Oral mucositis (OM) ranks among the most frequent side effects linked to cancer therapies. Research examining the risk factors for antineoplastic-induced OM and potential preventive strategies remains scarce. To address this, we performed a disproportionality analysis of antineoplastic drug-associated OM and investigated possible preventive agents using data from the Japanese Adverse Drug Event Report (JADER) database. According to JADER records spanning April 2004 to March 2022, antineoplastic agents were implicated in 210,822 adverse event reports, including 2,922 cases of OM. Forty-two drugs demonstrated a signal of association with OM. Application of the Weibull distribution revealed distinct time-to-onset profiles across antineoplastic drug classes. Cluster analysis grouped antineoplastic agents based on characteristic symptom profiles of OM. These results indicate that monitoring for antineoplastic-induced OM should account for distinct symptom expression patterns. Analysis of inverse associations identified several co-administered medications, such as lenalidomide hydrate and febuxostat, as potential candidates for preventing antineoplastic drug-induced OM. The co-administered drugs exhibiting inverse associations varied across Anatomical Therapeutic Chemical (ATC) categories. These observations may help prioritize agents for future clinical validation of their prophylactic efficacy against antineoplastic-induced OM.
