Identification of Drug Associated Factors for Gingival Disorders: A Real-World Pharmacovigilance Study

OBJECTIVE: This study aimed to evaluate the reports of drug adverse events associated with gingival disorders and explore potential drug associated factors. METHODS: Data were extracted from the Food and Drug Administration Adverse Event Reporting System (FAERS) database from the first quarter of 2004 to the third quarter of 2024. Reporting odds ratio (ROR) were calculated using disproportionality analysis to identify signals of potential associations. For drugs that met the criteria, the least absolute shrinkage and selection operator (LASSO) regression, and multifactor logistic regression were performed to further explore the potential associated factors. RESULTS: A total of 34,354 relevant reports were collected, with 62.1% of the cases being female. Forty-three drugs were identified as associated factors for gingival disorders, including antineoplastic agents, immunosuppressants, and antithrombotic drugs. The median time from drug use to the onset of gingival disorders was 35 days, with variations observed among different drugs. CONCLUSIONS: This study is the first comprehensive correlative associations of drugs related to gingival disorders using the Food and Drug Administration Adverse Event Reporting System database, providing preliminary safety signals for the rational monitoring of gingival disorders in clinical practice. Further research is required to validate these potential associations.