Oxandrin Side Effects

Generic Name: oxandrolone

Please note - some side effects for Oxandrin may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Side Effects of Oxandrin - for the Consumer

Oxandrin

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome when using Oxandrin:

Difficulty sleeping.

Seek medical attention right away if any of these SEVERE side effects occur when using Oxandrin:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); acne; changes in sexual desire; changes in skin color; confusion; dark urine; deepening of the voice, unusual hair growth (especially facial hair), or hoarseness; depression; easy bruising or bleeding; enlarged genitals or breasts; excitability; frequent or persistent erections; increased urination or thirst; irregular heartbeat; loss of appetite; menstrual irregularities; mental or mood changes; muscle cramps or twitching; nausea or vomiting; stomach pain; swelling of the ankles or hands; unusual tiredness; yellowing of the skin or eyes.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. To report side effects to the appropriate agency, please read the Guide to Reporting Problems to FDA.

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Oxandrin Side Effects - for the Professional

Oxandrin

Patients with moderate to severe COPD or COPD patients who are unresponsive to bronchodilators should be monitored closely for COPD exacerbation and fluid retention.

The following adverse reactions have been associated with use of anabolic steroids: Hepatic: Cholestatic jaundice with, rarely, hepatic necrosis and death. Hepatocellular neoplasms and peliosis hepatis with long-term therapy. Reversible changes in liver function tests also occur including increased bromsulfophthalein (BSP) retention, changes in alkaline phosphatase and increases in serum bilirubin, aspartate aminotransferase (AST, SGOT) and alanine aminotransferase (ALT, SGPT)

In males:

Prepubertal: Phallic enlargement and increased frequency or persistence of erections.

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

In females:

Clitoral enlargement, menstrual irregularities.

CNS: Habituation, excitation, insomnia, depression, and changes in libido.

Hematologic: Bleeding in patients on concomitant oral anticoagulant therapy.

Breast: Gynecomastia.

Larynx: Deepening of the voice in females.

Hair: Hirsutism and male pattern baldness in females.

Skin: Acne (especially in females and prepubertal males).

Skeletal: Premature closure of epiphyses in children.

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

Metabolic/Endocrine: Decreased glucose tolerance, increased creatinine excretion, increased serum levels of  creatinine phosphokinase (CPK). Masculinization of the fetus. Inhibition of gonadotropin secretion.

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Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included edema, with and without congestive heart failure.

Genitourinary

Genitourinary side effects following chronic administration and/or large dosages of anabolic steroids have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop. Female patients may experience virilization including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization. Alterations in libido may occur (increased/decreased).

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and hepatic abnormalities, such as hepatic neoplasms and hepatocellular carcinomas, following prolonged therapy with high doses of anabolic steroids. Tumor regression did not occur in all cases following medication withdrawal. Cholestatic hepatitis, jaundice, and abnormal liver function tests can occur at relatively low dosages.

Hepatic tumors associated with anabolic steroid use are more vascular than other hepatic tumors and may remain silent until the development of life-threatening abdominal hemorrhage. Peliosis hepatitis may present as mild liver dysfunction, but has resulted in liver failure.

Other

Other side effects have included virilization of female patients including deepening voice, hirsutism, acne, clitomegaly (not reversible), and menstrual abnormalities. Discontinuation of anabolic steroids at signs of mild virilization may prevent irreversible virilization

Musculoskeletal

Musculoskeletal effects have included termination of linear bone growth due to closure of the epiphyseal growth centers. Appropriate monitoring of bone age is recommended during use in prepubertal patients.

Hematologic

Hematologic side effects have included alterations in clotting factors II, V, VII and X, prolonged prothrombin time (PT), and increased red cell production.

Endocrine

Endocrine side effects have included inhibition of endogenous testosterone release by means of feedback inhibition of pituitary luteinizing hormone (LH). Large doses of exogenous anabolic steroids may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin and result in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction.

Metabolic

Metabolic side effects have included osteolytic-induced hypercalcemia in immobilized patients or those with metastatic breast disease. Anabolic steroids affect electrolyte balance, nitrogen retention, and urinary calcium excretion. Edema, with and without congestive heart failure, has occurred during anabolic steroid therapy. Decreased glucose tolerance requiring adjustments in hyperglycemic control has been noted in diabetic patients. The androgenic activity of anabolic steroids may decrease levels of thyroxin-binding globulin and result in decreased total T4 serum levels and increased resin uptake of T3 and T4. Free thyroid hormone levels remain unchanged and there is no clinical evidence of thyroid dysfunction. Significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL) have occurred.

Renal

Renal side effects have included retention of nitrogen, sodium, potassium, chloride, water and phosphorus, and decreased urinary excretion of calcium.

Oncologic

Oncologic side effects have included hepatic neoplasms and hepatocellular carcinomas following prolonged therapy with large doses of anabolic steroids.

Gastrointestinal

Gastrointestinal side effects have included nausea, vomiting, and diarrhea.

Psychiatric

Psychiatric side effects have included habituation, excitation, insomnia, depression, and libido changes.

Dermatologic

Dermatologic side effects have included acne and changes in skin color. The greatest incidence of occurrence has been in women and prepubertal males.

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