pharmacopeia
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/api/v1/drug/danazol

Boxed warning

Use of danazol in pregnancy is contraindicated. A sensitive test (e.g., beta subunit test if available) capable of determining early pregnancy is recommended immediately prior to start of therapy. Additionally a non-hormonal method of contraception should be used during therapy. If a patient becomes pregnant while taking danazol, administration of the drug should be discontinued and the patient should be apprised of the potential risk to the fetus. Exposure to danazol in utero may result in androgenic effects on the female fetus; reports of clitoral hypertrophy, labial fusion, urogenital sinus defect, vaginal atresia, and ambiguous genitalia have been received (see PRECAUTIONS: Pregnancy, Teratogenic Effects ). Thromboembolism, thrombotic and thrombophlebitic events including sagittal sinus thrombosis and life-threatening or fatal strokes have been reported. Experience with long-term therapy with danazol is limited. Peliosis hepatis and benign hepatic adenoma have been observed with long-term use. Peliosis hepatis and hepatic adenoma may be silent until complicated by acute, potentially life-threatening intraabdominal hemorrhage. The physician therefore should be alert to this possibility. Attempts should be made to determine the lowest dose that will provide adequate protection.

Mechanism of action

Sourced from openFDA

Mechanism-of-action class: Androgen Receptor Agonists.

Androgen Receptor

Indications

Sourced from openFDA
  • Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management.ICD-10: N80.9

Contraindications

Sourced from openFDA
  • Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function.contraindicated

Dosage & administration

Sourced from openFDA

Endometriosis. In moderate to severe disease, or in patients infertile due to endometriosis, a starting dose of 800 mg given in two divided doses is recommended. Amenorrhea and rapid response to painful symptoms is best achieved at this dosage level. Gradual downward titration to a dose sufficient to maintain amenorrhea may be considered depending upon patient response. For mild cases, an initial daily dose of 200 mg to 400 mg given in two divided doses is recommended and may be adjusted depending on patient response. Therapy should begin during menstruation. Otherwise, appropriate tests should be performed to ensure that the patient is not pregnant while on therapy with danazol capsules (see CONTRAINDICATIONS and WARNINGS ). It is essential that therapy continue uninterrupted for 3 to 6 months but may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted. Hereditary Angioedema. The dosage requirements for continuous treatment of hereditary angioedema with danazol capsules should be individualized on the basis of the clinical response of the patient. It is recommended that the patient be started on 200 mg, two or three times a day. After a favorable initial response is obtained in terms of prevention of episodes of edematous attacks, the proper continuing dosage should be determined by decreasing the dosage by 50% or less at intervals of one to three months or longer if frequency of attacks prior to treatment dictates. If an attack occurs, the daily dosage may be increased by up to 200 mg.

Adverse reactions

Sourced from openFDA

The following events have been reported in association with the use of danazol capsules: Androgen like effects include weight gain, acne and seborrhea. Mild hirsutism, edema, hair loss, voice change, which may take the form of hoarseness, sore throat or of instability or deepening of pitch, may occur and may persist after cessation of therapy. Hypertrophy of the clitoris is rare. Other possible endocrine effects are menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhea. Although cyclical bleeding and ovulation usually return within 60-90 days after discontinuation of therapy with danazol capsules, persistent amenorrhea has occasionally been reported. Flushing, sweating, vaginal dryness and irritation and reduction in breast size, may reflect lowering of estrogen. Nervousness and emotional lability have been reported. In the male a modest reduction in spermatogenesis may be evident during treatment. Abnormalities in semen volume, viscosity, sperm count, and motility may occur in patients receiving long-term therapy. Hepatic dysfunction, as evidenced by reversible elevated serum enzymes and/or jaundice, has been reported in patients receiving a daily dosage of danazol capsules of 400 mg or more. It is recommended that patients receiving danazol capsules be monitored for hepatic dysfunction by laboratory tests and clinical observation.

Approval history

Sourced from openFDA
  • Aug 9, 1996ANDAANDA074582Barr
  • Sep 28, 2005ANDAANDA077246Lannett Co Inc
  • Apr 19, 2007ANDAANDA078214Lannett

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
2,761 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Drug Ineffective45116%
  2. 2Off Label Use41815%
  3. 3Headache31912%
  4. 4Angioedema2278.2%
  5. 5Hypersensitivity2268.2%
  6. 6Hereditary Angioedema2218.0%
  7. 7Drug Intolerance2157.8%
  8. 8Drug Ineffective For Unapproved Indication2137.7%
  9. 9Dysphonia2127.7%
  10. 10Swelling Face2127.7%
  11. 11Swollen Tongue2077.5%
  12. 12Platelet Count Decreased1937.0%
  13. 13Fatigue1816.6%
  14. 14Nausea1786.4%
  15. 15Product Use In Unapproved Indication1535.5%

Literature

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Recent PubMed references pinned to Danazol as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 43 ClinicalTrials.gov registrations naming Danazol as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Danazol work?
Mechanism-of-action class: Androgen Receptor Agonists.
What is Danazol used for?
According to FDA labeling, Danazol carries indications including: Endometriosis. Danazol capsules are indicated for the treatment of endometriosis amenable to hormonal management.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Danazol?
Danazol is classified as Antigonadotropins and similar agents, Androgen, Androgen Receptor Agonists, Decreased Follicle Stimulating Hormone Secretion.
What are the contraindications for Danazol?
Danazol labeling lists contraindications including: Danazol capsules should not be administered to patients with: Undiagnosed abnormal genital bleeding. Markedly impaired hepatic, renal, or cardiac function.. Always consult the full prescribing information and a clinician.
Note. Data for danazol is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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