Drug information for COLAZAL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 750MG Prescription AB (Reference Drug) BALSALAZIDE DISODIUM balsalazide SALIX PHARMS 20610
2008-07-14 Letter

2007-11-08 Letter

2007-11-07 Label

2006-12-28 Label

2006-12-28 Letter

2006-09-25 Letter

2006-09-25 Label

2006-03-23 Letter

2002-06-18 Letter

2000-07-18 Label

2000-07-18 Letter

2000-07-18 Review

Drug Adverse Effects information for COLAZAL

Role code Indications Reaction # Reports
C ACNE ACNE 4
C ACNE ANAEMIA 4
C ACNE ARTHRALGIA 4
C ACNE COLITIS ULCERATIVE 4
C ACNE DEPRESSION 4
C ACNE FOLLICULITIS 4
C ACNE INFLAMMATORY BOWEL DISEASE 4
C ACNE INTESTINAL HAEMORRHAGE 4
C ACNE INTESTINAL OBSTRUCTION 4
C ACNE NAUSEA 4
C ACNE CYSTIC ABDOMINAL HERNIA 2
C ACNE CYSTIC ANAEMIA 2
C ACNE CYSTIC ANXIETY 2
C ACNE CYSTIC AORTIC ANEURYSM 2
C ACNE CYSTIC ARTHRITIS 2
C ACNE CYSTIC ASTHMA 2
C ACNE CYSTIC BACK PAIN 2
C ACNE CYSTIC BIPOLAR DISORDER 2
C ACNE CYSTIC CHRONIC FATIGUE SYNDROME 2
C ACNE CYSTIC COLITIS ULCERATIVE 2
C ACNE CYSTIC CROHN'S DISEASE 2
C ACNE CYSTIC CYSTITIS 2
C ACNE CYSTIC DEPERSONALISATION 2
C ACNE CYSTIC DEPRESSION 2
C ACNE CYSTIC FATIGUE 2
C ACNE CYSTIC FLIGHT OF IDEAS 2
C ACNE CYSTIC HYPERTENSION 2
C ACNE CYSTIC INFLAMMATORY BOWEL DISEASE 2
C ACNE CYSTIC INSOMNIA 2
C ACNE CYSTIC INTESTINAL HAEMORRHAGE 2
C ACNE CYSTIC IRRITABLE BOWEL SYNDROME 2
C ACNE CYSTIC LUNG NEOPLASM 2
C ACNE CYSTIC NECK INJURY 2
C ACNE CYSTIC OBSESSIVE-COMPULSIVE DISORDER 2
C ACNE CYSTIC OSTEOARTHRITIS 2
C ACNE CYSTIC PALPITATIONS 2
C ACNE CYSTIC PANIC ATTACK 2
C ACNE CYSTIC PHOBIA 2
C ACNE CYSTIC POLYP 2
C ACNE CYSTIC PROCTITIS ULCERATIVE 2
C ACNE CYSTIC SUICIDAL IDEATION 2
C ANXIETY ABDOMINAL HERNIA 4
C ANXIETY ANAEMIA 4
C ANXIETY ANXIETY 4
C ANXIETY AORTIC ANEURYSM 4
C ANXIETY ARTHRITIS 4
C ANXIETY ASTHMA 4
C ANXIETY BACK PAIN 4
C ANXIETY BIPOLAR DISORDER 4
C ANXIETY CHRONIC FATIGUE SYNDROME 4
C ANXIETY COLITIS ULCERATIVE 4
C ANXIETY CROHN'S DISEASE 4
C ANXIETY CYSTITIS 4
C ANXIETY DEPERSONALISATION 4
C ANXIETY DEPRESSION 4
C ANXIETY FATIGUE 4
C ANXIETY FLIGHT OF IDEAS 4
C ANXIETY HYPERTENSION 4
C ANXIETY INFLAMMATORY BOWEL DISEASE 4
C ANXIETY INSOMNIA 4
C ANXIETY INTESTINAL HAEMORRHAGE 4
C ANXIETY IRRITABLE BOWEL SYNDROME 4
C ANXIETY LUNG NEOPLASM 4
C ANXIETY NECK INJURY 4
C ANXIETY OBSESSIVE-COMPULSIVE DISORDER 4
C ANXIETY OSTEOARTHRITIS 4
