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Oxandrolone 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.

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

Oxandrolone may be habit-forming. Never share oxandrolone 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. Oxandrolone doses are based on weight in children.

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

Oxandrolone 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. Oxandrolone is a drug of abuse and you should be aware if anyone is using your medicine improperly or without a prescription.

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

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 oxandrolone may develop male characteristics, which could be irreversible if testosterone treatment is continued. Stop taking this medicine 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.

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