Oxymetholone

Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis have been reported in association with long-term androgenic anabolic steroid therapy (see WARNINGS).

In Men

Prepubertal: Phallic enlargement and increased frequency of erections.

Postpubertal: Inhibition of testicular function, testicular atrophy and oligospermia, impotence, chronic priapism, epididymitis, bladder irritability and decrease in seminal volume.

In Women

Clitoral enlargement, menstrual irregularities.

In Both Sexes

Increased or decreased libido.

CNS: Excitation, insomnia.

Gastrointestinal: Nausea, vomiting, diarrhea.

Hematologic: Bleeding in patients on concomitant anticoagulant therapy, iron-deficiency anemia.

Leukemia has been observed in patients with aplastic anemia treated with oxymetholone. The role, if any, of oxymetholone is unclear because malignant transformation has been seen in patients with blood dyscrasias and leukemia has been reported in patients with aplastic anemia who have not been treated with oxymetholone.

Breast: Gynecomastia.

Larynx: Deepening of the voice in women.

Hair: Hirsutism and male-pattern baldness in women, male-pattern of hair loss in postpubertal males.

Skin: Acne (especially in women and prepubertal boys).

Skeletal: Premature closure of epiphyses in children (see PRECAUTIONS, Pediatric Use), muscle cramps.

Body as a Whole: Chills.

Fluid and Electrolytes: Edema, retention of serum electrolytes (sodium, chloride, potassium, phosphate, calcium).

Metabolic/Endocrine: Decreased glucose tolerance (see PRECAUTIONS), increased serum levels of low-density lipoproteins and decreased levels of high-density lipoproteins (see PRECAUTIONS, Laboratory Tests), increased creatine and creatinine excretion, increased serum levels of creatinine phosphokinase (CPK). Reversible changes in liver function tests also occur, including increased Bromsulphalein (BSP) retention and increases in serum bilirubin, glutamic-oxaloacetic transaminase (SGOT), and alkaline phosphatase.

Drug Abuse And Dependence

ANADROL Tablets is considered to be a controlled substance and is listed in Schedule III.

Read the entire FDA prescribing information for Anadrol-50 (Oxymetholone)

Take oxymetholone exactly as prescribed by your doctor. Follow the directions on your prescription label carefully.

The Oxymetholone dose your doctor recommends will be based on the following (use any or all that apply):

• the condition being treated
• other medical conditions you have
• other medications you are taking
• how you respond to this medication
• your weight
• your height
• your age
• your gender

Oxymetholone is available in the following doses:

• Oxymetholone 50 Mg Oral Tablet

You should not use this medicine if you have severe liver or kidney disease, prostate cancer, male breast cancer, or female breast cancer with high levels of calcium in the blood.

Do not use oxymetholone if you are pregnant.

Long-term use of oxymetholone can cause liver tumors or blood-filled cysts in your liver or spleen. Call your doctor at once if you have upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes), or rapid weight gain (especially in your face and midsection).

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

• prostate cancer;

• male breast cancer;

• female breast cancer with high levels of calcium in the blood;

• severe liver disease;

• severe kidney disease; or

• if you are pregnant.

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

• liver or kidney disease;

• heart disease, congestive heart failure;

• coronary artery disease (hardened arteries);

• high cholesterol or triglycerides;

• diabetes;

• bleeding or blood clotting disorder;

• enlarged prostate; or

• if you also take a blood thinner (warfarin, Coumadin, Jantoven).

FDA pregnancy category X. This medicine can harm an unborn baby or cause birth defects. Do not use oxymetholone if you are pregnant. Tell your doctor right away if you become pregnant during treatment. Use effective birth control while you are using this medicine.

This medicine may affect fertility (your ability to have children), whether you are a man or a woman.

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

Do not give this medicine to anyone under 18 years old without medical advice. A child using oxymetholone may need x-rays every 6 months to make sure this medicine is not causing harmful effects on bone growth.

Do not share this medicine with another person.

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.

Other drugs may interact with oxymetholone, 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.

• It is used to treat anemia.

(oks i METH oh lone)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Tablet, Oral:

Anadrol-50: 50 mg [scored]

Hypersensitivity to oxymetholone or any component of the formulation; breast cancer in men; breast cancer in women with hypercalcemia; prostate cancer; severe hepatic dysfunction; nephrosis or nephrotic phase of nephritis; pregnancy or use in women who may become pregnant

Refer to adult dosing.

Peliosis hepatis, a condition in which liver and, sometimes, splenic tissue is replaced with blood-filled cysts, has occurred in patients receiving androgenic anabolic steroids. These cysts are sometimes present with minimal hepatic dysfunction and have been associated with liver failure. Often, they are not recognized until life-threatening liver failure or intra-abdominal hemorrhage develops. Withdrawal of drug usually results in complete disappearance of lesions.

Most often these tumors are benign and androgen-dependent, but fatal malignant tumors have occurred. Withdrawal of drug often results in regression or cessation of tumor progression. However, hepatic tumors associated with androgens or anabolic steroids are much more vascular than other hepatic tumors and may be silent until life-threatening, intra-abdominal hemorrhage develops.

Blood lipid changes associated with increased risk of atherosclerosis are seen in patients treated with androgens and anabolic steroids. These changes include decreased high-density lipoprotein (HDL) and, sometimes, increased low-density lipoprotein (LDL). The changes may be very marked and could have a serious impact on the risk of atherosclerosis and coronary artery disease.

Data not available