C ANXIETY PALPITATIONS 4
C ANXIETY PANIC ATTACK 4
C ANXIETY PHOBIA 4
C ANXIETY POLYP 4
C ANXIETY PROCTITIS ULCERATIVE 4
C ANXIETY SUICIDAL IDEATION 4
C BLOOD CHOLESTEROL INCREASED DRUG EFFECT DECREASED 1
C BLOOD CHOLESTEROL INCREASED HEPATITIS 1
C BLOOD CHOLESTEROL INCREASED INJECTION SITE PAIN 1
C BLOOD TRIGLYCERIDES ARTHRALGIA 1
C BLOOD TRIGLYCERIDES FATIGUE 1
C BLOOD TRIGLYCERIDES INFUSION RELATED REACTION 1
C BLOOD TRIGLYCERIDES MYALGIA 1
C BLOOD TRIGLYCERIDES NAUSEA 1
C BLOOD TRIGLYCERIDES PRURITUS GENERALISED 1
C BLOOD TRIGLYCERIDES THYROID DISORDER 1
C CHEST PAIN ARTHRITIS 1
C CHEST PAIN CARDIAC HYPERTROPHY 1
C CHEST PAIN CAROTID ARTERIOSCLEROSIS 1
C CHEST PAIN COLITIS ULCERATIVE 1
C CHEST PAIN GASTRIC ULCER 1
C CHEST PAIN GASTRITIS 1
C CHEST PAIN GASTROOESOPHAGEAL REFLUX DISEASE 1
C CHEST PAIN HELICOBACTER INFECTION 1
C CHEST PAIN HIATUS HERNIA 1
C CHEST PAIN HYPERTENSION 1
C CHEST PAIN RETINAL ARTERY OCCLUSION 1
C CHEST PAIN SKIN CANCER 1
C CHEST PAIN SPINAL OSTEOARTHRITIS 1
C CHEST PAIN ULCER 1
C CHEST PAIN URTICARIA 1
C COLITIS ULCERATIVE ABDOMINAL PAIN 1
C COLITIS ULCERATIVE ABNORMAL SENSATION IN EYE 6
C COLITIS ULCERATIVE ACNE 8
C COLITIS ULCERATIVE ACUTE CORONARY SYNDROME 1
C COLITIS ULCERATIVE ANAEMIA 9
C COLITIS ULCERATIVE ARTHRALGIA 9
C COLITIS ULCERATIVE ARTHRITIS ENTEROPATHIC 1
C COLITIS ULCERATIVE ATELECTASIS 1
C COLITIS ULCERATIVE CHEST PAIN 1
C COLITIS ULCERATIVE CHOLELITHIASIS 1
C COLITIS ULCERATIVE COLITIS 1
C COLITIS ULCERATIVE COLITIS ULCERATIVE 8
C COLITIS ULCERATIVE CROHN'S DISEASE 1
C COLITIS ULCERATIVE DEATH 1
C COLITIS ULCERATIVE DEPRESSION 8
C COLITIS ULCERATIVE DIZZINESS 4
C COLITIS ULCERATIVE DRUG EFFECT DECREASED 1
C COLITIS ULCERATIVE ELECTROCARDIOGRAM ABNORMAL 1
C COLITIS ULCERATIVE EMPHYSEMA 1
C COLITIS ULCERATIVE EXOPHTHALMOS 6
C COLITIS ULCERATIVE EYELID FUNCTION DISORDER 6
C COLITIS ULCERATIVE FATIGUE 2
C COLITIS ULCERATIVE FEELING COLD 3
C COLITIS ULCERATIVE FEELING DRUNK 6
C COLITIS ULCERATIVE FOLLICULITIS 8
C COLITIS ULCERATIVE GASTROINTESTINAL STENOSIS 1
C COLITIS ULCERATIVE HAEMATOCHEZIA 1
C COLITIS ULCERATIVE HAEMORRHAGE INTRACRANIAL 1
C COLITIS ULCERATIVE HEAD INJURY 1
C COLITIS ULCERATIVE HEADACHE 1
C COLITIS ULCERATIVE HEPATITIS 1
C COLITIS ULCERATIVE HYPERHIDROSIS 3
C COLITIS ULCERATIVE HYPERTENSION 1
C COLITIS ULCERATIVE HYPOXIA 1
C COLITIS ULCERATIVE ILEAL STENOSIS 1
