Spironolactone prescriptions among young women and girls increased substantially between 2000 and 2020, according to a cohort study.
Researchers analyzed data from the Merative MarketScan Commercial Claims and Encounters Database, identifying 451,234 new spironolactone users among 38 million insured female patients aged 12 to 40 years. The standardized monthly mean incidence of new prescriptions rose from 17 per 100,000 covered individuals in 2000 to 88 per 100,000 in 2020. The greatest increase occurred among individuals aged 19 to 25 years, although all age groups showed upward trends.
Diagnoses were assessed within 30 days before to 3 days after the first prescription fill. Acne was the most common diagnosis (55.5%), followed by hirsutism (8.3%) and polycystic ovary syndrome (8.1%). Hypertension (4.0%) and congestive heart failure (0.8%) were rare. A total of 29.4% of users lacked any recorded diagnosis for acne, hirsutism, polycystic ovary syndrome, hypertension, congestive heart failure, or hidradenitis suppurativa.
While spironolactone is FDA-approved for cardiovascular indications, its off-label use for androgen-related dermatologic conditions—such as acne—has become widespread. These conditions often require higher doses (100–200 mg/d) than those typically used for cardiovascular indications (25 mg/d).
“We estimate 1.2% of insured young women and girls initiated spironolactone, with this proportion rising considerably in recent years,” said Sarah E. Soppe, MPH, of the Department of Epidemiology, Gillings School of Global Public Health, The University of North Carolina at Chapel Hill in JAMA Network Open. “Most initiators had androgen-related conditions, indications frequently requiring higher doses than those examined in clinical trials for cardiovascular disease.”
The authors noted that some patients without a documented diagnosis may have been prescribed spironolactone to manage ascites or edema-related symptoms during cancer treatment, which could not be verified due to the absence of cancer registry linkage. They emphasized the need for further safety research to evaluate high-dose spironolactone use in younger populations.
Full disclosures are available in the research letter.