| Document Date: 2009-07-21 14:02:56
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Company Janssen Pharmaceuticals / Inc. / Ortho-McNeil-Janssen Pharmaceuticals Inc. / / Event FDA Phase / Product Issues / / Facility Laboratory Tests ADVERSE REACTIONS / / IndustryTerm beverage / Treatment of irritability associated with autistic disorder / / MedicalCondition abdominal pain / Priapism / pneumonia / schizophrenia / dementia / disease / Parkinsonism / I Disorder / Seizures / Leukopenia / Dysphagia / Carcinogenesis / Hyperglycemia / urinary incontinence / Neutropenia / stroke / nausea / mania / rhinitis / coughing / infectious / autistic disorder / fever / cardiac dysrhythmia / rhabdomyolysis / transient ischemic attack / tremor / Orthostatic hypotension / vomiting / CONTRAINDICATIONS Hypersensitivity / blister / fatigue / diabetes mellitus / heart failure / angioedema / Diseases / mg mania / disorder / both serious medical illness / tachycardia / myoglobinuria / Neuroleptic Malignant Syndrome / anaphylactic reactions / hypersensitivity / dystonia / dizziness / constipation / muscle rigidity / /day /day mania / rash / systemic infection / acute renal failure / respiratory tract infection / syndrome / Agranulocytosis / Hyperprolactinemia / hypotension / akathisia / / Organization DOSAGE AND ADMINISTRATION / FDA / Administration of RISPERDAL / / / Position physician / / Product Fluoxetine / Clozapine / phenytoin / Disintegrating Tablets Tablet / Disintegrating Tablet / ranitidine / Digoxin / RISPERDAL / Orally Disintegrating Tablet / M-TAB® Orally Disintegrating Tablet / Carbamazepine / risperidone / Cimetidine / M-TAB® Orally Disintegrating Tablets / rifampin / RISPERDAL® (risperidone) / hepatic function / / Technology Pharmacokinetics / Pharmacodynamics / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use RISPERDAL® safely and effectively. See full prescribing information for RISPERDAL®. RISPERDAL® (risperidone) tabl