C COLITIS ULCERATIVE INFLAMMATORY BOWEL DISEASE 8
C COLITIS ULCERATIVE INFUSION RELATED REACTION 4
C COLITIS ULCERATIVE INJECTION SITE PAIN 1
C COLITIS ULCERATIVE INTESTINAL HAEMORRHAGE 8
C COLITIS ULCERATIVE INTESTINAL OBSTRUCTION 8
C COLITIS ULCERATIVE LACERATION 1
C COLITIS ULCERATIVE LIGAMENT SPRAIN 1
C COLITIS ULCERATIVE LIVER DISORDER 1
C COLITIS ULCERATIVE LOSS OF CONSCIOUSNESS 1
C COLITIS ULCERATIVE LUNG NEOPLASM 1
C COLITIS ULCERATIVE MUCOUS STOOLS 1
C COLITIS ULCERATIVE MYALGIA 1
C COLITIS ULCERATIVE MYOCARDIAL INFARCTION 1
C COLITIS ULCERATIVE NARCOLEPSY 1
C COLITIS ULCERATIVE NAUSEA 9
C COLITIS ULCERATIVE NERVOUS SYSTEM DISORDER 1
C COLITIS ULCERATIVE OPTIC NERVE INJURY 6
C COLITIS ULCERATIVE ORTHOSTATIC HYPOTENSION 1
C COLITIS ULCERATIVE PRESYNCOPE 3
C COLITIS ULCERATIVE PRURITUS GENERALISED 1
C COLITIS ULCERATIVE PSEUDOPOLYP 1
C COLITIS ULCERATIVE PULMONARY FIBROSIS 1
C COLITIS ULCERATIVE RENAL CYST 1
C COLITIS ULCERATIVE RENAL NEOPLASM 1
C COLITIS ULCERATIVE SLEEP APNOEA SYNDROME 1
C COLITIS ULCERATIVE SPINAL OSTEOARTHRITIS 1
C COLITIS ULCERATIVE SPLEEN DISORDER 1
C COLITIS ULCERATIVE SYNCOPE 1
C COLITIS ULCERATIVE TACHYCARDIA 1
C COLITIS ULCERATIVE THERAPEUTIC RESPONSE DECREASED 6
C COLITIS ULCERATIVE THYROID DISORDER 1
C CROHN'S DISEASE ABDOMINAL PAIN 1
C CROHN'S DISEASE ACUTE CORONARY SYNDROME 1
C CROHN'S DISEASE ANAEMIA 1
C CROHN'S DISEASE ARTHRITIS ENTEROPATHIC 1
C CROHN'S DISEASE ATELECTASIS 1
C CROHN'S DISEASE CHEST PAIN 1
C CROHN'S DISEASE CHOLELITHIASIS 1
C CROHN'S DISEASE COLITIS 1
C CROHN'S DISEASE CROHN'S DISEASE 1
C CROHN'S DISEASE DEATH 1
C CROHN'S DISEASE DIZZINESS 1
C CROHN'S DISEASE ELECTROCARDIOGRAM ABNORMAL 1
C CROHN'S DISEASE EMPHYSEMA 1
C CROHN'S DISEASE FATIGUE 1
C CROHN'S DISEASE GASTROINTESTINAL STENOSIS 1
C CROHN'S DISEASE HAEMATOCHEZIA 1
C CROHN'S DISEASE HAEMORRHAGE INTRACRANIAL 1
C CROHN'S DISEASE HEAD INJURY 1
C CROHN'S DISEASE HEADACHE 1
C CROHN'S DISEASE HYPERTENSION 4
C CROHN'S DISEASE HYPOXIA 1
C CROHN'S DISEASE ILEAL STENOSIS 1
C CROHN'S DISEASE LACERATION 1
C CROHN'S DISEASE LIGAMENT SPRAIN 1
C CROHN'S DISEASE LIVER DISORDER 1
C CROHN'S DISEASE LOSS OF CONSCIOUSNESS 1
C CROHN'S DISEASE LUNG NEOPLASM 1
C CROHN'S DISEASE MUCOUS STOOLS 1
C CROHN'S DISEASE MYOCARDIAL INFARCTION 1
C CROHN'S DISEASE NARCOLEPSY 1
C CROHN'S DISEASE NERVOUS SYSTEM DISORDER 1
