Osman RADHWI, Bader ALAJLANI, Ahlam ALSHEHRI, Adel ALMARZOUKI, Ahmed BAREFAH, Salem BAHASHWAN, Hatem ALAHWAL, Eman ALTAKRONI, Eman MANSORY
Annals of Clinical and Analytical Medicine - 2026;17(10):1051-1055
Aim: The comparative risk of hypersensitivity reactions (HSRs) between two high-dose intravenous iron formulations, ferric derisomaltose (FDI) and ferric carboxymaltose (FCM), is not well-established in real-world settings. This study directly compared the incidence and characteristics of HSRs between these agents. Methods: A retrospective, single-center cohort study was conducted at King Abdulaziz University Hospital, Jeddah. We included a cohort of 120 adult patients who received either FDI ( n = 60) or FCM ( n = 60) between August and October 2024. The timing of the HSRs was used to categorize them as infusion-related (Fishbane-type), early (<=24 hours), or delayed (24-72 hours). Results: In the primary analysis, the overall incidence of any HSR showed a trend to be higher in the FDI group than it was in the FCM group (31.7% vs 15.0%; odds ratio [OR] 2.63; P = .051). Delayed HSRs were numerically higher in the FDI group ( P = .085). However, the association of drug type with HSR was no longer significant after adjustment for pregnancy status in a stratified analysis. It is important to note that there were no severe or life-threatening reactions in either group. Conclusion: In this real-world analysis of patients, while an unadjusted comparison showed a trend towards a higher incidence of HSRs with FDI, this association did not remain after adjusting for pregnancy status. Both FDI and FCM have an overall positive safety profile for severe events, but highlight the need for larger prospective trials to confirm formulation-specific risk and evaluate patient factors such as pregnancy.
