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Pronunciation:

(DA na zole)

U.S. Brand Names:

Danocrine®

Generic Available:

Yes

Canadian Brand Names:

Cyclomen®; Danocrine®

Use:

Treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema

Pregnancy Risk Factor:

Pregnancy Implications:

Pregnancy should be ruled out prior to treatment using a sensitive test (beta subunit test, if available). Nonhormonal contraception should be used during therapy. May cause androgenic effects to the female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been reported.

Lactation:

Enters breast milk/contraindicated

Contraindications:

Hypersensitivity to danazol or any component of the formulation; undiagnosed genital bleeding; pregnancy; breast-feeding; porphyria; markedly impaired hepatic, renal, or cardiac function

Warnings/Precautions:

Use with caution in patients with seizure disorders, migraine, or conditions influenced by edema. Thromboembolism, thrombotic, and thrombophlebitic events have been reported (including life-threatening or fatal strokes). Peliosis hepatis and benign hepatic adenoma have been reported with long-term use (may be complicated by acute intra-abdominal hemorrhage). May cause benign intracranial hypertension (pseudotumor cerebri). Breast cancer should be ruled out prior to treatment for fibrocystic breast disease. May increase risk of atherosclerosis and coronary artery disease due to decreased HDL and possible increase of LDL. May cause nonreversible androgenic effects. Pregnancy must be ruled out prior to treatment. Safety and efficacy in pediatric patients have not been established.

Adverse Reactions:

Frequency not defined.

Cardiovascular: Benign intracranial hypertension (rare), edema, flushing, hypertension

Central nervous system: Anxiety (rare), chills (rare), convulsions (rare), depression, dizziness, emotional lability, fainting, fever (rare), Guillain-Barré syndrome, headache, nervousness, sleep disorders, tremor

Dermatologic: Acne, hair loss, mild hirsutism, maculopapular rash, papular rash, petechial rash, pruritus, purpuric rash, seborrhea, Stevens-Johnson syndrome (rare), photosensitivity (rare), urticaria, vesicular rash

Endocrine & metabolic: Amenorrhea (which may continue post therapy), breast size reduction, clitoris hypertrophy, glucose intolerance, HDL decreased, LDL increased, libido changes, nipple discharge, menstrual disturbances (spotting, altered timing of cycle), semen abnormalities (changes in volume, viscosity, sperm count/motility), spermatogenesis reduction

Gastrointestinal: Appetite changes (rare), bleeding gums (rare), constipation, gastroenteritis, nausea, pancreatitis (rare), vomiting, weight gain

Genitourinary: Vaginal dryness, vaginal irritation, pelvic pain

Hematologic: Eosinophilia, erythrocytosis (reversible), leukocytosis, leukopenia, platelet count increased, polycythemia, RBC increased, thrombocytopenia

Hepatic: Cholestatic jaundice, hepatic adenoma, jaundice, liver enzymes (elevated), malignant tumors (after prolonged use), peliosis hepatis

Neuromuscular & skeletal: Back pain, carpal tunnel syndrome (rare), extremity pain, joint lockup, joint pain, joint swelling, muscle cramps, neck pain, paresthesia, spasms, weakness

Ocular: Cataracts (rare), visual disturbances

Renal: Hematuria

Respiratory: Nasal congestion (rare)

Miscellaneous: Voice change (hoarseness, sore throat, instability, deepening of pitch), diaphoresis

Drug Interactions:

Inhibits CYP3A4 (weak)

Carbamazepine: Danazol may increase carbamazepine concentrations, requiring a decreased dosage of carbamazepine; monitor

Cyclosporine: Danazol may increase cyclosporine concentrations leading to increased toxicity; dosage of cyclosporine may need decreased; monitor

HMG-CoA reductase inhibitors: Concomitant use may lead to severe myopathy or rhabdomyolysis; effect seen with lovastatin

Hormonal contraceptives: Danazol also inhibits ovulation, possibly by acting at (and competing for) the same hormonal receptors; nonhormonal birth control methods are recommended during therapy.

