A real-world pharmacovigilance study of FDA adverse event reporting system (FAERS) events for cabazitaxel

This study aimed to assess the real-world safety profile of cabazitaxel by analyzing adverse events (AEs) from the US FDA Adverse Event Reporting System (FAERS) database using data mining techniques. A total of 20,411,174 AE reports from the second quarter of 2010 to the first quarter of 2025 were collected. After screening, 2008 reports with cabazitaxel as the primary suspected drug were included in the analysis. Four signal detection methods were employed: reporting odds ratio (ROR), proportional reporting ratio (PRR), Bayesian confidence propagation neural network (BCPNN), and multi-item gamma Poisson shrinker (MGPS). The final signal mining identified 118 preferred terms (PTs) across 26 system organ categories (SOCs). The results showed that cabazitaxel-related AEs primarily occurred in males (85.81%) and elderly patients aged 65-75 years (34.11%), with the most common severe outcomes including hospitalization (27.79%) and death (21.12%). AEs primarily involved hematological and lymphatic system disorders (e.g., febrile neutropenia, neutropenia, and anemia), gastrointestinal disorders, and infections. Additionally, signal strength analysis identified several potential AEs not mentioned in the drug labels, such as pigmentary glaucoma, cystitis radiation, primary thrombocythemia, nephrostomy, and recall phenomena. This study revealed the known and potential risks of cabazitaxel, suggesting that clinical monitoring of drug use should be strengthened, especially in elderly patients, and the management of hematological toxicity. Simultaneously, attention should be paid to rare but significant adverse reactions.