Side effects may occur with all medications that treat Bipolar Disorder. The following information answers the most commonly asked questions about ABILIFY and side effects.

TEXT SIZE

PRINT PAGE

SHARE PAGE Email

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% and 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.

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.

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

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% ABILIFY 10 mg/day; 9.4% ABILIFY 30 mg/day compared with 3.3% for placebo.

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.

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

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.

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Will ABILIFY affect my blood sugar?

In clinical studies of adults with Bipolar Disorder, blood sugar levels were similar for 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

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

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, 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

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

Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.

Receive free tools and information to help you stay on track with your treatment.

IMPORTANT SAFETY INFORMATION and INDICATIONS for ABILIFY^® (aripiprazole)

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 (see Boxed WARNING).

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 professional right away, especially if they are severe or occur suddenly. ABILIFY is not approved for use in pediatric patients with depression (see Boxed WARNING).

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

Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY.

Decreases in white blood cells (infection fighting cells) have been reported in some patients taking antipsychotic agents, including ABILIFY. Patients with a history of a significant decrease in white blood cell (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.

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.

ABILIFY and medicines like it have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.

Tell your healthcare professional if you have a history of, or are at risk for seizures, or are pregnant or intend to become pregnant, and about all prescription and non-prescription medicines you are taking or plan to take, since there are some risks for drug interactions.

While taking ABILIFY, avoid:

Drinking alcohol
Breast-feeding an infant

Most common side effects (≥10%) from all clinical trials involving adults or pediatric patients include:

ADULTS: Nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety, insomnia, and restlessness
PEDIATRIC PATIENTS (6 to 17 years): Sleepiness, headache, vomiting, extrapyramidal disorder (for example, uncontrolled movement disorders or muscle disturbances such as restlessness, tremors and muscle stiffness), tiredness, increased appetite, insomnia, nausea, stuffy nose/sore throat, and increased weight

It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasms or contractions which may be signs of a condition called dystonia.

For patients who must limit their sugar intake, ABILIFY Oral Solution contains sugar.

For patients with phenylketonuria or PKU, ABILIFY DISCMELT^® (aripiprazole) contains phenylalanine.

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

INDICATIONS: ABILIFY is a prescription medication indicated for:

Use as an add-on treatment to an antidepressant for adults with Major Depressive Disorder who have had an inadequate response to antidepressant therapy
Treatment of manic and mixed episodes associated with Bipolar I Disorder in adults and in pediatric patients 10 to 17 years of age
Treatment of Schizophrenia in adults and in adolescents 13 to 17 years of age
Treatment of irritability associated with Autistic Disorder in pediatric patients 6 to 17 years of age

Special Considerations for Pediatric Uses:

Discuss the risks and benefits of treatment with your child’s healthcare provider. Treatment should be started only after a thorough diagnostic evaluation and as part of a total treatment program

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

The individuals who appear throughout this website are for illustrative purposes only. Except where noted, the individuals depicted are models and not actual patients.