Oxandrin is a man-made steroid, similar to the naturally occurring steroid testosterone. This medicine is an "anabolic" steroid that promotes the growth of muscle tissue.

Oxandrin is used to help you regain weight lost after surgery, severe trauma, or chronic infections. This medicine is also used in people who cannot gain or maintain a healthy weight for unknown medical reasons.

Oxandrin is also used to decrease muscle loss caused by using steroid medicines, and to reduce bone pain in people with osteoporosis.

Oxandrin may also be used for purposes not listed in this medication guide.

You should not use Oxandrin if you have prostate cancer, advanced kidney disease, high levels of calcium in your blood, breast cancer, or if you are pregnant.

Some people using anabolic steroid medicine have developed life-threatening side effects on the liver, spleen, and blood vessels. These conditions can occur without warning or symptoms and can lead to liver failure, internal bleeding, cancer, stroke, heart attack, or death. Talk with your doctor about the risks and benefits of using this medicine.

Oxandrin is usually given for only a few weeks. Follow all directions on your prescription label. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Oxandrin will not enhance athletic performance and should not be used for that purpose.

Oxandrin may be habit-forming. Never share this medicine with another person, especially someone with a history of drug abuse or addiction. Keep the medication in a place where others cannot get to it.

If a child is taking this medicine, tell your doctor if the child has any changes in weight. Oxandrin doses are based on weight in children.

While using Oxandrin, you will need frequent blood tests. Your kidney function may also need to be checked with urine tests.

Oxandrin can cause bone overgrowth in children, especially young children. Bone development may need to be checked with x-rays every 6 months during treatment.

Store at room temperature away from moisture and heat.

Keep track of the amount of medicine used from each new bottle. Oxandrin is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

You should not use Oxandrin if you are allergic to it, or if you have

• prostate cancer;

• advanced kidney disease;

• high levels of calcium in your blood (hypercalcemia);

• breast cancer (in men or in women who have hypercalcemia); or

• if you are pregnant.

Some people using anabolic steroid medicine have developed cysts or tumors of the liver or spleen. These conditions can occur without warning or symptoms and can lead to liver failure, internal bleeding, cancer, or death. Using anabolic steroid medicine may also cause cholesterol (lipid) changes within your blood, which can increase fatty buildup inside your arteries (also called atherosclerosis). This condition can lead to stroke or heart attack. Talk with your doctor about the risks and benefits of using Oxandrin.

To make sure Oxandrin is safe for you, tell your doctor if you have:

• liver disease;

• a history of heart disease;

• high cholesterol or triglycerides (a type of fat in the blood);

• diabetes;

• a thyroid disorder;

• chronic obstructive pulmonary disease (COPD);

• a history of stroke or blood clots;

• if you take a blood thinner (warfarin, Coumadin, Jantoven); or

• if you use other steroid medicines (prednisone, methylprednisolone, and others).

Oxandrin can harm an unborn baby or cause birth defects. Do not use if you are pregnant. Use effective birth control and tell your doctor right away if you become pregnant during treatment.

It is not known whether oxandrolone passes into breast milk or if it could harm a nursing baby. You should not breast-feed while using this medicine.

Older men may have an increased risk of developing an enlarged prostate or prostate cancer while taking this medicine. Talk with your doctor about your individual risk.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

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

Oxandrin may cause serious side effects. Call your doctor at once if you have:

• new or worsening acne;

• shortness of breath (even with mild exertion), swelling in your ankles or feet, rapid weight gain;

• increased or ongoing erection of the penis;

• unusual penis growth before puberty;

• impotence, ejaculation problems, decreased amounts of semen, decrease in testicle size;

• painful or difficult urination;

• liver problems--nausea, upper stomach pain, itching, tired feeling, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• high levels of calcium in your blood--vomiting, stomach pain, constipation, increased thirst or urination, muscle pain or weakness, joint pain, confusion, and feeling tired or restless.

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

• acne;

• changes in menstrual periods;

• male-pattern hair growth (such as on the chin or chest);

• hoarse or deepened voice; or

• enlarged clitoris.

Common side effects (in men or women) may include:

• breast swelling;

• feeling excited;

• sleep problems (insomnia); or

• increased or decreased interest in sex.

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.

Other drugs may interact with oxandrolone, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.