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Drospirenone/ethinyl estradiol was well-tolerated by the majority of women in clinical trials. The most commonly reported adverse events were similar to that associated with other oral contraceptives and included upper respiratory tract infection, headache, breast pain, vaginal moniliasis, vaginal leukorrhea, diarrhea, and nausea.
Because 3 mg of drospirenone has anti-mineralocorticoid activity similar to that of a 25-mg dose of spironolactone, the product should not be used in patients with conditions that predispose to hyperkalemia, such as renal insufficiency, hepatic dysfunction, or adrenal insufficiency.
Serum potassium levels should be checked during the first treatment cycle in women receiving long-term treatment with other medications that can cause hyperkalemia, such as angiotensin-converting enzyme inhibitors, angiotensin-II receptor antagonists, potassium-sparing diuretics, potassium supplementation, heparin, aldosterone antagonists, and nonsteroidal anti-inflammatory drugs.
Use of oral contraceptives is linked to increased risks for venous and arterial thrombotic and thromboembolic events (eg, myocardial infarction, thromboembolism, and stroke), hepatic neoplasia, gallbladder disease, and hypertension. The FDA notes that the risk for serious morbidity and mortality is small in healthy women without underlying risk factors, but increases significantly in the presence of conditions, such as hypertension, hyperlipidemias, obesity, and diabetes.
Oral contraceptives should not be used in heavy smokers (> 15 cigarettes/day) aged older than 35 years because of the increased risk for serious cardiovascular events.
The FDA notes that the effectiveness of the 24-day drospirenone/ethinyl estradiol regimen for PMDD when used for more than 3 menstrual cycles has not been evaluated nor has its efficacy been evaluated for the treatment of premenstrual syndrome. It previously was approved for contraceptive use in women. Each cycle consists of 24 active and 4 placebo tablets.cited in references".
http://www.medscape.com/viewarticle/547056
