Two Decades of Real-World Data Reveals: Vigilance Signals of Drug-Induced Gingival Bleeding

BACKGROUND: Gingival bleeding (GB) is often the initial symptom of gingivitis and periodontitis, and also an oral manifestation of certain systemic diseases. Its early prevention is of great significance for both oral and systemic health. This study aimed to identify risk drugs and their clinical characteristics using the FDA Adverse Event Reporting System (FAERS). METHODS: This study analysed data from the FAERS database from January 2004 to December 2024. A disproportionality analysis was conducted to assess drug-related GB with positive signals, and drugs were classified and evaluated based on their risk and patient demographics. RESULTS: From 2004 to 2024, the FAERS database recorded 12,310 reports related to GB. After disproportionality analysis and screening, 26 drugs were found to significantly increase the risk of drug-related GB. Among them, 14 were antithrombotic drugs, including alteplase (reporting odds ratio, ROR = 114.62), caplacizumab (ROR = 38.58), and eptifibatide (ROR = 17.73); 6 were antineoplastic drugs, including inotuzumab ozogamicin (ROR = 10.17), trastuzumab emtansine (ROR = 9.78), and mitoxantrone (ROR = 6.37); and 6 belonged to other categories. CONCLUSION: This study profiles drug-induced GB and identifies potential culprit drugs, which aids in understanding drug safety and optimising clinical practice.