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


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


RESULTS
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.


CONCLUSIONS
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.
Shaw
James C
JC
Division of Dermatology, University of Toronto, Toronto Western Hospital, Toronto, Ontario, Canada. jc.shaw@utoronto.ca
White
Lucile E
LE
D000152:Acne Vulgaris / Q000188:drug therapy*; D003625:Data Collection; D004231:Diuresis / Q000187:drug effects; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D008599:Menstruation Disturbances / Q000139:chemically induced; D000451:Mineralocorticoid Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D012449:Safety; D013148:Spironolactone / Q000009:adverse effects / Q000627:therapeutic use*; D011795:Surveys and Questionnaires; D013997:Time Factors
D000451:Mineralocorticoid Receptor Antagonists; D013148:Spironolactone