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DANOCRINE (DANAZOL) CAPSULES: ADVERSE REACTIONS / SIDE EFFECTS

The following events have been reported in association with the use of Danocrine (Danazol) capsules:

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 Danazol (Danocrine) of 400 mg or more. It is recommended that patients receiving this medication 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, glucagon, glucose tolerance, 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 Danazol (Danocrine) capsules has neither been confirmed nor refuted.

Allergic: urticaria, pruritus and rarely, nasal congestion.

CNS effects: nervousness and emotional lability, headache, dizziness and fainting, fatigue, depression, sleep disorders, paresthesias, tremor, weakness, visual disturbances, and rarely, benign intracranial hypertension, changes in appetite, anxiety, chills, and rarely convulsions, Guillain-Barre syndrome.

Gastrointestinal: nausea, vomiting, gastroenteritis, constipation, and rarely, pancreatitis and splenic peliosis.

Musculoskeletal: muscle cramps or spasms, or pains, joint lockup, joint pain, joint swelling, pain in neck, back, 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 (vesicular, maculopapular, papular, petechial, purpuric), and rarely, sun sensitivity, Stevens-Johnson syndrome and erythema multiforme.

Other: increased insulin requirements in diabetic patients, myocardial infarction, change in libido, palpitation, elevation in blood pressure, tachycardia, interstitial pneumonitis, and rarely, cataracts, bleeding gums, pelvic pain, fever, nipple discharge. Malignant liver tumors have been reported in rare instances, after long-term use.

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