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). 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.

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 and bladder irritability.

In women:   Clitoral enlargement, menstrual irregularities.

In both sexes:   Increased or decreased libido.

CNS:   Habituation, excitation, insomnia, depression.

Gastrointestinal:   Nausea, vomiting, diarrhea.

Hematologic:   Bleeding in patients on concomitant anticoagulant therapy.

Breast:   Gynecomastia.

Larynx:   Deepening of the voice in women.

Hair:   Hirsutism and male pattern baldness in women.

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

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

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).

Some virilizing changes in women are irreversible even after prompt discontinuance of therapy and are not prevented by concomitant use of estrogens (see PRECAUTIONS).

DRUG ABUSE AND DEPENDENCE

Controlled Substance Class: WINSTROL is classified as a controlled substance under the Anabolic Steroids Control Act of 1990 and has been assigned to Schedule III.

Anabolic steroids may increase sensitivity to anticoagulants; therefore, dosage of an anticoagulant may have to be decreased in order to maintain the prothrombin time at the desired therapeutic level.

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