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Synthetic anabolic androgen (gonadotrophin inhibitor) Pregnancy: US label CONTRAINDICATIONS: danazol should not be administered in pregnancy or during breast-feeding. Therapy for endometriosis should begin during menstruation; otherwise appropriate tests should be performed to ensure that the patient is not pregnant while on therapy. No section 4.6 equivalent was available in this bundle - verify against the UK SPC.

Danazol

Brand names: Danol

Danazol is a synthetic androgen derivative with anti-gonadotrophic activity used in endometriosis, benign fibrocystic breast disease, and hereditary angioedema.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Endometriosis, moderate to severe disease or infertility due to endometriosis: 800 mg daily given in two divided doses. Mild cases: 200 mg to 400 mg daily given in two divided doses.
Route: Oral
Frequency: In two divided doses
openFDA / DailyMed US prescribing information (danazol capsules, Chartwell RX) - no UK SPC was available in this bundle, so the regimen must be checked against the UK SPC before publication. ENDOMETRIOSIS: the 800 mg starting dose achieves amenorrhoea and rapid response to painful symptoms most reliably; gradual downward titration to a dose sufficient to maintain amenorrhoea may be considered depending on patient response. For mild cases the initial daily dose of 200-400 mg in two divided doses may be adjusted depending on response. Therapy should begin during menstruation; otherwise appropriate tests should be performed to ensure the patient is not pregnant while on therapy. It is essential that therapy continues uninterrupted for 3 to 6 months, but it may be extended to 9 months if necessary. After termination of therapy, if symptoms recur, treatment can be reinstituted. HEREDITARY ANGIOEDEMA: dosage requirements for continuous treatment should be individualised on the basis of clinical response; it is recommended that the patient be started on 200 mg two or three times a day, and after a favourable initial response is obtained in terms of prevention of oedematous attacks the continuing dosage should be determined by decreasing the dose by 50% or less at intervals of one to three months or longer, depending on the pre-treatment attack frequency. If an attack occurs, the daily dosage may be increased by up to 200 mg. During the dose-adjusting phase, monitor the response closely, particularly if the patient has a history of airway involvement. SCOPE LIMIT: the fetched label does not describe a cyclical mastalgia regimen - the mastalgia dosing shown on this page is not covered by this source. Monitor for hepatic dysfunction by laboratory tests; hepatic dysfunction with reversible elevated serum enzymes and/or jaundice has been reported at daily doses of 400 mg or more.

Dose auto-extracted from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Undiagnosed abnormal genital bleeding (US label)
  • Markedly impaired hepatic, renal or cardiac function
  • Pregnancy and breast-feeding
  • Porphyria - danazol can induce ALA synthetase activity and hence porphyrin metabolism
  • Androgen-dependent tumour; active thrombosis or thromboembolic disease and a history of such events; hypersensitivity to danazol

Side effects

  • Androgen-like effects: weight gain, acne, seborrhoea, mild hirsutism, oedema, hair loss and voice change (hoarseness, sore throat, instability or deepening of pitch) which may persist after cessation of therapy; hypertrophy of the clitoris is rare
  • Menstrual disturbances including spotting, alteration of the timing of the cycle and amenorrhoea; cyclical bleeding and ovulation usually return within 60-90 days of stopping, but persistent amenorrhoea has occasionally been reported
  • Oestrogen-lowering effects: flushing, sweating, vaginal dryness and irritation, and reduction in breast size
  • Nervousness and emotional lability
  • Hepatic dysfunction with reversible elevated serum enzymes and/or jaundice, reported at daily doses of 400 mg or more; in males, modest reduction in spermatogenesis and abnormalities of semen volume, viscosity, sperm count and motility with long-term therapy

Clinical monograph

How it works

It suppresses the pituitary release of gonadotrophins and has weak androgenic effects, reducing ovarian hormone production and inducing an anovulatory, hypo-oestrogenic state.

Prescribing in practice

  • It can cause androgenic adverse effects including weight gain, acne, hirsutism, and voice deepening, some of which may be irreversible, so women should be warned and treatment reviewed if virilisation occurs.
  • It is contraindicated in pregnancy because of the risk of virilising a female fetus, and effective non-hormonal contraception must be used throughout treatment.
  • Use with caution where there is hepatic impairment, cardiac or renal disease, or a history of thromboembolism, and avoid in undiagnosed abnormal genital bleeding.

Monitoring

Monitor liver function during treatment and watch for androgenic effects, weight gain, and signs of thromboembolism.

Counselling the patient

  • Report any deepening of the voice promptly, as this change may not fully reverse.
  • Use a reliable non-hormonal method of contraception, and stop the medicine and seek advice if you think you may be pregnant.
  • Tell your doctor about any abdominal pain, jaundice, or unusual swelling.

Evidence & guidelines

Danazol is an established but second-line hormonal treatment for endometriosis, generally reserved for when better-tolerated options are unsuitable because of its androgenic adverse-effect profile.

Reference: SmPC Danol; ESHRE Endometriosis Guideline 2022; HAE UK Consensus Document; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.