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. If the drug was begun at a time of exacerbation of hereditary angioneurotic edema due to trauma, stress or other cause, periodic attempts to decrease or withdraw therapy should be considered.
Danazol has been associated with several cases of benign intracranial hypertension also known as pseudotumor cerebri. Early signs and symptoms of benign intracranial hypertension include papilledema, headache, nausea and vomiting, and visual disturbances. Patients with these symptoms should be screened for papilledema and, if present, the patients should be advised to discontinue danazol immediately and be referred to a neurologist for further diagnosis and care.
DANOCRINE, brand of danazol, is a synthetic steroid derived from ethisterone. DANOCRINE suppresses the pituitary-ovarian axis.
DANOCRINE (danazol) is indicated for the following:
DANOCRINE is indicated for the treatment of endometriosis amenable to hormonal management.
Fibrocystic Breast Disease
Most cases of symptomatic fibrocystic breast disease may be treated by simple measures (e.g., padded brassieres and analgesics).
In infrequent patients, symptoms of pain and tenderness may be severe enough to warrant treatment by suppression of ovarian function. DANOCRINE is usually effective in decreasing nodularity, pain, and tenderness. It should be stressed to the patient that this treatment is not innocuous in that it involves considerable alterations of hormone levels and that recurrence of symptoms is very common after cessation of therapy.
DANOCRINE is indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
Published Studies Related to Danocrine (Danazol)
Danazol in the treatment of systemic lupus erythematosus: a qualitative systematic review. [2011.02]
OBJECTIVES: To review and summarize published information on the use, effectiveness, and adverse effects of danazol in patients with systemic lupus erythematosus (SLE)... CONCLUSIONS: Danazol is a useful drug in the treatment of SLE patients, especially in patients with refractory thrombocytopenia, autoimmune hemolytic anemia, and premenstrual flares, and in some mild nonhematologic manifestations of SLE. It appears to be relatively well tolerated, safe, and efficacious. Copyright (c) 2011 Elsevier Inc. All rights reserved.
Danazol in the Treatment of Systemic Lupus Erythematosus: A Qualitative Systematic Review. [2010.06.10]
OBJECTIVES: To review and summarize published information on the use, effectiveness, and adverse effects of danazol in patients with systemic lupus erythematosus (SLE)... CONCLUSIONS: Danazol is a useful drug in the treatment of SLE patients, especially in patients with refractory thrombocytopenia, autoimmune hemolytic anemia, and premenstrual flares, and in some mild nonhematologic manifestations of SLE. It appears to be relatively well tolerated, safe, and efficacious. Copyright (c) 2010 Elsevier Inc. All rights reserved.
Gestrinone versus danazol as preoperative treatment for hysteroscopic surgery: a prospective, randomized evaluation. [2006.04]
OBJECTIVE: To compare danazol and gestrinone treatment as preoperative endometrial preparation for operative hysteroscopy... However, the data suggest that gestrinone pretreatment is preferable to danazol.
A randomized, parallel, comparative study of the efficacy and safety of nafarelin versus danazol in the treatment of endometriosis in Taiwan. [2005.07]
BACKGROUND: The purpose of this study was to evaluate the efficacy and safety of nafarelin, a gonadotropin-releasing hormone (GnRH) analogue, versus danazol in the treatment of women with endometriosis in Taiwan... CONCLUSION: Nafarelin and danazol demonstrated similar clinical efficacy, but nafarelin was associated with fewer laboratory changes and a stable lipid profile, relative to danazol. Moreover, intranasally administered nafarelin is noninvasive, and may be a more comfortable and safer alternative to slow-release injectable GnRH agonists. Based on this study, we suggest that nafarelin, like other GnRH analogues, may be a treatment of choice for Taiwanese women with endometriosis. However, direct comparative studies of nafarelin with slow-release injectable GnRH agonists are now required.
Effect of liquid volume and food intake on the absolute bioavailability of danazol, a poorly soluble drug. [2005.03]
The influence of liquid intake and a lipid-rich meal on the bioavailability of a lipophilic drug was investigated. Danazol was used as the model substance.
Clinical Trials Related to Danocrine (Danazol)
Safety and Efficacy Trial of Danazol in Patients With Fanconi Anemia or Dyskeratosis Congenita [Recruiting]
Fanconi anemia (FA) and Dyskeratosis congenita (DC) are inherited bone marrow failure
syndromes. The current androgen treatments (e. g., oxymetholone) used to treat FA and DC can
cause unwanted masculinizing side effects, indicating a need for a different medication.
Danazol is a less potent androgen,and may therefore have fewer masculinizing side effects.
Danazol is currently approved by the Food and Drug Administration (FDA) for the treatment of
other diseases, but it has never been studied in patients with FA and DC.
The main purpose of this study is to see if danazol is a safe treatment for FA and DC.
Specifically,we would like to determine:
- the best dose of danazol;
- how fast hemoglobin (a protein that carries oxygen in the blood) levels rise in FA and
DC patients receiving danazol therapy; and
- the genetic pattern (known as expression profile) of certain cells in response to
danazol, which can predict how well people respond to the medication.
Subjects who enroll in the study will be treated with danazol for up to 24 weeks (about 6
months), and will have up to 11 study visits, including followup visits at 38 weeks (9
months) and 52 weeks (one year).
Ruxolitinib Phosphate and Danazol in Treating Anemia in Patients With Myelofibrosis [Not yet recruiting]
This phase II pilot trial studies how well ruxolitinib phosphate and danazol work in
treating anemia in patients with myelofibrosis. Ruxolitinib phosphate and danazol may cause
the body to make more red blood cells. They are used to treat anemia in patients with
Danazol in Treating Patients With Advanced or Recurrent Endometrial Cancer [Completed]
RATIONALE: Hormone therapy may be an effective treatment for endometrial cancer.
PURPOSE: Phase II trial to study the effectiveness of danazol in treating patients with
advanced or recurrent endometrial cancer.
Danazol Treatment in Endometriosis Women Before IVF [Recruiting]
The purpose of this study is to determine whether pre-treatment with danazol for at least 4
months before controlled ovarian hyperstimulation for IVF cycles improves pregnancy rate.
Safety Study of Danazol With Plasma Exchange and Steroids for the Treatment of Thrombotic Thrombocytopenic Purpura [Recruiting]
The purpose of the study is to find out if administration of Danazol with plasma exchange
and corticosteroids will reduce the number of plasma exchanges required to control
Thrombotic Thrombocytopenic Purpura.
Page last updated: 2011-12-09