Peliosis hepatis, a condition in which the liver contains blood-filled cysts, reported with androgen therapy. May present with minimal hepatic dysfunction, or effects may not be apparent until complicated by life-threatening liver failure or rupture of the cysts resulting in intra-abdominal hemorrhage. (See Hepatic Effects under Cautions.)
Discontinuance of androgen therapy usually results in resolution of liver lesions.
Hepatic Adenoma and Carcinoma
Liver cell tumors reported with androgen therapy. Tumors are usually benign and androgen dependent; hepatocellular carcinoma, sometimes fatal, also reported.
Liver cell tumors associated with androgens are more vascular than other hepatic tumors; hepatic effects may not be apparent until complicated by life-threatening intra-abdominal hemorrhage.
Discontinuance of androgen therapy often but not always results in regression or cessation of progression of the tumor.
Lipid Abnormalities
May markedly alter serum lipoprotein concentrations; decreased HDL- and increased LDL-cholesterol reported with androgen therapy. Consider increased risk of cardiovascular disease (e.g., atherosclerosis and CAD). (See Lipid Abnormalities under Cautions.)
OXANDROLONE (ox AN droe lone) is a steroid. This medicine is used to help people gain weight. It is also used to treat bone pain in patients with osteoporosis.
This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.
What should I tell my health care provider before I take this medicine?
They need to know if you have any of these conditions:
Take this medicine by mouth with a glass of water. Follow the directions on the prescription label. Take your doses at regular intervals. Do not take your medicine more often than directed.
Talk to your pediatrician regarding the use of this medicine in children. While this drug may be prescribed for selected conditions, precautions do apply.
Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.
NOTE: This medicine is only for you. Do not share this medicine with others.
What if I miss a dose?
If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.
This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.
What should I watch for while using this medicine?
Visit your doctor for regular check ups. You will need important blood work done while you are taking this medicine.
This medicine has not been shown to improve athletic ability.
This medicine may affect blood sugar levels. If you have diabetes, check with your doctor or health care professional before you change your diet or the dose of your diabetic medicine.
This medicine is banned from use by the US and the International Olympic Committees and other athletic organizations.
What side effects may I notice from receiving this medicine?
Side effects that you should report to your doctor or health care professional as soon as possible:
allergic reactions like skin rash, itching or hives, swelling of the face, lips, or tongue
breast enlargement
breathing problems
changes in mood, especially anger, depression, or rage
dark urine
in women: acne, change in monthly cycle, deep voice, enlarged clitoris, more face hair
This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Where should I keep my medicine?
Keep out of the reach of children. This medicine can be abused. Keep your medicine in a safe place to protect it from theft. Do not share this medicine with anyone. Selling or giving away this medicine is dangerous and against the law.
Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Keep container tightly closed. Throw away any unused medicine after the expiration date.
NOTE:This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.
Remember, keep this and all other medicines out of the reach of children,
never share your medicines with others, and use this medication only for the indication prescribed.
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