No

Androgen

Treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema

X

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

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

>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

CYP3A3/4 enzyme inhibitor

Suppresses pituitary output of follicle-stimulating hormone and luteinizing hormone that causes regression and atrophy of normal and ectopic endometrial tissue; decreases rate of growth of abnormal breast tissue; reduces attacks associated with hereditary angioedema by increasing levels of C4 component of complement

Onset of therapeutic effect: Within 4 weeks following daily doses

Metabolism: Extensive hepatic metabolism, primarily to 2-hydroxymethylethisterone

Half-life: 4.5 hours (variable)

Time to peak serum concentration: Within 2 hours

Elimination: In urine

Adults: Oral:

Female: Fibrocystic breast disease: Range: 10-400 mg/day in 2 divided doses

Male/Female: Hereditary angioedema: Initial: 200 mg 2-3 times/day; after favorable response, decrease the dosage by 50% or less at intervals of 1-3 months or longer if the frequency of attacks dictates. If an attack occurs, increase the dosage by up to 200 mg/day.

May cause dizziness

None reported

No information available to require special precautions

No effects or complications reported

Take as directed; do not discontinue without consulting prescriber. Therapy may take up to several months depending on purpose for therapy. Diabetics should monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. You may experience acne, growth of body hair, deepening of voice, loss of libido, impotence, or menstrual irregularity (usually reversible). Report changes in menstrual pattern; deepening of voice or unusual growth of body hair; persistent penile erections; fluid retention (swelling of ankles, feet, or hands, difficulty breathing, or sudden weight gain); change in color of urine or stool; yellowing of eyes or skin; unusual bruising or bleeding; or other adverse reactions.

Notify physician if masculinity effects occur

Capsule: 50 mg, 100 mg, 200 mg

Gately LE 3d and Andes WA, "Danazol and Erythema Multiforme," Ann Intern Med, 1988, 109(1):85.

Makdisi WJ, Cherian R, Vanveldhuizen PJ, et al, "Fatal Peliosis of the Liver and Spleen in a Patient With Agnogenic Myeloid Metaplasia Treated With Danazol," Am J Gastroenterol, 1995, 90(2):317-8.

Saenger P, "Abnormal Sex Differentiation," J Pediatr, 1984, 104(1):1-17.

Weinblatt ME, Kochen J, and Ortega J, "Danazol for Children With Immune Thrombocytopenic Purpura," Am J Dis Child, 1988, 142(12):1317-9.