Drug-induced gingival diseases: insights from the FDA Adverse Event Reporting System (FAERS) database analysis

Drug-induced gingival diseases are a common clinical condition. This study aims to identify potential drugs associated with such diseases by analyzing data from the FDA Adverse Event Reporting System (FAERS) database, covering the period 2004Q1 to 2024Q3. Potential signals were detected using disproportionality analyses, including reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian Confidence Propagation Neural Network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). Descriptive analyses summarized the demographic characteristics of the patients. From 2004 to 2024, 34,354 adverse events (AEs) related to drug-induced gingival diseases were reported, with the highest number of cases in 2015. Females (62.1 %) were more frequently affected, and reports increased with age. Consumers (44.9 %) were the primary reporting source, and most reports originated from the U.S. (56.1 %). Disproportionality analysis identified 83 drugs with positive risk signals. Notable examples include anti-osteoporotic agents (zoledronic acid, denosumab, alendronic acid) and cardiovascular drugs (amlodipine, rivaroxaban). Analysis of the FAERS database revealed that the risk of gingival diseases is not adequately documented for certain drugs. These findings could assist healthcare providers in recognizing drug-induced gingival diseases more effectively.