Androgens and Estrogens (Systemic)

Side Effects of This Medicine

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:

Less common

Yellow eyes or skin

Rare

Uncontrolled jerky muscle movements; vomiting of blood (with long-term use or high doses)

Also, check with your doctor as soon as possible if any of the following side effects occur:

More common

Acne or oily skin (severe); breast pain or tenderness; changes in vaginal bleeding (spotting, breakthrough bleeding, prolonged or heavier bleeding, or complete stoppage of bleeding); enlarged clitoris; 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

Confusion; dizziness; flushing or redness of skin; headaches (frequent or continuing); hives (especially at place of injection); shortness of breath (unexplained); skin rash, hives, or itching; unusual bleeding; unusual tiredness or drowsiness

With long-term use or high doses

Black, tarry, or light-colored stools; dark-colored urine; general feeling of discomfort or illness (continuing); hives (frequent or continuing); loss of appetite (continuing); lump in, or discharge from breast; nausea (severe); pain, swelling, or tenderness in stomach or upper abdomen (continuing); purple- or red-colored spots on body or inside the mouth or nose; sore throat or fever (continuing); unpleasant breath odor (continuing); vomiting (severe)

Other 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. However, check with your doctor if any of the following side effects continue or are bothersome:

More common

Bloating of abdomen or stomach; cramps of abdomen or stomach; loss of appetite (temporary); nausea (mild); stomach pain (mild); unusual increase in sexual desire; vomiting (mild)

Less common

Constipation; diarrhea (mild); dizziness (mild); headaches (mild); infection, redness, pain, or other irritation at place of injection; migraine headaches; 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 above may also occur in some patients. If you notice any other effects, check with your doctor.