Unveiling the risk: A comprehensive analysis of drug-induced aphthous ulcers using real-world data from FAERS

Drug-induced aphthous ulcers have emerged as a significant concern in clinical practice; however, their epidemiological characteristics remain unclear. This study aimed to investigate the link between various medications and the occurrence of drug-induced aphthous ulcers using real-world data for a comprehensive analysis. We conducted an extensive analysis of adverse event reports from the U.S. Food and Drug Administration's Adverse Event Reporting System (FAERS) from the third quarter of 2015 through the fourth quarter of 2024. By employing disproportionality analysis along with Bayesian confidence propagation neural network algorithms, we identified medications associated with aphthous ulcers, assessed their risk levels, and compared the time to onset for different drug categories. Additionally, univariate and multivariate logistic regression analyses were performed to explore independent risk factors (including demographic characteristics, clinical comorbidities, and drug exposure) for drug-induced aphthous ulcers. Our findings revealed that 426 medications were associated with the development of aphthous ulcers in the FAERS database. Disproportionality analysis identified 26 drugs with significant risk factors, with infliximab, methotrexate, everolimus, secukinumab, and palbociclib ranking among the top 5 drugs likely to induce aphthous ulcers. Logistic regression analyses confirmed that the top 5 drugs, along with 8 other medications, were independent risk factors for drug-induced aphthous ulcers. Age, sex, and multiple comorbidities were independent influencing factors. Additionally, the time-to-onset analysis indicated that most implicated drugs led to early failure. Identifying the risk factors associated with drug-induced aphthous ulcers underscores the need for a prevention-focused management strategy. Healthcare professionals must remain vigilant about the potential risks of specific medications in triggering aphthous ulcers and should proactively relay this information to patients. Increased awareness and continuous monitoring can significantly reduce the incidence of drug-related oral mucosal lesions.