Pharmacovigilance Analysis of Drug-Induced Stomatitis: Insights From Twenty-One Years of Real-World Data - PubMed
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- The study conducted a pharmacovigilance analysis on drug-induced stomatitis using FDA Adverse Event Reporting System data from 2004 to 2025.
- Out of over 58 million records, 55,735 stomatitis reports were identified, with most patients being female, aged 40-80, from the US, and reported by health professionals.
- 366 suspicious drugs were identified, with 222 confirmed as high-risk; strongest signals were in antineoplastic/immunomodulatory agents, followed by alimentary tract, nervous system, and anti-infective drugs.
- Time-to-onset analysis revealed heterogeneity in onset times across different drug categories.
- Key mechanisms of drug-induced stomatitis include mucosal epithelial injury, barrier repair disorder, local irritation, and immune imbalance.
- Findings provide evidence for clinical risk management, rational drug use, and early intervention to mitigate risks.