Drug information for XIBROM

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
SOLUTION/DROPS; OPHTHALMIC 0.09% **Federal Register determination that product was not discontinued or withdrawn for safety or efficacy reasons** Discontinued   BROMFENAC SODIUM bromfenac ISTA PHARMS INC 21664
2010-10-19 Letter
2010-10-19 Label
2009-06-08 Letter
2009-06-04 Label
2007-06-29 Review
2006-01-30 Letter
2006-01-27 Label
2005-03-29 Letter
2005-03-29 Label

Drug Adverse Effects information for XIBROM

Role code Indications Reaction # Reports
C ARTHRITIS DEATH 1
C BACK PAIN DEATH 1
C BLOOD GLUCOSE INCREASED DEATH 1
C DEPRESSION ARTHRALGIA 2
C DEPRESSION BASAL CELL CARCINOMA 2
C DEPRESSION COUGH 2
C DEPRESSION DEVICE BREAKAGE 2
C DEPRESSION DEVICE RELATED INFECTION 2
C DEPRESSION INJECTION SITE HAEMATOMA 2
C DEPRESSION INJECTION SITE HAEMORRHAGE 2
C DEPRESSION MONARTHRITIS 2
C DEPRESSION NASOPHARYNGITIS 2
C DEPRESSION NAUSEA 2
C DEPRESSION RESPIRATORY TRACT CONGESTION 2
C DEPRESSION RHINORRHOEA 2
C FATIGUE DRY EYE 1
C FATIGUE MACULAR OEDEMA 1
C FATIGUE PRESBYOPIA 1
C FATIGUE VISION BLURRED 1
C FATIGUE VISUAL ACUITY REDUCED 1
C FATIGUE VITRITIS 1
C FIBROMYALGIA ARTHRALGIA 2
C FIBROMYALGIA BASAL CELL CARCINOMA 2
C FIBROMYALGIA COUGH 2
C FIBROMYALGIA DEVICE BREAKAGE 2
C FIBROMYALGIA DEVICE RELATED INFECTION 2
C FIBROMYALGIA INJECTION SITE HAEMATOMA 2
C FIBROMYALGIA INJECTION SITE HAEMORRHAGE 2
C FIBROMYALGIA MONARTHRITIS 2
C FIBROMYALGIA NASOPHARYNGITIS 2
C FIBROMYALGIA NAUSEA 2
C FIBROMYALGIA RESPIRATORY TRACT CONGESTION 2
C FIBROMYALGIA RHINORRHOEA 2
C FLUID RETENTION DEATH 1
C GASTROOESOPHAGEAL REFLUX DISEASE DEATH 1
C HYPERSENSITIVITY DEATH 1
C HYPOTHYROIDISM ARTHRALGIA 2
C HYPOTHYROIDISM BASAL CELL CARCINOMA 2
C HYPOTHYROIDISM COUGH 2
C HYPOTHYROIDISM DEVICE BREAKAGE 2
C HYPOTHYROIDISM DEVICE RELATED INFECTION 2
C HYPOTHYROIDISM INJECTION SITE HAEMATOMA 2
C HYPOTHYROIDISM INJECTION SITE HAEMORRHAGE 2
C HYPOTHYROIDISM MONARTHRITIS 2
C HYPOTHYROIDISM NASOPHARYNGITIS 2
C HYPOTHYROIDISM NAUSEA 2
C HYPOTHYROIDISM RESPIRATORY TRACT CONGESTION 2
C HYPOTHYROIDISM RHINORRHOEA 2
C INSOMNIA DEATH 1
C MACULAR FIBROSIS ARTHRALGIA 1
C MACULAR FIBROSIS BASAL CELL CARCINOMA 1
C MACULAR FIBROSIS COUGH 1
C MACULAR FIBROSIS DEVICE BREAKAGE 1
C MACULAR FIBROSIS DEVICE RELATED INFECTION 1
C MACULAR FIBROSIS INJECTION SITE HAEMATOMA 1
C MACULAR FIBROSIS INJECTION SITE HAEMORRHAGE 1
C MACULAR FIBROSIS MONARTHRITIS 1
C MACULAR FIBROSIS NASOPHARYNGITIS 1
C MACULAR FIBROSIS NAUSEA 1
C MACULAR FIBROSIS RESPIRATORY TRACT CONGESTION 1
C MACULAR FIBROSIS RHINORRHOEA 1
C MACULOPATHY ARTHRALGIA 1
C MACULOPATHY BASAL CELL CARCINOMA 1
C MACULOPATHY COUGH 1
C MACULOPATHY DEVICE BREAKAGE 1
C MACULOPATHY DEVICE RELATED INFECTION 1
C MACULOPATHY INJECTION SITE HAEMATOMA 1
C MACULOPATHY INJECTION SITE HAEMORRHAGE 1
C MACULOPATHY MONARTHRITIS 1
C MACULOPATHY NASOPHARYNGITIS 1
C MACULOPATHY NAUSEA 1
C MACULOPATHY RESPIRATORY TRACT CONGESTION 1
C MACULOPATHY RHINORRHOEA 1
C MINERAL SUPPLEMENTATION ARTHRALGIA 2
C MINERAL SUPPLEMENTATION BASAL CELL CARCINOMA 2
C MINERAL SUPPLEMENTATION COUGH 2
C MINERAL SUPPLEMENTATION DEVICE BREAKAGE 2
C MINERAL SUPPLEMENTATION DEVICE RELATED INFECTION 2
