(DA na zole)
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Generic: 50 mg, 100 mg, 200 mg
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
Extensively hepatic, primarily to 2-hydroxymethyl danazol and ethisterone
Urine and feces
Onset of Action
Therapeutic: ~4 weeks
Time to Peak
Serum: Within 2-8 hours (median 4 hours)
~10 hours (variable; up to 24 hours following long-term use for endometriosis)
Use: Labeled Indications
Treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema
Hypersensitivity to danazol or any component of the formulation; undiagnosed genital bleeding; pregnancy; breast-feeding; porphyria; markedly impaired hepatic, renal, or cardiac function; androgen-dependent tumor; active or history of thrombosis or thromboembolic disease
Mild disease: Initial: 200-400 mg/day in 2 divided doses
Moderate-to-severe disease: Initial: 800 mg/day in 2 divided doses
Maintenance: Mild-severe disease: Dosage should be individualized. Continue therapy uninterrupted for 3-6 months (up to 9 months).
Females: Fibrocystic breast disease: Range: 100-400 mg/day in 2 divided doses. Pain and tenderness may be eliminated in 2-3 months; elimination of nodularity may require therapy for 4-6 months.
Males/Females: 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.
Dosage adjustment in renal impairment: Use is contraindicated in patients with markedly impaired renal function.
Dosage adjustment in hepatic impairment: Use is contraindicated in patients with markedly impaired hepatic function.
Endometriosis, fibrocystic breast disease: Initiate therapy during menstruation or ensure patient is not pregnant while on therapy. Symptoms may recur following discontinuation of therapy and treatment may need reinstated.
Store at controlled room temperature of 15°C to 30°C (59°F to 86°F).
Antidiabetic Agents: Hyperglycemia-Associated Agents may diminish the therapeutic effect of Antidiabetic Agents. Monitor therapy
ARIPiprazole: CYP3A4 Inhibitors (Weak) may increase the serum concentration of ARIPiprazole. Management: Monitor for increased aripiprazole pharmacologic effects. Aripiprazole dose adjustments may or may not be required based on concomitant therapy and/or indication. Consult full interaction monograph for specific recommendations. Monitor therapy
C1 inhibitors: Androgens may enhance the thrombogenic effect of C1 inhibitors. Monitor therapy
CarBAMazepine: Danazol may decrease the metabolism of CarBAMazepine. Consider therapy modification
Corticosteroids (Systemic): May enhance the fluid-retaining effect of Androgens. Monitor therapy
CycloSPORINE (Systemic): Androgens may enhance the hepatotoxic effect of CycloSPORINE (Systemic). Androgens may increase the serum concentration of CycloSPORINE (Systemic). Consider therapy modification
Dofetilide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Dofetilide. Monitor therapy
Flibanserin: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Flibanserin. Monitor therapy
HMG-CoA Reductase Inhibitors: Danazol may increase the serum concentration of HMG-CoA Reductase Inhibitors. Management: Concurrent use of simvastatin with danazol is contraindicated. Initiate lovastatin at an adult maximum dose of 10 mg/day, and do not exceed 20 mg/day, when danazol is given concomitantly. Fluvastatin, pravastatin and rosuvastatin may pose lower risk. Exceptions: Fluvastatin; Pravastatin; Rosuvastatin. Consider therapy modification
Hydrocodone: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Hydrocodone. Monitor therapy
Lomitapide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Lomitapide. Management: Limit the maximum adult dose of lomitapide to 30 mg daily when used in combination with any weak CYP3A4 inhibitor. Consider therapy modification
NiMODipine: CYP3A4 Inhibitors (Weak) may increase the serum concentration of NiMODipine. Monitor therapy
Pimozide: CYP3A4 Inhibitors (Weak) may increase the serum concentration of Pimozide. Avoid combination
Simvastatin: Danazol may increase the serum concentration of Simvastatin. Avoid combination
Tacrolimus (Systemic): Danazol may increase the serum concentration of Tacrolimus (Systemic). Monitor therapy
Tacrolimus (Topical): Danazol may increase the serum concentration of Tacrolimus (Topical). Monitor therapy
Vitamin D Analogs: Danazol may enhance the hypercalcemic effect of Vitamin D Analogs. Exceptions: Calcipotriene. Monitor therapy
Vitamin K Antagonists (eg, warfarin): Androgens may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification
Estradiol (Kishino, 2010); testosterone, androstenedione, dehydroepiandrosterone
Frequency not defined.
