Drug information for APRISO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE, EXTENDED RELEASE; ORAL 375MG Prescription  (Reference Drug) MESALAMINE Mesalamine SALIX PHARMS 22301
2009-12-30 Review

2009-12-30 Summary Review

2008-11-07 Letter

2008-11-07 Label

Drug Adverse Effects information for APRISO

Role code Indications Reaction # Reports
PS COLITIS ULCERATIVE PANCREATITIS ACUTE 1
C ANTICOAGULANT THERAPY MALAISE 1
C ANTICOAGULANT THERAPY NAUSEA 1
C ANTICOAGULANT THERAPY OESOPHAGEAL SPASM 1
C ANXIETY ABDOMINAL PAIN 2
C ANXIETY ABSCESS 2
C ANXIETY CROHN'S DISEASE 2
C ANXIETY FISTULA 2
C ANXIETY GASTROINTESTINAL INFECTION 2
C ANXIETY GASTROINTESTINAL INFLAMMATION 2
C ANXIETY GASTROINTESTINAL OEDEMA 2
C ANXIETY INJECTION SITE MASS 2
C ANXIETY INJECTION SITE PAIN 2
C ANXIETY INJECTION SITE PRURITUS 2
C ANXIETY INJECTION SITE URTICARIA 2
C ANXIETY MALNUTRITION 2
C ATRIAL FIBRILLATION MALAISE 1
C ATRIAL FIBRILLATION NAUSEA 1
C ATRIAL FIBRILLATION OESOPHAGEAL SPASM 1
C BLOOD CHOLESTEROL INCREASED DIARRHOEA 1
C BLOOD CHOLESTEROL INCREASED LUNG CANCER METASTATIC 1
C BLOOD CHOLESTEROL INCREASED METASTASES TO LIVER 1
C BLOOD CHOLESTEROL INCREASED WEIGHT DECREASED 1
C CARDIAC DISORDER MALAISE 1
C CARDIAC DISORDER NAUSEA 1
C CARDIAC DISORDER OESOPHAGEAL SPASM 1
C CLOSTRIDIAL INFECTION CLOSTRIDIAL INFECTION 1
C CLOSTRIDIAL INFECTION DEHYDRATION 1
C CLOSTRIDIAL INFECTION HAEMATOCHEZIA 1
C CLOSTRIDIAL INFECTION NAUSEA 1
C CLOSTRIDIAL INFECTION WEIGHT DECREASED 1
C COLITIS ABDOMINAL DISCOMFORT 1
C COLITIS CROHN'S DISEASE 1
C COLITIS DIARRHOEA 1
C COLITIS GASTROINTESTINAL INFLAMMATION 1
C COLITIS ULCERATIVE ACNE 7
C COLITIS ULCERATIVE COLITIS ULCERATIVE 7
C COLITIS ULCERATIVE DIARRHOEA 2
C COLITIS ULCERATIVE ERYTHEMA NODOSUM 7
C COLITIS ULCERATIVE FOLLICULITIS 4
C COLITIS ULCERATIVE JOINT SWELLING 7
C COLITIS ULCERATIVE LUNG CANCER METASTATIC 2
C COLITIS ULCERATIVE LUNG NEOPLASM MALIGNANT 1
C COLITIS ULCERATIVE METASTASES TO LIVER 3
C COLITIS ULCERATIVE RASH MACULO-PAPULAR 7
C COLITIS ULCERATIVE WEIGHT DECREASED 2
C CROHN'S DISEASE ABDOMINAL DISCOMFORT 3
C CROHN'S DISEASE ABDOMINAL PAIN 3
C CROHN'S DISEASE ABSCESS 3
C CROHN'S DISEASE ANORECTAL DISORDER 8
C CROHN'S DISEASE CLOSTRIDIAL INFECTION 1
C CROHN'S DISEASE CROHN'S DISEASE 15
C CROHN'S DISEASE DEHYDRATION 1
C CROHN'S DISEASE DEVICE RELATED INFECTION 3
C CROHN'S DISEASE DIARRHOEA 3
C CROHN'S DISEASE DRUG INEFFECTIVE 9
C CROHN'S DISEASE DUODENAL ULCER 3
C CROHN'S DISEASE DYSPNOEA 1
C CROHN'S DISEASE FISTULA 3
C CROHN'S DISEASE GASTROINTESTINAL DISORDER 1
