II. Indications

  1. FDA Approved
    1. Endometriosis
    2. Fibrocystic Breast Disease
  2. Off-Label
    1. Menorrhagia

III. Contraindications

  1. Hepatic Impairment
  2. Renal Impairment
  3. Cardiac dysfunction
  4. Pregnancy

IV. Mechanism

  1. Synthetic androgen derived from ethinyl Testosterone
  2. Inhibits gonadotropin (LH and FSH) secretion, resulting in decreased Estrogen secretion
  3. Danazol binds sex Hormone receptors in sensitive tissues
    1. Antiestrogenic and decreases Menstrual Bleeding
    2. Aanabolic and weakly androgenic (may affect voice)

V. Medications

  1. Danazol capsules: 50 mg, 100 mg, 200 mg

VI. Dosing

  1. Endometriosis
    1. Start: 400 mg orally twice daily
    2. Titrate dose DOWN to lowest effective dose with goal Amenorrhea for 3-6 months (up to 9 months)
  2. Fibrocystic Breast Disease (or cyclical Mastalgia - off label use)
    1. Danazol 100 to 200 mg orally twice daily for up to 4 to 6 months

VII. Adverse Effects:

  1. Benign Intracranial Hypertension (Pseudotumor Cerebri)
  2. Peliosis hepatis
  3. Benign Hepatic Adenoma
  4. Androgenic Effects
    1. Acne Vulgaris
    2. Flushes
    3. Sweats
    4. Edema
    5. Libido changes

VIII. Safety

  1. Contraindicated in pregnancy (Pregnancy Category X)
    1. Associated with congenital abnormalities
    2. Use reliable non-Hormonal Contraception while taking Danazol (black box warning)
  2. Avoid in Lactation

IX. Efficacy

  1. Same rate of pregnancy as with Provera or Surgery

X. Drug Interactions

  1. Insulin
    1. May increase Insulin requirements for adequate Glucose control
  2. Warfarin
    1. Increased INR with concurrent Danazol
  3. Danazol increases other drug levels
    1. Cyclosporine
    2. Tacrolimus
  4. Statins
    1. Increased risk of Statin-Induced Myopathy and Rhabdomyolysis

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Related Studies

Cost: Medications

danazol (on 12/21/2022 at Medicaid.Gov Survey of pharmacy drug pricing)
DANAZOL 200 MG CAPSULE Generic $4.05 each

Ontology: Danazol (C0010961)

Definition (NCI) A synthetic androgen derived from ethinyl testosterone. Danazol indirectly reduces estrogen production by decreasing pituitary secretion of follicle-stimulating hormone and luteinizing hormone, and binds to sex hormone receptors in target tissues, thereby exhibiting antiestrogenic, anabolic and weakly androgenic effects. (NCI04)
Definition (NCI_NCI-GLOSS) A synthetic hormone that belongs to the family of drugs called androgens and is used to treat endometriosis. It is being evaluated in the treatment of endometrial cancer.
Definition (MSH) A synthetic steroid with antigonadotropic and anti-estrogenic activities that acts as an anterior pituitary suppressant by inhibiting the pituitary output of gonadotropins. It possesses some androgenic properties. Danazol has been used in the treatment of endometriosis and some benign breast disorders.
Definition (PDQ) A synthetic androgen derived from ethinyl testosterone. Danazol indirectly reduces estrogen production by decreasing pituitary secretion of follicle-stimulating hormone and luteinizing hormone, and binds to sex hormone receptors in target tissues, thereby exhibiting antiestrogenic, anabolic and weakly androgenic effects. Check for "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39204&idtype=1" active clinical trials or "http://www.cancer.gov/Search/ClinicalTrialsLink.aspx?id=39204&idtype=1&closed=1" closed clinical trials using this agent. ("http://nciterms.nci.nih.gov:80/NCIBrowser/ConceptReport.jsp?dictionary=NCI_Thesaurus&code=C414" NCI Thesaurus)
Concepts Pharmacologic Substance (T121) , Hormone (T125) , Steroid (T110)
MSH D003613
SnomedCT 87881000, 126124009
LNC LP172589-6, MTHU046384
English Pregna-2,4-dien-20-yno(2,3-d)isoxazol-17-ol, (17alpha)-, danazol, 17Alpha-ethynyl-17beta-hydroxy-4-androsteno[2,3-d]isoxazole, 1-Ethynyl-2,3,3a,3b,4,5,10,10a,10b,11,12,12a-dodecahydro-10a,12a-dimethyl-1H-cyclopental[7,8]phenanthro[3,2-d]isoxazol-1-ol, (17Alpha)-pregna-2,4-dien-20-yno[2,3-d]-isoxazol-17-ol, DAN, danazol (medication), Danazol [Chemical/Ingredient], DANAZOL, (17alpha)-Pregna-2,4-dien-20-yno[2,3-d]isoxazol-17-ol, Danazol preparation, Danazol product, Danazol (substance), Danazol preparation (product), Danazol preparation (substance), Danazol
Swedish Danazol
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Russian DANAZOL, ДАНАЗОЛ
Japanese ダナゾール
Spanish danazol (producto), preparado con danazol (producto), preparado con danazol, danazol (sustancia), danazol, preparado de danazol (producto), preparado de danazol (sustancia), preparado de danazol, Danazol
Polish Danazol
French Danazol
German Danazol
Italian Danazolo
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