Danazol
Brand names: Danol
Danazol is a synthetic androgen derivative with anti-gonadotrophic activity used in endometriosis, benign fibrocystic breast disease, and hereditary angioedema.
Adult dose
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).
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