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Drug-associated gingival disorders: a retrospective pharmacovigilance assessment using disproportionality analysis

Kannan Sridharan¹, Gowri Sivaramakrishnan²

¹Department of Pharmacology & Therapeutics, College of Medicine & Health Sciences, Arabian Gulf University, Manama, Kingdom of Bahrain. skannandr@gmail.com.

|March 12, 2025

Abstract

Background:

Drug-associated gingival disorders can negatively impact on oral health. This study aimed to utilize the United States Food and Drug Administration Adverse Event Reporting System (USFDA AERS) to comprehensively assess the associations between medications and specific gingival disorders.

Methods:

Data were extracted from the USFDA AERS from 2004-2024 using Preferred Terms for eight gingival disorders. Reports were deduplicated and disproportionality analysis was conducted using frequentist and Bayesian approaches to detect potential signals. Volcano plots were generated for each gum disorder to identify the drugs with the strongest signals based on the statistical significance and magnitude of association.

Results:

A total of 11,465 reports were included. Several anti-osteoporotic drugs, anti-thrombotics, calcium channel blockers and immunosuppressants showed significant associations with multiple gingival disorders. Phenytoin was linked to hypertrophy and bleeding. Stomatological preparations were associated with discoloration and bleeding. Emergent signals were identified with finasteride, COVID-19 vaccine, and levothyroxine with gum disorders.

Conclusion:

This study highlights the need for increased awareness of oral side effects amongst healthcare providers. Future research should explore the mechanisms of drug-induced gingival disorders and develop interdisciplinary management strategies to enhance oral health in patients on long-term medications.

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