Drug Information for ANADROL -50 (oxymetholone) 50 mg Tablets (ALAVEN Pharmaceutical): ADVERSE REACTIONS

  • 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).

    Genitourinary System:

    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 Information Provided by National Library of Medicine (NLM).