Fluoxymesterone (floo-ox-i-MES-ter-one)

Treats a lack of natural testosterone in males and breast cancer in women.

Brand Name(s):

When This Medicine Should Not Be Used:

How to Use This Medicine:

Tablet

• Your doctor will tell you how much medicine to use and how often.

If a dose is missed:

• Use the missed dose as soon as possible, unless it is almost time for your next dose.
• Skip the missed dose if it is almost time for your next regular dose.
• You should not use two doses at the same time.

How to Store and Dispose of This Medicine:

• Store the tablets at room temperature, away from heat, moisture, and direct light.
• Keep all medicine out of the reach of children.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Tell your doctor if you are using insulin shots, or warfarin (Coumadin®).

Warnings While Using This Medicine:

• Talk with your doctor before using fluoxymesterone if you have liver, or kidney disease, heart failure, diabetes, an enlarged prostate, or high levels of calcium in your blood (hypercalcemia).
• Do not breastfeed while using this medicine. Do not get pregnant while you are being treated with this medicine. Fluoxymesterone may cause birth defects or be harmful to an unborn baby.
• If you are a young male receiving fluoxymesterone, you will have x-rays of your hands and wrists every six months to check your bone growth.
• All patients using this medicine may need tests on a regular schedule to make sure the medicine is not causing harmful side effects.
• Fluoxymesterone will not help you perform better in sports. This medicine should not be used for this purpose because of serious side effects.
• Some brands of fluoxymesterone contain a yellow dye called tartrazine, which may cause severe allergic reactions. Tell your doctor if you are allergic to dyes or aspirin.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Unusual bleeding or bruising
• Yellowing of eyes and skin

If you notice these less serious side effects, talk with your doctor:

• Swelling of hands, legs, or feet
• Baldness
• Acne
• Changes in menstrual periods
• Deepening of voice in women
• Enlarged clitoris
• Headache, anxiety
• Nausea or vomiting
• Skin rash
• Increase in facial hair in females
• Frequent and long lasting erections
• Changes in your skin color
• Swollen breasts in men

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088