Side Effects

Drug information provided by: Merative, Micromedex®

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:

More common

For females only
  1. Acne or oily skin
  2. decreased breast size
  3. irregular menstrual cycles
  4. hoarseness or deepening of voice
  5. increase in size of female genitals
  6. increase in unnatural hair growth or male pattern baldness
For males only
  1. Blistering of skin under patch (especially when the nonscrotal patch is applied to bony areas of the skin)
  2. breast soreness or enlargement
  3. frequent or continuing erection of penis lasting up to 4 hours or painful penile erections lasting longer than 4 hours
  4. frequent urge to urinate
  5. itching or redness of skin under patch (less likely with nonscrotal patch) or at site of implants, mild to severe
For prepubertal boys only
  1. Acne
  2. early growth of pubic hair
  3. enlargement of penis
  4. frequent or continuing erections

Less common

For males or females
  1. Dizziness
  2. frequent or continuing headache
  3. lack or loss of strength
  4. nausea
  5. overall body flushing, redness, or itching of skin
  6. rapidly changing moods, such as depersonalization, dysphoria, euphoria, depression, paranoia, and quick to react or overreact emotionally
  7. swelling of feet or lower legs
  8. unusual bleeding
  9. unusual tiredness
  10. 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
  1. Confusion or mental depression
  2. constipation
  3. increased thirst
  4. increased urge to urinate or increased amount of urine
For males only
  1. Black, tarry stools
  2. burning sensation or hardening or thickening of skin under patch
  3. chills
  4. continuing pain at site of implants
  5. difficulty in urinating
  6. itching, skin redness, or rash under patch, severe (less likely with nonscrotal patch)
  7. pain in scrotum or groin
  8. 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
  1. Abdominal or stomach pain, continuing
  2. bad breath odor, continuing
  3. black, tarry or light-colored stools or dark urine
  4. fever
  5. hives
  6. loss of appetite, continuing
  7. mood or mental changes
  8. purple or red spots on body or inside the mouth or nose
  9. sore throat
  10. swelling, pain, or tenderness of abdomen
  11. 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:

Less common

For males and females
  1. Acne, mild
  2. decrease or increase in sexual desire or drive
  3. diarrhea
  4. hair loss or thinning of hair
  5. increase in pubic hair growth
  6. infection, pain, redness, or other irritation at site of injection
  7. nervousness
  8. stomach pain
  9. trouble in sleeping
For males only
  1. Decrease in testicle size
  2. 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.