Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases - Report - MDSpire

Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases

  • By

  • Yuou Ying

  • Mengyuan Shen

  • Jinhan Chen

  • Tongfei Feng

  • Zejiong Li

  • Zhekai Ying

  • Dongdong Yang

  • Ruyi Ju

  • Jiannong Wu

  • July 7, 2026

  • 0 min

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Clinical Report: Investigating Drug-Related Inflammatory Bowel Disease

Overview

This study analyzes FAERS and JADER data to identify medications associated with inflammatory bowel disease (IBD). It highlights the prevalence of drug-related IBD reports and identifies specific drugs that demonstrate significant associations with the condition, utilizing disproportionality analyses and external validation.

Background

Inflammatory bowel disease (IBD) is a chronic condition affecting millions globally. This study aims to clarify the relationship between various drugs and IBD using large-scale adverse event reporting databases.

Data Highlights

DatabaseReports of Drug-Associated IBDPatients
FAERS52,39550,426

Key Findings

  • Females accounted for a higher proportion of drug-associated IBD reports than males.
  • The majority of cases occurred in individuals aged 18–64 years.
  • Anti-TNF-α inhibitors were the most frequently reported drugs associated with IBD.
  • Isotretinoin showed the strongest signal intensity for drug-related IBD.
  • The median time-to-onset for IBD was within one year for most drug-associated cases.
  • External validation using JADER confirmed consistent signals for certain anti-TNF-α inhibitors and other drug classes.

Clinical Implications

Healthcare professionals should be aware of the potential for certain medications to induce or exacerbate IBD.

Conclusion

This analysis provides insights into medications linked to IBD.

Related Resources & Content

  1. Journal of Crohn's and Colitis, 2021 -- Comparative Analysis of Adverse Event Reporting for Corticosteroids in Inflammatory Bowel Disease: Insights from Reporting Systems and Patient Surveys
  2. Drug Safety, 2021 -- Analysis of Thromboembolic Event Reporting Associated with JAK Inhibitors: Insights from the FAERS Database (2010–2019)
  3. Drug Safety, 2021 -- Real-World Analysis of Adverse Drug Reactions in Patients with Inflammatory Bowel Disease from the IBDREAM Registry
  4. American Gastroenterological Association -- Living guideline for pharmacological management of moderate-to-severe ulcerative colitis
  5. ECCO -- ECCO Topical Review on IBD-like patterns of drug-induced colitis
  6. Archives of Toxicology — Investigating the Molecular Mechanisms Behind Mood and Cognitive Side Effects Through Pharmacovigilance Data Analysis and Functional Enrichment Techniques
  7. Living guideline for pharmacological management of moderate-to-severe ulcerative colitis - American Gastroenterological Association
  8. ECCO Topical Review on IBD-like patterns of drug-induced colitis: a practical framework for diagnosis and management across diverse clinical patterns, including immune checkpoint inhibitor–associated disease - ECCO - European Crohn’s and Colitis Organisation
  9. Frontiers | Risk of new-onset inflammatory bowel disease in psoriasis patients treated with five different interleukin inhibitors: a systematic review and meta-analysis

Original Source(s)

Drug-associated inflammatory bowel disease: a real-world pharmacovigilance study using the FAERS and JADER databases

  • by Yuou Ying, Mengyuan Shen, Jinhan Chen, Tongfei Feng, Zejiong Li, Zhekai Ying, Dongdong Yang, Ruyi Ju, Jiannong Wu

  • July 7, 2026

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