Estradiol (a form of estrogen) and progesterone are female hormones.

Estradiol and progesterone is a combination medicine used to treat moderate to severe hot flashes caused by menopause.

This medicine is for use only in a woman who has not had her uterus removed.

Estradiol and progesterone may also be used for purposes not listed in this medication guide.

You should not take estradiol and progesterone if your uterus has been removed, or if you have:

• unusual vaginal bleeding that has not been checked by a doctor;
• liver disease;
• an increased risk of having blood clots due to a heart problem or a hereditary blood disorder;
• a history of heart attack, stroke, or blood clot; or
• a history of hormone-related cancer, or cancer of the breast, uterus/cervix, or vagina.

Tell your doctor if you have ever had:

• heart disease, high blood pressure;
• gallbladder disease;
• liver problems, or jaundice caused by pregnancy or taking hormones;
• kidney disease;
• diabetes;
• asthma;
• epilepsy or other seizure disorder;
• migraines;
• lupus;
• endometriosis or uterine fibroid tumors;
• hereditary angioedema;
• porphyria (a genetic enzyme disorder that causes symptoms affecting the skin or nervous system);
• a thyroid disorder; or
• high levels of calcium in your blood.

Estradiol and progesterone should not be used to prevent heart disease, stroke, or dementia. This medicine may actually increase your risk of developing these conditions.

Estrogens 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.

Estrogens may also increase your risk of cancer of the breast, uterus, or ovaries. Talk with your doctor about this risk.

Estradiol and progesterone is not for use in a woman who is pregnant or breast-feeding.

Use Estradiol And Progesterone (Oral) 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;
• signs of a blood clot--sudden vision loss, feeling short of breath, coughing up blood, pain or warmth in one or both legs;
• swelling, rapid weight gain;
• jaundice (yellowing of the skin or eyes);
• unusual vaginal bleeding, pelvic pain;
• a lump in your breast; or
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, lack of energy.

Common side effects may include:

• pelvic pain;
• vaginal bleeding or discharge;
• breast tenderness; or
• headache.

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 this medicine and lead to unwanted side effects. Avoid the use of grapefruit products.