Drug information for SAFYRAL

Form Dosage Status Therapeutic Equivalence Active Ingred Ref. Sponsor Document
TABLET; ORAL 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG Prescription   DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM beyaz BAYER HLTHCARE 22574
2012-04-12 Letter

2012-04-10 Label

2012-02-21 Letter

2012-02-14 Label

2011-11-16 Other Important Information from FDA

2011-07-15 Review

2011-07-15 Summary Review

2010-12-22 Label

2010-12-21 Letter

Drug Adverse Effects information for SAFYRAL

Role code Indications Reaction # Reports
PS CONTRACEPTION CHROMATURIA 1
PS CONTRACEPTION DRUG HYPERSENSITIVITY 1
PS CONTRACEPTION FATIGUE 1
PS CONTRACEPTION GENITAL HAEMORRHAGE 3
PS CONTRACEPTION HYPOAESTHESIA 1
PS CONTRACEPTION PAIN IN EXTREMITY 1
PS CONTRACEPTION PRURITUS 3
PS CONTRACEPTION SCRATCH 3
PS CONTRACEPTION URINE ODOUR ABNORMAL 1
PS CONTRACEPTION VAGINAL HAEMORRHAGE 1
PS CONTRACEPTION VOMITING 3
PS MENORRHAGIA DIZZINESS 1
PS MENORRHAGIA HYPERACUSIS 1
PS MENORRHAGIA MIGRAINE 1
PS MENSTRUATION IRREGULAR VAGINAL HAEMORRHAGE 1
PS POLYCYSTIC OVARIES ACNE 2
PS POLYCYSTIC OVARIES ADVERSE DRUG REACTION 1
PS POLYCYSTIC OVARIES ADVERSE EVENT 1
PS POLYCYSTIC OVARIES DISCOMFORT 2
PS POLYCYSTIC OVARIES MUSCLE SPASMS 2
PS POLYCYSTIC OVARIES WEIGHT INCREASED 2
SS CONTRACEPTION DIZZINESS 1
SS CONTRACEPTION HEADACHE 1
SS CONTRACEPTION HYPERACUSIS 1
SS CONTRACEPTION MIGRAINE 1
SS CONTRACEPTION PHOTOPHOBIA 1
SS MENORRHAGIA DIZZINESS 1
SS MENORRHAGIA HEADACHE 1
SS MENORRHAGIA HYPERACUSIS 1
SS MENORRHAGIA MIGRAINE 1
SS MENORRHAGIA PHOTOPHOBIA 1
SS PRODUCT USED FOR UNKNOWN INDICATION VAGINAL HAEMORRHAGE 2
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