Drug information for AMNESTEEM

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
CAPSULE; ORAL 10MG Prescription AB  ISOTRETINOIN Isotretinoin MYLAN 75945
2012-03-28 Review
2012-03-28 Review
2003-12-17 Other Important Information from FDA
2002-11-08 Letter
CAPSULE; ORAL 20MG Prescription AB (Reference Drug) ISOTRETINOIN Isotretinoin MYLAN   "
CAPSULE; ORAL 40MG Prescription AB (Reference Drug) ISOTRETINOIN Isotretinoin MYLAN   "

Drug Adverse Effects information for AMNESTEEM

Role code Indications Reaction # Reports
PS ACNE BLOOD CHOLESTEROL INCREASED 1
PS ACNE BLOOD TRIGLYCERIDES INCREASED 1
PS ACNE CONVULSION 1
PS ACNE DEPRESSION 1
PS ACNE EPISTAXIS 1
PS ACNE EYE PAIN 1
PS ACNE FEMALE REPRODUCTIVE NEOPLASM 1
PS ACNE HEADACHE 1
PS ACNE MAJOR DEPRESSION 1
PS ACNE SUICIDAL IDEATION 2
PS ACNE CYSTIC BLOOD CHOLESTEROL INCREASED 1
PS ACNE CYSTIC BLOOD TRIGLYCERIDES INCREASED 1
PS ACNE CYSTIC FEMALE REPRODUCTIVE NEOPLASM 1
PS ACNE CYSTIC MOOD ALTERED 1
PS ACNE CYSTIC PULMONARY EMBOLISM 1
PS ACNE CYSTIC SUICIDAL IDEATION 1
PS CELLULITIS PULMONARY EMBOLISM 1
PS CYST DEPRESSION 1
PS CYST SUICIDAL IDEATION 1
PS FOLLICULITIS DEPRESSION 1
PS FOLLICULITIS SUICIDAL IDEATION 1
SS ACNE ABDOMINAL PAIN 1
SS ACNE ACNE 4
SS ACNE ACUTE FEBRILE NEUTROPHILIC DERMATOSIS 3
SS ACNE ALANINE AMINOTRANSFERASE INCREASED 8
SS ACNE ALOPECIA 1
SS ACNE ANAEMIA 7
SS ACNE ANAL ABSCESS 7
SS ACNE ANAL FISSURE 15
SS ACNE ANAL FISTULA 9
SS ACNE ANXIETY 43
SS ACNE APHTHOUS STOMATITIS 3
SS ACNE ARTHRALGIA 8
SS ACNE ARTHRITIS 6
SS ACNE ASPARTATE AMINOTRANSFERASE INCREASED 23
SS ACNE BACK PAIN 13
SS ACNE BLOOD CHOLESTEROL INCREASED 10
SS ACNE BLOOD TRIGLYCERIDES INCREASED 42
SS ACNE BRONCHITIS 3
SS ACNE CHAPPED LIPS 6
SS ACNE CHEILITIS 3
SS ACNE CHEST PAIN 1
SS ACNE CLOSTRIDIUM DIFFICILE COLITIS 3
SS ACNE COLITIS 28
SS ACNE COLITIS ULCERATIVE 59
SS ACNE COLONIC POLYP 3
SS ACNE COUGH 1
SS ACNE CROHN'S DISEASE 40
SS ACNE DEPRESSION 40
SS ACNE DERMAL CYST 3
SS ACNE DERMATITIS CONTACT 13
SS ACNE DRY EYE 5
SS ACNE DRY MOUTH 3
SS ACNE DRY SKIN 22
SS ACNE EAR PAIN 13
SS ACNE ECZEMA 13
SS ACNE EMOTIONAL DISTRESS 15
SS ACNE EXTERNAL EAR CELLULITIS 3
SS ACNE FATIGUE 5
SS ACNE FEMALE REPRODUCTIVE NEOPLASM 1
SS ACNE FOLLICULITIS 4
SS ACNE FUNGAL INFECTION 3
SS ACNE GASTRITIS 1
SS ACNE GENITAL HERPES 3
SS ACNE GOITRE 13
SS ACNE HAEMORRHOIDS 19
SS ACNE HEADACHE 11
SS ACNE HYPOAESTHESIA 1
SS ACNE HYPOTHYROIDISM 13
SS ACNE ILEAL STENOSIS 4
SS ACNE INFLAMMATORY BOWEL DISEASE 108
SS ACNE INJURY 16
SS ACNE INTERVERTEBRAL DISC DEGENERATION 13
SS ACNE INTESTINAL HAEMORRHAGE 12
SS ACNE INTESTINAL OBSTRUCTION 12