C CROHN'S DISEASE GASTROINTESTINAL INFECTION 3
C CROHN'S DISEASE GASTROINTESTINAL INFLAMMATION 6
C CROHN'S DISEASE GASTROINTESTINAL OEDEMA 3
C CROHN'S DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 3
C CROHN'S DISEASE HAEMATOCHEZIA 1
C CROHN'S DISEASE HEART RATE IRREGULAR 1
C CROHN'S DISEASE HICCUPS 1
C CROHN'S DISEASE HYPERCOAGULATION 3
C CROHN'S DISEASE INFECTION 4
C CROHN'S DISEASE INFUSION SITE CELLULITIS 3
C CROHN'S DISEASE INJECTION SITE MASS 3
C CROHN'S DISEASE INJECTION SITE PAIN 3
C CROHN'S DISEASE INJECTION SITE PRURITUS 3
C CROHN'S DISEASE INJECTION SITE URTICARIA 3
C CROHN'S DISEASE INTESTINAL PERFORATION 1
C CROHN'S DISEASE INTESTINAL STENOSIS 1
C CROHN'S DISEASE IRON DEFICIENCY ANAEMIA 8
C CROHN'S DISEASE JEJUNAL ULCER 3
C CROHN'S DISEASE MALAISE 2
C CROHN'S DISEASE MALNUTRITION 3
C CROHN'S DISEASE MUSCLE SPASMS 1
C CROHN'S DISEASE NAUSEA 3
C CROHN'S DISEASE OESOPHAGEAL SPASM 2
C CROHN'S DISEASE PAIN 1
C CROHN'S DISEASE SMALL INTESTINAL OBSTRUCTION 1
C CROHN'S DISEASE WEIGHT DECREASED 1
C DEPRESSION MALAISE 1
C DEPRESSION NAUSEA 1
C DEPRESSION OESOPHAGEAL SPASM 1
C DIABETES MELLITUS DIARRHOEA 2
C DIABETES MELLITUS LUNG CANCER METASTATIC 2
C DIABETES MELLITUS METASTASES TO LIVER 2
C DIABETES MELLITUS WEIGHT DECREASED 2
C HYPERSENSITIVITY ABDOMINAL PAIN 1
C HYPERSENSITIVITY ABSCESS 1
C HYPERSENSITIVITY CROHN'S DISEASE 1
C HYPERSENSITIVITY FISTULA 1
C HYPERSENSITIVITY GASTROINTESTINAL INFECTION 1
C HYPERSENSITIVITY GASTROINTESTINAL INFLAMMATION 1
C HYPERSENSITIVITY GASTROINTESTINAL OEDEMA 1
C HYPERSENSITIVITY INJECTION SITE MASS 1
C HYPERSENSITIVITY INJECTION SITE PAIN 1
C HYPERSENSITIVITY INJECTION SITE PRURITUS 1
C HYPERSENSITIVITY INJECTION SITE URTICARIA 1
C HYPERSENSITIVITY MALNUTRITION 1
C PAIN CLOSTRIDIAL INFECTION 1
C PAIN DEHYDRATION 1
C PAIN HAEMATOCHEZIA 1
C PAIN NAUSEA 1
C PAIN WEIGHT DECREASED 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 2
C PRODUCT USED FOR UNKNOWN INDICATION ABSCESS 2
C PRODUCT USED FOR UNKNOWN INDICATION ACNE 1
C PRODUCT USED FOR UNKNOWN INDICATION CLOSTRIDIAL INFECTION 4
C PRODUCT USED FOR UNKNOWN INDICATION COLITIS ULCERATIVE 1
C PRODUCT USED FOR UNKNOWN INDICATION CROHN'S DISEASE 3
C PRODUCT USED FOR UNKNOWN INDICATION DEHYDRATION 4
C PRODUCT USED FOR UNKNOWN INDICATION DIARRHOEA 1
C PRODUCT USED FOR UNKNOWN INDICATION DRUG INEFFECTIVE 2
C PRODUCT USED FOR UNKNOWN INDICATION DYSPNOEA 1
C PRODUCT USED FOR UNKNOWN INDICATION ERYTHEMA NODOSUM 1
C PRODUCT USED FOR UNKNOWN INDICATION FISTULA 2
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL DISORDER 5
