Androgens (Systemic)

Side Effects of This Medicine

Discuss these possible effects with your doctor:

• Tumors of the liver, liver cancer, or 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.
• Androgens can stimulate existing prostate cancer in men who already have it but have not yet been diagnosed. Also, the prostate (a male gland) may become enlarged. Enlargement of the prostate does not mean that cancer will develop. If enlargement occurs and you have difficulty in urinating, it is a good idea to be checked by your doctor.
• 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 or enlarged clitoris, may not go away.
• When androgens are used in high doses in males, they interfere with the production of sperm. This effect is usually temporary and only happens during the time you are taking the medicine. However, discuss this possible effect with your doctor if you are planning on having children.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects appear very often, when they do occur they may require medical attention. Check with your doctor as soon as possible if any of the following side effects occur:

More common

For females only

Acne or oily skin; decreased breast size; irregular menstrual cycles; hoarseness or deepening of voice; increase in size of female genitals; increase in unnatural hair growth or male pattern baldness

Note:

These symptoms may occur in females whose male sexual partner uses a scrotal patch.

For males only

Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin); breast soreness or enlargement; frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours; frequent urge to urinate; itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe

For prepubertal boys only

Acne; early growth of pubic hair; enlargement of penis; frequent or continuing erections

Less common

For males or females

Dizziness; frequent or continuing headache; lack or loss of strength; nausea; overall body flushing, redness, or itching of skin; rapid weight gain; rapidly changing moods, such as depersonalization, dysphoria, euphoria, depression, paranoia, and quick to react or overreact emotionally; swelling of feet or lower legs; unusual bleeding; unusual tiredness; vomiting; yellow skin or eyes (occurring with fluoxymesterone or methyltestosterone more often than with testosterone)

For females with breast cancer or bedridden males or females - in addition to the side effects listed above

Confusion or mental depression; constipation; increased thirst; increased urge to urinate or increased amount of urine

For males only

Black, tarry stools; burning sensation or hardening or thickening of skin under patch; chills; continuing pain at site of implants; difficulty in urinating; itching, skin redness, or rash under patch, severe (less likely with nonscrotal patch); pain in scrotum or groin; vomiting of blood or material that looks like coffee grounds

Rare

For males or females - more likely with oral androgens or long-term or high doses of androgens

Abdominal or stomach pain, continuing; bad breath odor, continuing; black, tarry or light-colored stools or dark urine; fever; hives; loss of appetite, continuing; mood or mental changes; purple or red spots on body or inside the mouth or nose; sore throat; swelling, pain, or tenderness of abdomen; vomiting of blood

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:

Less common

For males and females

Acne, mild; diarrhea; hair loss or thinning of hair; increase in pubic hair growth; infection, pain, redness, or other irritation at site of injection; decrease or increase in sexual desire or drive; nervousness; stomach pain; trouble in sleeping

For males only

Decrease in testicle size; infection, pain, redness, swelling, sores, or other skin irritation underneath patch

Other side effects not listed above may also occur in some patients. If you notice any other effects, check with your doctor.