Danazol: Effective Androgen Therapy for Endometriosis and Hereditary Angioedema
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Synonyms | |||
Danazol is a synthetic androgen derivative with significant immunomodulatory and anti-gonadotropic properties, primarily indicated for the management of endometriosis and hereditary angioedema. As a modified ethisterone molecule, it demonstrates unique pharmacological actions by suppressing pituitary-ovarian axis function while exhibiting mild androgenic effects. This medication represents a specialized therapeutic option for conditions requiring hormonal modulation, particularly when conventional treatments prove insufficient or contraindicated. Clinical evidence supports its efficacy in reducing attack frequency in angioedema and alleviating endometriosis-associated pain through multifaceted mechanisms of action.
Features
- Synthetic steroid derived from ethisterone with modified androgenic properties
- Oral administration with bioavailability ranging from 30-80%
- Plasma half-life of approximately 4-5 hours with hepatic metabolism
- Demonstrable suppression of gonadotropin secretion (FSH and LH)
- Modulation of complement system components (C1 esterase inhibitor)
- Reduction in sex hormone-binding globulin (SHBG) production
- Available in 50mg, 100mg, and 200mg capsules
- Brand and generic formulations with consistent pharmacokinetic profiles
Benefits
- Provides significant reduction in frequency and severity of hereditary angioedema attacks through C1 esterase inhibitor modulation
- Effectively manages endometriosis-associated pelvic pain and dysmenorrhea by creating a pseudo-menopausal state
- Reduces need for surgical intervention in carefully selected endometriosis cases
- Demonstrates efficacy in fibrocystic breast disease management when conventional therapies fail
- Offers alternative therapeutic approach for autoimmune thrombocytopenia refractory to first-line treatments
- Provides predictable dose-response relationship allowing for tailored therapeutic regimens
Common use
Danazol is primarily prescribed for the treatment of endometriosis, particularly in cases where surgical management is not immediately indicated or when patients desire fertility preservation. It demonstrates notable efficacy in reducing pelvic pain, dysmenorrhea, and dyspareunia associated with endometrial implants. The medication is equally vital in managing hereditary angioedema (HAE), where it prevents attacks by increasing functional C1 esterase inhibitor levels. Off-label applications include management of fibrocystic breast disease, idiopathic thrombocytopenic purpura, and precocious puberty. Clinical decision-making must consider the androgenicity of the compound against its therapeutic benefits, particularly in long-term management scenarios.
Dosage and direction
For endometriosis management, initial dosing typically ranges from 400-800mg daily, divided into two to four doses. Therapy should commence during menstruation to exclude pregnancy and continue for 3-6 months based on clinical response. For hereditary angioedema, starting doses of 200mg two to three times daily are common, with maintenance doses titrated to the lowest effective level. Administration should occur with food to minimize gastrointestinal discomfort. Dose adjustments are necessary in hepatic impairment, and periodic liver function monitoring is mandatory. Treatment duration beyond six months requires careful risk-benefit assessment due to potential hepatotoxicity.
Precautions
Liver function must be monitored before initiation and at regular intervals during therapy due to potential hepatotoxicity. Patients should be advised regarding androgenic effects including acne, hirsutism, and voice changes which may prove irreversible. Regular lipid profile assessment is recommended due to potential alterations in cholesterol metabolism. Caution is warranted in patients with cardiac, renal, or hepatic impairment. Women of childbearing potential must use non-hormonal contraception during and after treatment due to potential virilization of female fetuses. Blood counts should be monitored in patients receiving long-term therapy due to potential erythrocytosis.
Contraindications
Danazol is absolutely contraindicated in pregnancy (Category X) due to risk of fetal virilization. Additional contraindications include severe hepatic dysfunction, porphyria, and undiagnosed abnormal genital bleeding. Patients with history of androgen-dependent tumors should not receive therapy. The medication is contraindicated in breastfeeding women due to secretion in breast milk. Known hypersensitivity to danazol or related compounds prohibits use. Patients with history of thromboembolic disorders require careful risk assessment before initiation. Pre-existing hypercalcemia represents another contraindication due to potential exacerbation.
