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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