Head & face medicine · 2026
Global pharmacovigilance analysis of antimicrobials used in periodontal therapy: safety profiles of minocycline, doxycycline, and chlorhexidine.
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Ning Wanchen, Huang Xiangyu, Li Simin, Jiang Linxin, Reissmann Daniel R, Kreher Deborah, Schmalz Gerhard, Chu Hongxing, Huang Shaohong
Аннотация
BACKGROUND: Minocycline, doxycycline, and chlorhexidine are widely used as adjuncts to non-surgical periodontal therapy. Although their efficacy has been demonstrated in clinical trials, comparative real-world safety data across diverse populations remain limited. This study aimed to characterize and compare adverse drug reaction (ADR) profiles associated with these agents using global pharmacovigilance data.
MATERIALS AND METHODS: This cross-sectional pharmacovigilance study analyzed ADR reports for minocycline, doxycycline, and chlorhexidine retrieved from the World Health Organization (WHO) VigiAccess database. ADRs were classified by System Organ Classes (SOCs) and Preferred Terms (PTs) according to the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis was performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs).
RESULTS: A total of 78,891 ADR reports were analyzed (16,917 minocycline, 49,980 doxycycline, and 11,994 chlorhexidine), revealing distinct safety signal patterns. Minocycline showed prominent disproportionality signals for endocrine disorders (ROR = 9.64, 95% CI: 7.73-12.02) and hepatobiliary disorders (ROR = 3.69, 95% CI: 3.43-3.96). Doxycycline signals were mainly concentrated in gastrointestinal disorders (ROR = 1.55, 95% CI: 1.51-1.60) and psychiatric disorders (ROR = 1.41, 95% CI: 1.32-1.50). Chlorhexidine exhibited a distinct profile characterized by product-related issues (ROR = 4.52, 95% CI: 3.89-5.25) and a high number of oral-specific PT-level signals (n = 79). ADRs were more frequently reported in females (56.9-60.8%) and adults aged 18-44 years (26.7-39.6%). Serious outcomes were uncommon, with mortality rates of 0.143%, 0.10%, and 0.07% for minocycline, doxycycline, and chlorhexidine, respectively.
CONCLUSIONS: Adjunctive antimicrobial agents used in periodontal therapy demonstrate heterogeneous real-world safety signal profiles. Disproportionality patterns indicate that local administration does not preclude systemic biological relevance, underscoring the need for agent-specific, guideline-concordant risk-benefit assessment in clinical decision-making.
MATERIALS AND METHODS: This cross-sectional pharmacovigilance study analyzed ADR reports for minocycline, doxycycline, and chlorhexidine retrieved from the World Health Organization (WHO) VigiAccess database. ADRs were classified by System Organ Classes (SOCs) and Preferred Terms (PTs) according to the Medical Dictionary for Regulatory Activities (MedDRA). Disproportionality analysis was performed using reporting odds ratios (RORs) with 95% confidence intervals (CIs).
RESULTS: A total of 78,891 ADR reports were analyzed (16,917 minocycline, 49,980 doxycycline, and 11,994 chlorhexidine), revealing distinct safety signal patterns. Minocycline showed prominent disproportionality signals for endocrine disorders (ROR = 9.64, 95% CI: 7.73-12.02) and hepatobiliary disorders (ROR = 3.69, 95% CI: 3.43-3.96). Doxycycline signals were mainly concentrated in gastrointestinal disorders (ROR = 1.55, 95% CI: 1.51-1.60) and psychiatric disorders (ROR = 1.41, 95% CI: 1.32-1.50). Chlorhexidine exhibited a distinct profile characterized by product-related issues (ROR = 4.52, 95% CI: 3.89-5.25) and a high number of oral-specific PT-level signals (n = 79). ADRs were more frequently reported in females (56.9-60.8%) and adults aged 18-44 years (26.7-39.6%). Serious outcomes were uncommon, with mortality rates of 0.143%, 0.10%, and 0.07% for minocycline, doxycycline, and chlorhexidine, respectively.
CONCLUSIONS: Adjunctive antimicrobial agents used in periodontal therapy demonstrate heterogeneous real-world safety signal profiles. Disproportionality patterns indicate that local administration does not preclude systemic biological relevance, underscoring the need for agent-specific, guideline-concordant risk-benefit assessment in clinical decision-making.