Cardiovascular: Benign intracranial hypertension (rare), edema, flushing, hypertension, MI, palpitation, tachycardia
Central nervous system: Anxiety (rare), chills (rare), convulsions (rare), depression, dizziness, emotional lability, fainting, fatigue, fever (rare), Guillain-Barré syndrome (rare), headache, nervousness, sleep disorders
Dermatologic: Acne, alopecia, erythema multiforme (rare), 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 (rare), glucose intolerance/glucagon changes, HDL decreased, LDL increased, libido changes, nipple discharge (rare), menstrual disturbances (spotting, altered timing of cycle), semen abnormalities (changes in volume, viscosity, sperm count/motility), sex hormone-binding globulin changes, spermatogenesis reduction, thyroid binding globulin changes
Gastrointestinal: Appetite changes (rare), bleeding gums (rare), constipation, gastroenteritis, nausea, pancreatitis (rare), splenic peliosis (rare), vomiting, weight gain
Genitourinary: Vaginal dryness, vaginal irritation, pelvic pain (rare)
Hematologic: Eosinophilia, erythrocytosis (reversible), leukocytosis, leukopenia, platelet count increased, polycythemia, RBC increased, thrombocytopenia
Hepatic: Cholestatic jaundice, hepatic adenoma, jaundice, liver enzymes increased, malignant tumors (after prolonged use), peliosis hepatis
Neuromuscular & skeletal: Back pain, carpal tunnel syndrome (rare), CPK changes, extremity pain, joint lockup, joint pain, joint swelling, muscle cramps, neck pain, paresthesia, spasms, tremor, weakness
Ocular: Cataracts (rare), visual disturbances
Respiratory: Interstitial pneumonitis, nasal congestion (rare)
Miscellaneous: Diaphoresis, voice change (hoarseness, sore throat, instability, deepening of pitch)
Postmarketing and/or case reports (Limited to important or life-threatening): Hepatotoxicity (idiosyncratic) (Chalasani, 2014)
Concerns related to adverse effects:
• Androgenic effects: May cause nonreversible androgenic effects.
• Blood lipid changes: Anabolic steroids may cause blood lipid changes with increased risk of arteriosclerosis.
• Hepatic effects: [U.S. Boxed Warning]: Peliosis hepatis and benign hepatic adenoma have been reported with long-term use (may be complicated by acute intra-abdominal hemorrhage). Monitor closely for potential hepatotoxicity during therapy.
• Intracranial hypertension: [U.S. Boxed Warning]: May cause benign intracranial hypertension (pseudotumor cerebri); monitor for headache, nausea/vomiting, visual disturbances and/or papilledema.
• Thromboembolic events: [U.S. Boxed Warning]: Thromboembolism, thrombotic, and thrombophlebitic events have been reported (including life-threatening or fatal strokes).
• Diabetes: Use with caution in patients with diabetes mellitus; insulin requirements may be increased; monitor carefully.
• Edematous conditions: Use with caution in patients with conditions influenced by edema (eg, cardiovascular disease, migraine, seizure disorder, renal impairment); may cause fluid retention.
• Fibrocystic disease: Breast cancer should be ruled out prior to treatment for fibrocystic breast disease. Symptoms of pain and tenderness may recur following discontinuation of therapy. Ovulation may not be suppressed at doses used for fibrocystic disease therefore nonhormonal contraception is recommended.
• Hepatic impairment: Use with caution in patients with hepatic impairment; use is contraindicated with marked impairment.
• Porphyria: May cause exacerbations of acute intermittent porphyria; use is contraindicated in patients with porphyria.
• Pregnancy: [U.S. Boxed Warning]: Pregnancy must be ruled out prior to treatment; a nonhormonal method of contraception should be used during therapy.
Liver and renal function tests (periodically). Signs and symptoms of intracranial hypertension (papilledema, headache, nausea, vomiting), lipoproteins, androgenic changes
Pregnancy Risk Factor
[U.S. Boxed Warning]: 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. Therapy should be discontinued for 2 months prior to attempting pregnancy (Caballero, 2012).
• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)
• Patient may experience flushing, alopecia, nausea, emotional instability, acne, sexual dysfunction, or signs of virilization (in females a deep voice, facial hair, pimples, or period changes). Have patient report immediately to prescriber signs of liver problems (dark urine, feeling tired, lack of appetite, nausea, abdominal pain, light-colored stools, vomiting, or yellow skin or eyes), signs of severe cerebrovascular disease (change in strength on 1 side is greater than the other, trouble speaking or thinking, change in balance, or change in eyesight), signs of DVT (edema, warmth, numbness, change in color, or pain in the extremities), angina, shortness of breath, excessive weight gain, swelling of arm or leg, severe dizziness, passing out, severe headache, anxiety, mood changes, sudden vision changes, eye pain, eye irritation, lump in breast, or amenorrhea (HCAHPS).
• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.
Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.
More about danazol
- Other brands: Danocrine