Hypoglycemic agents: Danazol effects glucose metabolism, concurrent use may lead to hypoglycemia; monitor

Tacrolimus: Danazol may increase tacrolimus concentrations leading to increased toxicity; monitor

Warfarin: Increased anticoagulant effect; avoid concomitant use if possible

Ethanol/Nutrition/Herb Interactions:

Food: Delays time to peak; high-fat meal increases plasma concentration

Stability:

Store at controlled room temperature of 15°C to 30°C (59°F to 86°F).

Mechanism of Action:

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

Pharmacodynamics/Kinetics:

Onset of action: Therapeutic: ~4 weeks

Metabolism: Extensively hepatic, primarily to 2-hydroxymethylethisterone

Half-life elimination: 4.5 hours (variable)

Time to peak, serum: Within 2 hours

Excretion: Urine

Dosage:

Adults: Oral:

Female: Endometriosis: Initial: 200-400 mg/day in 2 divided doses for mild disease; individualize dosage. Usual maintenance dose: 800 mg/day in 2 divided doses to achieve amenorrhea and rapid response to painful symptoms. Continue therapy uninterrupted for 3-6 months (up to 9 months).

Female: Fibrocystic breast disease: Range: 100-400 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.

Monitoring Parameters:

Signs and symptoms of intracranial hypertension (papilledema, headache, nausea, vomiting), lipoproteins, androgenic changes, hepatic function

Test Interactions:

Testosterone, androstenedione, dehydroepiandrosterone

Patient Education:

Inform prescriber of all prescriptions, OTC medications, or herbal products you are taking, and any allergies you have. Do not take any new medication during therapy unless approved by prescriber. Take as directed; do not discontinue without consulting prescriber. Therapy may take up to several months depending on purpose for therapy. If you have diabetes, monitor serum glucose closely and notify prescriber of changes; this medication can alter hypoglycemic requirements. Consult prescriber for appropriate self-breast-exam technique. May cause headache, sleeplessness, anxiety (use caution when driving or engaging in potentially hazardous tasks until response to drug is known); 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 (eg, swelling of ankles, feet, or hands, respiratory difficulty, or sudden weight gain); change in color of urine or stool; yellowing of eyes or skin; unusual bruising or bleeding; or other adverse reactions. Pregnancy/breast-feeding precautions: Inform prescriber if you are pregnant. Consult prescriber for appropriate contraceptive measures. This drug may cause severe fetal defects. Do not donate blood during or for 1 month following therapy. Do not breast-feed.

Dental Health: Effects on Dental Treatment:

No significant effects or complications reported

Dental Health: Vasoconstrictor/Local Anesthetic Precautions:

No information available to require special precautions

Mental Health: Effects on Mental Status:

May cause dizziness

Mental Health: Effects on Psychiatric Treatment:

None reported

Dosage Forms:

Capsule: 50 mg, 100 mg, 200 mg

International Brand Names:

Anargil® (CZ, TH); Azol® (AU, ID, SG); Cipladanogen® (CO); Cyclomen® (CA); Danasin® (TR); Danatrol® (BE, CH, ES, FR, IT, LU, NL); Danazant® (HK, IE); Danazol® (GB, PL); Danazol-ratiopharm® (DE); Danocrine® (AU, CA, DK, FI, HK, ID, IL, NO, NZ, SE); Danodiol® (CY, EC); Danogar® (CL); Danogen® (IN); Danokrin® (AT); Danol® (BG, CY, CZ, EG, GB, IE, JO, KW, LB, RO, RU); Danol-Danazol® (PL); Danoval® (CZ, HR, HU, PL, RO, RU, SI); Dzol® (NZ); Ectopal® (HK, TH); Ladogal® (AR, BR, CO, MX, SG, TH); Norciden® (MX); Vabon® (TH); Zendol® (IN)

References

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.

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