FDA Adverse Event Reporting System (FAERS) Essentials: A Guide to Understanding, Applying, and Interpreting Adverse...

Area of Science:

• Pharmacovigilance
• Drug Safety
• Regulatory Science

Background:

• The US Food and Drug Administration (FDA) conducts drug safety assessments throughout a drug's lifecycle.
• Postmarketing safety surveillance is vital for identifying adverse events that may not be apparent at the time of drug approval.
• Adverse event reports, known as individual case safety reports (ICSRs), are submitted to the FDA and stored in the FDA Adverse Event Reporting System (FAERS).

Purpose of the Study:

• To highlight key considerations for utilizing the FAERS database.
• To explain fundamental concepts related to FAERS data.
• To promote accurate analysis and interpretation of FAERS data for drug safety evaluations.

Main Methods:

• Review of the FAERS database structure and content.
• Analysis of how ICSRs are collected and stored.
• Examination of methods for detecting safety signals using FAERS data.
• Discussion of approaches for evaluating potential causal associations between drugs and adverse events.

Main Results:

• FAERS is a powerful resource for drug safety surveillance.
• Accurate interpretation of FAERS data requires understanding its content and application.
• Multiple data sources are often reviewed alongside FAERS for comprehensive safety assessments.

Conclusions:

• Proper understanding of FAERS is essential for scientifically and medically accurate drug safety conclusions.
• Contextualizing FAERS findings is necessary for reliable interpretation.
• This article provides foundational knowledge to improve the use of FAERS in drug safety surveillance.