| Document Date: 2014-12-22 11:04:58
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City Reference / / Company Pfizer Inc. / Alteon Inc. / / Event FDA Phase / Product Issues / / Facility Laboratory Tests CBCs / Laboratory Abnormalities Reported / / IndustryTerm treatment of gastrointestinal stromal tumor after disease / food / / MedicalCondition Torsade de Pointes Hypertension Hemorrhagic Events Osteonecrosis / loss of consciousness / rash / hand-foot syndrome / Osteonecrosis / normal and cardiac failure / syndrome Neurology Altered taste / pulmonary hemorrhage / headache / left ventricular dysfunction / cardiac failure / liver failure / pNET / Any Gastrointestinal Diarrhea / cerebrovascular accident / nausea / Alopecia / toxic epidermal necrolysis / hyperthyroidism / metastatic disease / Stevens-Johnson Syndrome / transient ischemic attack / severe infection / Torsade de Pointes / StevensJohnson syndrome / fatigue / unstable angina / necrotizing fasciitis / encephalopathy / symptomatic hypoglycemia / erythema multiforme / bradycardia / pulmonary embolism / diarrhea / renal cell carcinoma / cardiac arrest / constipation / Hypoglycemia / Thyroid dysfunction / Gastrointestinal Disorders / back pain / progressive skin rash / adrenal insufficiency / pancreatic neuroendocrine tumors / Study A. Tumor / blisters / Proteinuria / abdominal pain / tumor / Epistaxis / congestive heart failure / Gastrointestinal stromal tumor / necrosis / Hypertension / liver metastases / mucositis/stomatitis / ventricular dysfunction / cardiomyopathy / brain hemorrhages / severe and life-threatening hemoptysis / disease / arthralgia / Hypoglycemia SUTENT / dyspnea / hypothyroidism / Treatment-emergent acquired hypothyroidism / stromal tumor / pulmonary tumors / Carcinogenesis / dental disease / malignant hypertension / Reversible Posterior Leukoencephalopathy Syndrome / thyroiditis / fever / mucositis / myocardial disorders / high tumor / nephrotic syndrome / pain / vomiting / Advanced Pancreatic Neuroendocrine Tumors / myocardial infarction / lung cancer / heart failure / cardiac disease / Proteinuria Proteinuria / metastatic lung cancer / cough / renal failure / inflammation / hand-foot syndrome / Advanced renal cell carcinoma / Cardiac Hypertension / Rash / / MedicalTreatment surgery / bypass / / Organization DOSAGE AND ADMINISTRATION / FDA / / / Product ACTH / rifampin / ketoconazole / SUTENT / wound healing / / Technology MRI / Pharmacokinetics / / URL www.fda.gov/medwatch / /
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SUTENT (sunitinib malate) Label