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 a combination medicine used to treat symptoms of menopause such as hot flashes, and vaginal dryness, burning, and irritation. This medicine is for use only if you have a uterus (if you have not had a hysterectomy).

Drospirenone and estradiol may also be used for purposes not listed in this medication guide.

You should not use this medicine if you are allergic to drospirenone or estradiol, or if you have:

• unusual vaginal bleeding that a doctor has not checked;
• a bleeding disorder;
• coronary artery disease;
• a history of heart attack, stroke, or blood clot;
• kidney disease;
• liver disease;
• an adrenal gland disorder;
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina; or
• if you have had your uterus removed (hysterectomy).

Do not use drospirenone and estradiol if you are pregnant. Tell your doctor right away if you become pregnant during treatment.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack. You are even more at risk if you have high blood pressure, diabetes, high cholesterol, if you are overweight, or if you smoke.

Drospirenone and estradiol should not be used to prevent heart disease, stroke, or dementia, because this medicine may actually increase your risk of developing these conditions.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• a thyroid disorder;
• gallbladder disease;
• jaundice caused by pregnancy or taking hormones;
• high triglycerides (a type of fat in the blood);
• asthma;
• epilepsy or other seizure disorder;
• migraine headaches;
• lupus;
• endometriosis or uterine fibroid tumors;
• high levels of calcium or potassium in your blood, or low sodium levels;
• hereditary angioedema (an immune system disorder); or
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system).

Using drospirenone and estradiol may increase your risk of breast cancer. Talk with your doctor about your risk before using this medicine long term.

This medicine lowers the hormone needed to produce breast milk and can slow breast milk production. You should not breast-feed while taking drospirenone and estradiol.

Use Drospirenone And Estradiol (Angeliq) exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended.

Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• signs of a stroke--sudden numbness or weakness (especially on one side of the body), sudden severe headache, slurred speech, problems with vision or balance;
• signs of a blood clot--sudden vision loss, stabbing chest pain, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• sudden vision loss;
• swelling, rapid weight gain;
• jaundice (yellowing of the skin or eyes);
• memory problems, confusion, unusual behavior;
• unusual vaginal bleeding;
• a lump in your breast; or
• high blood sugar--increased thirst, increased urination, dry mouth, fruity breath odor.

Common side effects may include:

• headache, mood changes;
• vaginal itching or discharge, changes in your menstrual periods, breakthrough bleeding;
• breast pain;
• nausea, diarrhea, stomach pain; or
• fluid retention (swelling, rapid weight gain).

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Avoid smoking. It can greatly increase your risk of blood clots, stroke, or heart attack while using this medicine.

Grapefruit may interact with drospirenone and estradiol and lead to unwanted side effects. Avoid the use of grapefruit products.