IMPORTANT INFORMATION ABOUT ABILIFY
2, 5, 10, 15, 20, 30 mg Tablets
This summary of the Package Insert contains risk and safety information for patients about ABILIFY. This summary does not include all information about ABILIFY and is not meant to take the place of discussions with your healthcare professional about your treatment. Please read this important information carefully before you start taking ABILIFY and discuss any questions about ABILIFY with your healthcare professional.
Depression is a common but serious medical condition. Symptoms may include sadness, loss of interest in activities you once enjoyed, loss of energy, difficulty concentrating or making decisions, feelings of worthlessness or excessive guilt, insomnia or excessive sleep, a change in appetite causing weight loss or gain, or thoughts of death or suicide. These could be depression symptoms if they interfere with daily life at home, at work, or with friends and last most of the day, nearly every day for at least 2 weeks.
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 ABILIF Y, are at an increased risk of death when compared to patients who are treated with a placebo (sugar pill). ABILIFY is not approved for the treatment of patients 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.
patients with dementia (for example, increased memory loss and inability to perform daily activities). ABILIFY (aripiprazole) is not approved for treating patients with dementia. Neuroleptic malignant syndrome (NMS): Very high fever, rigid muscles, shaking, confusion, sweating, or increased heart rate and blood pressure may be signs of NMS, a rare but serious side effect that could be fatal. Tardive dyskinesia (TD): Abnormal or uncontrollable movements of face, tongue, or other parts of body may be signs of a serious condition known as TD, which may be permanent.
High blood sugar and diabetes: Patients with diabetes and those having risk factors for diabetes (for example, obesity, family history of diabetes), as well as those with symptoms such as unexpected increases in thirst, urination, or hunger should have their blood sugar levels checked before and during treatment. 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. Orthostatic hypotension: Lightheadedness or faintness caused by a sudden change in heart rate and blood pressure when rising too quickly from a sitting or lying position (orthostatic hypotension) has been reported with ABILIFY. Leukopenia, Neutropenia, and Agranulocytosis: 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 due to drug therapy should have their blood tested and monitored during the first few months of therapy.
Suicidal thoughts: If you have suicidal thoughts, you should tell your healthcare professional right away. Dysphagia: Medicines like ABILIFY have been associated with swallowing problems (dysphagia). If you had or have swallowing problems, you should tell your healthcare professional.
Patients and their families or caregivers should watch for new or worsening depression symptoms, unusual changes in behavior and thoughts of suicide, as well as for anxiety, agitation, panic attacks, difficulty sleeping, irritability, hostility, aggressiveness, impulsivity, restlessness, or extreme hyperactivity. Call your healthcare provider right away if you have thoughts of suicide or if any of these symptoms are severe or occur suddenly. Be especially observant within the first few months of antidepressant treatment or whenever there is a change in dose.
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or diabetes
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feeding
Common side effects in adults include: nausea, vomiting, constipation, headache, dizziness, an inner sense of restlessness or need to move (akathisia), anxiety and insomnia. It is important to contact your healthcare professional if you experience prolonged, abnormal muscle spasm or contraction which may be signs of a condition called dystonia.
This is not a complete list of side effects. For full patient information, visit www.abilify.com. Talk to your healthcare professional if you have questions or develop any side effects. What percentage of people stopped taking ABILIFY due to side effects?
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professional
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or without food
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However, if it is time for your next dose, skip the missed
dose and take only your regularly scheduled dose
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or changing your dose
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temperature
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that ABILIFY Oral Solution contains sugar
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Based on Full Prescribing Information as of 07/09 1239550A5.
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