Drug information for ULTRAM ER

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET, EXTENDED RELEASE; ORAL 100MG Prescription AB1 (Reference Drug) TRAMADOL HYDROCHLORIDE Tramadol VALEANT INTL 21692
2009-03-19 Letter
2008-02-25 Label
2008-02-25 Label
2008-02-22 Letter
2008-02-22 Letter
2006-08-07 Letter
2006-08-04 Label
2006-07-25 Review
2006-06-06 Letter
2005-09-09 Label
2005-09-09 Letter
TABLET, EXTENDED RELEASE; ORAL 200MG Prescription AB1  TRAMADOL HYDROCHLORIDE Tramadol VALEANT INTL   "
TABLET, EXTENDED RELEASE; ORAL 300MG Prescription AB1  TRAMADOL HYDROCHLORIDE Tramadol VALEANT INTL   "

Drug Adverse Effects information for ULTRAM ER

Role code Indications Reaction # Reports
PS ABDOMINAL PAIN ADRENAL INSUFFICIENCY 1
PS ABDOMINAL PAIN PITUITARY TUMOUR BENIGN 1
PS PRODUCT USED FOR UNKNOWN INDICATION ADRENAL INSUFFICIENCY 1
PS PRODUCT USED FOR UNKNOWN INDICATION PITUITARY TUMOUR BENIGN 1
SS ABDOMINAL PAIN ADRENAL INSUFFICIENCY 1
SS ABDOMINAL PAIN PITUITARY TUMOUR BENIGN 1
SS PRODUCT USED FOR UNKNOWN INDICATION ADRENAL INSUFFICIENCY 1
SS PRODUCT USED FOR UNKNOWN INDICATION PITUITARY TUMOUR BENIGN 1
C BLOOD CHOLESTEROL ABNORMAL DRUG DISPENSING ERROR 2
C BLOOD CHOLESTEROL ABNORMAL HEART RATE IRREGULAR 2
C BLOOD CHOLESTEROL INCREASED COELIAC DISEASE 1
C BLOOD CHOLESTEROL INCREASED MYALGIA 1
C BLOOD CHOLESTEROL INCREASED MYOSITIS 1
C FIBROMYALGIA DRUG DISPENSING ERROR 8
C FIBROMYALGIA HEART RATE IRREGULAR 8
C GASTROOESOPHAGEAL REFLUX DISEASE CHEST DISCOMFORT 2
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA 2
C GASTROOESOPHAGEAL REFLUX DISEASE DYSPNOEA EXERTIONAL 1
C GASTROOESOPHAGEAL REFLUX DISEASE IRRITABILITY 2
C GASTROOESOPHAGEAL REFLUX DISEASE POLLAKIURIA 2
C GASTROOESOPHAGEAL REFLUX DISEASE PRURITUS 2
C GASTROOESOPHAGEAL REFLUX DISEASE URINARY TRACT INFECTION 2
C GASTROOESOPHAGEAL REFLUX DISEASE URTICARIA 2
C HEPATIC STEATOSIS COELIAC DISEASE 1
C HEPATIC STEATOSIS MYALGIA 1
C HEPATIC STEATOSIS MYOSITIS 1
C HYPERSENSITIVITY CHEST DISCOMFORT 2
C HYPERSENSITIVITY DYSPNOEA 2
C HYPERSENSITIVITY DYSPNOEA EXERTIONAL 1
C HYPERSENSITIVITY IRRITABILITY 2
C HYPERSENSITIVITY POLLAKIURIA 2
C HYPERSENSITIVITY PRURITUS 2
C HYPERSENSITIVITY URINARY TRACT INFECTION 2
C HYPERSENSITIVITY URTICARIA 2
C MIGRAINE CHEST DISCOMFORT 2
C MIGRAINE DYSPNOEA 2
C MIGRAINE DYSPNOEA EXERTIONAL 1
C MIGRAINE IRRITABILITY 2
C MIGRAINE POLLAKIURIA 2
C MIGRAINE PRURITUS 2
C MIGRAINE URINARY TRACT INFECTION 2
C MIGRAINE URTICARIA 2
C PAIN CHEST DISCOMFORT 2
C PAIN DYSPNOEA 2
C PAIN DYSPNOEA EXERTIONAL 1
C PAIN IRRITABILITY 2
C PAIN POLLAKIURIA 2
C PAIN PRURITUS 2
C PAIN URINARY TRACT INFECTION 2
C PAIN URTICARIA 2
C PRODUCT USED FOR UNKNOWN INDICATION CHEST DISCOMFORT 8
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 8
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA EXERTIONAL 4
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE REACTION 1
C PRODUCT USED FOR UNKNOWN INDICATION IRRITABILITY 8
C PRODUCT USED FOR UNKNOWN INDICATION POLLAKIURIA 8
C PRODUCT USED FOR UNKNOWN INDICATION PRURITUS 8
C PRODUCT USED FOR UNKNOWN INDICATION URINARY TRACT INFECTION 8
C PRODUCT USED FOR UNKNOWN INDICATION URTICARIA 8
C RHEUMATOID ARTHRITIS BODY TEMPERATURE INCREASED 1
C RHEUMATOID ARTHRITIS CHEST DISCOMFORT 2
C RHEUMATOID ARTHRITIS CHOLELITHIASIS 1
C RHEUMATOID ARTHRITIS DYSPNOEA 2
C RHEUMATOID ARTHRITIS DYSPNOEA EXERTIONAL 1
C RHEUMATOID ARTHRITIS IRRITABILITY 2
C RHEUMATOID ARTHRITIS POLLAKIURIA 2
C RHEUMATOID ARTHRITIS PRURITUS 2
C RHEUMATOID ARTHRITIS SOMNOLENCE 1
C RHEUMATOID ARTHRITIS URINARY TRACT INFECTION 2
C RHEUMATOID ARTHRITIS URTICARIA 2
C SLEEP DISORDER DRUG DISPENSING ERROR 2
C SLEEP DISORDER HEART RATE IRREGULAR 2
C URINARY TRACT INFECTION CHEST DISCOMFORT 4
C URINARY TRACT INFECTION DYSPNOEA 4
C URINARY TRACT INFECTION DYSPNOEA EXERTIONAL 2
C URINARY TRACT INFECTION IRRITABILITY 4
C URINARY TRACT INFECTION POLLAKIURIA 4
C URINARY TRACT INFECTION PRURITUS 4
C URINARY TRACT INFECTION URINARY TRACT INFECTION 4
C URINARY TRACT INFECTION URTICARIA 4
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