Ultram

[Tramadol]

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

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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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