C CROHN'S DISEASE ORTHOSTATIC HYPOTENSION 1
C CROHN'S DISEASE PRE-ECLAMPSIA 3
C CROHN'S DISEASE PREMATURE LABOUR 3
C CROHN'S DISEASE PSEUDOPOLYP 1
C CROHN'S DISEASE PULMONARY FIBROSIS 1
C CROHN'S DISEASE RENAL CYST 1
C CROHN'S DISEASE RENAL NEOPLASM 1
C CROHN'S DISEASE SLEEP APNOEA SYNDROME 1
C CROHN'S DISEASE SPINAL OSTEOARTHRITIS 1
C CROHN'S DISEASE SPLEEN DISORDER 1
C CROHN'S DISEASE SYNCOPE 1
C CROHN'S DISEASE TACHYCARDIA 1
C DYSPEPSIA HYPERTENSION 2
C DYSPEPSIA PRE-ECLAMPSIA 2
C DYSPEPSIA PREMATURE LABOUR 2
C GASTRIC DISORDER ARTHRITIS 1
C GASTRIC DISORDER CARDIAC HYPERTROPHY 1
C GASTRIC DISORDER CAROTID ARTERIOSCLEROSIS 1
C GASTRIC DISORDER COLITIS ULCERATIVE 1
C GASTRIC DISORDER GASTRIC ULCER 1
C GASTRIC DISORDER GASTRITIS 1
C GASTRIC DISORDER GASTROOESOPHAGEAL REFLUX DISEASE 1
C GASTRIC DISORDER HELICOBACTER INFECTION 1
C GASTRIC DISORDER HIATUS HERNIA 1
C GASTRIC DISORDER HYPERTENSION 1
C GASTRIC DISORDER RETINAL ARTERY OCCLUSION 1
C GASTRIC DISORDER SKIN CANCER 1
C GASTRIC DISORDER SPINAL OSTEOARTHRITIS 1
C GASTRIC DISORDER ULCER 1
C GASTRIC DISORDER URTICARIA 1
C GASTROINTESTINAL BACTERIAL INFECTION ARTHRITIS 1
C GASTROINTESTINAL BACTERIAL INFECTION CARDIAC HYPERTROPHY 1
C GASTROINTESTINAL BACTERIAL INFECTION CAROTID ARTERIOSCLEROSIS 1
C GASTROINTESTINAL BACTERIAL INFECTION COLITIS ULCERATIVE 1
C GASTROINTESTINAL BACTERIAL INFECTION GASTRIC ULCER 1
C GASTROINTESTINAL BACTERIAL INFECTION GASTRITIS 1
C GASTROINTESTINAL BACTERIAL INFECTION GASTROOESOPHAGEAL REFLUX DISEASE 1
C GASTROINTESTINAL BACTERIAL INFECTION HELICOBACTER INFECTION 1
C GASTROINTESTINAL BACTERIAL INFECTION HIATUS HERNIA 1
C GASTROINTESTINAL BACTERIAL INFECTION HYPERTENSION 1
C GASTROINTESTINAL BACTERIAL INFECTION RETINAL ARTERY OCCLUSION 1
C GASTROINTESTINAL BACTERIAL INFECTION SKIN CANCER 1
C GASTROINTESTINAL BACTERIAL INFECTION SPINAL OSTEOARTHRITIS 1
C GASTROINTESTINAL BACTERIAL INFECTION ULCER 1
C GASTROINTESTINAL BACTERIAL INFECTION URTICARIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE ARTHRITIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE CARDIAC HYPERTROPHY 1
C GASTROOESOPHAGEAL REFLUX DISEASE CAROTID ARTERIOSCLEROSIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE COLITIS ULCERATIVE 1
C GASTROOESOPHAGEAL REFLUX DISEASE GASTRIC ULCER 1
C GASTROOESOPHAGEAL REFLUX DISEASE GASTRITIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE GASTROOESOPHAGEAL REFLUX DISEASE 1