SS ACNE INTESTINAL PERFORATION 1
SS ACNE IRON DEFICIENCY ANAEMIA 3
SS ACNE IRRITABLE BOWEL SYNDROME 34
SS ACNE LIP DRY 38
SS ACNE LIPIDS INCREASED 13
SS ACNE LIVER FUNCTION TEST ABNORMAL 5
SS ACNE MENTAL DISORDER 2
SS ACNE MUSCULOSKELETAL PAIN 6
SS ACNE NASAL DRYNESS 3
SS ACNE NAUSEA 4
SS ACNE OBSESSIVE-COMPULSIVE DISORDER 3
SS ACNE OESOPHAGITIS 4
SS ACNE ORAL HERPES 9
SS ACNE PANIC ATTACK 2
SS ACNE PHOTOPSIA 13
SS ACNE POLYP 5
SS ACNE PROCTITIS 13
SS ACNE PROTEINURIA 1
SS ACNE PYODERMA GANGRENOSUM 3
SS ACNE QUALITY OF LIFE DECREASED 1
SS ACNE RASH PRURITIC 3
SS ACNE RECTAL ABSCESS 8
SS ACNE SINUSITIS 1
SS ACNE SMALL INTESTINAL OBSTRUCTION 8
SS ACNE STRESS 4
SS ACNE SUBCUTANEOUS ABSCESS 1
SS ACNE SUICIDAL IDEATION 12
SS ACNE TINEA INFECTION 3
SS ACNE TOOTH EXTRACTION 3
SS ACNE ULCER 1
SS ACNE UPPER RESPIRATORY TRACT INFECTION 13
SS ACNE URINARY TRACT INFECTION 8
SS ACNE VIRAL INFECTION 13
SS ACNE XEROSIS 13
SS ACNE CYSTIC ABDOMINAL PAIN 1
SS ACNE CYSTIC ACNE 4
SS ACNE CYSTIC ALOPECIA 1
SS ACNE CYSTIC ANXIETY 1
SS ACNE CYSTIC ARTHRALGIA 1
SS ACNE CYSTIC BLOOD CHOLESTEROL INCREASED 2
SS ACNE CYSTIC BLOOD TRIGLYCERIDES INCREASED 3
SS ACNE CYSTIC CHAPPED LIPS 4
SS ACNE CYSTIC CHEST PAIN 1
SS ACNE CYSTIC COLITIS ULCERATIVE 4
SS ACNE CYSTIC COUGH 1
SS ACNE CYSTIC CROHN'S DISEASE 3
SS ACNE CYSTIC DEPRESSION 17
SS ACNE CYSTIC DRY SKIN 16
SS ACNE CYSTIC EMOTIONAL DISTRESS 1
SS ACNE CYSTIC FEMALE REPRODUCTIVE NEOPLASM 1
SS ACNE CYSTIC GASTRITIS 1
SS ACNE CYSTIC GASTROINTESTINAL HAEMORRHAGE 4
SS ACNE CYSTIC HAEMORRHOIDS 4
SS ACNE CYSTIC HYPOAESTHESIA 1
SS ACNE CYSTIC ILEAL STENOSIS 1
SS ACNE CYSTIC INFLAMMATORY BOWEL DISEASE 7
SS ACNE CYSTIC INJURY 1
SS ACNE CYSTIC INTESTINAL OBSTRUCTION 2
SS ACNE CYSTIC INTESTINAL PERFORATION 1
SS ACNE CYSTIC IRRITABLE BOWEL SYNDROME 4
SS ACNE CYSTIC LIP DRY 13
SS ACNE CYSTIC OESOPHAGITIS 1
SS ACNE CYSTIC ORAL HERPES 1
SS ACNE CYSTIC PROTEINURIA 1
SS ACNE CYSTIC PULMONARY EMBOLISM 1
SS ACNE CYSTIC QUALITY OF LIFE DECREASED 1
SS ACNE CYSTIC RASH 4
SS ACNE CYSTIC SINUSITIS 1
SS ACNE CYSTIC STRESS 1
SS ACNE CYSTIC SUBCUTANEOUS ABSCESS 1
SS ACNE CYSTIC SUICIDAL IDEATION 12
SS ACNE CYSTIC ULCER 1
SS BLOOD CHOLESTEROL INCREASED ACNE 2
SS BLOOD CHOLESTEROL INCREASED CHAPPED LIPS 2
SS BLOOD CHOLESTEROL INCREASED COLITIS ULCERATIVE 2
SS BLOOD CHOLESTEROL INCREASED DEPRESSION 2
SS BLOOD CHOLESTEROL INCREASED DRY SKIN 2
SS BLOOD CHOLESTEROL INCREASED GASTROINTESTINAL HAEMORRHAGE 2
SS BLOOD CHOLESTEROL INCREASED HAEMORRHOIDS 2
SS BLOOD CHOLESTEROL INCREASED INFLAMMATORY BOWEL DISEASE 2
SS BLOOD CHOLESTEROL INCREASED IRRITABLE BOWEL SYNDROME 2
