Objective  To mine and analyze adverse drug reaction (ADR) signals of fluorouracil injections within real-world settings, and to offer a reference for the safe use of medications in clinical practice and for post-marketing safety assessments by pharmaceutical license holders.

Methods  The ADR reports for fluorouracil injections extracted from the database of the National Adverse Drug Reaction Monitoring System of Hubei province were collected from January 2004 to April 2024. The retrospective review was used to analyze the basic information, medication details and ADR manifestations of the patient. The ADR signals were mined and analyzed by using the reporting odds ratio (ROR) method, the Medicines and Healthcare Products Regulatory Agency (MHRA) method, and the Bayesian confidence propagation neural network (BCPNN) method.

Results  The study identified 1,292 ADR reports involving fluorouracil injections, encompassing 1,429 instances of the drug and 1,901 ADR manifestations across 18 system-organ classes. The demographic analysis revealed a male predominance and a peak proportion (61.07%) among patients aged 45 to 64 years. The majority of the underlying diseases were digestive system malignancies, accounting for 73.37% of the cases. ADRs were predominantly reported within the first 5 days post-administration (77.17%), with a favorable outcome in 85.84% of the patients. The ROR method identified 35 risk signals, including 15 novel signals, while the MHRA method identified 33 signals, with 14 being novel. The BCPNN method detected 19 signals, of which 6 were novel. Notably, elevated aspartate aminotransferase and alanine aminotransferase levels emerged as novel ADRs with significant signal strength across all three detection methods.

Conclusion  The common ADR signals of fluorouracil injections are consistent with instruction. However, it is essential to increase vigilance regarding ADRs such as liver and gallbladder system diseases, which are not recorded in the drug instruction, to bolster the safety profile of fluorouracil injections in clinical use.

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