Evidence map›Paper›PMID 42214318›Full record

ArticleInternational dental journal2026

Pharmacovigilance Analysis of Drug-Induced Stomatitis: Insights From Twenty-One Years of Real-World Data.

Zhichao Liu, Lianjie Peng, Shihan Wang, Zhenyi Liu, Leyi Hu, Huiming Wang, Mengfei Yu, Ying Zhou

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Article in International dental journal, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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1 · What the graph read from it

What it found

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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

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3 · Its place in the literature

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4 · The record

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PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

8 authors.

Zhichao LiuStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China.
Lianjie PengStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China.
Shihan WangStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China.
Zhenyi LiuMedical School, Shandong Xiehe University, Jinan, Shandong, China.
Leyi HuChangsha Medical University; Changsha, Hunan Province, China.
Huiming WangStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China. Electronic address: whmwhm@zju.edu.cn.
Mengfei YuStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China. Electronic address: yumengfei@zju.edu.cn.
Ying ZhouStomatology Hospital, School of Stomatology, Zhejiang University School of Medicine, Zhejiang Provincial Clinical Research Center for Oral Diseases, Key Laboratory of Oral Biomedical Research of Zhejiang Province, Cancer Center of Zhejiang University, Engineering Research Center of Oral Biomaterials and Devices of Zhejiang Province, Hangzhou, Zhejiang Province, China. Electronic address: zhouying071@zju.edu.cn.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundStomatitis is a common oral disease that seriously affects patients' quality of life. However, the risk of drug-induced stomatitis has not been systematically evaluated based on large-scale real-world data.

objectivesTo identify and validate high-risk drugs associated with drug-induced stomatitis, characterize the baseline features and time-to-onset heterogeneity of drug-induced stomatitis, preliminarily explore underlying mechanisms and provide evidence for clinical risk management.

methodsThis pharmacovigilance study used the FDA Adverse Event Reporting System (FAERS, 2004 Q1-2025 Q3). Disproportionality analysis (ROR, PRR, IC, EBGM), multivariable logistic regression, and time-to-onset (TTO) analysis were applied to identify high-risk drugs.

resultsA total of 55,735 stomatitis reports were screened from 58,209,958 records. The majority were female (62.1%), aged 40-80 years, from the United States (55.5%), and reported by health professionals (58.3%). We identified 366 suspicious drugs and confirmed 222 high-risk drugs. The strongest signals were found in antineoplastic and immunomodulatory agents, followed by alimentary tract, nervous system, and anti-infective drugs. TTO analysis showed obvious heterogeneity in onset time among different drug categories.

conclusionThis study first systematically identifies high-risk drugs associated with drug-induced stomatitis. The main mechanisms involve mucosal epithelial injury, barrier repair disorder, local irritation, and immune imbalance. These results provide evidence for clinical risk management, rational drug use, and early intervention.

Indexed as

PharmacovigilanceStomatitisAdolescentAdultAdverse Drug Reaction Reporting SystemsAgedAged, 80 and overAntineoplastic AgentsDrug-Related Side Effects and Adverse ReactionsFemaleHumansMaleMiddle AgedRisk FactorsUnited StatesAntineoplastic AgentsAdverse drug reactionDisproportionality analysisFAERSPharmacovigilanceStomatitis

Identifiers

PMID42214318
PMCPMC13242004

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Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.