Oxandrolone (ox-AN-droe-lone)

Helps you regain weight lost because of severe health conditions (such as surgery, illness, or trauma). Helps your body recover from side effects caused by long-term corticosteroid use. Also treats bone pain caused by osteoporosis. This medicine is an anabolic steroid.

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. Do not use more than directed.
• This medicine is not for long-term use. It is most often used for a total of 2 to 4 weeks. Your doctor may then repeat your treatment after a rest period.

If a dose is missed:

• Take a dose as soon as you remember. If it is almost time for your next dose, wait until then and take a regular dose. Do not take extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine:

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine out of the reach of children. Never share your medicine with anyone.

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 other steroids, blood thinners (warfarin, Coumadin®), or oral diabetes medicine (such as glipizide, glyburide, metformin, Actos®, Avandia®, Glucotrol®, Glucophage®, Glucovance®).

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, high cholesterol, liver disease, kidney disease, prostate problems, or hemophilia (bleeding disorders). Tell your doctor if you have diabetes or have recently had a heart attack.
• Your doctor will check your progress and the effects of this medicine at regular visits. Keep all appointments. Children using this medicine may need to have their bone growth rate checked with x-rays every few months.
• Tell any doctor or dentist who treats you that you are using this medicine. This medicine may affect certain medical test results.
• This medicine will not enhance or improve athletic performance or ability.

Possible Side Effects While Using This Medicine:

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

• Dark-colored urine or pale stools.
• In men: Frequent or ongoing erection of your penis, acne.
• In women: Acne, facial or chest hair growth, deeper voice.
• Nausea, vomiting, loss of appetite, pain in your upper stomach.
• Rapid weight gain.
• Swelling in your hands, ankles, or feet.
• Unusual bleeding or bruising.
• Yellowing of your skin or the whites of your eyes.

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

• Changes in your menstrual periods.
• Changes in hair growth or skin color.
• Breast swelling or tenderness.

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