BOX 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 nonhormonal 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 intra-abdominal 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.
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DANAZOL SUMMARY
DANAZOL CAPSULES, USP
Danazol is a synthetic steroid derived from ethisterone.
Endometriosis:
Danazol 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. Danazol 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.
Hereditary Angioedema:
Danazol is indicated for the prevention of attacks of angioedema of all types (cutaneous, abdominal, laryngeal) in males and females.
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NEWS HIGHLIGHTS
Published Studies Related to Danazol
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 Danazol
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.
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.
Open Label Extension Study of AMG 531 in Thrombocytopenic Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP) [Enrolling by invitation]
The purpose of this study is to determine the safety of AMG 531 as a long-term treatment in
thrombocytopenic subjects with ITP, to evaluate the long-term platelet response to AMG 531,
and to evaluate changes in patient reported outcomes due to the use of AMG 531. Subjects must
have previously completed an AMG 531 ITP study.
Progestin Treatment for Endometrial Stromal Cells in Adenomyosis [Recruiting]
Long term treatment of progestin has been demonstrated to have an inhibitory effect on
endometrial angiogenesis and the proliferation of endometrial stromal cells. As a result,
progestin is now widely employed in the treatment of endometrial cancer, endometrial
hyperplasia, and dysfunction uterine bleeding. In the treatment of adenomyosis, however, the
beneficial effect of progestin was limited. It might imply that the behavior of endometrial
cells in women with adenomyosis is different from that in women without adenomyosis.
Our previous study revealed that the expression of killer inhibitory receptors (KIRs) on NK
cells was decreased in eutopic endometrium in women with adenomyosis. It may be a
compensatory effect in which the NK cytotoxicity is activated in order to wipe out the
abnormal endometrial cells that might go out of the eutopic site of endometrium. It implies
that the formation of adenomyosis might be due to “abnormal” endometrial tissues, but not
the aberrant local immunological dysfunction in myometrium. This finding is compatible with
previous reports in which eutopic endometrium obtained from women with endometriosis or
adenomyosis was found to behave differently from endometrium in unaffected women.
In this study, we try to collect endometrial tissues from women with and without
adenomyosis, and then purify the endometrial stromal cells from endometrium. The endometrial
stromal cells are cultured for 8 days with the supplement of medroxyprogesterone (MPA) or
danazol. Quantification of IL-6 and IL-8 mRNA in endometrial cells, and the concentrations
of IL-6 and IL-8 in cultured media will be done with real time RT-PCR and ELISA
respectively. The expression of different cytokines of endometrial cells in response to
progestin might be further elucidated after our experiment.
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PATIENT REVIEWS / RATINGS / COMMENTSBased on a total of 2 ratings/reviews, Danazol has an overall score of 7. The effectiveness score is 8 and the side effect score is 6. The scores are on ten point scale: 10 - best, 1 - worst.
| | Danazol review by 32 year old female patient | | | Rating |
| Overall rating: | |   |
| Effectiveness: | | Moderately Effective |
| Side effects: | | Mild Side Effects | | |
Treatment Info |
| Condition / reason: | | endometriosis |
| Dosage & duration: | | 2 capsules twice daily taken twice daily for the period of 3 months |
| Other conditions: | | no other conditions |
| Other drugs taken: | | no other drugs | | |
Reported Results |
| Benefits: | | no period since on Danazol which is good for endometriosis.
the cyst on ovary did not grow since on Danazol.
the side effects are tolerable, do not seem to interfere with daily life. |
| Side effects: | | had frequent muscle cramps, not just on legs, but on back, neck, even abdomen.
cramps are quite uncomfortable.
suffered slight depression.
but did not have nausea, dizziness. |
| Comments: | | had a cyst on left ovary, removed by surgery, another 4cm cyst developed on left ovary one month after surgery, had a history of endometriosis.
was put on Danazol after the new cyst was revealed by ultrasound. had no period since put on Danazol, did monthly ultrasound to monitor cyst. the cyst didn't grow but didn't not shrink either.
stopped Danazol after three months for fear of possible damage to liver. |
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| | Danazol review by 34 year old female patient | | | Rating |
| Overall rating: | | |
| Effectiveness: | | Highly Effective |
| Side effects: | | Severe Side Effects | | |
Treatment Info |
| Condition / reason: | | Ovarian cyst |
| Dosage & duration: | | One tablet/capsule per day taken once a day for the period of Three months |
| Other conditions: | | IgA Nephropathy |
| Other drugs taken: | | None | | |
Reported Results |
| Benefits: | | After a month taking, the cyst is shrinking considerably. It was a few cm big. By the end of three months, the cyst was completely gone. I'm cyst free since then. |
| Side effects: | | It stopped my menstrual cycle but after three months, my period came as usual so it's not a big problem. But the worst side effect for me was I got acne which was severe and left pitted scars. Not only that, I noticed my skin (whole body and face) after the acne stopped was very very dry and aged very fast. It took long time for my skin to become somewhat normal again. Hairs on my legs were getting longer and more prominent too. And another side effect was weight gain with enormous appetite which you could feel was not normal appetite. I gained about 8kg and then lost it which result in sagging skin on my face. |
| Comments: | | The treatment was easy enough. The gynaecologist prescribed Danazol for the ovarian cyst I had and it was very effective. The cyst was gone and didn't come back too. |
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Page last updated: 2007-02-12
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