Can Remicade (infliximab) cause headaches?

Headache as a Side Effect of Remicade (Infliximab)

Yes, Remicade (infliximab) can cause headaches, which are a common side effect of this medication. According to the FDA drug label, headache is listed among the most common side effects of infliximab products 1.

Frequency and Severity of Headaches

Headaches with infliximab range from mild to severe, with different potential mechanisms:

• Common side effect: Headache is specifically listed as one of the most common side effects in the FDA drug label 1
• Spectrum of severity: Headaches can range from mild to severe, with rare cases progressing to more serious neurological complications

Potential Mechanisms

Headaches associated with infliximab may occur through several mechanisms:

1. Direct medication effect: As a common side effect of the medication itself
2. Infusion-related reaction: May occur during or shortly after infusion (within 2 hours) 1
3. Immune-mediated reaction: In rare cases, headaches may be part of an immune-mediated response to the medication 2

Timing of Headaches

Headaches may occur at different timepoints:

• Acute infusion reactions: Can occur during or up to 2 hours after infusion 1
• Delayed reactions: Some patients experience delayed allergic reactions 3-12 days after receiving treatment 1

More Serious Neurological Considerations

While headaches are common and usually benign, they can occasionally be a warning sign of more serious neurological complications:

• Aseptic meningitis: In rare cases, infliximab-induced headache may progress to aseptic meningitis with symptoms including headache, fever, meningismus, and cerebrospinal fluid showing neutrophilic pleocytosis 2
• Central nervous system manifestations: The European Crohn's and Colitis Organisation (ECCO) notes that central nervous system manifestations may be more common in IBD patients treated with anti-TNF therapy 3
• Optic neuritis: Very rare cases of optic neuritis have been reported, with one case resulting in permanent blindness 4

Management Recommendations

If a patient on Remicade experiences headaches:

1. For mild headaches:

   • Monitor symptoms
   • Consider standard headache treatments (acetaminophen, NSAIDs if not contraindicated)
   • Document timing in relation to infusions

2. For moderate to severe headaches:

   • Evaluate for signs of more serious neurological complications
   • Consider premedication before future infusions 1
   • Possible premedications include antihistamines, acetaminophen, and/or corticosteroids 1

3. For headaches with concerning features (severe, persistent, associated with fever, neck stiffness, visual changes, or other neurological symptoms):

   • Urgent medical evaluation
   • Consider discontinuation of infliximab if serious neurological complications are confirmed 3

Important Warnings and Precautions

• Central demyelination: May worsen with anti-TNF therapy and is a contraindication to continued use 3
• Posterior reversible encephalopathy syndrome (PRES): Has been reported in patients receiving infliximab, characterized by headache, seizures, visual disturbance, altered mental status 3
• Stroke risk: Some patients have experienced stroke within approximately 24 hours of infusion 1

Monitoring Recommendations

• Document headache characteristics, timing, and severity
• Monitor for development of other neurological symptoms
• Report persistent or severe headaches to the prescribing physician

Conclusion

Headaches are a recognized side effect of Remicade (infliximab) treatment. While most are mild and self-limiting, healthcare providers should be vigilant for signs of more serious neurological complications, especially when headaches are severe, persistent, or accompanied by other neurological symptoms.