Fluoxymesterone is a man-made form of testosterone, a naturally occurring sex hormone that is produced in a man’s testicles. Small amounts of testosterone are also produced in a woman’s ovaries and adrenal system.

Fluoxymesterone is used in men and boys to treat conditions caused by a lack of this hormone, such as delayed puberty or other hormonal imbalances.

Fluoxymesterone is also used in women to treat breast cancer that has spread to other parts of the body. Fluoxymesterone treats only the symptoms of metastatic breast cancer but does not treat the cancer itself.

Fluoxymesterone may also be used for purposes not listed in this medication guide.

What is the most important information I should know about fluoxymesterone?

This medicine can cause birth defects. Do not use fluoxymesterone if you are pregnant.

You should not use fluoxymesterone if you have prostate cancer or male breast cancer.

Fluoxymesterone will not enhance athletic performance and should not be used for that purpose or shared with another person.

What should I discuss with my healthcare provider before taking fluoxymesterone?

You should not use fluoxymesterone if you are allergic to it, or if you have:

• prostate cancer;
• male breast cancer; or
• if you are pregnant.

Fluoxymesterone will not enhance athletic performance and should not be used for that purpose or shared with another person.

To make sure fluoxymesterone is safe for you, tell your doctor if you have:

• benign prostatic hypertrophy (BPH);
• breast cancer;
• delayed puberty (unless you are taking fluoxymesterone to treat it);
• liver or kidney disease;
• diabetes;
• any debilitating condition; or
• heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.

This medication can harm an unborn baby or cause birth defects. Do not use fluoxymesterone if you are pregnant. Use effective birth control to avoid pregnancy during your treatment with fluoxymesterone. Follow your doctor’s instructions about how long to prevent pregnancy after your treatment ends.