To report SUSPECTED ADVERSE REACTIONS, contact Otsuka America Pharmaceutical, Inc. Adult patients with agitation associated with schizophrenia or bipolar mania: nausea.Pediatric patients (6 to 18 years) with Tourette's disorder: sedation, somnolence, nausea, headache, nasopharyngitis, fatigue, increased appetite.Pediatric patients (6 to 17 years) with autistic disorder: sedation, fatigue, vomiting, somnolence, tremor, pyrexia, drooling, decreased appetite, salivary hypersecretion, extrapyramidal disorder, and lethargy.Adult patients with major depressive disorder (adjunctive treatment to antidepressant therapy): akathisia, restlessness, insomnia, constipation, fatigue, and blurred vision.Pediatric patients (10 to 17 years) with bipolar mania: somnolence, extrapyramidal disorder, fatigue, nausea, akathisia, blurred vision, salivary hypersecretion, and dizziness.Adult patients (adjunctive therapy with lithium or valproate) with bipolar mania: akathisia, insomnia, and extrapyramidal disorder.Adult patients (monotherapy) with bipolar mania: akathisia, sedation, restlessness, tremor, and extrapyramidal disorder.Pediatric patients (13 to 17 years) with schizophrenia: extrapyramidal disorder, somnolence, and tremor.Adult patients with schizophrenia: akathisia.Closely supervise high-risk patients ( 5.14)Ĭommonly observed adverse reactions (incidence ≥5% and at least twice that for placebo) were ( 6.1): Suicide: The possibility of a suicide attempt is inherent in schizophrenia and bipolar disorder.Potential for Cognitive and Motor Impairment: Use caution when operating machinery ( 5.12).Seizures/Convulsions: Use cautiously in patients with a history of seizures or with conditions that lower the seizure threshold ( 5.11).Patients with a history of a clinically significant low white blood cell count (WBC) or a drug-induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ABILIFY should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors ( 5.10)

Leukopenia, Neutropenia, and Agranulocytosis: have been reported with antipsychotics including ABILIFY.

Orthostatic Hypotension: Monitor heart rate and blood pressure and warn patients with known cardiovascular or cerebrovascular disease, and risk of dehydration or syncope ( 5.8).

Pathological Gambling and Other Compulsive Behaviors: Consider dose reduction or discontinuation ( 5.7).

Weight Gain: Weight gain has been observed with atypical antipsychotic use.

Dyslipidemia: Undesirable alterations in lipid levels have been observed in patients treated with atypical antipsychotics ( 5.6).

Hyperglycemia/Diabetes Mellitus: Monitor glucose regularly in patients with and at risk for diabetes ( 5.6).

Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes that include hyperglycemia/diabetes mellitus, dyslipidemia, and body weight gain ( 5.6).Tardive Dyskinesia: Discontinue if clinically appropriate ( 5.5).Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring ( 5.4).Cerebrovascular Adverse Reactions in Elderly Patients with Dementia-Related Psychosis: Increased incidence of cerebrovascular adverse reactions (e.g., stroke, transient ischemic attack, including fatalities) ( 5.2).Known CYP2D6 poor metabolizers: Half of the usual dose ( 2.7).IM injection: Wait at least 2 hours between doses.Oral formulations: Administer once daily without regard to meals ( 2).Irritability associated with autistic disorder – pediatric patients ( 2.4)Īgitation associated with schizophrenia or bipolar mania – adults ( 2.6)

Major Depressive Disorder – adults: adjunct to antidepressants ( 2.3) Bipolar mania – adults: monotherapy ( 2.2)īipolar mania – adults: adjunct to lithium or valproate ( 2.2)īipolar mania – pediatric patients: monotherapy or as an adjunct to lithium or valproate ( 2.2)

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