There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
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|offLabelAdultNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
<!--Pediatric Indications and Dosage-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
<!--Off-Label Use and Dosage (Pediatric)-->
<!--Guideline-Supported Use (Pediatric)-->
|offLabelPedGuideSupport======Condition1=====
* Developed by:
* Class of Recommendation:
* Strength of Evidence:
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
* Dosing Information
:* Dosage
=====Condition2=====
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
<!--Contraindications-->
|contraindications=* Condition1
<!--Warnings-->
|warnings=* Description
====Precautions====
* Description
<!--Adverse Reactions-->
<!--Clinical Trials Experience-->
|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
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=====Skin and Hypersensitivy Reactions=====
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=====Urogenital=====
=====Miscellaneous=====
<!--Postmarketing Experience-->
|postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
=====Body as a Whole=====
=====Cardiovascular=====
=====Digestive=====
=====Endocrine=====
=====Hematologic and Lymphatic=====
=====Metabolic and Nutritional=====
=====Musculoskeletal=====
=====Neurologic=====
=====Respiratory=====
=====Skin and Hypersensitivy Reactions=====
=====Special Senses=====
=====Urogenital=====
=====Miscellaneous=====
<!--Drug Interactions-->
|drugInteractions=* Drug
:* Description
<!--Use in Specific Populations-->
|FDAPregCat=
|useInPregnancyFDA=* '''Pregnancy Category'''
|useInPregnancyAUS=* '''Australian Drug Evaluation Committee (ADEC) Pregnancy Category'''
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=There is no FDA guidance on the use of {{PAGENAME}} with respect to nursing mothers.
|useInPed=There is no FDA guidance on the use of {{PAGENAME}} with respect to pediatric patients.
|useInGeri=There is no FDA guidance on the use of {{PAGENAME}} with respect to geriatric patients.
|useInGender=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific gender populations.
|useInRace=There is no FDA guidance on the use of {{PAGENAME}} with respect to specific racial populations.
|useInRenalImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with renal impairment.
|useInHepaticImpair=There is no FDA guidance on the use of {{PAGENAME}} in patients with hepatic impairment.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
<!--Administration and Monitoring-->
|administration=* Oral
* Intravenous
|monitoring=There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
* Description
<!--IV Compatibility-->
|IVCompat=There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
<!--Overdosage-->
|overdose====Acute Overdose===
====Signs and Symptoms====
* Description
====Management====
* Description
===Chronic Overdose===
There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
<!--Pharmacology-->
<!--Drug box 2-->
|drugBox=<!--Mechanism of Action-->
|mechAction=*
<!--Structure-->
|structure=*
: [[File:{{PAGENAME}}01.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
<!--Pharmacodynamics-->
|PD=There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
<!--Pharmacokinetics-->
|PK=There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
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|nonClinToxic=There is limited information regarding <i>Nonclinical Toxicology</i> of {{PAGENAME}} in the drug label.
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|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
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|howSupplied=*
|storage=
|packLabel=
<!--Patient Counseling Information-->
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=* ®<ref>{{Cite web | title = | url = }}</ref>
<!--Look-Alike Drug Names-->
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web | last = | first = | title = http://www.ismp.org | url = http://www.ismp.org | publisher = | date = }}</ref>
<!--Drug Shortage Status-->
|drugShortage=
}}
}}
{{SI}}
{{PillImage
'''Danazol''' is a derivative of the synthetic [[steroid]] [[ethisterone]], a modified [[testosterone]]. Before becoming available as a [[generic drug]], Danazol was marketed as '''Danocrine''' in the United States. It was approved by the U.S. [[Food and Drug Administration]] (FDA) as the first drug to specifically treat [[endometriosis]] in the early 1970s.<ref name=Dmowski>{{cite journal |author=Dmowski WP, Scholer HF, Mahesh VB, Greenblatt RB |title=Danazol--a synthetic steroid derivative with interesting physiologic properties |journal=Fertil. Steril. |volume=22 |issue=1 |pages=9–18 |year=1971 |pmid=5538758 |doi=}}</ref> Although effective for endometriosis, its use is limited by its masculinizing side-effects.<ref>{{cite journal |author=Selak V, Farquhar C, Prentice A, Singla A |title=Danazol for pelvic pain associated with endometriosis |journal=Cochrane database of systematic reviews (Online) |volume= |issue=4 |pages=CD000068 |year=2007 |pmid=17943735 |doi=10.1002/14651858.CD000068.pub2}}</ref> Its role as a treatment for endometriosis has been largely replaced by the [[Gonadotropin-releasing hormone agonist|GnRH agonists]].
