What should I watch for?
Visit your doctor or health care professional for regular checks on your progress. You will need a regular breast and pelvic exam and Pap smear while on this medicine. You should also discuss the need for regular mammograms with your health care professional, and follow his or her guidelines for these tests.
This medicine can make your body retain fluid, making your fingers, hands, or ankles swell. Your blood pressure can go up. Contact your doctor or health care professional if you feel you are retaining fluid.
If you have any reason to think you are pregnant, stop taking this medicine right away and contact your doctor or health care professional.
Smoking increases the risk of getting a blood clot or having a stroke while you are taking this medicine, especially if you are more than 35 years old. You are strongly advised not to smoke.
If you wear contact lenses and notice visual changes, or if the lenses begin to feel uncomfortable, consult your eye doctor or health care professional.
This medicine can 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 this medicine lowers the risk of developing this condition. Therefore, if your uterus has not been removed (by a hysterectomy), your doctor may prescribe a progestin for you to take together with your estrogen. You should know, however, that taking estrogens with progestins may have additional health risks. You should discuss the use of estrogens and progestins with your health care professional to determine the benefits and risks for you.
If you are going to have surgery, you may need to stop taking this medicine. Consult your health care professional for advice before you schedule the surgery.
Common and Rare Side Effects
Discuss these possible effects with your doctor:
Tumors of the liver, liver cancer, and peliosis hepatis (a form of liver disease) have occurred during long-term, high-dose therapy with androgens. Although these effects are rare, they can be very serious and may cause death.
When androgens are used in women, especially in high doses, male-like changes may occur, such as hoarseness or deepening of the voice, unnatural hair growth, or unusual hair loss. Most of these changes will go away if the medicine is stopped as soon as the changes are noticed. However, some changes, such as voice changes, may not go away.
The prolonged use of estrogens has been reported to increase the risk of endometrial cancer (cancer of the uterus lining) in women after menopause. The risk seems to increase as the dose and the length of use increase. When estrogens are used in low doses for less than one year, there is less risk. The risk is also reduced if a progestin (another female hormone) is added to, or replaces part of, your estrogen dose. If the uterus has been removed by surgery (total hysterectomy), there is no risk of endometrial cancer.
It is not yet known whether the use of estrogens increases the risk of breast cancer in women. Although some large studies show an increased risk, most studies and information gathered to date do not support this idea.
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
Uncontrolled jerky muscle movements
vomiting of blood (with long-term use or high doses)
Check with your doctor as soon as possible if any of the following side effects occur:
Acne or oily skin (severe)
breast pain or tenderness
enlargement or decrease in size of breasts
hoarseness or deepening of voice
swelling of feet or lower legs
unnatural hair growth
unusual hair loss
weight gain (rapid)
Less common or rare
flushing or redness of skin
headaches (frequent or continuing)
hives (especially at place of injection)
shortness of breath (unexplained)
unusual tiredness or drowsiness
With long-term use or high doses
Black, tarry, or light-colored stools
general feeling of discomfort or illness (continuing)
hives (frequent or continuing)
loss of appetite (continuing)
lump in, or discharge from breast
pain, swelling, or tenderness in stomach or upper abdomen (continuing)
purple- or red-colored spots on body or inside the mouth or nose
unpleasant breath odor (continuing)
Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:
Bloating of abdomen or stomach
cramps of abdomen or stomach
loss of appetite (temporary)
stomach pain (mild)
unusual increase in sexual desire
infection, redness, pain, or other irritation at place of injection
problems in wearing contact lenses
trouble in sleeping
Also, many women who are taking a progestin (another type of female hormone) with this medicine will begin to have monthly vaginal bleeding again, similar to menstrual periods. This effect will continue for as long as this medicine is used. However, monthly bleeding will not occur in women who have had the uterus removed by surgery (total hysterectomy).
Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.
Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.