INDIVIDUAL ARTICLE: Real-World Study of Topical Corticosteroid-Associated Adverse Events in the FDA Adverse Event Reporting System

Background: Corticosteroids (CS) and topical CS (TCS) are widely used, yet the real-world burden and reporting patterns of associated adverse events (AEs) remain incompletely characterized.
Methods: Reports in the FDA Adverse Event Reporting System (FAERS) from 1999-2025 containing 18 CS terms corresponding to US FDA-approved topical active ingredients were identified using the openFDA application programming interface. AEs, temporal trends, treatment duration, age, seriousness, and potency were characterized.
Results: 422,947 AE reports identified CS as a suspected cause. Among 1,619,452 coded reaction terms in 294,811 reports with CS as a product, systemic terms (38.8%) were more frequent than cutaneous (8.4%); known CS AEs were infrequently reported. 57.1% of reports reflected ≤2 weeks of use and 12.7% >12 months. Adults aged ≥65 years were disproportionately represented. Regarding TCS, reports showed no clear pattern in relation to potency; however, serious and systemic AEs were more prominent among milder classes. Nearly two-thirds (64.5%) of reports were received after 2018, coinciding with increased regulatory and public attention to TCS-associated AEs.
Discussion: This analysis identifies real-world CS AE reporting patterns not readily apparent from established safety concerns or product labeling. The findings highlight gaps in our understanding of CS-associated AEs and the need to better characterize their spectrum, use patterns, and affected populations. However, spontaneous reporting is subject to biases and cannot estimate AE incidence or comparative risk.
Conclusion: This large-scale analysis characterizes >25 years of CS-associated AE reporting and supports further characterization of CS-associated AEs to inform clinical guidance, regulatory labeling, and patient monitoring.