| Document Date: 2012-11-02 15:43:30
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City Reference / / Company Takeda Pharmaceuticals / CLINICAL STUDIES / Alteon Inc. / / Currency pence / / Event FDA Phase / / Facility Laboratory Parameters / / IndustryTerm food / organ systems / chemical structure / Monitor for signs and symptoms / / MedicalCondition anaphylactic reaction / Lesch-Nyhan syndrome / chest pain / Lymphatic System Disorders / headache / herpes zoster / Vascular Disorders / Stevens Johnson Syndrome / liver disorder / ear and labyrinth disorders / Adverse Reactions Arthralgia Rash / arthritis / panic attack / bronchitis / dermatitis / non-fatal myocardial infarctions / non-fatal strokes / Immune System Disorder / cerebrovascular accident / nausea / muscle spasms / anaphylaxis / thrombocytopenia / Gout Flares Gout / alopecia / hyperhidrosis / breast pain / Hepatobiliary Disorders / non-fatal myocardial infarction / balance disorder / transient ischemic attack / tremor / gout / fatigue / angina pectoris / hemiparesis / deafness / gastritis / hypoesthesia / Cardiac Disorders / tubulointerstitial nephritis / tachycardia / hypersensitivity / hepatitis / proteinuria / renal failure / gastroesophageal reflux disease / constipation / sinus bradycardia / pruritus / Infections / Gastrointestinal Disorders / nephrolithiasis / upper respiratory tract infection / skin and subcutaneous tissue disorders / gynecomastia / hypotension / Nutrition Disorders / purpura / Mediastinal Disorders / abdominal pain / insomnia / epistaxis / non-fatal stroke / hematochezia / peptic ulcer / hypertension / petechiae / flushing / Nervous System Disorders / arthralgia / Urinary Disorders / dyspnea / cholelithiasis/cholecystitis / leukocytosis/leukopenia / hypertriglyceridemia / hematuria / Guillain-Barré syndrome / Carcinogenesis / hyperglycemia / erectile dysfunction / fatal and non-fatal hepatic failure / neutropenia / eczema / stroke / vertigo / migraine / malignant disease / hyperlipidemia / lethargy / rhabdomyolysis / pain / vomiting / renal insufficiency / Psychiatric Disorders / myocardial infarction / diabetes mellitus / urticaria / hepatic failure / pancreatitis / atrial fibrillation / Immune System Disorders / Connective Tissue Disorders / dizziness / liver injury / cough / depression / hypokalemia / idiopathic thrombocytopenic purpura / rash / hyposmia / lacunar infarction / chronic management / paresthesia / anemia / tinnitus / hypercholesterolemia / Disorders / pancytopenia / throat irritation / dehydration / / MedicalTreatment chemotherapy / organ transplant / dialysis / / Organization Concomitant administration / US Federal Reserve / DOSAGE AND ADMINISTRATION / FDA / / Person Stevens Johnson / / / Position General Information *Sections / treating physician / / Product mercaptopurine / allopurinol / naproxen / indomethacin / theophylline / ULORIC tablets / azathioprine / hydrochlorothiazide / adverse / / ProvinceOrState Michigan / / Technology Pharmacokinetics / Chemotherapy / Pharmacodynamics / dialysis / / URL www.fda.gov/medwatch / /
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HIGHLIGHTS OF PRESCRIBING INFORMATION These HIGHLIGHTS do not include all the information needed to use ULORIC safely and effectively. See full prescribing information for ULORIC. ULORIC (febuxostat) tablet for oral use