Analyzing adverse event signals of aprepitant using FAERS database data in real-world settings: Broadening the adverse event spectrum of aprepitant and its clinical implications

Medicine (Baltimore). 2025 Dec 5;104(49):e46681. doi: 10.1097/MD.0000000000046681.

ABSTRACT

Aprepitant, a neurokinin-1 receptor antagonist approved by the US FDA for chemotherapy- and postoperative-induced nausea and vomiting, has limited real-world safety data; we therefore interrogated the FDA Adverse Event Reporting System from Q1 2004 to Q3 2023 to systematically characterize aprepitant-associated adverse drug events. After extracting 8271 reports on 3033 patients, we applied a combined signal detection framework - reporting odds ratio, proportional reporting ratio and the Bayesian confidence propagation neural network with multi-item gamma Poisson shrinker - and analyzed demographics, reporter profiles and temporal trends. Women represented 54.10% of cases, the 45 to 65-year age group 27.86%, and healthcare professionals filed 65.64% of reports; the United States, France, Japan, the United Kingdom, and China contributed most cases, peaking during 2013 to 2019. While labeled toxicities were confirmed, novel high-strength signals emerged, including joint deposition, oral mucosal roughening, encephalopathy, dysplasia, febrile myelodysplasia, small cell lung cancer and tonic-clonic movements, whereas dyspnea and nausea remained the 2 most frequently reported events. These findings corroborate known risks and unveil previously under-recognized aprepitant related adverse reactions, providing actionable safety guidance for clinicians and suggesting that the strong joint deposition signal warrants prospective investigation of aprepitant in arthritic disorders.

PMID:41366886 | DOI:10.1097/MD.0000000000046681