Monitoring Drug-Induced Dental Caries: Insights from FAERS Pharmacovigilance Data

Objective Dental caries has emerged as a significant public health concern, impacting quality of life. Conducting a comprehensive investigation into this association is crucial, particularly considering the potential for drug-induced dental caries. Methods This study aimed to identify and analyze risk-related signals of drug-induced dental caries while enhancing drug safety assessment. Statistical algorithms, including Proportional Reporting Ratio (PPR), Reporting Odds Ratio (ROR), and Empirical Bayes Geometric Mean (EBGM), were employed to analyze data obtained from the FDA's Adverse Event Reporting System (FAERS) spanning from Q1 2004 to Q3 2024, in order to detect potential adverse reaction signals. Medications associated with dental caries were categorized into different treatment classes. Results A case analysis of 17,484 reported adverse drug events (ADE) related to dental caries revealed a higher incidence among women aged ≥ 68. The number of dental caries reports has steadily increased since the establishment of the FAERS database, peaking in 2010, primarily in the United States. Disproportionate analysis of drugs identified the top five medications associated with adverse events in dental caries. Conclusions This study provides real-world data regarding the identification of drugs that potentially induce dental caries, offering a comprehensive approach to explore drug safety concerning dental caries. Our findings support the development of pharmacovigilance strategies targeting dental caries and contribute to optimizing medication management in clinical practice.