Possible side effect
Androgenic effects including acne (15-25% of patients), hirsutism (10-20%), and voice changes (5-10%) are commonly observed. Metabolic alterations such as weight gain (20-30%), fluid retention, and lipid profile changes occur frequently. Hepatic enzyme elevations manifest in approximately 5-15% of patients, with rare cases of hepatocellular damage. Gastrointestinal disturbances including nausea and vomiting affect 10-15% of users. Musculoskeletal complaints such as muscle cramps and joint pain are reported in 5-10% of cases. Rare but serious adverse effects include pancreatitis, intracranial hypertension, and leukopenia. Most side effects are dose-dependent and reversible upon discontinuation.
Drug interaction
Danazol significantly inhibits cytochrome P450 3A4, potentially increasing concentrations of substrates including carbamazepine, cyclosporine, and tacrolimus. Concurrent use with warfarin necessitates frequent INR monitoring due to enhanced anticoagulant effect. Insulin requirements may change due to altered carbohydrate metabolism. Concomitant use with other hepatotoxic agents increases risk of liver injury. Corticosteroid metabolism may be altered, requiring dose adjustments. The medication may reduce sex hormone-binding globulin, affecting free fractions of concomitant hormonal therapies. Statin concentrations may increase, elevating risk of myopathy.
Missed dose
If a dose is missed within 4 hours of the scheduled time, administration should occur immediately. Beyond this window, the missed dose should be skipped to maintain the regular dosing schedule. Doubling doses to compensate for missed administration is contraindicated due to increased risk of adverse effects. Patients should maintain a medication diary to track adherence, particularly given the chronobiological aspects of hormonal therapy. Persistent missed doses may compromise therapeutic efficacy, necessitating clinical reassessment rather than dose adjustment.
Overdose
Acute overdose may manifest as exaggerated pharmacological effects including severe nausea, vomiting, and neurological symptoms. There is no specific antidote; management involves supportive care and symptomatic treatment. Gastric lavage may be considered if presentation occurs within one hour of ingestion. Activated charcoal administration can reduce absorption. Liver function tests and complete blood count should be monitored closely. Hemodialysis is ineffective due to high protein binding. Cases of significant overdose require hospitalization for monitoring of metabolic and hepatic parameters.
Storage
Store at controlled room temperature (20-25°C/68-77°F) in original packaging protected from light and moisture. Keep containers tightly closed to prevent degradation. Do not freeze capsules. Keep out of reach of children and pets. Avoid storage in bathrooms or areas with high humidity. Check expiration dates regularly and dispose of expired medication properly. Do not transfer capsules to other containers as this may affect stability. Protect from extreme temperature variations during transport or storage.
Disclaimer
This information provides educational content regarding danazol therapy but does not replace professional medical advice. Treatment decisions must be made by qualified healthcare providers considering individual patient circumstances. Actual dosing, indications, and precautions may vary based on practice guidelines and emerging evidence. Patients should consult their prescribing physician regarding specific medical concerns or adverse effects. The manufacturer’s prescribing information constitutes the primary reference for safe medication use.
Reviews
Clinical studies demonstrate danazol’s efficacy in reducing endometriosis symptoms in 80-90% of patients during therapy, though recurrence rates approach 30-50% within two years post-treatment. For hereditary angioedema, attack frequency reduction of 70-90% is typically achieved with appropriate dosing. Patient satisfaction varies considerably based on side effect tolerance, with androgenic effects representing the primary reason for discontinuation. Long-term registry data support maintained efficacy in HAE prophylaxis with appropriate monitoring. Comparative studies show superior efficacy to placebo but variable performance against newer agents like tranexamic acid or gonadotropin-releasing hormone analogs.