The pharmacovigilance analysis of adverse events of erlotinib based on the open access FAERS database

Background: Lung cancer and pancreatic cancer are solid tumors that threaten human health and affect the human quality of life. Erlotinib is used to treat lung and pancreatic cancer, therefore larger monitoring of erlotinib’s adverse events (AEs) would be more beneficial to guide patients on medication. Methods: The disproportionality of erlotinib-related AEs was calculated using multiple methods, including the reporting odds ratio (ROR), the proportional reporting ratio (PRR), the Bayesian confidence propagation neural network (BCPNN), and the empirical Bayes geometric mean (EBGM) algorithms, as measures of detecting erlotinib-associated AEs signals. Results: A total of 9,360,316 case reports participated in statistical analysis from the FAERS database, 2,870 reports of erlotinib as the ‘primary suspected (PS)’ AEs were recorded, and 177 erlotinib-related ADRs at preferred terms (PTs) level were selected through disproportionality analyses. Erlotinib-induced ADRs occurrence targeted 21 organ systems. Some AEs confirmed by this study were consistent with clinical observations, such as dermatitis acneiform, and EGFR gene mutation, etc. Besides, unexpected significant AEs such as growth of eyelashes, metastases to thorax, alopecia scarring, etc. might occur, which are not labeled on the drug instruction. Conclusion: In this study, we found potential new and unexpected ADR signals for erlotinib, suggesting further prospective clinical studies were essential to confirm the relationship between ADRs and erlotinib. The study could provide new insight to detect signals of AEs.