Common and Rare Side Effects
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 may occur, if they do occur they may need medical attention.
Check with your doctor immediately if any of the following side effects occur:
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
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
early growth of pubic hair
enlargement of penis
frequent or continuing erections
For males or females
frequent or continuing headache
lack or loss of strength
overall body flushing, redness, or itching of skin
rapidly changing moods, such as depersonalization, dysphoria, euphoria, depression, paranoia, and quick to react or overreact emotionally
swelling of feet or lower legs
For females with breast cancer or bedridden males or females—in addition to the side effects listed above
Confusion or mental depression
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
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
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
loss of appetite, continuing
mood or mental changes
purple or red spots on body or inside the mouth or nose
swelling, pain, or tenderness of abdomen
vomiting of blood
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:
For males and females
decrease or increase in sexual desire or drive
hair loss or thinning of hair
increase in pubic hair growth
infection, pain, redness, or other irritation at site of injection
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 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.