Danazol: Potent Androgen Therapy for Endometriosis Management
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Synonyms | |||
Danazol is a synthetic steroid derived from ethisterone, possessing potent androgen, weak anabolic, and anti-estrogenic properties. It functions primarily by suppressing the pituitary-ovarian axis through inhibiting the output of gonadotropins (FSH and LH), leading to a reversible atrophy of endometrial tissue. This makes it a cornerstone therapeutic option for managing endometriosis and other estrogen-dependent conditions where hormonal modulation is clinically indicated. Its unique mechanism provides significant symptomatic relief while offering a non-surgical alternative for suitable patients.
Features
- Synthetic steroid with attenuated androgenic, anabolic, and anti-estrogenic activity
- Primary mechanism: suppression of pituitary gonadotropin (FSH and LH) secretion
- Available in 50 mg, 100 mg, and 200 mg oral capsules
- Significant first-pass hepatic metabolism; major metabolites include 2-hydroxymethylethisterone
- Plasma half-life of approximately 4-5 hours
- High protein binding, primarily to albumin and sex hormone-binding globulin (SHBG)
Benefits
- Effectively induces endometrial tissue atrophy, reducing pelvic pain and dysmenorrhea associated with endometriosis
- Provides a non-surgical management strategy for fibrocystic breast disease, often resulting in nodule reduction and pain relief
- Serves as a first-line prophylactic agent for hereditary angioedema by increasing levels of functional C1 esterase inhibitor
- Can induce amenorrhea, offering symptomatic relief and improved quality of life during treatment periods
- Demonstrates a reversible effect on the hypothalamic-pituitary-ovarian axis, allowing for the potential return of fertility post-therapy
Common use
Danazol is primarily indicated for the treatment of endometriosis, providing significant relief from pain and reducing endometrial implant size. It is also approved for the management of fibrocystic breast disease when severe pain and nodularity are present and refractory to simple analgesics. Additionally, it is used as a prophylactic treatment for attacks of hereditary angioedema in males and females. Off-label uses may include the management of menorrhagia, precocious puberty, and some cases of autoimmune thrombocytopenia, though these applications require careful specialist oversight.
Dosage and direction
For endometriosis, the typical starting dosage is 200 mg to 400 mg administered orally twice daily. Treatment should begin during menstruation and continue uninterrupted for 3 to 6 months, but may extend to 9 months depending on clinical response. For fibrocystic breast disease, doses range from 100 mg to 400 mg daily in two divided doses. Hereditary angioedema prophylaxis typically starts with 200 mg two or three times daily, which may be reduced by 50% at intervals of 1-3 months depending on symptom frequency. Dosage should always be individualized; administration with food may minimize gastrointestinal upset.
Precautions
Liver function tests should be monitored periodically due to the potential for hepatotoxicity, including rare cases of hepatocellular adenoma and peliosis hepatis. Lipid profiles should be assessed before and during therapy, as danazol may adversely affect cholesterol levels. Patients should be advised that danazol may cause androgenic effects such as acne, hirsutism, voice deepening, and clitoral enlargement, which may not be fully reversible. Use with caution in patients with cardiac, renal, or hepatic impairment. Danazol may cause fluid retention; caution is advised in patients with conditions that might be compromised by this effect, such as epilepsy, migraine, or cardiac dysfunction.
Contraindications
Danazol is contraindicated in patients with undiagnosed abnormal genital bleeding. It must not be used during pregnancy (Pregnancy Category X) or in nursing mothers. Contraindications also include severe hepatic, renal, or cardiac dysfunction, and in patients with porphyria. It is contraindicated in individuals with known hypersensitivity to danazol or any component of the formulation. Use is prohibited in men with breast cancer or known or suspected prostate cancer.
Possible side effect
Common adverse reactions include weight gain, edema, acne, oily skin, reduced breast size, flushing, sweating, vaginitis, nervousness, and emotional lability. Androgenic effects may include hirsutism, clitoral hypertrophy, voice deepening, and hair loss. Gastrointestinal disturbances such as nausea, vomiting, and indigestion may occur. Hepatic dysfunction, though rare, can present as jaundice, elevated liver enzymes, or rarely, hepatocellular tumors. Musculoskeletal cramps and muscle spasms have been reported. Some patients may experience dizziness, headache, fatigue, or sleep disorders.
Drug interaction
Danazol may potentiate the effects of warfarin and other oral anticoagulants, requiring careful monitoring of prothrombin time. It may increase blood levels of cyclosporine, carbamazepine, and tacrolimus, potentially enhancing their toxicity. Concurrent use with insulin or oral hypoglycemic agents may alter glycemic control. Danazol may interfere with the metabolism of statins, increasing the risk of myopathy or rhabdomyolysis. It can reduce thyroid-binding globulin, leading to decreased total T4 levels and increased resin T3 uptake. Coadministration with other hepatotoxic drugs should be avoided.
Missed dose
If a dose is missed, it should be taken as soon as remembered unless it is nearly time for the next scheduled 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. Consistent daily administration is important for maintaining stable hormonal suppression; patients should be advised to establish a routine to minimize missed doses.
Overdose
Symptoms of overdose may include exaggerated pharmacological effects such as severe nausea, vomiting, dizziness, headache, and pronounced androgenic effects. There is no specific antidote for danazol overdose. Management should be supportive and symptomatic, including gastric lavage if ingestion was recent. Monitoring of vital signs and appropriate symptomatic treatment is indicated. Due to danazol’s hepatic metabolism, hemodialysis is unlikely to be effective.
Storage
Store at controlled room temperature between 20°C to 25°C (68°F to 77°F), with excursions permitted between 15°C to 30°C (59°F to 86°F). Keep in the original container, tightly closed, and protect from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging. Do not transfer capsules to other containers, as this may affect stability.
Disclaimer
This information is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional for diagnosis and treatment decisions. Dosage and treatment duration should be determined by a physician based on individual patient factors. The prescriber should be familiar with the complete prescribing information and potential risks before initiating therapy. Patient response should be monitored regularly, and therapy should be discontinued if serious adverse reactions occur.
Reviews
Clinical studies have demonstrated danazol’s efficacy in reducing endometriosis-associated pain, with approximately 80-90% of patients experiencing significant improvement in symptoms during treatment. Many patients report substantial quality of life improvements, particularly in pain reduction and decreased menstrual bleeding. However, side effects, particularly androgenic changes, are frequently noted and may impact treatment adherence. Some patients describe the medication as “transformative for pain management” while noting that “side effects require careful consideration and monitoring.” Long-term follow-up studies indicate that symptom recurrence is common after discontinuation, necessitating comprehensive management planning.