When This Medicine Should Not Be Used:
You should not use this medicine if you are a man with breast cancer or prostate cancer. You should not use this medicine if you are a woman who is pregnant or plans to become pregnant.

How to Use This Medicine:
Capsule, Tablet

• Take your medicine as directed. Your dose may need to be changed several times to find what works best for you.

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

• Make sure your doctor knows if you are also using insulin, oxyphenbutazone, or a blood thinner such as warfarin (Coumadin®).

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant.
• Make sure your doctor knows if you are breast feeding, or if you have heart disease, kidney disease, or liver disease.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.
• A boy using this medicine for delayed puberty should have his bone growth checked by a doctor every 6 months.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• Using this medicine over a long period of time may increase your risk of liver damage or liver cancer. Older adult men who use this medicine may have an increased risk of prostate cancer or enlargement. Talk with your doctor about your personal risks.

Possible Side Effects While Using This Medicine:
Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Dark-colored urine or pale stools.
• (In men): Acne, hair loss, erection of the penis that happens too often or lasts too long.
• (In women): Acne, facial hair growth, deeper voice, enlarged clitoris, changes in menstrual periods.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding, bruising, or weakness.
• Yellowing of your skin or the whites of your eyes.

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

• Anxiety, depression.
• Enlarged breasts (in women or men).
• Headache, numbness, or tingling.
• Increased or decreased interest in sex.

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