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What is 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.

Precautions

Instructions

Side Effects

Interactions

Precautions

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

• high blood pressure, angina, or heart disease;
• high levels of cholesterol or triglycerides in your blood;
• liver disease;
• kidney disease;
• asthma;
• epilepsy;
• migraines;
• diabetes;
• depression;
• gallbladder disease;
• uterine fibroids; or
• had a hysterectomy (uterus removed).

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.

There are no restrictions on food, beverages, or activity while taking esterified estrogens unless your doctor directs otherwise.

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Instructions

An overdose of this medication is unlikely to threaten life. Consult an emergency room or poison control center for advice.

Symptoms of an overdose of esterified estrogens include nausea, vomiting, and breakthrough bleeding in females.

Take the missed dose as soon as you remember. Do not take a double dose of this medication unless otherwise directed by your doctor.

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Side Effects

If you experience any of the following serious side effects, stop taking esterified estrogens and seek emergency medical attention:

• an allergic reaction (difficulty breathing; closing of your throat; swelling of your lips, tongue, or face; or hives);
• a blood clot (pain, redness, and swelling in an arm or leg, shortness of breath, chest pain, headache, blurred vision, or confusion);
• a lump in a breast; or
• liver damage (yellowing of the skin or eyes, nausea, abdominal pain or discomfort, unusual bleeding or bruising, severe fatigue).

Other, less serious side effects may be more likely to occur. Continue to take esterified estrogens and talk to your doctor if you experience

• decreased appetite, nausea, or vomiting;
• swollen or tender breasts;
• acne or skin color changes;
• decreased sex drive;
• migraine headaches or dizziness;
• water retention (swollen hands, feet, or ankles);
• problems with wearing contact lenses;
• depression; or
• changes in your menstrual cycle or breakthrough bleeding.

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.

It is unclear to what extent estrogen treatments may affect the risk of breast cancer.

Side effects other than those listed here may also occur. Talk to your doctor about any side effect that seems unusual or that is especially bothersome. You may report side effects to FDA at 1-800-FDA-1088.

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Interactions

Before taking esterified estrogens, tell your doctor if you are taking any of the following medicines:

• an anticoagulant (blood thinner) such as warfarin (Coumadin);
• a thyroid medication such as Synthroid, Levoxyl, Levothroid, and others;
• insulin or an oral diabetes medicine such as glipizide (Glucotrol) or glyburide (Diabeta, Micronase);
• tamoxifen (Nolvadex);
• didanosine (Videx);
• phenytoin (Dilantin) or ethotoin (Peganone);
• carbamazepine (Tegretol);
• phenobarbital (Solfoton, Luminal);
• primidone (Mysoline); or
• rifampin (Rifadin).

A dosage adjustment or special monitoring may be required during treatment if you are taking any of the medicines listed above.

Drugs other than those listed here may also interact with esterified estrogens. Talk to your doctor and pharmacist before taking any prescription or over-the-counter medicines.

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