When This Medicine Should Not Be Used:
You should not use this medicine if you have had an allergic reaction to fluoxymesterone, if you have serious heart, liver, or kidney disease, or if you are a man with breast cancer or prostate cancer. You should not use this medicine if you are pregnant or plan to become pregnant.

How to Use This Medicine:
Tablet

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

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