Treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema

Use with caution in patients with seizure disorders, migraine, or conditions influenced by edema; impaired hepatic, renal, or cardiac disease, pregnancy, lactation

Undiagnosed genital bleeding, hypersensitivity to danazol or any component; pregnancy

>10% : Cardiovascular: Edema ; Dermatologic: Oily skin, acne, hirsutism ; Endocrine & metabolic: Fluid retention, breakthrough bleeding, irregular menstrual periods, decreased breast size; Gastrointestinal: Weight gain; Hepatic: Hepatic impairment ; Miscellaneous: Voice deepening ;

1% to 10% : Endocrine & metabolic: Virilization, androgenic effects, amenorrhea, hypoestrogenism ; Neuromuscular & skeletal: Weakness ;<1% : Benign intracranial hypertension, dizziness, headache, skin rashes, photosensitivity, pancreatitis, bleeding gums, monilial vaginitis, testicular atrophy, enlarged clitoris, cholestatic jaundice, carpal tunnel syndrome

Increased toxicity: Decreased insulin requirements; warfarin may increase anticoagulant effects

Notify physician if masculinity effects occur; virilization may occur in female patients; report menstrual irregularities; male patients report persistent penile erections; all patients should report persistent GI distress, diarrhea, or jaundice