SS BLOOD CHOLESTEROL INCREASED RASH 2
SS CELLULITIS PULMONARY EMBOLISM 1
SS COLITIS ULCERATIVE ACNE 8
SS COLITIS ULCERATIVE ANAEMIA 8
SS COLITIS ULCERATIVE ARTHRALGIA 8
SS COLITIS ULCERATIVE COLITIS ULCERATIVE 8
SS COLITIS ULCERATIVE DEPRESSION 8
SS COLITIS ULCERATIVE FOLLICULITIS 8
SS COLITIS ULCERATIVE INFLAMMATORY BOWEL DISEASE 8
SS COLITIS ULCERATIVE INTESTINAL HAEMORRHAGE 8
SS COLITIS ULCERATIVE INTESTINAL OBSTRUCTION 8
SS COLITIS ULCERATIVE NAUSEA 8
SS CONTRACEPTION ABORTION SPONTANEOUS 4
SS CONTRACEPTION ACNE 2
SS CONTRACEPTION BLIGHTED OVUM 4
SS CONTRACEPTION CHAPPED LIPS 2
SS CONTRACEPTION COLITIS ULCERATIVE 2
SS CONTRACEPTION DEPRESSION 2
SS CONTRACEPTION DRY SKIN 2
SS CONTRACEPTION GASTROINTESTINAL HAEMORRHAGE 2
SS CONTRACEPTION HAEMORRHOIDS 2
SS CONTRACEPTION INFLAMMATORY BOWEL DISEASE 2
SS CONTRACEPTION IRRITABLE BOWEL SYNDROME 2
SS CONTRACEPTION MATERNAL EXPOSURE BEFORE PREGNANCY 4
SS CONTRACEPTION RASH 2
SS CONTRACEPTION VAGINAL HAEMORRHAGE 4
SS CYST DEPRESSION 1
SS CYST SUICIDAL IDEATION 1
SS FOLLICULITIS DEPRESSION 1
SS FOLLICULITIS SUICIDAL IDEATION 1
SS HYPERTENSION ANXIETY 3
SS HYPERTENSION BLOOD CHOLESTEROL INCREASED 3
SS HYPERTENSION BLOOD TRIGLYCERIDES INCREASED 3
SS HYPERTENSION CHEST PAIN 3
SS HYPERTENSION COUGH 3
SS HYPERTENSION CROHN'S DISEASE 3
SS HYPERTENSION EMOTIONAL DISTRESS 3
SS HYPERTENSION HYPOAESTHESIA 3
SS HYPERTENSION INFLAMMATORY BOWEL DISEASE 3
SS HYPERTENSION INJURY 3
SS HYPERTENSION INTESTINAL OBSTRUCTION 3
SS HYPERTENSION SINUSITIS 3
SS HYPOTHYROIDISM ABDOMINAL PAIN 1
SS HYPOTHYROIDISM ALOPECIA 1
SS HYPOTHYROIDISM ARTHRALGIA 1
SS HYPOTHYROIDISM BLOOD TRIGLYCERIDES INCREASED 1
SS HYPOTHYROIDISM CROHN'S DISEASE 1
SS HYPOTHYROIDISM DEPRESSION 1
SS HYPOTHYROIDISM ILEAL STENOSIS 1
SS HYPOTHYROIDISM INFLAMMATORY BOWEL DISEASE 1
SS HYPOTHYROIDISM INTESTINAL PERFORATION 1
SS HYPOTHYROIDISM LIP DRY 1
SS HYPOTHYROIDISM PROTEINURIA 1
SS HYPOTHYROIDISM QUALITY OF LIFE DECREASED 1
SS HYPOTHYROIDISM STRESS 1
SS HYPOTHYROIDISM SUBCUTANEOUS ABSCESS 1
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 6
SS PRODUCT USED FOR UNKNOWN INDICATION COLITIS ULCERATIVE 4
SS PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 1
SS PRODUCT USED FOR UNKNOWN INDICATION INFLAMMATORY BOWEL DISEASE 7
SS PRODUCT USED FOR UNKNOWN INDICATION INJURY 4
SS PRODUCT USED FOR UNKNOWN INDICATION IRRITABLE BOWEL SYNDROME 4
SS SEBACEOUS HYPERPLASIA COLITIS ULCERATIVE 1
SS SEBACEOUS HYPERPLASIA EMOTIONAL DISTRESS 1
SS SEBACEOUS HYPERPLASIA INFLAMMATORY BOWEL DISEASE 1
SS SEBACEOUS HYPERPLASIA MENTAL DISORDER 1
SS STOMATITIS CROHN'S DISEASE 1
