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Administration of Danazol has been reported to cause exacerbation of the manifestations of acute intermittent porphyriaSee CONTRAINDICATIONS

Androgen like effects include weight gainacne and seborrheaMild hirsutismedemahair lossvoice changewhich may take the form of hoarsenesssore throat or of instability or deepening of pitchmay occur and may persist after cessation of therapyHypertrophy of the clitoris is rare.

There is epidemiological and toxicological evidence of hazard in human pregnancyDanazol is known to be associated with the risk of virilisation to the female foetus if administered during human pregnancyDanazol should not be used during pregnancyWomen of childbearing age should be advised to use an effectivenon-hormonalmethod of contraceptionIf the patient conceives during therapyDanazol should be stopped.

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until more data are available, danazol should be used very cautiously, if at all, in patients receiving statins which are cyp3a4 substrates.