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Medications and Drugs

Brand Names: Androxy

Generic Name: fluoxymesterone (Pronunciation: floo OX i MES te rone)

What is fluoxymesterone (Androxy)?

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.

Fluoxymestrone 10 mg-UPS

round, green, imprinted with 832, 86

What are the possible side effects of fluoxymesterone (Androxy)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using fluoxymesterone and call your doctor at once if you have a serious side effect such as:

  • feeling short of breath, even with mild exertion;
  • swelling in your ankles, rapid weight gain;
  • increased or ongoing erection of the penis;
  • nausea, vomiting, loss of appetite, increased thirst, muscle weakness, confusion, and feeling tired or restless; or
  • upper stomach pain, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Women receiving fluoxymesterone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medication and call your doctor at once if you notice any of these signs of excess testosterone:

  • changes in menstrual periods;
  • male-pattern hair growth (such as on the chin or chest);
  • hoarse voice; or
  • enlarged clitoris.

Less serious side effects (in men or women) may include:

  • acne, changes in skin color;
  • increased hair growth;
  • male pattern baldness;
  • increased or decreased interest in sex;
  • breast swelling;
  • headache, anxiety, depression; or
  • numbness, burning, pain, or tingly feeling.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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

Fluoxymesterone can harm an unborn baby or cause birth defects. Do not use if you are pregnant.

You should not use this medication if you are allergic to fluoxymesterone, or have prostate cancer or male breast cancer.

Before taking fluoxymesterone, 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, any debilitating condition, heart disease, coronary artery disease (hardened arteries), congestive heart failure, or a history of heart attack.

To be sure this medication is helping your condition, your blood will need to be tested often. Your liver function may also need to be tested. Visit your doctor regularly. In boys who are treated for delayed puberty, bone development may need to be checked with x-rays every 6 months during treatment.

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

Report Problems to the Food and Drug Administration

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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