SS STOMATITIS GASTRITIS 1
SS STOMATITIS INFLAMMATORY BOWEL DISEASE 1
SS STOMATITIS INTESTINAL OBSTRUCTION 1
SS STOMATITIS OESOPHAGITIS 1
SS STOMATITIS ORAL HERPES 1
SS STOMATITIS ULCER 1
C ACNE ABDOMINAL PAIN 1
C ACNE ABORTION SPONTANEOUS 1
C ACNE ANXIETY 2
C ACNE CHEST PAIN 1
C ACNE CHOLECYSTITIS CHRONIC 1
C ACNE DEEP VEIN THROMBOSIS 1
C ACNE DYSPNOEA 1
C ACNE EMOTIONAL DISTRESS 2
C ACNE FEAR 1
C ACNE GALLBLADDER NON-FUNCTIONING 1
C ACNE GENERAL PHYSICAL HEALTH DETERIORATION 2
C ACNE INJURY 2
C ACNE MENTAL DISORDER 1
C ACNE MUSCLE SWELLING 1
C ACNE OEDEMA PERIPHERAL 1
C ACNE PAIN 2
C ACNE PAIN IN EXTREMITY 1
C ACNE PULMONARY EMBOLISM 1
C ACNE PULMONARY INFARCTION 1
C ACNE THROMBOPHLEBITIS SUPERFICIAL 1
C ACNE THROMBOSIS 1
C ACNE CYSTIC ABORTION SPONTANEOUS 3
C ACNE CYSTIC ANXIETY 3
C ACNE CYSTIC CHEST PAIN 3
C ACNE CYSTIC DEEP VEIN THROMBOSIS 3
C ACNE CYSTIC DYSPNOEA 3
C ACNE CYSTIC EMOTIONAL DISTRESS 3
C ACNE CYSTIC FEAR 3
C ACNE CYSTIC GENERAL PHYSICAL HEALTH DETERIORATION 3
C ACNE CYSTIC INJURY 3
C ACNE CYSTIC MUSCLE SWELLING 3
C ACNE CYSTIC OEDEMA PERIPHERAL 3
C ACNE CYSTIC PAIN 3
C ACNE CYSTIC PAIN IN EXTREMITY 3
C ACNE CYSTIC PULMONARY EMBOLISM 3
C ACNE CYSTIC PULMONARY INFARCTION 3
C ACNE CYSTIC THROMBOPHLEBITIS SUPERFICIAL 3
C ACNE CYSTIC THROMBOSIS 3
C CONTRACEPTION ABDOMINAL PAIN 1
C CONTRACEPTION ABORTION SPONTANEOUS 1
C CONTRACEPTION ANXIETY 2
C CONTRACEPTION CHEST PAIN 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION DEEP VEIN THROMBOSIS 1
C CONTRACEPTION DYSPNOEA 1
C CONTRACEPTION EMOTIONAL DISTRESS 2
C CONTRACEPTION FEAR 1
C CONTRACEPTION GALLBLADDER NON-FUNCTIONING 1
C CONTRACEPTION GENERAL PHYSICAL HEALTH DETERIORATION 2
C CONTRACEPTION INJURY 2
C CONTRACEPTION MENTAL DISORDER 1
C CONTRACEPTION MUSCLE SWELLING 1
C CONTRACEPTION OEDEMA PERIPHERAL 1
C CONTRACEPTION PAIN 2
C CONTRACEPTION PAIN IN EXTREMITY 1
C CONTRACEPTION PULMONARY EMBOLISM 1
C CONTRACEPTION PULMONARY INFARCTION 1
C CONTRACEPTION THROMBOPHLEBITIS SUPERFICIAL 1
C CONTRACEPTION THROMBOSIS 1
C INFECTION ABORTION SPONTANEOUS 1
C INFECTION ANXIETY 1
C INFECTION CHEST PAIN 1
C INFECTION DEEP VEIN THROMBOSIS 1
C INFECTION DYSPNOEA 1
C INFECTION EMOTIONAL DISTRESS 1
C INFECTION FEAR 1
C INFECTION GENERAL PHYSICAL HEALTH DETERIORATION 1
C INFECTION INJURY 1
C INFECTION MUSCLE SWELLING 1
C INFECTION OEDEMA PERIPHERAL 1
C INFECTION PAIN 1
C INFECTION PAIN IN EXTREMITY 1
C INFECTION PULMONARY EMBOLISM 1
C INFECTION PULMONARY INFARCTION 1
C INFECTION THROMBOPHLEBITIS SUPERFICIAL 1
C INFECTION THROMBOSIS 1
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