Drug information for SEASONALE

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 0.03MG;0.15MG Prescription AB (Reference Drug) ETHINYL ESTRADIOL; LEVONORGESTREL Seasonale DURAMED RES 21544
2004-03-24 Review

2003-09-25 Letter

2003-09-25 Label

Drug Adverse Effects information for SEASONALE

Role code Indications Reaction # Reports
SS CONTRACEPTION DRUG EFFECT DECREASED 2
SS CONTRACEPTION PAIN 2
SS DYSFUNCTIONAL UTERINE BLEEDING DRUG EFFECT DECREASED 2
SS DYSFUNCTIONAL UTERINE BLEEDING PAIN 2
SS MUSCLE CONTRACTIONS INVOLUNTARY DRUG EFFECT DECREASED 2
SS MUSCLE CONTRACTIONS INVOLUNTARY PAIN 2
SS PAIN DRUG EFFECT DECREASED 2
SS PAIN PAIN 2
SS PRODUCT USED FOR UNKNOWN INDICATION PULMONARY EMBOLISM 1
SS PSORIASIS PULMONARY EMBOLISM 1
C CONTRACEPTION ANXIETY 2
C CONTRACEPTION BILIARY COLIC 2
C CONTRACEPTION CHOLELITHIASIS 2
C CONTRACEPTION GALLBLADDER POLYP 2
C CONTRACEPTION MENSTRUAL DISORDER 2
C CONTRACEPTION NEPHROLITHIASIS 2
C CONTRACEPTION PAIN 2
C ENDOMETRIOSIS DRUG EFFECT DECREASED 1
C ENDOMETRIOSIS EMOTIONAL DISORDER 1
C ENDOMETRIOSIS ENDOMETRIOSIS 1
C ENDOMETRIOSIS FEELING ABNORMAL 1
C PREMENSTRUAL SYNDROME ANXIETY 2
C PREMENSTRUAL SYNDROME BILIARY COLIC 2
C PREMENSTRUAL SYNDROME CHOLELITHIASIS 2
C PREMENSTRUAL SYNDROME GALLBLADDER POLYP 2
C PREMENSTRUAL SYNDROME MENSTRUAL DISORDER 2
C PREMENSTRUAL SYNDROME NEPHROLITHIASIS 2
C PREMENSTRUAL SYNDROME PAIN 2
C PRODUCT USED FOR UNKNOWN INDICATION DRUG EFFECT DECREASED 5
C PRODUCT USED FOR UNKNOWN INDICATION EMOTIONAL DISORDER 5
C PRODUCT USED FOR UNKNOWN INDICATION FEELING ABNORMAL 5
C PRODUCT USED FOR UNKNOWN INDICATION HEADACHE 1
C PRODUCT USED FOR UNKNOWN INDICATION INJECTION SITE ERYTHEMA 1
C PULMONARY ARTERIAL HYPERTENSION ABORTION INDUCED 1
C PULMONARY ARTERIAL HYPERTENSION FATIGUE 1
C PULMONARY ARTERIAL HYPERTENSION PREGNANCY 1
C PULMONARY ARTERIAL HYPERTENSION VOMITING IN PREGNANCY 1
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