Estradiol is a form of estrogen. Estrogen is a female sex hormone that is involved in the development and maintenance of the female reproductive system.

Norethindrone is a form of progesterone. Progesterone is a female hormone important for the regulation of ovulation and menstruation.

Together, estradiol and norethindrone are used to treat the symptoms of menopause such as feelings of warmth in the face, neck and chest, or sudden intense spells of heat and sweating ("hot flashes" or "hot flushes"); to treat vulvar and vaginal changes (itching, burning, dryness in or around the vagina, difficulty or burning with urination) caused by menopause; and to replace estrogen in conditions such as hypogonadism, removal of the ovaries, or primary ovarian failure that result in a lack of estrogen. Estradiol and norethindrone is also used to prevent thinning of the bones (osteoporosis).

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

Estradiol increases the risk of developing endometrial hyperplasia, a condition that may lead to cancer of the lining of the uterus. Using a progestin, such as norethindrone, with estradiol lowers the risk of developing this condition. Visit your doctor regularly and report any unusual vaginal bleeding right away.

Have yearly physical exams and examine your breasts for lumps on a monthly basis while taking estradiol and norethindrone.

Do not take estradiol and norethindrone without first talking to your doctor if you have

• a circulation, bleeding, or blood-clotting disorder;

• undiagnosed, abnormal vaginal bleeding;

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

• liver disease.

Taking estradiol and norethindrone may be dangerous in some cases if you have any of the conditions listed above.

Before taking estradiol and norethindrone, tell your doctor if you have

• high blood pressure, angina, or heart disease;

• high levels of cholesterol or triglycerides in your blood;

• kidney disease;

• asthma;

• epilepsy;

• migraines;

• depression;

• diabetes;

• gallbladder disease;

• uterine fibroids; or

• had a hysterectomy (uterus removed).

You may not be able to take estradiol and norethindrone, or you may need a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Estradiol and norethindrone is in the FDA pregnancy category X. This means that estradiol and norethindrone is known to cause birth defects in an unborn baby. Do not take estradiol and norethindrone if you are pregnant or could become pregnant during treatment.

Estradiol and norethindrone may decrease milk flow and have other effects on milk composition. Do not take estradiol and norethindrone without first talking to your doctor if you are breast-feeding a baby.