IMPORTANT SAFETY INFORMATION:
Elderly individuals with psychosis related to dementia, when treated with antipsychotic medications like ABILIFY, face an increased risk of death compared to placebo. ABILIFY is not approved for treating psychosis related to dementia.
Antidepressant medications may heighten suicidal thoughts or actions in some children, teenagers, and young adults, particularly at the beginning of treatment or during dosage adjustments. Depression and other serious mental illnesses are inherently linked to a higher suicide risk. Patients on antidepressants, along with their families or caregivers, should be vigilant for new or worsening depression symptoms, unusual behavior changes, or suicidal thoughts. Any such symptoms should be immediately reported to a healthcare provider, especially if severe or sudden. ABILIFY is not approved for treating depression in pediatric patients.
Do not take ABILIFY if you have an allergy to aripiprazole or any of its ingredients. Allergic reactions can manifest as rash, hives, itching, or even anaphylaxis, characterized by breathing difficulties, chest tightness, and swelling of the mouth, face, lips, or tongue.
ABILIFY can lead to serious side effects, including:
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Stroke in elderly patients with dementia-related psychosis, potentially resulting in death.
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Neuroleptic Malignant Syndrome (NMS). Seek immediate medical attention if you experience symptoms like high fever, muscle stiffness, confusion, sweating, and changes in pulse, heart rate, and blood pressure. These could indicate NMS, a rare but life-threatening condition.
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Tardive Dyskinesia, characterized by uncontrollable movements in the face, tongue, or other body parts. This condition may be irreversible, even after stopping ABILIFY, and can also emerge after discontinuation.
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Metabolic Problems:
- Hyperglycemia and Diabetes: ABILIFY can cause elevated blood sugar levels, potentially leading to coma or death. If you have diabetes or risk factors, regular blood sugar monitoring before and during ABILIFY treatment is crucial.
Contact your healthcare provider immediately if you notice symptoms of high blood sugar while taking ABILIFY:
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Excessive thirst
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Frequent urination
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Extreme hunger
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Weakness or fatigue
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Nausea
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Confusion or fruity breath odor
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Increased Cholesterol and Triglycerides: ABILIFY can elevate fat levels in your blood.
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Weight Gain: Regular weight checks are recommended while on ABILIFY.
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Unusual Urges: Some individuals taking ABILIFY have reported experiencing intense urges related to gambling, compulsive eating (binge eating or uncontrolled eating), compulsive shopping, and heightened sexual urges. Inform your healthcare provider if you or your family notice any unusual urges or behaviors.
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Orthostatic Hypotension: Dizziness or fainting upon standing up too quickly from sitting or lying down may occur due to decreased blood pressure.
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Falls: ABILIFY can cause drowsiness, dizziness, low blood pressure upon position changes, and slowed thinking and motor skills, increasing the risk of falls and subsequent injuries.
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Low White Blood Cell Count.
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Seizures (Convulsions).
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Body Temperature Regulation Issues: Difficulty controlling body temperature, especially during exercise or in hot environments. Staying hydrated is crucial. Avoid overheating and dehydration by drinking plenty of water, avoiding overexertion, staying in cool places during hot weather, and wearing light clothing.
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Swallowing Difficulties: This can lead to food or liquid entering the lungs.
Avoid driving, operating heavy machinery, or engaging in hazardous activities until you understand how ABILIFY affects you, as it may cause drowsiness.
Before starting ABILIFY, inform your healthcare provider about all your medical conditions, especially if you have or have had:
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Diabetes or a family history of diabetes. Blood sugar monitoring will be necessary before and during treatment.
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Seizures (convulsions).
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Low or high blood pressure.
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Heart problems or stroke.
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Pregnancy or plans for pregnancy. The effects of ABILIFY on an unborn baby are unknown. If you become pregnant while on ABILIFY, discuss registering with the National Pregnancy Registry for Atypical Antipsychotics at 1-866-961-2388 or visit http://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/.
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Breast-feeding or plans to breast-feed. ABILIFY can pass into breast milk and potentially harm your baby. Discuss the best infant feeding options with your healthcare provider if you are taking ABILIFY.
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Low white blood cell count.
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Phenylketonuria. ABILIFY DISCMELT® Orally Disintegrating Tablets contain phenylalanine.
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Sugar intake restrictions. ABILIFY Oral Solution contains sugar.
Disclose all medications you are taking to your healthcare provider, including prescriptions, over-the-counter drugs, vitamins, and herbal supplements.
ABILIFY and other medications can interact, potentially leading to serious side effects. ABILIFY may alter the effects of other drugs, and vice versa. Do not start or stop any medications while on ABILIFY without consulting your healthcare provider first.
Common side effects of ABILIFY in adults include: nausea, vomiting, constipation, headache, blurred vision, upper respiratory infection, dizziness, anxiety, insomnia, restlessness, and akathisia (inner restlessness or need to move).
Common side effects of ABILIFY in children include: sleepiness, headache, vomiting, fatigue, increased or decreased appetite, increased saliva or drooling, insomnia, nausea, nasal congestion, weight gain, uncontrolled movements like restlessness or tremor, and muscle stiffness.
Prolonged, abnormal muscle spasms or contractions, which may indicate dystonia, should be reported to your healthcare provider.
This is not an exhaustive list of all possible side effects of ABILIFY.
Consult your doctor for medical advice about side effects.
If you have any health concerns or medication-related questions, always consult your healthcare provider.
Report side effects of ABILIFY to Otsuka America Pharmaceutical, Inc. at 1-800-438-9927 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
INDICATIONS:
ABILIFY is prescribed for the treatment of:
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Schizophrenia in adults and adolescents (13-17 years).
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Manic or mixed episodes of Bipolar I Disorder in adults and pediatric patients (10-17 years).
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Major Depressive Disorder in adults, used as an add-on treatment to antidepressants when the response to antidepressant therapy alone is inadequate. This approach is considered when an initial antidepressant for depression diagnosis does not yield sufficient improvement.
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Irritability associated with Autistic Disorder in pediatric patients (6-17 years). An accurate autism diagnosis is crucial before considering Abilify for managing irritability.
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Tourette’s Disorder in pediatric patients (6-18 years).
Special Considerations for Pediatric Uses:
Discuss the risks and benefits of ABILIFY treatment with your child’s healthcare provider. Treatment initiation should follow a comprehensive diagnostic evaluation and be part of a holistic treatment plan.
For complete prescribing information, refer to the U.S. FULL PRESCRIBING INFORMATION, including the BOXED WARNING, and the MEDICATION GUIDE.
