Danazol

DEA Class; Rx

Common Brand Names; 

Synthetic steroid derived from ethisterone (ethinyl testosterone). Is antiestrogenic and weakly androgenic. Used for endometriosis, unless the process has advanced to the stage of surgical correction. Also used in the palliative treatment of fibrocystic breast disease and hereditary angioedema in both males and females.

Pregnancy, breastfeeding

Porphyria

Undiagnosed abnormal genital bleeding

Severe liver/renal/cardiac disease

Androgen-dependent tumor

Active thrombosis or thromboembolic disease and history of such events

Hypersensitivity

Intracranial hypertension

Increased blood pressure

Thromboembolism

Anxiety

Depression

Dizziness

Urticaria

Androgenic Effects (common)

• Mild hirsutism
• Decreased breast size
• Voice changes
• Sore throat, acne
• Increased oiliness of skin or hair
• Hair loss

Menstrual irregularities (common)

Gastroenteritis

Nausea

Vomiting

Elevated LFTs

Joint pain

Muscle spasm

A temporary alteration of lipoproteins in the form of decreased high-density lipoproteins and possibly increased low-density lipoproteins reported during therapy

These alterations may be marked, and prescribers should consider potential impact on risk of atherosclerosis and coronary artery disease in accordance with potential benefit of therapy to the patient

Before initiating therapy of fibrocystic breast disease, carcinoma of the breast should be excluded; however, nodularity, pain, tenderness due to fibrocystic breast disease may prevent recognition of underlying carcinoma before treatment is begun

If any nodule persists or enlarges during treatment, carcinoma should be considered and ruled out; patients should be watched closely for signs of androgenic effects some of which may not be reversible even when drug administration is stopped

Because this drug may cause some degree of fluid retention, conditions that might be influenced by this factor, such as epilepsy, migraine, cardiac, or renal dysfunction, polycythemia, and hypertension require careful observation

Use with caution in patients with diabetes mellitus; since hepatic dysfunction manifested by modest increases in serum transaminases levels reported in patients receiving therapy, periodic liver function tests should be performed

Administration of this drug has been reported to cause exacerbation of manifestations of acute intermittent porphyria; laboratory monitoring of hematologic state should be considered

Exposure to drug in utero may result in androgenic effects on female fetus; clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia reported

Contraindicated in breastfeeding patients