An Evaluation of Duplicate Adverse Event Reports Characteristics in the Food and Drug Administration Adverse Event Reporting System.

ABSTRACT:

Introduction

The Food and Drug Administration (FDA) Adverse Event Reporting System (FAERS) receives duplicate reports of adverse events associated with drug and therapeutic biological products. Duplicate reports, defined as multiple reports of the same adverse event(s) related to the administration of the same marketed product(s) to the same individual patient at a particular point in time, may be received in FAERS for many reasons. The presence of duplicate reports can negatively impact public health surveillance efforts by impeding both safety signal identification and signal evaluation.

Objectives

To characterize the features and contributing factors associated with duplicate reports in FAERS.

Methods

We manually assessed a convenience sample of individual case saf

SUBMITTER: Janiczak S 

PROVIDER: S-EPMC12423208 | biostudies-literature | 2025 Oct

REPOSITORIES: biostudies-literature