Analysis of Adverse Events Associated with Chlorhexidine Using Food and Drug Administration Adverse Event Reporting System Data

Objectives: Chlorhexidine, a key component of periodontal treatments and preventive dentistry, can occasionally cause various side effects. This study aims to compare the adverse effects of chlorhexidine used in dental applications, analyzing them by demographic factors and severity, as reported in the Food and Drug Administration Adverse Event Reporting System.Materials and Methods: Dental adverse event reports related to the use of chlorhexidine for dental and/or oral reasons, from the Food and Drug Administration Adverse Event Reporting System database, were retrospectively analyzed from the reporting start date to December 2025. Adverse effects were categorized based on the patients' demographic and clinical characteristics and compared according to their severity.Results: A search of the database using the keywords "chlorhexidine" and "chlorhexidine gluconate" related to dental and oral indications between 1977 and 2025 identified a total of 651 cases. Of these, 407 cases (62.5%) were classified as serious, and 18 deaths have been reported. Among the cases, 66.4% involved females, 26.3% involved males, and gender information was not reported for 7.4%. Regarding age distribution, most cases (46.4%) occurred in individuals aged 18–64 years. Of these cases, 37.6% reported only systemic adverse effects, 45.9% reported only dental/oral adverse effects, and 16.4% reported both systemic and oral adverse effects. The most frequently reported dental/oral adverse events were tooth discoloration, dry mouth, and gingival pain.Conclusions: The data reveal that a significant proportion of adverse events reported from chlorhexidine use for dental and/or oral purposes involved mucosal, periodontal and inflammatory reactions. While serious consequences were linked to the use of additional medications, it is important to emphasize that 18 fatalities were reported. Integrating clinical evidence with pharmacovigilance data has the potential to influence clinicians’ prescribing preferences for chlorhexidine in dental practice, facilitating more informed and evidence-based decision-making.