Danazol: Effective Androgen Therapy for Endometriosis Management

Danazol

Danazol

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Product dosage: 100mg
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Product dosage: 200mg
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Product dosage: 50mg
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Synonyms

Danazol is a synthetic steroid derived from ethisterone, possessing potent antigonadotropic and mild androgenic properties. It is primarily indicated for the treatment of endometriosis, fibrocystic breast disease, hereditary angioedema, and other hormone-responsive conditions. By suppressing pituitary-ovarian axis function, danazol reduces the production of gonadotropins (FSH and LH), leading to a hypoestrogenic environment that inhibits the growth of abnormal endometrial tissue. Its therapeutic efficacy, coupled with a well-documented safety profile when used under medical supervision, makes it a cornerstone in managing select gynecological and immunological disorders.

Features

  • Synthetic steroid with androgenic and antigonadotropic activity
  • Oral administration in capsule form (typically 50 mg, 100 mg, or 200 mg strengths)
  • Half-life of approximately 4–5 hours
  • Metabolized extensively in the liver
  • Excreted primarily via urine and feces

Benefits

  • Significantly reduces pelvic pain and dysmenorrhea associated with endometriosis
  • Induces atrophy of ectopic endometrial implants
  • Decreases frequency and severity of hereditary angioedema attacks
  • Alleviates symptoms of fibrocystic breast disease
  • Provides a non-surgical management option for select gynecological conditions
  • May help preserve fertility in certain clinical contexts by avoiding surgical intervention

Common use

Danazol is most frequently prescribed for the treatment of endometriosis, particularly in cases where pain is a predominant symptom and where other therapies have proven ineffective or are contraindicated. It is also used in the management of hereditary angioedema to prevent attacks, and for the treatment of fibrocystic breast disease when symptoms are severe and refractory to conservative measures. Off-label uses may include the treatment of precocious puberty, menorrhagia, and gynecomastia, though these applications require careful clinical judgment.

Dosage and direction

Dosage must be individualized based on the condition being treated, severity of symptoms, and patient response. For endometriosis, typical starting doses range from 400–800 mg per day, divided into two doses. For hereditary angioedema, initial doses are usually 200 mg two or three times daily, which may be reduced once adequate control is achieved. For fibrocystic breast disease, doses of 100–400 mg daily in divided doses are common. Danazol should be taken with food to minimize gastrointestinal upset. Regular monitoring of liver function, lipid profiles, and hematologic parameters is recommended during therapy.

Precautions

Patients should be advised that danazol may cause virilizing effects such as acne, hirsutism, deepening of the voice, and clitoromegaly, which may not be reversible. Liver function tests should be performed periodically due to the risk of hepatotoxicity. Lipid profiles should be monitored as danazol may adversely affect cholesterol levels. Use with caution in patients with cardiac, renal, or hepatic impairment. Danazol may cause fluid retention; caution is advised in patients with epilepsy, migraine, or cardiac dysfunction. Patients should use non-hormonal contraception during therapy as danazol may cause fetal harm.

Contraindications

Danazol is contraindicated in patients with:

  • Pregnancy or women who may become pregnant
  • Undiagnosed abnormal genital bleeding
  • Severe hepatic, renal, or cardiac dysfunction
  • Porphyria
  • History of thromboembolic disorders
  • Androgen-dependent tumors such as prostate or breast cancer
  • Hypersensitivity to danazol or any component of the formulation

Possible side effect

Common side effects include:

  • Weight gain
  • Acne
  • Oily skin
  • Hirsutism
  • Deepening of the voice
  • Hot flashes
  • Menstrual irregularities
  • Headache
  • Dizziness
  • Gastrointestinal disturbances

Less common but serious side effects may include:

  • Hepatic dysfunction including jaundice
  • Thromboembolic events
  • Pancreatitis
  • Benign intracranial hypertension
  • Visual disturbances
  • Leukopenia or thrombocytopenia
  • Allergic reactions

Drug interaction

Danazol may interact with:

  • Warfarin and other anticoagulants (increased anticoagulant effect)
  • Cyclosporine (increased cyclosporine levels)
  • Insulin and oral hypoglycemics (altered glucose control)
  • Statins (increased risk of myopathy)
  • Carbamazepine (increased carbamazepine levels)
  • Tacrolimus (increased tacrolimus levels)
  • Oral contraceptives (reduced efficacy)

Missed dose

If a dose is missed, it should be taken as soon as remembered unless it is almost time for the next dose. Do not double the dose to make up for a missed one. Patients should maintain regular dosing schedules to ensure consistent therapeutic effects and should consult their healthcare provider if multiple doses are missed.

Overdose

Symptoms of overdose may include exaggerated pharmacological effects such as severe androgenization, hepatic toxicity, nausea, vomiting, and dizziness. There is no specific antidote for danazol overdose. Treatment should be supportive and symptomatic, including gastric lavage if ingestion was recent. Liver function should be monitored closely, and appropriate medical care should be provided based on presenting symptoms.

Storage

Store at room temperature (15–30°C or 59–86°F) in a tightly closed container, protected from light and moisture. Keep out of reach of children and pets. Do not use after the expiration date printed on the packaging.

Disclaimer

This information is provided for educational purposes only and does not constitute medical advice. Danazol is a prescription medication that should only be used under the supervision of a qualified healthcare professional. Patients should not initiate, discontinue, or change dosage without consulting their physician. The full prescribing information should be consulted before use.

Reviews

Clinical studies and patient reports generally indicate that danazol is effective in reducing symptoms of endometriosis and preventing angioedema attacks. Many patients experience significant relief from pain and other symptoms, though side effects—particularly androgenic effects—are commonly reported. Satisfaction often depends on adequate patient education and management of expectations regarding potential adverse effects. Long-term use requires careful monitoring due to potential hepatic and metabolic effects.