C GASTROOESOPHAGEAL REFLUX DISEASE HELICOBACTER INFECTION 1
C GASTROOESOPHAGEAL REFLUX DISEASE HIATUS HERNIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE HYPERTENSION 2
C GASTROOESOPHAGEAL REFLUX DISEASE PRE-ECLAMPSIA 1
C GASTROOESOPHAGEAL REFLUX DISEASE PREMATURE LABOUR 1
C GASTROOESOPHAGEAL REFLUX DISEASE RETINAL ARTERY OCCLUSION 1
C GASTROOESOPHAGEAL REFLUX DISEASE SKIN CANCER 1
C GASTROOESOPHAGEAL REFLUX DISEASE SPINAL OSTEOARTHRITIS 1
C GASTROOESOPHAGEAL REFLUX DISEASE ULCER 1
C GASTROOESOPHAGEAL REFLUX DISEASE URTICARIA 1
C HELICOBACTER INFECTION ARTHRITIS 1
C HELICOBACTER INFECTION CARDIAC HYPERTROPHY 1
C HELICOBACTER INFECTION CAROTID ARTERIOSCLEROSIS 1
C HELICOBACTER INFECTION COLITIS ULCERATIVE 1
C HELICOBACTER INFECTION GASTRIC ULCER 1
C HELICOBACTER INFECTION GASTRITIS 1
C HELICOBACTER INFECTION GASTROOESOPHAGEAL REFLUX DISEASE 1
C HELICOBACTER INFECTION HELICOBACTER INFECTION 1
C HELICOBACTER INFECTION HIATUS HERNIA 1
C HELICOBACTER INFECTION HYPERTENSION 1
C HELICOBACTER INFECTION RETINAL ARTERY OCCLUSION 1
C HELICOBACTER INFECTION SKIN CANCER 1
C HELICOBACTER INFECTION SPINAL OSTEOARTHRITIS 1
C HELICOBACTER INFECTION ULCER 1
C HELICOBACTER INFECTION URTICARIA 1
C HYPERSENSITIVITY HYPERTENSION 1
C HYPERSENSITIVITY PRE-ECLAMPSIA 1
C HYPERSENSITIVITY PREMATURE LABOUR 1
C INSOMNIA HYPERTENSION 1
C INSOMNIA PRE-ECLAMPSIA 1
C INSOMNIA PREMATURE LABOUR 1
C PAIN HYPERTENSION 1
C PAIN PRE-ECLAMPSIA 1
C PAIN PREMATURE LABOUR 1
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION ACUTE CORONARY SYNDROME 5
C PRODUCT USED FOR UNKNOWN INDICATION ANAEMIA 5
C PRODUCT USED FOR UNKNOWN INDICATION ARTHRITIS ENTEROPATHIC 5
C PRODUCT USED FOR UNKNOWN INDICATION ATELECTASIS 5
C PRODUCT USED FOR UNKNOWN INDICATION CHEST PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION CHOLELITHIASIS 5
C PRODUCT USED FOR UNKNOWN INDICATION COLITIS 5
C PRODUCT USED FOR UNKNOWN INDICATION CROHN'S DISEASE 5
C PRODUCT USED FOR UNKNOWN INDICATION DEATH 5
C PRODUCT USED FOR UNKNOWN INDICATION DIZZINESS 5
C PRODUCT USED FOR UNKNOWN INDICATION DRUG EFFECT DECREASED 2
C PRODUCT USED FOR UNKNOWN INDICATION ELECTROCARDIOGRAM ABNORMAL 5
C PRODUCT USED FOR UNKNOWN INDICATION EMPHYSEMA 5
C PRODUCT USED FOR UNKNOWN INDICATION FATIGUE 5
C PRODUCT USED FOR UNKNOWN INDICATION GASTROINTESTINAL STENOSIS 5
