ArticleInternational journal of women's dermatology2020
Retrospective analysis of adverse events with spironolactone in females reported to the United States Food and Drug Administration.
Article in International journal of women's dermatology, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 15 papers.
What it found
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The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
15 citing papers in PubMed, 20 citations in OpenAlex.
- Efficacy of Spironolactone Compared with Doxycycline in Moderate Acne in Adult Females: Results of the Multicentre, Controlled, Randomized, Double-blind Prospective and Parallel Female Acne Spironolactone vs doxyCycline Efficacy (FASCE) Study.Acta dermato-venereologica · 2024Trial
- Cost-effectiveness of Spironolactone for Adult Female Acne (SAFA): economic evaluation alongside a randomised controlled trial.BMJ open · 2023Trial
- Pharmacological assessment of drugs retained in the 1Naunyn-Schmiedeberg's archives of pharmacology · 2026Article
- Article
- Androgenetic Alopecia in Women: A Narrative Review of Pathophysiology, Clinical Evaluation, and Treatments.American journal of clinical dermatology · 2026Review
- Pharmacovigilance profiles of three generations of mineralocorticoid receptor antagonists and network toxicology analysis.Frontiers in medicine · 2026Article
- Oral and Topical Spironolactone in Adult Female Acne: A Narrative Review Comparing Systemic and Local Approaches.Clinical, cosmetic and investigational dermatology · 2026Review
- The Role of Pharmacists in Identifying and Preventing Drug-Related Problems in PCOS Management.Pharmacy (Basel, Switzerland) · 2025Review
- Article
- Comparative safety profiles of spironolactone, eplerenone, and finerenone: a pharmacovigilance study based on FAERS data from 2004 to 2024.Frontiers in pharmacology · 2025Article
- Clinical implications of mineralocorticoid receptor overactivation.Clinical kidney journal · 2025Review
- Treatment Patterns, Adverse Events, and Clinical Outcomes with Steroidal Mineralocorticoid Receptor Antagonists: A Retrospective Analysis of Administrative Claims Data (RELICS).Pragmatic and observational research · 2025Article
- Steroidal Mineralocorticoid Receptor Antagonist Side Effects and Reasons for Discontinuation: A Patient Survey (RELICS-PS).Pragmatic and observational research · 2025Article
- Polymeric Nanoparticles as Tunable Nanocarriers for Targeted Delivery of Drugs to Skin Tissues for Treatment of Topical Skin Diseases.Pharmaceutics · 2023Review
- Retrospective study of acne telemedicine and in-person visits at an academic center during the COVID-19 pandemic.Journal of cosmetic dermatology · 2022Article
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
backgroundSpironolactone is an off-label acne treatment that is commonly prescribed due to its low cost, efficacy, and tolerability.
objectiveThis study aimed to classify the most common adverse reactions associated with spironolactone in women of all ages and analyze the relative risk of hyperkalemia for different age groups.
methodsThe U.S. Food and Drug Administration Adverse Event Reporting System (FAERS) database was analyzed for common adverse reactions associated with female patients taking spironolactone. Reported hyperkalemia adverse events with spironolactone were further subdivided by age group. Google Trends was used to examine public interest, and Altmetric was used to quantitate scholarly mentions of spironolactone. Yearly data were compared with adverse events in the FAERS database.
resultsThe most common adverse reaction in women taking spironolactone was hyperkalemia (16.1% of all adverse events), but it was extremely uncommon in women age ≤45 years (1.9% of all hyperkalemia cases). Increased Google searches and scholarly mentions in the Altmetric database for spironolactone were also associated with increased reporting of adverse events in the FAERS database for men and women combined.
conclusionWomen taking spironolactone should be counseled that hyperkalemia is the most common adverse event but is uncommon in those age ≤45 years. Public and academic interest in spironolactone has increased in recent years, and although prescribing data are not available, this interest may account for the increased reporting to FAERS during the same time period.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.