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

Şükran Acıpınar; Arzu Koçkanat; Burcu Şahinbaş

doi:10.7126/cumudj.1852297

EN TR

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

Abstract

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. Among dental/oral adverse events, tooth discoloration, dry mouth, and gingival pain were the most frequently reported, while the highest Reporting Odds Ratio (ROR) value was observed in taste disorder (ROR: 378.7). 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. Keywords: Chlorhexidine, chlorhexidine gluconate, pharmacovigilance, tooth discoloration, United States Food and Drug Administration

Keywords

Gıda ve İlaç İdaresi Olumsuz Olay Bildirim Sistemi Verileri Kullanılarak Klorheksidin ile İlişkili Olumsuz Olayların Analizi

Öz

Amaç: Periodontal tedavilerin ve önleyici diş hekimliği uygulamalarının ayrılmaz parçası olan klorheksidin zaman zaman çeşitli yan etkilere yol açabilir. Bu çalışmanın amacı ABD Gıda ve İlaç Dairesi Advers Olayları Raporlama Sistemi'nde diş hekimliği nedenleriyle kullanılan klorheksidinin advers etkilerini demografik olarak ve şiddetine göre karşılaştırmaktır. Gereç ve Yöntemler: Gıda ve İlaç Dairesi Advers Olayları Raporlama Sistemi veri tabanında dental ve/veya oral sebeplerle klorheksidin kullanımına ilişkin dental advers olay raporları, raporlama başlangıcından Aralık 2025'e kadar retrospektif olarak analiz edildi. Advers etkileri hastaların demografik ve klinik özelliklerine göre tanımlandı ve şiddetlerine göre karşılaştırıldı. Bulgular: Veri tabanında 1977–2025 yılları arasında dental ve oral endikasyonlarla ilişkili kullanılan “chlorhexidine” ve “chlorhexidine gluconate” anahtar kelimeleriyle yapılan taramada, toplam 651 olgu tanımlanmıştır. Bu olguların 407’si (%62,5) ciddi olarak sınıflandırılmış, 18 adet ölüm vakası bildirilmiştir. Vakaların %66,4’ü kadın, %26,3’ü erkek olup %7,4’ünde cinsiyet bilgisi bildirilmemiştir. Olguların büyük çoğunluğu klorheksidin glukonat (%85,6) kullanımına bağlıdır. Yaş dağılımı incelendiğinde vakaların çoğunun 18–64 yaş aralığında olduğu (%46,4) görülmüştür. Bu vakaların %37,6’sı yalnızca sistemik, %45,9’u yalnızca dental/oral, %16,4’ü ise hem sistemik hem oral advers etki bildirmiştir. Dental/oral advers olaylar arasında en sık diş renklenmesi, ağız kuruluğu ve gingival ağrı bildirilirken, en yüksek Raporlama Olasılık Oranı (ROO) değeri tat bozukluğunda (ROO: 378,7) saptanmıştır. Sonuçlar: Veriler, dental ve/veya oral sebeplerle klorheksidin kullanımına bağlı bildirilen advers olayların önemli bir bölümünde inflamatuar, mukozal ve periodontal reaksiyonların ortaya çıktığını ortaya koymaktadır. Ciddi sonuçlar ek ilaç kullanımının bildirildiği durumlarla ilişkili olmakla birlikte, 18 ölüm vakasının olduğu vurgulanmalıdır. Klinik kanıtların farmakovijilans verileriyle bütünleştirilmesi, klinisyenlerin diş hekimliği uygulamalarında klorheksidin reçete etme tercihlerini etkileme potansiyeline sahiptir ve daha bilgili ve kanıta dayalı karar almaya olanak tanır. Anahtar Kelimeler: Amerika Birleşik Devletleri Gıda ve İlaç Dairesi, diş renklenmesi, farmakovijilans, klorheksidin, klorheksidin glukonat

Anahtar Kelimeler

Project Number

none

Ethical Statement

As this study is based on publicly available data from the FDA Adverse Event Reporting System (FAERS), ethical approval was not required.

References

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Details

Primary Language

English

Subjects

Dental Therapeutics, Pharmacology and Toxicology , Periodontics

Journal Section

Research Article

Authors

Şükran Acıpınar ^*
0000-0003-1711-2183
Türkiye

Arzu Koçkanat
0009-0006-8177-9096
Türkiye

Burcu Şahinbaş
0000-0002-9866-052X
Türkiye

Publication Date

March 27, 2026

Submission Date

December 31, 2025

Acceptance Date

February 11, 2026

Published in Issue

Year 2026 Volume: 29 Number: 1

DOI

https://doi.org/10.7126/cumudj.1852297

IZ

https://izlik.org/JA64YX68KS

Cite

RIS / Bibtex

EndNote

Acıpınar Ş, Koçkanat A, Şahinbaş B (March 1, 2026) Analysis of Adverse Events Associated with Chlorhexidine Using the U.S. Food and Drug Administration Adverse Event Reporting System Data. Cumhuriyet Dental Journal 29 1 148–157.