C PRODUCT USED FOR UNKNOWN INDICATION HAEMATOCHEZIA 5
C PRODUCT USED FOR UNKNOWN INDICATION HAEMORRHAGE INTRACRANIAL 5
C PRODUCT USED FOR UNKNOWN INDICATION HEAD INJURY 5
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 5
C PRODUCT USED FOR UNKNOWN INDICATION HEPATITIS 2
C PRODUCT USED FOR UNKNOWN INDICATION HYPERTENSION 7
C PRODUCT USED FOR UNKNOWN INDICATION HYPOXIA 5
C PRODUCT USED FOR UNKNOWN INDICATION ILEAL STENOSIS 5
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 2
C PRODUCT USED FOR UNKNOWN INDICATION LACERATION 5
C PRODUCT USED FOR UNKNOWN INDICATION LIGAMENT SPRAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION LIVER DISORDER 5
C PRODUCT USED FOR UNKNOWN INDICATION LOSS OF CONSCIOUSNESS 5
C PRODUCT USED FOR UNKNOWN INDICATION LUNG NEOPLASM 5
C PRODUCT USED FOR UNKNOWN INDICATION MALIGNANT MELANOMA 23
C PRODUCT USED FOR UNKNOWN INDICATION MELANOCYTIC NAEVUS 23
C PRODUCT USED FOR UNKNOWN INDICATION MUCOUS STOOLS 5
C PRODUCT USED FOR UNKNOWN INDICATION MYOCARDIAL INFARCTION 5
C PRODUCT USED FOR UNKNOWN INDICATION NARCOLEPSY 5
C PRODUCT USED FOR UNKNOWN INDICATION NERVOUS SYSTEM DISORDER 5
C PRODUCT USED FOR UNKNOWN INDICATION ORTHOSTATIC HYPOTENSION 5
C PRODUCT USED FOR UNKNOWN INDICATION PRE-ECLAMPSIA 2
C PRODUCT USED FOR UNKNOWN INDICATION PREMATURE LABOUR 2
C PRODUCT USED FOR UNKNOWN INDICATION PSEUDOPOLYP 5
C PRODUCT USED FOR UNKNOWN INDICATION PULMONARY FIBROSIS 5
C PRODUCT USED FOR UNKNOWN INDICATION RENAL CYST 5
C PRODUCT USED FOR UNKNOWN INDICATION RENAL NEOPLASM 5
C PRODUCT USED FOR UNKNOWN INDICATION SLEEP APNOEA SYNDROME 5
C PRODUCT USED FOR UNKNOWN INDICATION SPINAL OSTEOARTHRITIS 5
C PRODUCT USED FOR UNKNOWN INDICATION SPLEEN DISORDER 5
C PRODUCT USED FOR UNKNOWN INDICATION SYNCOPE 5
C PRODUCT USED FOR UNKNOWN INDICATION TACHYCARDIA 5
C PSORIATIC ARTHROPATHY DRUG EFFECT DECREASED 1
C PSORIATIC ARTHROPATHY HEPATITIS 1
C PSORIATIC ARTHROPATHY INJECTION SITE PAIN 1
C RHEUMATOID ARTHRITIS MALIGNANT MELANOMA 2
C RHEUMATOID ARTHRITIS MELANOCYTIC NAEVUS 2
C THROMBOSIS PROPHYLAXIS HYPERTENSION 1
C THROMBOSIS PROPHYLAXIS PRE-ECLAMPSIA 1
C THROMBOSIS PROPHYLAXIS PREMATURE LABOUR 1
C VITAMIN SUPPLEMENTATION HYPERTENSION 1
C VITAMIN SUPPLEMENTATION PRE-ECLAMPSIA 1
C VITAMIN SUPPLEMENTATION PREMATURE LABOUR 1
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