- What common side effects should I know about?
- In 6-week clinical studies of adults with MDD, the most commonly observed side effects associated with ABILIFY plus antidepressant therapy (ADT) reported in greater than or equal to 5% and twice the rate of placebo plus antidepressant therapy included an inner sense of restlessness or need to move (akathisia), insomnia, fatigue, blurred vision, and constipation. In clinical studies, few patients discontinued the use of ABILIFY due to side effects (6% for ABILIFY + antidepressant vs 2% for placebo + antidepressant).
- Will ABILIFY make me feel sleepy or drowsy?
- Feeling sleepy or drowsy is defined as somnolence and sedation. 6-week clinical studies of adults with MDD showed a low rate of somnolence and sedation, (10% of patients treated with ABILIFY + ADT felt sleepy or drowsy vs 6% of patients treated with ADT alone). Although you may not feel tired, you should not drive or operate hazardous machinery until you know how ABILIFY affects you.
- Will ABILIFY make me gain weight?
- In 6-week clinical studies of adults with MDD, ABILIFY plus ADT showed a low rate of significant weight gain. The percentage of people who gained more than or equal to 7% of their baseline body weight was 5% for ABILIFY plus ADT vs 1% for placebo plus ADT. The average weight change at Week 6 with people taking ABILIFY plus ADT was 3.7 lb vs 0.9 lb for placebo plus ADT.
- Does ABILIFY affect sexual function?
- In 6-week clinical trials of adults with MDD, ABILIFY plus ADT showed a minimal impact on sexual function as measured by the Sexual Function Inventory (SFI) Questionnaire. In addition, the rate of patient-reported adverse reactions related to sexual dysfunction with ABILIFY plus ADT was less than 2%.
- Will ABILIFY affect my cholesterol?
- In 6-week clinical studies of adults with MDD, ABILIFY plus ADT was not shown to significantly elevate levels of fasting HDL-C, LDL-C, or total cholesterol compared to placebo plus ADT.
- The average percent change (median) in triglycerides was 5% in patients treated with ABILIFY plus ADT vs 0% in patients treated with placebo plus ADT.
- Will ABILIFY affect my blood sugar?
- In 6-week clinical studies of adults with MDD, ABILIFY plus ADT was not shown to significantly elevate levels of fasting glucose. Serious side effects can occur with any antipsychotic medicine, including ABILIFY. Tell your healthcare professional right away if you have any conditions or side effects, including the following:
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- Diabetes: Risk factors for diabetes include obesity, family history of diabetes, or unexpected increases in thirst, urination, or hunger
- Increases in blood sugar levels (hyperglycemia): In some cases, serious risks related to increases in blood sugar 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.
- What additional important safety considerations should I know about?
- 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.
- 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.
- Serious side effects may also include:
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- 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.
- Other risks may include lightheadedness upon standing, decreases in white blood cells, seizures, trouble swallowing or impairment in judgment or motor skills.
- Find out about additional IMPORTANT SAFETY INFORMATION for ABILIFY.
- Side effects you may be experiencing with your current antidepressant should be discussed with your healthcare professional.
If you have any questions about your health or prescription medicines such as ABILIFY, talk to your healthcare professional.
Please see U.S. FULL PRESCRIBING INFORMATION, including Boxed WARNINGS, and Medication Guide.
Learn more about Adding ABILIFY to your current antidepressant.
