Danocrine Side Effects

Generic Name: danazol

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

Danocrine Side Effects - for the Professional

Danocrine

The following events have been reported in association with the use of Danocrine:

Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare.

Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60–90 days after discontinuation of therapy with Danocrine, persistent amenorrhea has occasionally been reported.

Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy.

Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of Danocrine of 400 mg or more. It is recommended that patients receiving Danocrine be monitored for hepatic dysfunction by laboratory tests and clinical observation. Serious hepatic toxicity including cholestatic jaundice, peliosis hepatis, and hepatic adenoma have been reported.

Abnormalities in laboratory tests may occur during therapy with Danocrine including CPK, glucose tolerance, glucagon, thyroid binding globulin, sex hormone binding globulin, other plasma proteins, lipids and lipoproteins.

The following reactions have been reported, a causal relationship to the administration of Danocrine has neither been confirmed nor refuted; allergic: urticaria, pruritus and rarely, nasal congestion; CNS effects: headache, nervousness and emotional lability, dizziness and fainting, depression, fatigue, sleep disorders, tremor, paresthesias, weakness, visual disturbances, and rarely, benign intracranial hypertension, anxiety, changes in appetite, chills, and rarely convulsions, Guillain-Barre syndrome; gastrointestinal: gastroenteritis, nausea, vomiting, constipation, and rarely, pancreatitis; musculoskeletal: muscle cramps or spasms, or pains, joint pain, joint lockup, joint swelling, pain in back, neck, or extremities, and rarely, carpal tunnel syndrome which may be secondary to fluid retention; genitourinary: hematuria, prolonged posttherapy amenorrhea; hematologic: an increase in red cell and platelet count. Reversible erythrocytosis, leukocytosis or polycythemia may be provoked. Eosinophilia, leukopenia and thrombocytopenia have also been noted. Skin: rashes (maculopapular, vesicular, papular, purpuric, petechial), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme; other: increased insulin requirements in diabetic patients, change in libido, myocardial infarction, palpitation, tachycardia, elevation in blood pressure, interstitial pneumonitis, and rarely, cataracts, bleeding gums, fever, pelvic pain, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

Side Effects by Body System - for Healthcare Professionals

Cardiovascular

Cardiovascular side effects have included edema and congestive heart failure.

Endocrine

Endocrine side effects have included the inhibition of estrogen synthesis, resulting in flushing, sweating, vaginal dryness and irritation, and reduction in breast size. During administration of danazol, endogenous testosterone synthesis and release may be inhibited through feedback inhibition of pituitary luteinizing hormone (LH). Large doses of danazol may suppress spermatogenesis through inhibition of pituitary follicle stimulating hormone (FSH). Danazol may decrease levels of thyroxine-binding globulin, resulting 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.

Gastrointestinal

Gastrointestinal side effects have included nausea and vomiting. Rare cases of pancreatitis have been reported.

Genitourinary

Genitourinary side effects have included oligospermia and decreased ejaculatory volume. Elderly male patients may experience prostatic enlargement resulting in urinary obstruction. Priapism and excessive stimulation may develop.

In female patients, the use of danazol may result in virilization including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities. Discontinuation of medication at signs of mild virilization may prevent irreversible virilization.

Alterations in libido may occur (increased/decreased).

Hematologic

Hematologic side effects have included thromboembolic and thrombophlebotic events (including sagittal sinus thrombosis), some resulting in fatal strokes, and increased red cell production.

Metabolic

Metabolic side effects have included significant increases in low density lipoproteins (LDL) and decreases in high density lipoproteins (HDL). Decreased glucose tolerance requiring adjustments in hyperglycemic control has occurred.

Other

Other side effects in female patients have included virilization, including deepening voice, hirsutism, acne, clitomegaly (rare), and menstrual abnormalities, due the androgenic activity of danazol. Discontinuation of danazol at signs of mild virilization may prevent irreversible virilization. Reduction in breast size may occur due to decreased estrogen synthesis.

Renal

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

Oncologic

Oncologic side effects have included rare cases of hepatic neoplasms following prolonged use.

Hepatic

Hepatic side effects have included life-threatening peliosis hepatitis and benign hepatic adenoma following prolonged danazol administration. Rare cases of hepatic neoplasms following prolonged use have been reported. Danazol can exacerbate acute intermittent porphyria. Serum transaminase levels may be increased.

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