| Document Date: 2014-02-04 18:53:48
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City ULTRAM / RARITAN / / Company OMP DIVISION ORTHO-McNEIL PHARMACEUTICAL INC. / Janssen Ortho LLC / ORTHO-McNEIL PHARMACEUTICAL INC. / Ames / / Country Puerto Rico / United States / / Event FDA Phase / / Facility Laboratory Abnormalities / / IndustryTerm machinery / food / chemical name / / MedicalCondition tremors / Allergic reaction / lymphoma / Headache / seizures / Urinary retention / neonatal withdrawal syndrome / Liver failure / hives / coma / hallucinations / nausea / cirrhosis / Stomatitis / Anaphylaxis / toxic epidermal necrolysis / Stevens-Johnson syndrome / tremor / Syncope / pulmonary / Deafness / Pulmonary edema / head trauma / tachycardia / Pulmonary embolism / diarrhea / hypersensitivity / Hepatitis / cardiac arrest / metabolic disorders / constipation / pruritus / head injury / Hypotension / incoordination / Proteinuria / Abdominal pain / insomnia / panic attacks / Hypertension / convulsions / bronchospasm / hyperreflexia / tumors / disease / Cataracts / Dyspnea / Amnesia / Dysgeusia / Carcinogenesis / chronic / vertigo / Migraine / fever / lethargy / seizure / Orthostatic hypotension / Cognitive dysfunction / vomiting / Urticaria / angioedema / Speech disorders / allergic reactions / rigors / fetal death / respiratory depression / epilepsy / dizziness / withdrawal symptoms / depression / miosis / Rash / paresthesias / Paresthesia / Myocardial ischemia / Tinnitus / syndrome / / MedicalTreatment Concomitant therapy / surgery / pain management / Hemodialysis / drug therapy / dialysis / / Position physician / Major / / Product acetaminophen / oxycodone hydrochloride / promethazine / linezolid / tramadol hydrochloride / Carbamazepine / TYLENOL / polyethylene glycol / erythromycin / Cimetidine / naloxone / fluoxetine / Digoxin / ketoconazole / TYLOX / Healthy Adults / ULTRAM® / ULTRAM / healthy / CYP3A4 / / ProvinceOrState New Jersey / / Technology drug metabolism / Pharmacokinetics / Pharmacodynamics / dialysis / /
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ULTRAM®(tramadol hydrochloride) Tablets