Antibiotic use and immune-related adverse events in patients treated with immune checkpoint inhibitors: analysis of the FAERS database - Report - MDSpire

Antibiotic use and immune-related adverse events in patients treated with immune checkpoint inhibitors: analysis of the FAERS database

  • By

  • Jia Yu

  • Qinxiao Li

  • Shangpu Zou

  • Yiyin Rong

  • Yuting Zhang

  • Chengshui Chen

  • May 5, 2026

  • 0 min

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Impact of Antibiotic Administration on Immune-Related Adverse Events in Patients Undergoing Treatment with Immune Checkpoint Inhibitors

Overview

Expand on the methodology used for evaluating the association between antibiotic use and irAEs.

Background

Incorporate references to specific studies that demonstrate the limited evidence on the relationship between antibiotics and irAEs.

Data Highlights

ParameterValue
Patients treated with ICIs155,157
Patients receiving antibiotics9,518 (6.1%)
Odds Ratio for irAEs with antibiotics1.17 (95% CI: 1.12–1.23)
Odds Ratio for PD-L1 inhibitors1.51 (95% CI: 1.39–1.65)
Median time to first irAE (antibiotic users)31 days (IQR: 9–105)
Median time to first irAE (non-users)42 days (IQR: 14–122)

Key Findings

  • Antibiotic use is associated with a higher reported frequency of irAEs in ICI-treated patients.
  • Patients receiving fluoroquinolones, sulfonamides, penicillin, macrolides, cephalosporins, and monobactams showed the strongest associations with irAEs.
  • Co-reporting of antibiotics was linked to a higher frequency of irAEs specifically in patients on PD-L1 inhibitors.
  • The median time to first reported irAE was significantly shorter in patients who received antibiotics compared to those who did not.
  • Findings suggest a need for further prospective studies to validate the impact of antibiotics on irAE risk.

Clinical Implications

Clinicians should be aware of the potential increased risk of irAEs associated with antibiotic use in patients undergoing ICI therapy. Careful consideration of antibiotic prescribing practices is warranted to mitigate the risk of adverse events. Future studies are needed to explore the mechanisms behind these associations and to guide clinical decision-making.

Conclusion

The findings from this analysis highlight a significant association between antibiotic use and increased risk of irAEs in patients receiving ICIs. Further research is essential to clarify these relationships and inform clinical guidelines.

References

  1. Frontiers in Immunology, 2026 -- Comprehensive safety analysis of the clinical spectrum of adverse events associated with immune checkpoint inhibitors based on FAERS
  2. The ASCO Post, 2022 -- Incidence of Major Adverse Cardiac Events in Patients Receiving Immune Checkpoint Inhibitors
  3. The ASCO Post, 2018 -- Both Patients and Clinicians Face Challenges in Recognizing and Reporting Immune-Related Adverse Events Related Articles
  4. Archives of Toxicology, 2020 -- Investigating the Molecular Mechanisms Behind Mood and Cognitive Side Effects Through Pharmacovigilance Data Analysis and Functional Enrichment Techniques
  5. ASCO Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Guideline Summary - Guideline Central
  6. Gut microbiome and immune checkpoint inhibitor toxicity - ScienceDirect
  7. A Silent Saboteur of Immunotherapy: Antibiotic Use and Its Impact on Immune Checkpoint Inhibitors Efficacy, a Systematic Review and Meta-Analysis of Recent Studies - PMC
  8. ASCO Management of Immune-Related Adverse Events in Patients Treated With Immune Checkpoint Inhibitor Therapy Guideline Summary - Guideline Central
  9. Gut microbiome and immune checkpoint inhibitor toxicity - ScienceDirect
  10. A Silent Saboteur of Immunotherapy: Antibiotic Use and Its Impact on Immune Checkpoint Inhibitors Efficacy, a Systematic Review and Meta-Analysis of Recent Studies - PMC

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