FDA Adverse Event Reporting System (FAERS) Database: A Comprehensive Analysis of Its Structure, Functionality, and Limitations

Abstract

The study provides a comprehensive analysis of the FDA Adverse Event Reporting System (FAERS) database, which is an important resource for pharmacovigilance and drug safety monitoring. We describe the structure and functionality of the database, including the types of data fields and how the data is collected, processed, and analyzed. Additionally, the paper identifies limitations associated with the database, such as issues related to data quality, completeness, and accuracy, and discusses the efforts made to address these limitations. It highlights the importance of the FAERS database in identifying and evaluating drug safety concerns while acknowledging its limitations. The paper suggests future improvements such as exploring the use of machine learning and natural language processing techniques to improve data quality and increase reporting of adverse events by healthcare professionals and consumers. The study emphasizes the importance of considering the limitations of the database while interpreting and using the data and provides recommendations for future research and improvements to enhance the database's usefulness and accuracy.