Safety evaluation of subcutaneous and intravenous administration of infliximab: a real-world study based on the FAERS database - Report - MDSpire

Safety evaluation of subcutaneous and intravenous administration of infliximab: a real-world study based on the FAERS database

  • By

  • Xiaoke Zheng

  • Minpeng Xie

  • Huan Luo

  • Jingyue Cai

  • Rongrong Xu

  • Tao Ling

  • June 1, 2026

  • 0 min

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Clinical Report: Assessment of Safety for Subcutaneous Versus Intravenous Infliximab

Overview

Revise to specify the types of adverse events analyzed and their clinical relevance.

Background

Inflammatory Bowel Disease (IBD) significantly impacts patients' quality of life and is associated with increased complications. Infliximab, a key therapeutic agent for moderate-to-severe IBD, is administered either intravenously or subcutaneously. Understanding the safety profiles of these administration routes is crucial for optimizing patient care and minimizing adverse reactions.

Data Highlights

Administration RouteAdverse EventsMedian Onset Time (days)
Intravenous5,144436.5
Subcutaneous1,084376

Key Findings

  • 178,925 adverse reaction reports associated with infliximab were identified.
  • Infection-related adverse reactions were common for both administration routes.
  • Infusion-related reactions were more frequently reported with intravenous administration.
  • Delayed hypersensitivity reactions were more prominently reported with subcutaneous administration.
  • The median onset time for AEs was shorter for subcutaneous (376 days) compared to intravenous (436.5 days) administration.

Clinical Implications

Clinicians should weigh the differences in adverse event profiles and onset times when choosing between intravenous and subcutaneous infliximab for IBD treatment. This knowledge can help tailor therapy to individual patient needs, balancing efficacy with safety.

Conclusion

The study underscores the importance of understanding the safety profiles of infliximab administration routes, which can guide clinicians in optimizing treatment strategies for patients with IBD.

Related Resources & Content

  1. Journal of Crohn's and Colitis, 2025 -- Subcutaneous Infliximab Cutoff Points in Patients With Inflammatory Bowel Disease: Data From the ENEIDA Registry
  2. Clinical Rheumatology, 2008 -- A Pilot Open-Label Study Assessing Adalimumab's Efficacy in Rheumatoid Arthritis Patients with Prior Infliximab Treatment: Correlation with Reasons for Treatment Failure and Anti-Infliximab Antibody Levels
  3. Drug Safety, 2019 -- Pregnancy Outcomes Following Infliximab Exposure: Insights from Post-Marketing Surveillance
  4. Official journal of the American College of Gastroenterology, 2025 -- ACG Clinical Guideline Update: Ulcerative Colitis
  5. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY), 2024
  6. Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease, 2023
  7. Blood Cancer Journal — Assessment of the safety and effectiveness of subcutaneous isatuximab combined with carfilzomib and dexamethasone in individuals with relapsed/refractory multiple myeloma: findings from the Phase 2 IZALCO trial
  8. Official journal of the American College of Gastroenterology | ACG
  9. Subcutaneous Infliximab (CT-P13 SC) as Maintenance Therapy for Inflammatory Bowel Disease: Two Randomized Phase 3 Trials (LIBERTY) - ScienceDirect
  10. Meta-Analysis: Intravenous Versus Subcutaneous Infliximab in Inflammatory Bowel Disease - PubMed

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