Drug information for SEASONIQUE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 0.03MG,0.01MG;0.15MG,N/A Prescription AB (Reference Drug) ETHINYL ESTRADIOL; LEVONORGESTREL Levonorgestrel TEVA WOMENS 21840
2010-08-09 Letter

2010-07-29 Label

2008-07-09 Review

2006-05-26 Label

2006-05-26 Letter

Drug Adverse Effects information for SEASONIQUE

Role code Indications Reaction # Reports
PS CONTRACEPTION BILE DUCT OBSTRUCTION 1
PS CONTRACEPTION CHOLELITHIASIS 1
PS CONTRACEPTION DEEP VEIN THROMBOSIS 1
PS CONTRACEPTION DIZZINESS 1
PS CONTRACEPTION FATIGUE 1
PS CONTRACEPTION GALLBLADDER DISORDER 1
PS CONTRACEPTION GASTROOESOPHAGEAL REFLUX DISEASE 1
PS CONTRACEPTION HEADACHE 1
PS CONTRACEPTION MOOD SWINGS 1
PS CONTRACEPTION PALPITATIONS 1
PS CONTRACEPTION PULMONARY EMBOLISM 1
PS CONTRACEPTION SYNCOPE 1
PS DYSMENORRHOEA MAJOR DEPRESSION 1
PS DYSMENORRHOEA SUICIDAL IDEATION 1
PS HYPOMENORRHOEA BILE DUCT OBSTRUCTION 1
PS HYPOMENORRHOEA CHOLELITHIASIS 1
PS HYPOMENORRHOEA DEEP VEIN THROMBOSIS 1
PS HYPOMENORRHOEA GALLBLADDER DISORDER 1
PS HYPOMENORRHOEA GASTROOESOPHAGEAL REFLUX DISEASE 1
PS HYPOMENORRHOEA PALPITATIONS 1
PS HYPOMENORRHOEA PULMONARY EMBOLISM 1
PS MENORRHAGIA EYE DISORDER 1
PS MENORRHAGIA GLARE 1
PS MENORRHAGIA QUALITY OF LIFE DECREASED 1
PS MENORRHAGIA VISION BLURRED 1
PS MENORRHAGIA VISUAL ACUITY REDUCED 1
PS UTERINE LEIOMYOMA EYE DISORDER 1
PS UTERINE LEIOMYOMA GLARE 1
PS UTERINE LEIOMYOMA QUALITY OF LIFE DECREASED 1
PS UTERINE LEIOMYOMA VISION BLURRED 1
PS UTERINE LEIOMYOMA VISUAL ACUITY REDUCED 1
SS CONTRACEPTION ANAEMIA 2
SS CONTRACEPTION CONCOMITANT DISEASE PROGRESSION 2
SS CONTRACEPTION DYSMENORRHOEA 2
SS CONTRACEPTION ENDOMETRIAL CANCER 2
SS CONTRACEPTION EXPLORATIVE LAPAROTOMY 2
SS CONTRACEPTION GAIT DISTURBANCE 2
SS CONTRACEPTION HYSTERECTOMY 2
SS CONTRACEPTION MALIGNANT TUMOUR EXCISION 2
SS CONTRACEPTION MULTIPLE SCLEROSIS RELAPSE 2
SS MENORRHAGIA ANAEMIA 4
SS MENORRHAGIA CONCOMITANT DISEASE PROGRESSION 4
SS MENORRHAGIA DYSMENORRHOEA 4
SS MENORRHAGIA ENDOMETRIAL CANCER 4
SS MENORRHAGIA EXPLORATIVE LAPAROTOMY 4
SS MENORRHAGIA GAIT DISTURBANCE 4
SS MENORRHAGIA HYSTERECTOMY 4
SS MENORRHAGIA MALIGNANT TUMOUR EXCISION 4
SS MENORRHAGIA MULTIPLE SCLEROSIS RELAPSE 4
C ABDOMINAL PAIN CHOLECYSTECTOMY 2
C ABDOMINAL PAIN CHOLECYSTITIS CHRONIC 2
C ABDOMINAL PAIN PAIN 2
C ACNE CHOLECYSTITIS CHRONIC 1
C ACNE CHOLELITHIASIS 1
C ACNE GALLBLADDER DISORDER 1
C ACNE INJURY 1
C ACNE PAIN 1
C CHRONIC FATIGUE SYNDROME BLISTER 3
C CHRONIC FATIGUE SYNDROME SKIN EXFOLIATION 3
C CHRONIC FATIGUE SYNDROME SKIN IRRITATION 3
C CONTRACEPTION BILIARY DYSKINESIA 1
C CONTRACEPTION BLISTER 3
C CONTRACEPTION CHEST PAIN 1
