Detection of drug-induced acute respiratory distress syndrome risk signals in FAERS: a real-world pharmacovigilance study - Report - MDSpire

Detection of drug-induced acute respiratory distress syndrome risk signals in FAERS: a real-world pharmacovigilance study

  • By

  • Yunhan Zhao

  • Feiyang Zhao

  • Haoxiang Hu

  • Jianghai He

  • Yiting Ni

  • Pingping Jin

  • Xiao Wang

  • Zheru Jin

  • Yiren Hu

  • June 11, 2026

  • 0 min

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Clinical Report: Identification of Risk Indicators for Drug-Induced ARDS in FAERS

Overview

This study identifies multiple drug classes significantly associated with drug-induced acute respiratory distress syndrome (ARDS) using data from the US FDA Adverse Event Reporting System (FAERS). Key findings highlight the prevalence of ARDS reports among middle-aged and older adults, with specific drugs such as mycophenolic acid and amiodarone showing strong associations.

Background

Drug-induced ARDS is a critical yet often overlooked adverse reaction that can lead to severe clinical outcomes. Despite its potential severity, systematic evaluations of drug-related ARDS using large-scale data are limited. Understanding the risk factors and drug classes associated with ARDS is essential for improving clinical monitoring and patient safety.

Data Highlights

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Key Findings

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Clinical Implications

Healthcare professionals should be vigilant in monitoring patients prescribed high-risk medications, particularly immunosuppressants and antineoplastic agents, for signs of ARDS. Early recognition and intervention can improve patient outcomes and reduce the risk of severe complications associated with drug-induced ARDS.

Conclusion

This study underscores the importance of pharmacovigilance in identifying drug-induced ARDS risks, providing valuable insights for clinical practice and patient safety. Continued evaluation of drug safety signals is essential for effective risk management.

Related Resources & Content

  1. Drug Safety, 2014 -- Analyzing the Effects of FDA Alerts on Adverse Event Reporting Trends in the FAERS Database
  2. Archives of Toxicology, 2020 -- Investigating the Molecular Mechanisms Behind Mood and Cognitive Side Effects Through Pharmacovigilance Data Analysis and Functional Enrichment Techniques
  3. Drug Safety, 2023 -- Evaluating Risk Subgroups for Safety: A Comparison of Statistical Alerts and Patient Characteristics
  4. Drug Safety, 2013 -- Emerging Signals of Torsadogenic Risk Associated with Antipsychotic Medications: Insights from the US FDA Adverse Event Reporting System
  5. BMJ Best Practice -- Acute respiratory distress syndrome (ARDS) - Criteria
  6. 2025 -- Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults
  7. Acute respiratory distress syndrome (ARDS) - Criteria | BMJ Best Practice
  8. Severe Acute Respiratory Failure Associated With Trimethoprim/Sulfamethoxazole Among Adolescent and Young Adults: An Active Comparator-Restricted Disproportionality Analysis From the FDA Adverse Event Reporting System (FAERS) Database - Fatemeh Ahmadi, Niaz Chalabianloo, Eric McArthur, Mohammad Ali Omrani, Sheikh S. Abdullah, Facundo Garcia-Bournissen, Flory T Muanda, 2025

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