Drug Notebook

FDA Alerts

  • Estrogens increase the risk of endometrial cancer in postmenopausal women. (See Endometrial Cancer under Cautions.)
  • Do not use estrogens with or without progestins for prevention of cardiovascular disease (See Cardiovascular Risk Reduction under Uses and Cardiovascular Disorders under Cautions) or dementia (See Alzheimer’s Disease under Uses).
  • The Women’s Health Initiative (WHI) study of estrogen alone reported increased risks of stroke and DVT in postmenopausal women receiving approximately 7 years of therapy with conjugated estrogens 0.625 mg daily.
  • The WHI study of estrogen plus progestin reported increased risks of MI, stroke, invasive breast cancer, pulmonary embolism, and DVT in postmenopausal women receiving ≥5 years of therapy with conjugated estrogens 0.625 mg in conjunction with medroxyprogesterone acetate 2.5 mg daily.
  • The WHI Memory Study (WHIMS) reported increased risk of developing probable dementia in postmenopausal women ≥65 years of age receiving long-term (4–5 years) therapy with conjugated estrogens in conjunction with medroxyprogesterone acetate or conjugated estrogen alone. Not known whether this finding also applies to younger postmenopausal women.
  • Other dosages of conjugated estrogens with medroxyprogesterone and other combinations or dosage forms of estrogens with progestin not studied in WHI trials; in the absence of comparable data, assume risks are similar.
  • Prescribe estrogens (with or without progestins) at the lowest effective dose and for the shortest duration consistent with treatment goals and risks for the individual woman.

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esterified estrogens
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What is the most important information I should know about esterified estrogens?

Esterified estrogens increase the risk of developing a condition (endometrial hyperplasia) that may lead to cancer of the lining of the uterus. Taking progestins, another hormone drug, with esterified estrogens lowers the risk of developing this condition. Therefore, if your uterus has not been removed, your doctor may prescribe a progestin for you to take together with the estrogen. 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 esterified estrogens.

Do not take esterified estrogens if you are pregnant.

What are esterified estrogens?

Estrogen is a female sex hormone necessary for many processes in the body.

Esterified estrogens are naturally occurring female sex hormones that are used to treat symptoms of menopause; deficiency in ovary function (including underdevelopment of female sexual characteristics and some types of infertility); some types of breast cancer in men and in postmenopausal women; degeneration of the vagina; and urethra and prostate cancer. In addition, esterified estrogens are used to prevent osteoporosis.

Esterified estrogens may also be used for purposes other than those listed in this medication guide.

Who should not take esterified estrogens?

Do not take esterified estrogens without first talking to your doctor if you have
  • a circulation, bleeding, or blood-clotting disorder;

  • undiagnosed, abnormal vaginal bleeding; or

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

Taking esterified estrogens may be dangerous in some cases if you have any of the conditions listed above.

Before taking esterified estrogens, tell your doctor if you have

You may not be able to take esterified estrogens, or you may require a dosage adjustment or special monitoring during treatment if you have any of the conditions listed above.

Esterified estrogens are in the FDA pregnancy category X. This means that esterified estrogens will cause birth defects in an unborn baby. Do not take this medication if you are pregnant or are planning a pregnancy. Esterified estrogens may decrease milk flow and have other effects on milk composition. Do not use this medication without first talking to your doctor if you are breast-feeding a baby.
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