Analysis of Adverse Reactions of Aspirin in Prophylaxis Medication Based on FAERS Database

OBJECTIVE: As the most commonly used drug in the world, aspirin has shown benefits for myocardial infarction, stroke, and vascular death in many secondary prevention trials and their meta-analysis. The purpose of this study was to evaluate the association between aspirin and its adverse reactions as a preventive drug using the FDA adverse event reporting system (FAERS). METHODS: The FAERS database was queried for the adverse drug events (ADE) reported from the first quarter of 2004 to the second quarter of 2021. We counted and trended reports to FAERS in which aspirin was associated with anaphylaxis or anaphylaxis followed by death. RESULTS: The search retrieved 858 aspirin-associated cases within the reporting period; 108 AE pairs with significant disproportionality were retained. The top 10 AE pairs associated with using aspirin for prophylaxis were melaena, duodenal ulcer, gastritis erosive, gastric ulcer hemorrhage, etc. The top 10 AE pairs for thrombosis prophylaxis were melaena, duodenal ulcer, microcytic anemia, lip erosion, vascular stent thrombosis, etc. The screened adverse event reports are classified and counted according to the system organ class (SOC); it mainly focuses on gastrointestinal disorders, general disorders, and administration site conditions. Among the 858 cases of aspirin used as prophylaxis medication in the FAERS database, the reporting areas were mainly in Europe and the Americas. CONCLUSION: Adverse drug reactions may occur in the clinical use of aspirin. It should strengthen patient medication education, pay close attention to adverse reactions, and adjust the administration method in time to ensure the safety of medication.