Danazol: Potent Androgen Therapy for Endometriosis & Hereditary Angioedema
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Synonyms | |||
Danazol is a synthetic steroid derived from ethisterone, possessing potent androgen, anti-estrogenic, and anti-gonadotropic properties. It is primarily indicated for the treatment of endometriosis, fibrocystic breast disease, and hereditary angioedema. As an attenuated androgen, danazol suppresses pituitary-ovarian axis function, leading to reduced secretion of follicle-stimulating hormone (FSH) and luteinizing hormone (LH), which subsequently decreases estrogen production. This makes it a cornerstone in managing estrogen-dependent conditions. Its immunomodulatory effects also play a critical role in preventing attacks of hereditary angioedema by increasing levels of C1 esterase inhibitor. Clinicians value danazol for its targeted mechanism and efficacy in specific patient populations where hormonal manipulation is warranted.
Features
- Synthetic steroid with attenuated androgenic activity
- Anti-gonadotropic and anti-estrogenic effects
- Oral administration with high bioavailability
- Typically supplied in 50 mg, 100 mg, and 200 mg capsules
- Hepatic metabolism via CYP3A4
- Half-life of approximately 4–5 hours
Benefits
- Effectively reduces pelvic pain and lesion size in endometriosis
- Decreases the frequency and severity of hereditary angioedema attacks
- Provides symptomatic relief in fibrocystic breast disease
- Offers an alternative to surgical intervention in select cases
- Helps preserve fertility in endometriosis patients when used appropriately
- Modulates immune response in autoimmune-related angioedema
Common use
Danazol is most frequently prescribed for the management of endometriosis, particularly in cases where pain is significant and other treatments have failed or are contraindicated. It is also a first-line therapy for the prophylaxis of hereditary angioedema attacks, reducing both the frequency and severity of episodes. Additionally, it is used off-label in certain autoimmune disorders, immune thrombocytopenic purpura (ITP), and for the treatment of gynecomastia. Its use in fibrocystic breast disease has declined with the advent of other therapies but remains an option in refractory cases.
Dosage and direction
Dosage must be individualized based on the condition being treated, severity, and patient response. For endometriosis, the typical starting dose is 200–400 mg twice daily, which may be adjusted downward after initial response. For hereditary angioedema prophylaxis, the starting dose is usually 200 mg two or three times daily, with subsequent adjustments to the lowest effective dose. Administration should be with food to minimize gastrointestinal upset. Treatment duration varies; for endometriosis, therapy is usually limited to 6–9 months to minimize androgenic side effects. Regular monitoring of liver function, lipids, and hematologic parameters is advised during treatment.
Precautions
Patients should be monitored for signs of virilization, such as acne, hirsutism, clitoromegaly, and voice changes. Liver function tests should be performed periodically due to the risk of hepatotoxicity. Lipid profiles may be adversely affected, necessitating baseline and follow-up assessments. Use with caution in patients with cardiac, renal, or hepatic impairment. Danazol may cause fluid retention; caution is advised in patients with hypertension, heart failure, or migraine. It is not recommended during pregnancy or breastfeeding. Patients should be advised to use non-hormonal contraception during therapy.
Contraindications
Danazol is contraindicated in patients with known hypersensitivity to the drug or any of its components. It must not be used during pregnancy (Pregnancy Category X) or in nursing mothers. Other contraindications include undiagnosed abnormal genital bleeding, severe hepatic, renal, or cardiac dysfunction, and porphyria. It is also contraindicated in men with breast or prostate cancer and in patients with a history of thromboembolic disorders.
Possible side effect
Common side effects include weight gain, acne, oily skin, hirsutism, deepening of the voice, reduced breast size, flushing, sweating, and menstrual irregularities. Less frequently, patients may experience headache, dizziness, emotional lability, fatigue, muscle cramps, and gastrointestinal disturbances. Serious adverse effects include hepatotoxicity (elevated transaminases, jaundice, hepatitis), thromboembolic events, increased LDL cholesterol, and benign intracranial hypertension. Androgenic effects are often dose-dependent and may be irreversible in some cases.
Drug interaction
Danazol is a moderate inhibitor of CYP3A4 and may increase plasma concentrations of drugs metabolized by this enzyme, such as cyclosporine, tacrolimus, statins, and certain calcium channel blockers. Concurrent use with anticoagulants like warfarin may potentiate anticoagulant effect, requiring close monitoring of INR. It may also interact with insulin or oral hypoglycemics, altering glycemic control. Concomitant use with other hepatotoxic drugs should be avoided. Coadministration with carbamazepine, phenytoin, or rifampin may reduce danazol efficacy due to induction of metabolism.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next dose. In that case, the missed dose should be skipped, and the regular dosing schedule resumed. Doubling the dose to make up for a missed one is not recommended, as it may increase the risk of adverse effects. Patients should be advised to maintain a consistent dosing routine to ensure therapeutic efficacy, especially in conditions like hereditary angioedema prophylaxis.
Overdose
Symptoms of overdose may include exaggerated androgenic effects, nausea, vomiting, dizziness, and headache. There is no specific antidote for danazol overdose. Management is supportive and symptomatic, including gastric lavage if ingestion was recent and monitoring of vital signs. Hemodialysis is unlikely to be effective due to danazol’s high protein binding and extensive metabolism. Patients should be monitored for hepatic dysfunction and electrolyte imbalances. Contact a poison control center for further guidance.
Storage
Store danazol capsules at room temperature, between 15–30°C (59–86°F), in a tightly closed container. Protect from light, moisture, and excessive heat. Keep out of reach of children and pets. Do not use beyond the expiration date printed on the packaging. Proper disposal of unused medication is recommended to prevent accidental ingestion or environmental contamination.
Disclaimer
This information is intended for educational purposes and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the advice of your physician or other qualified health provider with any questions you may have regarding a medical condition or medication. Do not disregard professional medical advice or delay in seeking it because of something you have read here. Dosage, indications, and safety information may change; refer to the latest prescribing information or consult a healthcare professional.
Reviews
Clinical studies and patient reports generally support the efficacy of danazol in reducing symptoms of endometriosis and preventing hereditary angioedema attacks. Many experts note its value as a second-line or specialized agent, though its androgenic side effect profile limits long-term use. Patients often report significant improvement in pain and quality of life, but some discontinue due to undesirable virilizing effects. Overall, it remains an important therapeutic option in well-selected patients under careful supervision.