|fileName=No image.jpg
}}
==Chemistry==
{{LabelImage
The agent is fat-soluble. It is an [[isoxazole]] of testosterone with isolated weak androgenic activity and no estrogenic or progestagenic effects.<ref name=Dmowski/>
|fileName={{PAGENAME}}11.png
}}
{{LabelImage
|fileName={{PAGENAME}}11.png
}}
<!--Pill Image-->
==Method of action==
Danazol inhibits ovarian steroidgenesis resulting in decreased secretion of estradiol and may increase androgens. Pituitary hormones are largely unaffected although luteinizing hormone ([[Luteinizing hormone|LH]]) may be slightly elevated.<ref>{{cite journal |author=Steingold KA, Lu JK, Judd HL, Meldrum DR |title=Danazol inhibits steroidogenesis by the human ovary in vivo. |journal=Fertil Steril |year= 1986|volume=45|pages=649-54 |id=PMID 3084301}}</ref>
==Indications==
Danazol has been used - mostly off-label - for other indications, namely in the management of [[menorrhagia]], [[fibrocystic breast disease]], [[immune thrombocytopenic purpura]] and of [[hereditary angioedema]]. Though danazol prevents pregnancy, it is not licenced for use as a contraceptive agent.
==Side-effects==
<!--Label Display Image-->
Androgenic side effects are of concern, because in sensitive female patients, danazol can enhance unwanted hair growth, leading to [[hirsutism]]. On rare occasion, it can deepen the voice. Other possible side effects include [[Acne vulgaris|acne]] and oily skin. Because danazol is metabolized by the [[liver]], it cannot be used by patients with liver disease, and in patients receiving long-term therapy, liver function must be monitored on a periodic basis. Some patients who use danazol experience weight gain and fluid retention. Due to these limitations, danazol is seldom prescribed continuously beyond six months.
The use of danazol for endometriosis has been linked to an increased risk of ovarian cancer.<ref>{{cite journal |author=Cottreau CM, Ness RB, Modugno F, Allen GO, Goodman MT|title=Endometriosis and Its Treatment with Danazol or Lupron in Relation to Ovarian Cancer |journal=Clinical Cancer Research |volume=9 |issue= |pages=5142~5144 |year=2003 |pmid=14613992 |doi=}}</ref> Patients with endometriosis have specific risk factors for ovarian cancer so this may not apply for other uses.
Danazol has, like most other androgenic agents, been linked with an increased risk of liver tumors. These are generally benign.<ref>{{cite journal |author=Velazquez I, Alter BP |title=Androgens and liver tumors: Fanconi's anemia and non-Fanconi's conditions |journal=Am. J. Hematol. |volume=77 |issue=3 |pages=257–67 |year=2004 |pmid=15495253 |doi=10.1002/ajh.20183}}</ref>
Unlike GnRH agonists, danazol does not induce [[osteoporosis]]. Also, symptoms of hot flushes tend to be less common or severe.
==Contraindications==
Danazol is contraindicated in pregnancy because it could masculinize a female fetus.
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Black Box Warning
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Overview
Danazol is a that is FDA approved for the of . There is a Black Box Warning for this drug as shown here. Common adverse reactions include .
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Condition1
Dosing Information
Dosage
Condition2
Dosing Information
Dosage
Condition3
Dosing Information
Dosage
Condition4
Dosing Information
Dosage
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Danazol in adult patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Danazol in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding FDA-Labeled Use of Danazol in pediatric patients.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
Condition1
Developed by:
Class of Recommendation:
Strength of Evidence:
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Guideline-Supported Use of Danazol in pediatric patients.
Non–Guideline-Supported Use
Condition1
Dosing Information
Dosage
Condition2
There is limited information regarding Off-Label Non–Guideline-Supported Use of Danazol in pediatric patients.
Contraindications
Condition1
Warnings
ConditionName:
See full prescribing information for complete Boxed Warning.
ConditionName:
Content
Description
Precautions
Description
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Clinical Trial Experience of Danazol in the drug label.
Body as a Whole
Cardiovascular
Digestive
Endocrine
Hematologic and Lymphatic
Metabolic and Nutritional
Musculoskeletal
Neurologic
Respiratory
Skin and Hypersensitivy Reactions
Special Senses
Urogenital
Miscellaneous
Postmarketing Experience
There is limited information regarding Postmarketing Experience of Danazol in the drug label.
