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J Cutan Med Surg. 2002 Nov-Dec;6(6):541-5. Epub 2002 Sep 12.

Long-term safety of spironolactone in acne: results of an 8-year followup study.

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Division of Dermatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada.



Spironolactone has been used for over 20 years as an antiandrogen in the treatment of acne and hirsutism. No long-term studies of the safety of spironolactone used in this manner have been published. We present a study of the long-term safety and tolerance of spironolactone in 91 women with acne who were followed for up to 8 years.


A survey questionnaire was sent to 210 patients, and a comparison chart review of all patients to whom the survey was sent was made.


Ninety-one completed surveys were analyzed, comprising 506 person-years of followup and 200 person-years of spironolactone exposure. Mean treatment length was 28.5 months (range = 0.5-122 months). During the 8-year followup period, there were no cases of serious illness attributable to spironolactone use. Side effects were present in 59% and resulted in cessation of the drug in 15%. Diuretic effect and menstrual irregularities were the most common adverse effects.


After 200 person-years of exposure to spironolactone and 506 person-years of followup over 8 years, no serious illnesses thought to be attributed to spironolactone were reported. The long-term use of spironolactone in the treatment of acne in women appears to be safe. Side effects, however, are common, although not usually a cause for stopping the drug.

[Indexed for MEDLINE]

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