taking ABILIFY gained an average of 12.8 pounds compared with 3.1 pounds in patients taking placebo.
In clinical studies that included pediatric patients with bipolar I disorder taking ABILIFY, some patients experienced significant weight gain. After 4 to 6 weeks, the percentage of patients who gained significant weight (based on gaining 7% or more of body weight) was 5.2% for ABILIFY compared with 1.6% for patients taking placebo. After 26 weeks, the percentage of ABILIFY patients who gained significant weight was 32.8%, which is not clinically significant when adjusted for normal growth.See More Safety Information
Will ABILIFY affect my child's blood sugar?
Increases in blood sugar levels (hyperglycemia) can happen in some patients who take ABILIFY. Extremely high blood sugar can lead to coma or death. If your child has diabetes, or risk factors (for example, obesity, family history of diabetes), or has the following symptoms: increases in thirst, urination, or hunger, feel weak or tired, sick to their stomach, or confused (or breath smells fruity), their blood sugar
In clinical studies that included pediatric patients 10 to 17 years of age with bipolar I disorder, the average change in fasting blood sugar level was not significantly different among patients treated with ABILIFY compared with patients treated
The percentage of patients who changed from borderline to high blood sugar levels was 4.5% among patients taking ABILIFY compared with 0% among patients taking placebo.See More Safety Information
Side Effects Checklist
Here you'll find a checklist to help youGet started
discuss the side effects of your
child's treatment with the doctor.
Resources and Support
There may be resources available in your community: for example, schools, healthcare professionals, hospitals, and local and national organizations.More