Abstract: Objective To mine and analyze the risk signals of adverse drug reactions (ADR) leading to cardiac disorders in the adverse drug reaction monitoring database in order to provide reference for safe and rational drug use and for research on post-marketing drug safety. Methods The ADR reports from the adverse drug reaction monitoring system database of one province collected between 2021 and 2023 were retrieved and subjected to data cleaning. The reporting odds ratio (ROR) method was employed for detection of ADR signals, and the ROR values and their 95% confidence intervals of drugs causing cardiac disorders risks were calculated. The risk signals mined were analyzed and assessed. Results A total of 72 398 ADR reports were retrieved over the past three years. After excluding duplicate and incomplete reports, 3 697 ADR reports involving the cardiovascular system were finally included in the analysis. Female patients outnumbered male ones, and ADR occurred predominantly in patients over 65 years old after medication. Diseases related to the respiratory system, mediastinal diseases, vascular and lymphatic diseases and heart diseases accounted for nearly 60% of the primary diseases. In over half of the reports, ADR occurred within less than one day of medication, and more than 60% of the ADR occurred on the very day of medication. The overall outcome of adverse reactions was favorable. Among the 263 suspected drugs analyzed, 70 risk signals of cardiac disorders were identified using the ROR method, including 62 anticipated signals documented in the package inserts and 8 unanticipated ones not documented in the package inserts. Conclusion The ROR method is generally reliable for mining and analyzing risk signals of cardiac disorders. However, the signals generated by this method are far from conclusive in that their credibility and robustness are influenced by the quantity, quality, and confounding factors of the data. In addition to focusing on drugs that may cause cardiac disorders, pharmacovigilance personnel should also take into consideration the differences between individual patients and clinical medication risk factors to minimize drug-induced cardiac risks and ensure safe medication.

Key words: adverse drug reaction, pharmacovigilance, cardiac disorders, risk signal, reporting odds ratio, rational drug use