Drospirenone is a female hormone that helps regulate ovulation and menstruation.

Estradiol is a female hormone involved in development and maintenance of the female reproductive system.

Drospirenone and estradiol is used to treat the symptoms of menopause such as hot flashes or vaginal changes (itching, burning, dryness, urination problems). It is also used to prevent thinning of the bones (osteoporosis).

Drosperinone and estradiol also treats the symptoms of premenstrual dysphoric disorder (PMDD). The symptoms of PMDD include depression, anxiety, persistent anger or irritability, trouble concentrating, sleep or appetite changes, and feeling out of control. PMDD also includes physical symptoms such as breast tenderness, headache, joint or muscle pain, bloating, and weight gain.

PMDD is not the same condition as premenstrual syndrome (PMS). This medication is not meant to treat PMS.

Drospirenone and estradiol may also be used for purposes other than those listed in this medication guide.

This medication can cause birth defects in an unborn baby. Do not use if you are pregnant. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and estradiol, tell your doctor about all of your current and past medical conditions, and about all the medicines you use.

Stop using this medication and call your doctor at once if you feel short of breath, have sudden numbness or weakness on one side of the body, sudden headache, confusion, or problems with vision, speech, or balance.

Call your doctor right away if you have a breast lump, unusual vaginal bleeding, or jaundice (yellowing of the skin or eyes).

Drospirenone may raise potassium levels in your blood. Other medical conditions can also affect potassium levels. Before using drospirenone and estradiol, tell your doctor if you have any of the following:

• a history of liver disease;

• a history of jaundice (yellowing of the skin or eyes) during a pregnancy or while using birth control pills;

• kidney disease;

• adrenal insufficiency;

• hemophilia or other bleeding disorder;

• a history of stroke or blood clot;

• unusual vaginal bleeding; or

• any type of breast, uterine, or hormone-dependent cancer.

Certain medicines can also affect potassium levels. Tell your doctor if you use any of the following drugs:

• heparin;

• aspirin or other NSAIDs (non-steroidal anti-inflammatory drugs) such as celecoxib (Celebrex), diclofenac (Voltaren), ibuprofen (Motrin, Advil), indomethacin, naproxen (Aleve, Naprosyn), piroxicam (Feldene);

• a diuretic ("water pill") such as spironolactone (Aldactone), triamterene (Dyrenium, Dyazide, Maxzide), amiloride (Midamor), or eplerenone (Inspra);

• a potassium supplement such as Klor-Con, K-Dur, K-Tab;

• an ACE inhibitor such as benazepril (Lotensin), lisinopril (Prinivil, Zestril), enalapril (Vasotec); or

• blood pressure medicine such as candesartan (Atacand), losartan (Cozaar), telmisartan (Micardis).

If you have any of the following conditions, you may not be able to use drospirenone and estradiol, or you may need a dosage adjustment or special tests during treatment:

• high blood pressure, angina, heart disease, high cholesterol or triglycerides;

• liver or kidney disease;

• asthma;

• epilepsy;

• migraines, depression;

• diabetes;

• gallbladder disease;

• uterine fibroids; or

• you have had a hysterectomy (uterus removed).

FDA pregnancy category X. This medication can cause birth defects. Do not use this medication if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Drospirenone and estradiol may affect breast milk. Do not take drospirenone and estradiol without telling your doctor if you are breast-feeding a baby.

Estradiol may increase your risk of developing a condition that may lead to uterine cancer. Taking the combination of drospirenone and estradiol may reduce this risk. Talk with your doctor about your individual situation, and report any unusual vaginal bleeding right away.