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A Real-World Pharmacovigilance Study of FDA Adverse Event Reporting System Events for Avelumab

  • kenashman
  • May 8
  • 1 min read

Cureus : Published 27 March 2025


This study utilized data from the FDA Adverse Event Reporting System (FAERS) to investigate adverse drug events (ADEs) associated with avelumab, spanning from the third quarter of 2015 to the first quarter of 2024.


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While avelumab offers significant therapeutic benefits, its use carries potential adverse effects. Clinicians must remain vigilant in monitoring patients, particularly for severe symptoms, such as thrombocytopenia, hypothyroidism, and renal impairment, to ensure prompt intervention and minimize risks. Early detection of these and other potential events will help healthcare providers better manage and mitigate the risks associated with avelumab treatment.


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