Body as a Whole Accidental injury, Allergic reaction, Anaphylaxis, Death, Suicidal tendency, Weight loss, Serotonin syndrome (mental status change, hyperreflexia, fever, shivering, tremor, agitation, diaphoresis, seizures and coma). Cardiovascular Orthostatic hypotension, Syncope, Tachycardia. Central Nervous System Abnormal gait, Amnesia, Cognitive dysfunction, Depression, Difficulty in concentration, Hallucinations, Paresthesia, Seizure (see WARNINGS), Tremor. Respiratory Dyspnea. Skin Stevens-Johnson syndrome/ Toxic epidermal necrolysis, Urticaria, Vesicles. Special Senses Dysgeusia. Urogenital Dysuria, Menstrual disorder. Other adverse experiences, causal relationship unknown: A variety of other adverse events were reported infrequently in patients taking ULTRAM during clinical trials and/ or reported in post-marketing experience. A causal relationship between ULTRAM and these events has not been determined. However, the most significant events are listed below as alerting information to the physician. Cardiovascular Abnormal ECG, Hypertension, Hypotension, Myocardial ischemia, Palpitations, Pulmonary edema, Pulmonary embolism. Central Nervous System Migraine, Speech disorders. Gastrointestinal Gastrointestinal bleeding, Hepatitis, Stomatitis, Liver failure. Laboratory Abnormalities: Creatinine increase, Elevated liver enzymes, Hemoglobin decrease, Proteinuria. Sensory Cataracts, Deafness, Tinnitus. | ||||
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