Drug information for ORTHO TRI-CYCLEN LO

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL-28 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,0.25MG Prescription AB (Reference Drug) ETHINYL ESTRADIOL; NORGESTIMATE norgestimate JANSSEN PHARMS 21241
2006-07-11 Review
2004-08-26 Review
2002-08-22 Letter
2002-08-22 Label

Drug Adverse Effects information for ORTHO TRI-CYCLEN LO

Role code Indications Reaction # Reports
PS CONTRACEPTION INAPPROPRIATE SCHEDULE OF DRUG ADMINISTRATION 1
PS CONTRACEPTION MALAISE 1
PS CONTRACEPTION PULMONARY EMBOLISM 1
PS CONTRACEPTION THYROID DISORDER 1
PS CONTRACEPTION TONSILLAR DISORDER 1
PS MENSTRUAL DISORDER ATTENTION DEFICIT/HYPERACTIVITY DISORDER 1
PS MENSTRUAL DISORDER DRUG DOSE OMISSION 1
PS MENSTRUAL DISORDER OFF LABEL USE 1
PS PRODUCT USED FOR UNKNOWN INDICATION INFERTILITY 1
PS PRODUCT USED FOR UNKNOWN INDICATION VAGINAL HAEMORRHAGE 1
C ABDOMINAL PAIN CHOLECYSTITIS 1
C ABDOMINAL PAIN HEART RATE INCREASED 1
C ABDOMINAL PAIN PAIN 1
C ABDOMINAL PAIN PALPITATIONS 1
C ABDOMINAL PAIN SINUS TACHYCARDIA 1
C ABDOMINAL PAIN SPHINCTER OF ODDI DYSFUNCTION 1
C CIRCADIAN RHYTHM SLEEP DISORDER DERMATITIS BULLOUS 1
C CIRCADIAN RHYTHM SLEEP DISORDER OEDEMA 1
C CIRCADIAN RHYTHM SLEEP DISORDER RASH PRURITIC 1
C COLITIS MICROSCOPIC CHOLECYSTITIS 1
C COLITIS MICROSCOPIC HEART RATE INCREASED 1
C COLITIS MICROSCOPIC PAIN 1
C COLITIS MICROSCOPIC PALPITATIONS 1
C COLITIS MICROSCOPIC SINUS TACHYCARDIA 1
C COLITIS MICROSCOPIC SPHINCTER OF ODDI DYSFUNCTION 1
C CONTRACEPTION ABDOMINAL PAIN 1
C CONTRACEPTION ANXIETY 1
C CONTRACEPTION CHEST DISCOMFORT 1
C CONTRACEPTION CHOLECYSTITIS 1
C CONTRACEPTION CHOLECYSTITIS CHRONIC 2
C CONTRACEPTION CHOLELITHIASIS 2
C CONTRACEPTION DEEP VEIN THROMBOSIS 1
C CONTRACEPTION DIARRHOEA 1
C CONTRACEPTION HEART RATE INCREASED 1
C CONTRACEPTION MENSTRUATION IRREGULAR 1
C CONTRACEPTION NAUSEA 2
C CONTRACEPTION PAIN 1
C CONTRACEPTION PALPITATIONS 1
C CONTRACEPTION POLYMENORRHOEA 1
C CONTRACEPTION SINUS TACHYCARDIA 1
C CONTRACEPTION SPHINCTER OF ODDI DYSFUNCTION 1
C CONTRACEPTION VOMITING 2
C CROHN'S DISEASE DEEP VEIN THROMBOSIS 2
C CROHN'S DISEASE DEPRESSION 2
C CROHN'S DISEASE INJURY 2
C CROHN'S DISEASE PAIN 2
C DRUG DEPENDENCE ABDOMINAL PAIN 1
C DRUG DEPENDENCE ANXIETY 1
C DRUG DEPENDENCE CHEST DISCOMFORT 1
C DRUG DEPENDENCE DIARRHOEA 1
C GASTROOESOPHAGEAL REFLUX DISEASE ABDOMINAL PAIN 1
C GASTROOESOPHAGEAL REFLUX DISEASE ANXIETY 1
C GASTROOESOPHAGEAL REFLUX DISEASE CHEST DISCOMFORT 1
C GASTROOESOPHAGEAL REFLUX DISEASE DIARRHOEA 1
C HYPERTENSION CHOLECYSTITIS CHRONIC 1
C HYPERTENSION CHOLELITHIASIS 1
C HYPERTENSION NAUSEA 1
C HYPERTENSION VOMITING 1
C INSOMNIA CHOLECYSTITIS 1
C INSOMNIA HEART RATE INCREASED 1
C INSOMNIA PAIN 1
C INSOMNIA PALPITATIONS 1
C INSOMNIA SINUS TACHYCARDIA 1
C INSOMNIA SPHINCTER OF ODDI DYSFUNCTION 1
C MENSTRUAL CYCLE MANAGEMENT INJURY 1
C MENSTRUAL CYCLE MANAGEMENT PAIN 1
C MENSTRUAL CYCLE MANAGEMENT PULMONARY EMBOLISM 1
C OVARIAN CYST INJURY 1
C OVARIAN CYST PAIN 1
C OVARIAN CYST PULMONARY EMBOLISM 1
C PAIN CHOLECYSTITIS 1
C PAIN CHOLECYSTITIS CHRONIC 2
C PAIN CHOLELITHIASIS 2
C PAIN HEART RATE INCREASED 1
C PAIN NAUSEA 2
C PAIN PAIN 1
C PAIN PALPITATIONS 1
C PAIN SINUS TACHYCARDIA 1
C PAIN SPHINCTER OF ODDI DYSFUNCTION 1
C PAIN VOMITING 2
C PALPITATIONS CHOLECYSTITIS 1
C PALPITATIONS HEART RATE INCREASED 1
C PALPITATIONS PAIN 1
C PALPITATIONS PALPITATIONS 1
C PALPITATIONS SINUS TACHYCARDIA 1
C PALPITATIONS SPHINCTER OF ODDI DYSFUNCTION 1
C POLYCYSTIC OVARIES CHOLECYSTITIS 1
C POLYCYSTIC OVARIES HEART RATE INCREASED 1
C POLYCYSTIC OVARIES PAIN 1
C POLYCYSTIC OVARIES PALPITATIONS 1
C POLYCYSTIC OVARIES SINUS TACHYCARDIA 1
C POLYCYSTIC OVARIES SPHINCTER OF ODDI DYSFUNCTION 1
C POST COITAL CONTRACEPTION ABDOMINAL PAIN 1
C POST COITAL CONTRACEPTION ANXIETY 1
C POST COITAL CONTRACEPTION CHEST DISCOMFORT 1
C POST COITAL CONTRACEPTION DIARRHOEA 1
C POST COITAL CONTRACEPTION MENSTRUATION IRREGULAR 1
C PREMENSTRUAL SYNDROME DEEP VEIN THROMBOSIS 1
C PREMENSTRUAL SYNDROME DEPRESSION 1
C PREMENSTRUAL SYNDROME INJURY 1
C PREMENSTRUAL SYNDROME PAIN 1
C TENDONITIS DEEP VEIN THROMBOSIS 2
C TENDONITIS DEPRESSION 2
C TENDONITIS INJURY 2
C TENDONITIS PAIN 2
C VAGINITIS BACTERIAL CHOLECYSTITIS CHRONIC 1
C VAGINITIS BACTERIAL CHOLELITHIASIS 1
C VAGINITIS BACTERIAL NAUSEA 1
C VAGINITIS BACTERIAL VOMITING 1
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