Drug information for ORTHO CYCLEN-28

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL-28 0.035MG;0.25MG Prescription AB (Reference Drug) ETHINYL ESTRADIOL; NORGESTIMATE norgestimate JANSSEN PHARMS 19653
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2009-01-12 Review
2008-06-03 Letter
2007-05-09 Letter
2007-05-07 Label

Drug Adverse Effects information for ORTHO CYCLEN-28

Role code Indications Reaction # Reports
C ABDOMINAL PAIN BLOOD CHOLESTEROL INCREASED 1
C ABDOMINAL PAIN CROHN'S DISEASE 1
C ABDOMINAL PAIN EMOTIONAL DISTRESS 1
C ABDOMINAL PAIN INFLAMMATORY BOWEL DISEASE 1
C ABDOMINAL PAIN INTESTINAL OBSTRUCTION 1
C ABDOMINAL PAIN IRRITABLE BOWEL SYNDROME 1
C ACNE ACNE 8
C ACNE ANXIETY 8
C ACNE APPENDICECTOMY 8
C ACNE APPENDICITIS 8
C ACNE BLOOD CHOLESTEROL INCREASED 3
C ACNE CHOLECYSTITIS CHRONIC 8
C ACNE COLITIS ULCERATIVE 1
C ACNE CROHN'S DISEASE 3
C ACNE DEPRESSION 1
C ACNE EMOTIONAL DISTRESS 12
C ACNE GALLBLADDER INJURY 8
C ACNE INFLAMMATORY BOWEL DISEASE 4
C ACNE INTESTINAL OBSTRUCTION 3
C ACNE IRRITABLE BOWEL SYNDROME 4
C ACNE PAIN 8
C ACNE PANIC ATTACK 1
C ARTHRALGIA BLOOD CHOLESTEROL INCREASED 1
C ARTHRALGIA CROHN'S DISEASE 1
C ARTHRALGIA EMOTIONAL DISTRESS 1
C ARTHRALGIA INFLAMMATORY BOWEL DISEASE 1
C ARTHRALGIA INTESTINAL OBSTRUCTION 1
C ARTHRALGIA IRRITABLE BOWEL SYNDROME 1
C CONTRACEPTION ANXIETY 5
C CONTRACEPTION BILIARY DYSKINESIA 4
C CONTRACEPTION BLOOD CHOLESTEROL INCREASED 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 5
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION CROHN'S DISEASE 1
C CONTRACEPTION EMOTIONAL DISORDER 2
C CONTRACEPTION EMOTIONAL DISTRESS 3
C CONTRACEPTION GALLBLADDER DISORDER 3
C CONTRACEPTION GALLBLADDER INJURY 4
C CONTRACEPTION INFLAMMATORY BOWEL DISEASE 1
C CONTRACEPTION INJURY 5
C CONTRACEPTION INTESTINAL OBSTRUCTION 1
C CONTRACEPTION IRRITABLE BOWEL SYNDROME 1
C CONTRACEPTION MENTAL DISORDER 5
C CONTRACEPTION PAIN 5
C CONTRACEPTION POST CHOLECYSTECTOMY SYNDROME 4
C CONTRACEPTION ROAD TRAFFIC ACCIDENT 1
C CONTRACEPTION SYNCOPE 1
C DYSPEPSIA ANXIETY 2
C DYSPEPSIA BILIARY DYSKINESIA 2
C DYSPEPSIA CHOLECYSTITIS CHRONIC 2
C DYSPEPSIA EMOTIONAL DISORDER 1
C DYSPEPSIA EMOTIONAL DISTRESS 1
C DYSPEPSIA GALLBLADDER DISORDER 1
C DYSPEPSIA GALLBLADDER INJURY 2
C DYSPEPSIA INJURY 2
C DYSPEPSIA MENTAL DISORDER 2
C DYSPEPSIA PAIN 2
C DYSPEPSIA POST CHOLECYSTECTOMY SYNDROME 2
C HEADACHE ABDOMINAL PAIN 1
C HEADACHE ANXIETY 4
C HEADACHE BILIARY DYSKINESIA 2
C HEADACHE CHOLECYSTITIS CHRONIC 4
C HEADACHE CHOLELITHIASIS 2
C HEADACHE EMOTIONAL DISORDER 1
C HEADACHE EMOTIONAL DISTRESS 1
C HEADACHE GALLBLADDER DISORDER 2
C HEADACHE GALLBLADDER INJURY 2
C HEADACHE INJURY 3
C HEADACHE MENTAL DISORDER 3
C HEADACHE PAIN 4
C HEADACHE POST CHOLECYSTECTOMY SYNDROME 2
C HEADACHE ROAD TRAFFIC ACCIDENT 1
C HEADACHE SYNCOPE 1
C ORAL CONTRACEPTION ABDOMINAL PAIN 1
C ORAL CONTRACEPTION ACNE 4
C ORAL CONTRACEPTION ANXIETY 6
C ORAL CONTRACEPTION APPENDICECTOMY 4
C ORAL CONTRACEPTION APPENDICITIS 4
C ORAL CONTRACEPTION CHOLECYSTITIS CHRONIC 6
C ORAL CONTRACEPTION CHOLELITHIASIS 2
C ORAL CONTRACEPTION EMOTIONAL DISTRESS 4
C ORAL CONTRACEPTION GALLBLADDER DISORDER 1
C ORAL CONTRACEPTION GALLBLADDER INJURY 4
C ORAL CONTRACEPTION INJURY 1
C ORAL CONTRACEPTION MENTAL DISORDER 1
C ORAL CONTRACEPTION PAIN 6
C ORAL CONTRACEPTION ROAD TRAFFIC ACCIDENT 1
C ORAL CONTRACEPTION SYNCOPE 1
C PAIN ABDOMINAL PAIN 2
C PAIN ANXIETY 2
C PAIN CHOLECYSTITIS CHRONIC 2
C PAIN CHOLELITHIASIS 2
C PAIN PAIN 2
C PREMENSTRUAL SYNDROME ABDOMINAL PAIN 1
C PREMENSTRUAL SYNDROME ACNE 4
C PREMENSTRUAL SYNDROME ANXIETY 5
C PREMENSTRUAL SYNDROME APPENDICECTOMY 4
C PREMENSTRUAL SYNDROME APPENDICITIS 4
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 5
C PREMENSTRUAL SYNDROME CHOLELITHIASIS 1
C PREMENSTRUAL SYNDROME EMOTIONAL DISTRESS 4
C PREMENSTRUAL SYNDROME GALLBLADDER INJURY 4
C PREMENSTRUAL SYNDROME PAIN 5
C PRODUCT USED FOR UNKNOWN INDICATION ABDOMINAL PAIN UPPER 1
C PRODUCT USED FOR UNKNOWN INDICATION ANXIETY 1
C PRODUCT USED FOR UNKNOWN INDICATION CHOLECYSTITIS CHRONIC 1
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISTRESS 1
C PRODUCT USED FOR UNKNOWN INDICATION FEAR 1
C PRODUCT USED FOR UNKNOWN INDICATION GALLBLADDER DISORDER 1
C PRODUCT USED FOR UNKNOWN INDICATION INJURY 1
C PRODUCT USED FOR UNKNOWN INDICATION NAUSEA 1
C PRODUCT USED FOR UNKNOWN INDICATION PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION PSYCHOLOGICAL TRAUMA 1
C PRODUCT USED FOR UNKNOWN INDICATION VOMITING 1
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