Characterization of skin adverse events associated with cetuximab: real-world insights from the two global pharmacovigilance databases of FAERS and VigiAccess

Real-world pharmacovigilance data from two independent international databases demonstrate consistent and strong disproportionality signals for cetuximab-associated cutaneous AEs. Common events such as rash and dermatitis acneiform, as well as several less frequently described reactions, warrant heightened clinical vigilance, especially in older and male patients. Prospective and mechanistic studies are needed to confirm these associations and to refine strategies for preventing and managing cetuximab-induced skin toxicity.