Drug-associated oropharyngeal infection: a real-world pharmacovigilance study using the FDA adverse event reporting system database

OBJECTIVE: Drug-associated oropharyngeal infection represents a common yet frequently overlooked safety concern in clinical practice, potentially increasing patient discomfort, prolonging hospitalization, and elevating healthcare burdens. However, there is a lack of large-scale, systematic real-world studies comprehensively identifying the implicated drugs. This study investigated the primary drugs associated with oropharyngeal infection reports in the FDA Adverse Event Reporting System (FAERS) to assess their potential risk and to provide references for clinical risk identification and monitoring. METHODS: We reviewed publicly available FAERS data from the first quarter (Q1) of 2004 to the second quarter (Q2) of 2025. Disproportionality analyses were performed using the Reporting Odds Ratio (ROR), Proportional Reporting Ratio (PRR), the Medicines and Healthcare Products Regulatory Agency (MHRA) algorithm, the Bayesian Confidence Propagation Neural Network (BCPNN), and the Multi-item Gamma Poisson Shrinker (MGPS) to process and analyze reports of drugs associated with oropharyngeal infection. RESULTS: From Q1 2004 to Q2 2025, FAERS recorded 75,512 reports of oropharyngeal infection. Reports involving male patients were significantly higher than those for female patients. We identified 69 high-risk drugs of oropharyngeal infection, of which 43 were not mentioned in their prescribing information. According to Anatomical Therapeutic Chemical (ATC) classification, the category with the highest risk was L04 (Immunosuppressants). The median time to onset of oropharyngeal infection was 45 days (interquartile range [IQR] 4-317). Analysis using the Weibull shape parameter (WSP) indicated an early failure-type profile. CONCLUSIONS: This study highlights key drugs with significant disproportionality signals for drug-associated oropharyngeal infection and underscores the importance of early risk assessment and close monitoring, particularly during the initial treatment phase. These findings contribute to a better understanding of drug-associated oropharyngeal infections and provide a basis for future research into their underlying mechanisms.