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL INFECTION 2
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL INFLAMMATION 2
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL OEDEMA 2
C PRODUCT USED FOR UNKNOWN INDICATION HAEMATOCHEZIA 4
C PRODUCT USED FOR UNKNOWN INDICATION HEART RATE IRREGULAR 1
C PRODUCT USED FOR UNKNOWN INDICATION HICCUPS 1
C PRODUCT USED FOR UNKNOWN INDICATION INFECTION 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE MASS 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PRURITUS 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE URTICARIA 2
C PRODUCT USED FOR UNKNOWN INDICATION INTESTINAL PERFORATION 5
C PRODUCT USED FOR UNKNOWN INDICATION INTESTINAL STENOSIS 5
C PRODUCT USED FOR UNKNOWN INDICATION JOINT SWELLING 1
C PRODUCT USED FOR UNKNOWN INDICATION LUNG CANCER METASTATIC 1
C PRODUCT USED FOR UNKNOWN INDICATION MALNUTRITION 2
C PRODUCT USED FOR UNKNOWN INDICATION METASTASES TO LIVER 1
C PRODUCT USED FOR UNKNOWN INDICATION MUSCLE SPASMS 1
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 4
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION RASH MACULO-PAPULAR 1
C PRODUCT USED FOR UNKNOWN INDICATION SMALL INTESTINAL OBSTRUCTION 2
C PRODUCT USED FOR UNKNOWN INDICATION UNEVALUABLE EVENT 42
C PRODUCT USED FOR UNKNOWN INDICATION WEIGHT DECREASED 5
C PROPHYLAXIS CLOSTRIDIAL INFECTION 1
C PROPHYLAXIS DEHYDRATION 1
C PROPHYLAXIS HAEMATOCHEZIA 1
C PROPHYLAXIS NAUSEA 1
C PROPHYLAXIS WEIGHT DECREASED 1
C SEASONAL ALLERGY ABDOMINAL PAIN 1
C SEASONAL ALLERGY ABSCESS 1
C SEASONAL ALLERGY CROHN'S DISEASE 1
C SEASONAL ALLERGY FISTULA 1
C SEASONAL ALLERGY GASTROINTESTINAL INFECTION 1
C SEASONAL ALLERGY GASTROINTESTINAL INFLAMMATION 1
C SEASONAL ALLERGY GASTROINTESTINAL OEDEMA 1
C SEASONAL ALLERGY INJECTION SITE MASS 1
C SEASONAL ALLERGY INJECTION SITE PAIN 1
C SEASONAL ALLERGY INJECTION SITE PRURITUS 1
C SEASONAL ALLERGY INJECTION SITE URTICARIA 1
C SEASONAL ALLERGY MALNUTRITION 1
C ULCER DIARRHOEA 1
C ULCER LUNG CANCER METASTATIC 1
C ULCER METASTASES TO LIVER 1
C ULCER WEIGHT DECREASED 1
C UTERINE LEIOMYOMA UNEVALUABLE EVENT 3
C VITAMIN B12 DEFICIENCY DIARRHOEA 1
C VITAMIN B12 DEFICIENCY LUNG CANCER METASTATIC 1
C VITAMIN B12 DEFICIENCY METASTASES TO LIVER 1
C VITAMIN B12 DEFICIENCY WEIGHT DECREASED 1
C VITAMIN SUPPLEMENTATION GASTROINTESTINAL DISORDER 1
C VITAMIN SUPPLEMENTATION INTESTINAL PERFORATION 1
C VITAMIN SUPPLEMENTATION INTESTINAL STENOSIS 1
C VITAMIN SUPPLEMENTATION PAIN 1
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