A retrospective analysis of gastrointestinal adverse events associated with nicorandil using the FDA Adverse Event Reporting System (FAERS) following STROBE guidelines

This study investigated the possible association between nicorandil and gastrointestinal adverse events using the FDA Adverse Event Reporting System (FAERS), aiming to provide more comprehensive safety guidance for clinical application and support the formulation of pharmacovigilance policies in the future. This study is a retrospective study based on FAERS. Adverse event reports in FAERS from the first quarter of 2016 to the fourth quarter of 2023 were extracted. Disproportionality analyses were employed to assess the association between nicorandil and gastrointestinal adverse events, and to conduct a further analysis of clinical characteristics. We also performed sensitivity analyses stratified by gender and age. A total of 138 reports of nicorandil-related gastrointestinal adverse events were retrieved from FAERS, with a large proportion of elderly patients (aged > 65 years, n = 98). The results of the disproportionality analysis indicated an elevated risk of gastrointestinal adverse events associated with nicorandil (reporting odds ratio:1.23, 95% CI: 1.09-1.39; information component025 = 2.43). Clinical prioritization analysis identified melaena, colonic polyp, and upper gastrointestinal bleeding as events of moderate clinical priority. Most gastrointestinal adverse events tend to occur within 1 week after the initiation of dosing. Sensitivity analyses revealed that nicorandil was significantly associated with gastrointestinal adverse events regardless of gender and age. The use of nicorandil was significantly associated with gastrointestinal adverse events. This study assists healthcare professionals in providing appropriate guidance and advice to patients prior to drug administration.