Utility and limitations of the FDA adverse events reporting system public dashboard for safety analyses: a case study with vesicular monoamine transporter 2 inhibitors.
Journal:
Expert opinion on drug safety
Published Date:
Nov 17, 2025
Abstract
INTRODUCTION: The United States Food and Drug Administration (FDA) requires post-marketing surveillance of approved drugs, and pharmaceutical manufacturers maintain comprehensive programs that include adverse event monitoring, internal safety assessments, and reporting to the FDA Adverse Events Reporting System (FAERS). AREAS COVERED: This report provides an overview of FAERS within the broader framework of post-marketing surveillance by pharmaceutical manufacturers. It also identifies several limitations to FAERS public dashboard data for safety analyses. A PubMed search for published findings of FAERS safety analyses with vesicular monoamine transporter 2 (VMAT2) inhibitors provide a case study that illustrates the need for careful interpretation based on the limitations of the FAERS database. EXPERT OPINION: Using a case study of VMAT2 inhibitors, we identified factors in data quality and manufacturer pharmacovigilance programs that must be considered when interpreting published analyses of FAERS public safety data. The application of artificial intelligence methodologies may prove helpful in identifying novel safety signals more accurately and more rapidly. At the same time, as clinicians consider individual treatment choices with their patients, discussion of safety data from the FAERS public dashboard should be contextualized within each drug's known safety profile.
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