What are the side effects of infliximab (chimeric monoclonal antibody against tumor necrosis factor-alpha, TNF-alpha)?

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From the Guidelines

Infliximab can cause several side effects ranging from common to rare but serious reactions, including infusion reactions, upper respiratory infections, and increased risk of serious infections and certain cancers, as reported in the most recent study 1.

Common Side Effects

  • Infusion reactions (fever, chills, chest pain, blood pressure changes) typically occur during or shortly after administration
  • Upper respiratory infections, headache, nausea, abdominal pain, and fatigue are frequently experienced by patients

Serious Side Effects

  • Serious infections due to immune suppression, particularly tuberculosis reactivation, fungal infections, and opportunistic infections
  • Increased risk of certain cancers, especially lymphomas and non-melanoma skin cancers
  • Neurological complications like demyelinating disorders (multiple sclerosis-like symptoms), liver injury, heart failure exacerbation, and blood disorders (cytopenias) may occur
  • Some patients develop lupus-like syndrome with joint pain and rash, as noted in 1 and 1
  • Delayed hypersensitivity reactions can emerge even after previous successful treatments

Monitoring and Precautions

  • Patients should undergo tuberculosis screening before starting treatment, as recommended in 1
  • Regular monitoring for infections, malignancies, and other complications is necessary throughout therapy, with consideration of national cancer screening programs and regular dermatological assessments for skin cancer, as suggested in 1

From the FDA Drug Label

Symptoms may include chest discomfort or pain, arm pain, stomach pain, shortness of breath, anxiety, lightheadedness, dizziness, fainting, sweating, nausea, vomiting, fluttering or pounding in your chest, and/or a fast or a slow heartbeat. Liver Injury Some patients receiving infliximab products have developed serious liver problems Blood Problems In some patients receiving infliximab products, the body may not make enough of the blood cells that help fight infections or help stop bleeding Nervous System Disorders Some patients receiving infliximab products have developed problems with their nervous system Allergic Reactions Some patients have had allergic reactions to infliximab products. Lupus-like Syndrome Some patients have developed symptoms that are like the symptoms of Lupus Psoriasis Some people receiving infliximab products had new psoriasis or worsening of psoriasis they already had The most common side effects of infliximab products include: • respiratory infections, such as sinus infections and sore throat • headache • coughing • stomach pain Infusion reactions can happen up to 2 hours after your infusion of RENFLEXIS Symptoms of infusion reactions may include: • fever • chills • chest pain • low blood pressure or high blood pressure • shortness of breath • rash • itching

The side effects of infliximab include respiratory infections, headache, coughing, and stomach pain. Infliximab can also cause infusion reactions, liver injury, blood problems, nervous system disorders, allergic reactions, lupus-like syndrome, and psoriasis. Patients should be monitored for signs of these side effects, such as fever, chills, chest pain, and shortness of breath. 2

From the Research

Side Effects of Infliximab

The side effects of infliximab can be significant and may lead to discontinuation of therapy. Some of the common side effects include:

  • Infusion reactions, which can occur in 3-22% of patients 3
  • Systemic adverse reactions, which can occur in 8.9% of patients 4
  • Neurological complications, such as polyneuropathy and central nervous system syndrome 5
  • Elevated C-reactive protein (CRP) levels, which can increase the risk of infusion reactions 6

Risk Factors for Side Effects

Certain risk factors can increase the likelihood of side effects from infliximab, including:

  • Elevated CRP levels before therapy initiation 6
  • History of inflammatory bowel disease or other conditions being treated with infliximab 4
  • Use of infliximab for off-label indications, such as hidradenitis suppurativa or pyoderma gangrenosum 3

Management of Side Effects

Management of side effects from infliximab can include:

  • Desensitization protocols, which can be safe and effective in patients who develop systemic adverse reactions 4
  • Premedication and decreased infusion rate 4
  • Close monitoring of patients with elevated CRP levels or other risk factors 6
  • Consideration of alternative therapies or adjunctive strategies, such as high-dose infliximab therapy for severe central nervous system tuberculosis 7

References

Guideline

Guideline Directed Topic Overview

Dr.Oracle Medical Advisory Board & Editors, 2025

Research

Adverse reactions to infliximab and the outcome of desensitization.

Annals of allergy, asthma & immunology : official publication of the American College of Allergy, Asthma, & Immunology, 2015

Research

Neurological complications of infliximab.

The Journal of rheumatology, 2006

Research

Risk factors for infliximab-induced infusion reactions based on a retrospective study of medical information.

International journal of clinical pharmacology and therapeutics, 2024

Professional Medical Disclaimer

This information is intended for healthcare professionals. Any medical decision-making should rely on clinical judgment and independently verified information. The content provided herein does not replace professional discretion and should be considered supplementary to established clinical guidelines. Healthcare providers should verify all information against primary literature and current practice standards before application in patient care. Dr.Oracle assumes no liability for clinical decisions based on this content.

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