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Background <p>Linaclotide, a guanylate cyclase-C agonist, is widely used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). While effective, concerns about adverse events (AEs) persist, requiring a detailed analysis using spontaneous reports from FAERS.</p> Methods <p>This study analyzed data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024 to identify linaclotide-related AEs. Disproportionality analyses were performed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). The Weibull distribution assessed the timing of AE onset.</p> Results <p>A total of 31,179 linaclotide-related AEs were identified. Gastrointestinal disorders were the most common, with diarrhoea (<i>n</i> = 4,003) being the strongest AE signal. Constipation (<i>n</i> = 961) was unexpectedly reported as an AE. Other AEs included injury, poisoning, and procedural complications. Most AEs occurred within the first 30 days of treatment, indicating the need for early safety monitoring.</p> Conclusion <p>Linaclotide generally demonstrates a favorable safety profile; however, it is associated with AEs such as diarrhoea, dehydration, and unrecognized constipation. These findings underscore the importance of careful AE monitoring and further studies to optimize risk management.</p>

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Disproportionality Analysis of Linaclotide-Associated Adverse Events Using Individual case Safety Reports from the FDA Adverse Event Reporting System

  • 期刊论文

  • 发表日期：

    2026年3月19日

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  • Meiyao Chen,
  • Zhiyang Chen,
  • Ziwei Xiong,
  • Qian Guo,
  • Yingqi Yang,
  • Sicheng Shen,
  • Chuyue Wang,
  • Zhuoqun Zhu,
  • Xiaopeng Wang,
  • Jiacheng Li

摘要

Background

Linaclotide, a guanylate cyclase-C agonist, is widely used to treat irritable bowel syndrome with constipation (IBS-C) and chronic idiopathic constipation (CIC). While effective, concerns about adverse events (AEs) persist, requiring a detailed analysis using spontaneous reports from FAERS.

Methods

This study analyzed data from the FDA Adverse Event Reporting System (FAERS) from Q1 2004 to Q3 2024 to identify linaclotide-related AEs. Disproportionality analyses were performed using reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and Multi-Item Gamma Poisson Shrinker (MGPS). The Weibull distribution assessed the timing of AE onset.

Results

A total of 31,179 linaclotide-related AEs were identified. Gastrointestinal disorders were the most common, with diarrhoea (n = 4,003) being the strongest AE signal. Constipation (n = 961) was unexpectedly reported as an AE. Other AEs included injury, poisoning, and procedural complications. Most AEs occurred within the first 30 days of treatment, indicating the need for early safety monitoring.

Conclusion

Linaclotide generally demonstrates a favorable safety profile; however, it is associated with AEs such as diarrhoea, dehydration, and unrecognized constipation. These findings underscore the importance of careful AE monitoring and further studies to optimize risk management.