DATA-DRIVEN SIGNAL DETECTION OF ADVERSE DRUG REACTIONS USING FAERS: A PRR AND ROR-BASED PHARMACOVIGILANCE STUDY

Authors

  • Dr. Y. Karen Chen
  • Dr. Saad Shakir
  • Dr. Marie Lindquist
  • Dr. Fatheya Al Awadi

Abstract

Pharmacovigilance plays a crucial role in ensuring drug safety through the detection of adverse drug reactions (ADRs) in real-world settings. This study aimed to perform a data-driven signal detection analysis using the FDA Adverse Event Reporting System (FAERS) database by applying two widely used disproportionality methods: Proportional Reporting Ratio (PRR) and Reporting Odds Ratio (ROR). A retrospective observational design was employed, analyzing 392,550 drug-adverse event pairs after data preprocessing. Signal detection was conducted using standard thresholds (PRR ≥ 2 and ROR > 1), followed by comparative and statistical analyses. The results showed that PRR identified 247,220 signals,
whereas ROR detected 313,936 signals, with 247,220 signals common to both methods and 66,716 uniquely identified by ROR. A near-perfect correlation (r = 0.9999) was observed between log-transformed PRR and ROR values, indicating strong methodological consistency. Distribution analysis revealed a right-skewed pattern with extreme outliers, suggesting the presence of rare but high-risk drug–event associations. Frequently reported adverse events included drug ineffectiveness and off-label use. Despite inherent limitations of spontaneous reporting systems, the findings highlight the
effectiveness of FAERS-based analyses and demonstrate that ROR provides greater sensitivity, while PRR offers more conservative signal detection. These insights support improved pharmacovigilance practices and data-driven drug safety monitoring.

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Published

2025-12-28

How to Cite

Chen, D. Y. K., Shakir, D. S., Lindquist, D. M., & Al Awadi, D. F. (2025). DATA-DRIVEN SIGNAL DETECTION OF ADVERSE DRUG REACTIONS USING FAERS: A PRR AND ROR-BASED PHARMACOVIGILANCE STUDY. International Journal For Research In Biology & Pharmacy, 10(4), 20–28. Retrieved from https://ijrbp.com/index.php/bp/article/view/2499

Issue

Vol. 10 No. 4 (2024): International Journal For Research In Biology & Pharmacy (ISSN: 2208-2093)

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