Esterified estrogens

Estrogen is a female hormone made by the ovaries. It is important for many functions in the body.

Esterified estrogens are a synthetic mix of estrogens used to help with menopause symptoms like hot flashes, vaginal dryness, vaginal burning or irritation, or other hormonal changes in the vagina.

Esterified estrogens is also used to replace estrogen in women who have ovarian failure or other conditions that lead to low natural estrogen levels in the body.

In some situations, esterified estrogens is used to manage symptoms of breast cancer in both men and women. Esterified estrogens is also prescribed for men to help with symptoms of advanced prostate cancer. Esterified estrogens only addresses the symptoms of cancer but does not treat the cancer itself.

Esterified estrogens may also be used for purposes not mentioned in this medication guide.

Follow all directions on your prescription label. Do not take esterified estrogens in larger or smaller amounts or for longer than recommended.

Esterified estrogens can be taken daily or on a cycled schedule, depending on the condition being treated.

If you take this medicine on a cycled schedule, you will take it daily for several days or weeks, then have 7 to 10 days off the medicine, to mimic your body's natural monthly cycle.

If you are taking esterified estrogens to treat cancer, you may take the medicine more than once per day.

Follow your doctor's dosing instructions very carefully.

No matter what your dosing schedule is, try to take the medicine at the same time each day you take it.

Call your doctor right away if you have any unusual vaginal bleeding.

To help lower your risk of uterine cancer, your doctor may want you to take a progestin medication. Follow all dosing directions carefully.

If you need surgery, medical tests, or if you will be on bed rest, you may need to stop taking your medicine for a short time. Any doctor or surgeon who treats you should know that you are taking esterified estrogens.

Store this medicine at room temperature away from moisture and heat.

Read all patient information, medication guides, and instruction sheets provided to you. Ask your doctor or pharmacist if you have any questions.

While taking esterified estrogens, you will need to visit your doctor regularly. Self-examine your breasts for lumps every month and have regular mammograms.

Do not use if you are pregnant.

You should not take esterified estrogens if you have any of the following conditions: unusual vaginal bleeding, a blood-clotting disorder, breast cancer (unless you are taking esterified estrogens for breast cancer symptoms), or if you have ever had thyroid cancer or uterine cancer, or a blood clot caused by taking hormones.

Esterified estrogens may increase your risk of developing a condition that may lead to uterine cancer. Call your doctor at once if you have any unusual vaginal bleeding while using this medicine.

This medicine can harm an unborn baby or cause birth defects. Do not use if you are pregnant, and tell your doctor right away if you become pregnant.

You should not use esterified estrogens if you are allergic to it, if you are pregnant, or if you have:

• unusual vaginal bleeding that a doctor has not checked;
• a bleeding or blood-clotting disorder;
• breast cancer (unless you are taking esterified estrogens to treat breast cancer symptoms);
• a history of hormone-dependent cancer (such as breast, uterine, ovarian, or thyroid cancer); or
• a history of blood clots caused by taking birth control pills or hormone replacement medicine.

Taking this medicine can increase your risk of blood clots, stroke, or heart attack, especially if you have certain other conditions.

To make sure esterified estrogens is safe for you, tell your doctor if you have:

• heart disease (coronary artery disease, chest pain, history of heart attack, stroke, or blood clot);
• gallbladder disease;
• a history of depression;
• liver disease;
• a history of fibrocystic breast disease, lumps, nodules, or an abnormal mammogram;
• a family history of breast cancer;
• diabetes;
• kidney disease;
• epilepsy;
• migraines;
• a history of jaundice caused by pregnancy or birth control pills;
• if you have had your uterus removed (hysterectomy);
• if you are pregnant or plan to become pregnant;
• if you have had a heart attack or stroke; or
• if you have ever had a blood clot (especially in your lung or your lower body).

The hormones in esterified estrogens can pass into breast milk and may harm a nursing baby. This medicine may also slow breast milk production. Do not use if you are breastfeeding a baby.

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

Esterified estrogens may cause serious side effects. Stop using esterified estrogens and call your doctor immediately if you have:

• 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 in the lung--chest pain, sudden cough, wheezing, rapid breathing, coughing up blood;
• signs of a blood clot in your leg--pain, swelling, warmth, or redness in one or both legs;
• heart attack symptoms--chest pain or pressure, pain spreading to your jaw or shoulder, nausea, sweating;
• liver problems--severe stomach pain, fever, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);
• high levels of calcium in your blood--nausea, vomiting, constipation, increased thirst or urination, muscle weakness, bone pain, confusion, lack of energy, or tired feeling;
• a change in the pattern or severity of migraine headaches;
• swelling in your hands, ankles, or feet;
• a breast lump; or
• severe skin reaction--fever, sore throat, swelling in your face or tongue, burning in your eyes, skin pain followed by a red or purple skin rash that spreads (especially in the face or upper body) and causes blistering and peeling.

Common side effects of esterified estrogens may include:

• light vaginal bleeding or spotting;
• breast pain or tenderness;
• nausea, vomiting, bloating;
• skin color changes, increased facial hair, thinning scalp hair;
• headache, dizziness, mood changes, decreased sex drive;
• vaginal itching or discharge, very light menstrual periods; or
• problems with contact lenses.

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.

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose. Do not take extra medicine to make up for the missed dose.

If you forget to start taking esterified estrogens again after your regular time off in your dosing cycle, call your doctor for instructions.

Seek emergency medical help or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions regarding any limits on food, drinks, or activities.

Other drugs may interact with esterified estrogens, including prescription and over-the-counter medicines, vitamins, and herbal products. Inform each of your health care providers about all medicines you are currently using and any medicine you begin or discontinue.