C MINERAL SUPPLEMENTATION INJECTION SITE HAEMATOMA 2
C MINERAL SUPPLEMENTATION INJECTION SITE HAEMORRHAGE 2
C MINERAL SUPPLEMENTATION MONARTHRITIS 2
C MINERAL SUPPLEMENTATION NASOPHARYNGITIS 2
C MINERAL SUPPLEMENTATION NAUSEA 2
C MINERAL SUPPLEMENTATION RESPIRATORY TRACT CONGESTION 2
C MINERAL SUPPLEMENTATION RHINORRHOEA 2
C MULTIPLE SCLEROSIS DRY EYE 1
C MULTIPLE SCLEROSIS MACULAR OEDEMA 1
C MULTIPLE SCLEROSIS PRESBYOPIA 1
C MULTIPLE SCLEROSIS VISION BLURRED 1
C MULTIPLE SCLEROSIS VISUAL ACUITY REDUCED 1
C MULTIPLE SCLEROSIS VITRITIS 1
C MUSCLE DISORDER ARTHRALGIA 2
C MUSCLE DISORDER BASAL CELL CARCINOMA 2
C MUSCLE DISORDER COUGH 2
C MUSCLE DISORDER DEVICE BREAKAGE 2
C MUSCLE DISORDER DEVICE RELATED INFECTION 2
C MUSCLE DISORDER INJECTION SITE HAEMATOMA 2
C MUSCLE DISORDER INJECTION SITE HAEMORRHAGE 2
C MUSCLE DISORDER MONARTHRITIS 2
C MUSCLE DISORDER NASOPHARYNGITIS 2
C MUSCLE DISORDER NAUSEA 2
C MUSCLE DISORDER RESPIRATORY TRACT CONGESTION 2
C MUSCLE DISORDER RHINORRHOEA 2
C NEUROPATHY PERIPHERAL DEATH 1
C PAIN DRY EYE 1
C PAIN MACULAR OEDEMA 1
C PAIN PRESBYOPIA 1
C PAIN VISION BLURRED 1
C PAIN VISUAL ACUITY REDUCED 1
C PAIN VITRITIS 1
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRALGIA 6
C PRODUCT USED FOR UNKNOWN INDICATION BASAL CELL CARCINOMA 6
C PRODUCT USED FOR UNKNOWN INDICATION COUGH 6
C PRODUCT USED FOR UNKNOWN INDICATION DEVICE BREAKAGE 6
C PRODUCT USED FOR UNKNOWN INDICATION DEVICE RELATED INFECTION 6
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE HAEMATOMA 6
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE HAEMORRHAGE 6
C PRODUCT USED FOR UNKNOWN INDICATION MONARTHRITIS 6
C PRODUCT USED FOR UNKNOWN INDICATION NASOPHARYNGITIS 6
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 6
C PRODUCT USED FOR UNKNOWN INDICATION RESPIRATORY TRACT CONGESTION 6
C PRODUCT USED FOR UNKNOWN INDICATION RHINORRHOEA 6
C PROPHYLAXIS DEATH 1
C PRURITUS DEATH 3
C PULMONARY HYPERTENSION DEATH 1
C PYREXIA DRY EYE 1
C PYREXIA MACULAR OEDEMA 1
C PYREXIA PRESBYOPIA 1
C PYREXIA VISION BLURRED 1
C PYREXIA VISUAL ACUITY REDUCED 1
C PYREXIA VITRITIS 1
C RESTLESS LEGS SYNDROME ARTHRALGIA 2
C RESTLESS LEGS SYNDROME BASAL CELL CARCINOMA 2
C RESTLESS LEGS SYNDROME COUGH 2
C RESTLESS LEGS SYNDROME DEVICE BREAKAGE 2
C RESTLESS LEGS SYNDROME DEVICE RELATED INFECTION 2
C RESTLESS LEGS SYNDROME INJECTION SITE HAEMATOMA 2
C RESTLESS LEGS SYNDROME INJECTION SITE HAEMORRHAGE 2
C RESTLESS LEGS SYNDROME MONARTHRITIS 2
C RESTLESS LEGS SYNDROME NASOPHARYNGITIS 2
C RESTLESS LEGS SYNDROME NAUSEA 2
C RESTLESS LEGS SYNDROME RESPIRATORY TRACT CONGESTION 2
C RESTLESS LEGS SYNDROME RHINORRHOEA 2
C RHEUMATOID ARTHRITIS ARTHRALGIA 2
C RHEUMATOID ARTHRITIS BASAL CELL CARCINOMA 2
C RHEUMATOID ARTHRITIS COUGH 2
C RHEUMATOID ARTHRITIS DEVICE BREAKAGE 2
C RHEUMATOID ARTHRITIS DEVICE RELATED INFECTION 2
C RHEUMATOID ARTHRITIS INJECTION SITE HAEMATOMA 2
C RHEUMATOID ARTHRITIS INJECTION SITE HAEMORRHAGE 2
C RHEUMATOID ARTHRITIS MONARTHRITIS 2
C RHEUMATOID ARTHRITIS NASOPHARYNGITIS 2
C RHEUMATOID ARTHRITIS NAUSEA 2
C RHEUMATOID ARTHRITIS RESPIRATORY TRACT CONGESTION 2
C RHEUMATOID ARTHRITIS RHINORRHOEA 2
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