C CONTRACEPTION CHILLS 2
C CONTRACEPTION CHOLECYSTITIS CHRONIC 1
C CONTRACEPTION CHOLELITHIASIS 1
C CONTRACEPTION EMOTIONAL DISTRESS 1
C CONTRACEPTION GALLBLADDER DISORDER 2
C CONTRACEPTION INJURY 2
C CONTRACEPTION MENORRHAGIA 1
C CONTRACEPTION MENSTRUATION IRREGULAR 1
C CONTRACEPTION NAUSEA 2
C CONTRACEPTION PAIN 4
C CONTRACEPTION PELVIC PAIN 2
C CONTRACEPTION PYREXIA 2
C CONTRACEPTION SKIN EXFOLIATION 3
C CONTRACEPTION SKIN IRRITATION 3
C CONTRACEPTION VOMITING 1
C DEPRESSION CHOLECYSTECTOMY 2
C DEPRESSION CHOLECYSTITIS CHRONIC 2
C DEPRESSION PAIN 2
C DYSPEPSIA CHOLECYSTECTOMY 2
C DYSPEPSIA CHOLECYSTITIS CHRONIC 2
C DYSPEPSIA PAIN 2
C ENDOMETRIOSIS ABDOMINAL PAIN 12
C ENDOMETRIOSIS BONE PAIN 12
C ENDOMETRIOSIS CRYING 12
C ENDOMETRIOSIS DEPRESSION 12
C ENDOMETRIOSIS LOCALISED INTRAABDOMINAL FLUID COLLECTION 12
C ENDOMETRIOSIS NAUSEA 12
C ENDOMETRIOSIS OVARIAN CYST 12
C ENDOMETRIOSIS PAIN 12
C ENDOMETRIOSIS VOMITING 12
C FIBROMYALGIA BLISTER 3
C FIBROMYALGIA SKIN EXFOLIATION 3
C FIBROMYALGIA SKIN IRRITATION 3
C HYPERSENSITIVITY BLISTER 6
C HYPERSENSITIVITY CHOLECYSTECTOMY 2
C HYPERSENSITIVITY CHOLECYSTITIS CHRONIC 2
C HYPERSENSITIVITY PAIN 2
C HYPERSENSITIVITY SKIN EXFOLIATION 6
C HYPERSENSITIVITY SKIN IRRITATION 6
C MULTIPLE SCLEROSIS FATIGUE 1
C MULTIPLE SCLEROSIS VISUAL IMPAIRMENT 1
C NARCOLEPSY REACTION TO DRUG EXCIPIENTS 1
C NARCOLEPSY URTICARIA 1
C NARCOLEPSY WHEEZING 1
C OSTEOPOROSIS HOSPITALISATION 1
C OSTEOPOROSIS NEPHROLITHIASIS 2
C OSTEOPOROSIS RENAL DISORDER 2
C OSTEOPOROSIS RENAL TUBULAR DISORDER 2
C OSTEOPOROSIS URINARY RETENTION 2
C OSTEOPOROSIS URINARY TRACT OBSTRUCTION 2
C POLYCYSTIC OVARIES ABDOMINAL PAIN 18
C POLYCYSTIC OVARIES BONE PAIN 18
C POLYCYSTIC OVARIES CRYING 18
C POLYCYSTIC OVARIES DEPRESSION 18
C POLYCYSTIC OVARIES LOCALISED INTRAABDOMINAL FLUID COLLECTION 18
C POLYCYSTIC OVARIES NAUSEA 18
C POLYCYSTIC OVARIES OVARIAN CYST 18
C POLYCYSTIC OVARIES PAIN 18
C POLYCYSTIC OVARIES VOMITING 18
C POST COITAL CONTRACEPTION CHILLS 2
C POST COITAL CONTRACEPTION MENORRHAGIA 1
C POST COITAL CONTRACEPTION MENSTRUATION IRREGULAR 1
C POST COITAL CONTRACEPTION NAUSEA 2
C POST COITAL CONTRACEPTION PAIN 2
C POST COITAL CONTRACEPTION PELVIC PAIN 2
C POST COITAL CONTRACEPTION PYREXIA 2
C PREMENSTRUAL SYNDROME CHOLECYSTECTOMY 2
C PREMENSTRUAL SYNDROME CHOLECYSTITIS CHRONIC 2
C PREMENSTRUAL SYNDROME PAIN 2
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PAIN 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE PRURITUS 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE REACTION 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE SWELLING 1
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