Objective  To detect risk signals of adverse events (AEs) associated with cetuximab and provide references for rational clinical use.

Methods  Adverse event reports related to cetuximab from the FAERS database were retrieved, covering the period from Q1 2004 to Q2 2025. The reports were classified according to the Medical Dictionary for Regulatory Activities (MedDRA) system organ classification (SOC) and preferred terms (PT). Four signal detection methods were employed for analysis: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and empirical Bayesian geometric mean. Subgroup analyses were conducted based on gender and age, and the Weibull distribution model was used to assess the time-risk patterns.

Results  A total of 12,007 cases related to cetuximab were identified, comprising 33,797 adverse events (AEs) and resulting in 320 significant signals. Common adverse events included rash, neutropenia, and dehydration. New potential signals were also discovered, including hyperkalemia, disseminated intravascular coagulation, acute respiratory distress syndrome, dysphagia, and intestinal obstruction. Subgroup analyses indicated that males were more prone to hypotension, mucosal inflammation, allergic reactions, and interstitial pneumonia, while females primarily experienced rash and hypokalemia. The age group of 18-﹤60 years was associated with adverse reactions such as bone marrow suppression, malignant tumor progression, rash, and deep vein thrombosis. Elderly patients (≥60 years) should be cautious of rapidly occurring severe allergic reactions, interstitial lung disease, anaphylactic shock, and acute respiratory distress syndrome. The median time-to-onset of AEs occurrence was 15 days (interquartile range 10-20 days), indicating an early failure pattern.

Conclusion  By analyzing real-world AEs data associated with cetuximab, potential risk signals for AEs were identified, which can help standardize rational clinical use and provide data support for clinical risk management.

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