From the Guidelines
Infliximab can cause several serious side effects, including increased risk of infections, serious infections, and potentially life-threatening conditions such as heart failure and certain cancers, and therefore, its use should be carefully considered and monitored. The most common side effects of infliximab include:
- Infections: Due to its immunosuppressive nature, infliximab increases the risk of various infections, including upper respiratory tract infections, sinusitis, and urinary tract infections 1.
- Infusion reactions: These can occur during or shortly after the infusion and may include fever, chills, chest pain, and difficulty breathing 1.
- Headache and nausea
- Abdominal pain and diarrhea
- Skin rashes or itching More serious, but less common side effects include:
- Serious infections: Including tuberculosis reactivation, fungal infections, and sepsis 1.
- Increased risk of certain cancers: Particularly lymphomas, although the data is not conclusive 1.
- Liver problems: Including hepatitis B reactivation in carriers and elevation in liver transaminases 1.
- Heart failure: New onset or worsening of existing condition, as shown in the ATTACH trial 1.
- Blood disorders: Such as low blood cell counts, including leukopenia and neutropenia 1.
- Neurological issues: Including multiple sclerosis-like symptoms and demyelination disorders 1. Patients should be closely monitored during treatment and report any new or worsening symptoms to their healthcare provider immediately. Regular blood tests and screenings are typically recommended to detect potential complications early 1. The benefits of infliximab in treating conditions like rheumatoid arthritis, Crohn's disease, and ulcerative colitis often outweigh these risks for many patients, but individual risk-benefit assessment is crucial.
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 Remicade (Infliximab) include:
- Respiratory problems: respiratory infections, such as sinus infections and sore throat
- Gastrointestinal problems: stomach pain, nausea, vomiting
- Cardiovascular problems: chest discomfort or pain, arm pain, shortness of breath, fever, chills, chest pain, low blood pressure or high blood pressure
- Nervous system problems: anxiety, lightheadedness, dizziness, fainting, numbness or tingling in any part of the body, seizures
- Blood problems: anemia, leukopenia, neutropenia
- Allergic reactions: hives, difficulty breathing, chest pain, high or low blood pressure, fever, chills
- Lupus-like syndrome: chest discomfort or pain that does not go away, shortness of breath, joint pain, rash on the cheeks or arms that gets worse in the sun
- Psoriasis: red scaly patches or raised bumps on the skin that are filled with pus
- Infusion reactions: fever, chills, chest pain, low blood pressure or high blood pressure, shortness of breath, rash, itching 2
From the Research
Side Effects of Remicade (Infliximab)
The side effects of Remicade (Infliximab) can be categorized into several types, including:
- Acute infusion reactions, which occur during or shortly after infusion and may include symptoms such as fever, chills, nausea, dyspnea, and headaches 3
- Delayed reactions, which may occur 3-12 days after infusion and can include symptoms such as myalgias, arthralgias, fever, rash, pruritus, facial, hand or lip oedema, dysphagia, urticaria, sore throat, and headache 3
- Infusion reactions, which can be mild to moderate in severity and may include symptoms such as pruritus, flushing, or dyspnea 4
- Systemic adverse reactions, which can lead to discontinuation of therapy and may include symptoms such as rash, urticaria, and anaphylaxis 5
Factors Associated with Side Effects
Several factors have been associated with an increased incidence of side effects, including:
- Antihistamine premedication, which may increase the risk of infusion reactions 4
- Number of previous infusion reactions, which may increase the risk of subsequent reactions 4
- Female sex, which may be associated with an increased risk of infusion reactions 4
- Concomitant administration of immunomodulators or corticosteroids, which may help to minimize adverse reactions 3
Management of Side Effects
The management of side effects may include:
- Premedication with antihistamines, intravenous steroids, or acetaminophen to prevent infusion reactions 4, 6
- Desensitization protocols, which can be effective in allowing patients to continue therapy despite systemic adverse reactions 5
- Adjustment of infusion rates or doses to minimize the risk of reactions 3, 6
- Monitoring for signs of infection, malignancy, or other adverse events 7