Drug-drug interactions: A descriptive analysis of FDA adverse event reporting system

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Abstract

A drug-drug interaction (DDI) occurs when the administration of 1 medication alters the effects of another and is a potentially avoidable source of medication-related harm. This study aimed to characterize the DDI reports submitted to the Food and Drug Administration Adverse Event Reporting System (FAERS). The current study is a retrospective study that used the FAERS. It includes DDI data filed before 1st of April 2024. In all, 167,065 cases were reported to the FAERS. 153,383 of these events were classed as significant interactions, and 14,723 resulted in death. The most commonly reported medications were warfarin (4.33%), aspirin (4.19%), sertraline hydrochloride (3.25%), tacrolimus (3.02%), simvastatin (2.93%), and fluoxetine hydrochloride (2.84%). Healthcare practitioners should educate their patients about potential adverse events, such as drug interactions, and how to avoid them. These findings have implications for clinical practice, pharmacovigilance initiatives, and public health measures focused on reducing the risks of drug interactions and enhancing patient safety.

Original languageEnglish
Pages (from-to)e44606
JournalMedicine (United States)
Volume104
Issue number38
DOIs
StatePublished - 19 Sep 2025

Keywords

  • FAERS
  • adverse events
  • drug interactions
  • reporting

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