There is still a challenge to comprehensively assess the safety of enfortumab vedotin (EV) in the real world with limited data. In the present study, we aimed to characterize the main features of EV-related adverse drug reactions (ADRs) and identify any potential safety signal using the US Food and Drug Administration Adverse Event Reporting System (FAERS). The evaluation included FAERS reports from Jan. 1, 2004 to Nov. 4, 2021. Standard descriptive statistics were used to summarize the study population characteristics. The chi-square tests for categorical variables were used for between-group comparisons. The disproportionality analysis was conducted by using Bayesian confidence propagation neural network of information component (IC) and reporting odds ratio (ROR). 409 EV-related reports were identified. No significant differences were found in gender, age, reporting year, or reporting region between fatal and non-fatal cases. Potentially serious ADRs were found, including kidney injury (IC025 1.25, ROR025 2.82, weak signal), urinary tract infection (IC025 0.28, ROR025 1.44, weak signal), and febrile neutropenia (IC025 0.62, ROR025 2.22, weak signal). Life-threatening ADRs, including Stevens-Johnson syndrome (SJS, IC025 2.88, ROR025 15.20, middle signal), toxic epidermal necrolysis (TEN, IC025 2.52, ROR025 15.52, middle signal), acute kidney injury (IC025 0.47, ROR025 1.67, weak signal), and multiple organ dysfunction syndrome (MODS, IC025 0.03, ROR025 2.23, weak signal), were also detected to be significantly associated with EV use. EV could lead to kidney injury, urinary tract infection, and febrile neutropenia. Life-threatening ADRs, including SJS, TEN, acute kidney injury, and MODS, were also significantly associated with EV use.
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