Drug information for SOTRET

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 10MG Prescription AB  ISOTRETINOIN Isotretinoin RANBAXY 76041
2005-07-22 Review

2003-12-17 Other Important Information from FDA
CAPSULE; ORAL 20MG Prescription AB  ISOTRETINOIN Isotretinoin RANBAXY   "
CAPSULE; ORAL 40MG Prescription AB  ISOTRETINOIN Isotretinoin RANBAXY   "
CAPSULE; ORAL 30MG Prescription AB  ISOTRETINOIN Isotretinoin RANBAXY 76503
2005-07-22 Review

2003-12-17 Other Important Information from FDA

Drug Adverse Effects information for SOTRET

Role code Indications Reaction # Reports
SS ACNE ACUTE FEBRILE NEUTROPHILIC DERMATOSIS 6
SS ACNE ALANINE AMINOTRANSFERASE INCREASED 8
SS ACNE ANAEMIA 6
SS ACNE ANAL FISSURE 27
SS ACNE ANKYLOSING SPONDYLITIS 15
SS ACNE ANXIETY 32
SS ACNE APHTHOUS STOMATITIS 6
SS ACNE ARTHRALGIA 3
SS ACNE ARTHRITIS 6
SS ACNE ASPARTATE AMINOTRANSFERASE INCREASED 8
SS ACNE BLOOD CHOLESTEROL INCREASED 20
SS ACNE BLOOD TRIGLYCERIDES INCREASED 43
SS ACNE CHAPPED LIPS 3
SS ACNE CHEILITIS 15
SS ACNE CLOSTRIDIUM DIFFICILE COLITIS 3
SS ACNE COLITIS 27
SS ACNE COLITIS ULCERATIVE 33
SS ACNE CROHN'S DISEASE 30
SS ACNE DEPRESSION 26
SS ACNE DERMAL CYST 3
SS ACNE DRY EYE 12
SS ACNE DRY MOUTH 3
SS ACNE DRY SKIN 11
SS ACNE EMOTIONAL DISTRESS 4
SS ACNE INFECTED CYST 12
SS ACNE INFLAMMATORY BOWEL DISEASE 76
SS ACNE INJURY 12
SS ACNE INTESTINAL OBSTRUCTION 6
SS ACNE IRON DEFICIENCY ANAEMIA 12
SS ACNE IRRITABLE BOWEL SYNDROME 18
SS ACNE LIP DRY 16
SS ACNE MOOD ALTERED 12
SS ACNE MUSCULOSKELETAL PAIN 9
SS ACNE OBSESSIVE-COMPULSIVE DISORDER 3
SS ACNE OESOPHAGITIS 6
SS ACNE ORAL HERPES 12
SS ACNE PITYRIASIS ALBA 12
SS ACNE PYODERMA GANGRENOSUM 6
SS ACNE RECTAL ABSCESS 8
SS ACNE SACROILIITIS 15
SS ACNE URINARY TRACT INFECTION 8
SS ACNE CYSTIC ABDOMINAL ADHESIONS 4
SS ACNE CYSTIC BLOOD CHOLESTEROL INCREASED 4
SS ACNE CYSTIC COLITIS ULCERATIVE 4
SS ACNE CYSTIC CROHN'S DISEASE 4
SS ACNE CYSTIC DEPRESSION 4
SS ACNE CYSTIC DRY SKIN 4
SS ACNE CYSTIC ENDOMETRIOSIS 4
SS ACNE CYSTIC GASTROOESOPHAGEAL REFLUX DISEASE 4
SS ACNE CYSTIC HAEMATOCRIT DECREASED 4
SS ACNE CYSTIC HAEMOGLOBIN DECREASED 4
SS ACNE CYSTIC INFLAMMATORY BOWEL DISEASE 4
SS ACNE CYSTIC LIP BLISTER 4
SS ACNE CYSTIC LIP DRY 4
SS ACNE CYSTIC PELVIC ADHESIONS 4
SS ACNE CYSTIC PROCTITIS 4
SS ACNE CYSTIC RASH PAPULAR 4
SS ACNE CYSTIC RED BLOOD CELL COUNT DECREASED 4
SS ACNE CYSTIC SLEEP APNOEA SYNDROME 4
SS ACNE CYSTIC STRESS 4
SS ACNE CYSTIC URINARY TRACT INFECTION 4
SS ACNE CYSTIC XEROSIS 4
SS NASOPHARYNGITIS BLOOD CHOLESTEROL INCREASED 4
SS NASOPHARYNGITIS BLOOD TRIGLYCERIDES INCREASED 4
SS NASOPHARYNGITIS COLITIS ULCERATIVE 4
SS NASOPHARYNGITIS DEPRESSION 4
SS NASOPHARYNGITIS INFLAMMATORY BOWEL DISEASE 4
SS NASOPHARYNGITIS RECTAL ABSCESS 4
SS PAIN BLOOD CHOLESTEROL INCREASED 2
SS PAIN BLOOD TRIGLYCERIDES INCREASED 2
SS PAIN COLITIS ULCERATIVE 2
SS PAIN DEPRESSION 2
SS PAIN INFLAMMATORY BOWEL DISEASE 2
SS PAIN RECTAL ABSCESS 2
SS PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 7
SS PRODUCT USED FOR UNKNOWN INDICATION COLITIS ULCERATIVE 4
SS PRODUCT USED FOR UNKNOWN INDICATION INFLAMMATORY BOWEL DISEASE 8
SS PRODUCT USED FOR UNKNOWN INDICATION INJURY 4
SS PRODUCT USED FOR UNKNOWN INDICATION IRRITABLE BOWEL SYNDROME 4
SS PRODUCT USED FOR UNKNOWN INDICATION LIP DRY 1
C ACNE ANXIETY 1
C ACNE BILIARY COLIC 2
C ACNE CHOLECYSTITIS 3
C ACNE CHOLELITHIASIS 1
C ACNE EMOTIONAL DISTRESS 1
C ACNE INJURY 1
C ACNE PAIN 3
C CONTRACEPTION ANXIETY 1
C CONTRACEPTION CHOLECYSTITIS 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION EMOTIONAL DISTRESS 1
C CONTRACEPTION INJURY 1
C CONTRACEPTION PAIN 1
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