Background: Hypophosphatemia is a known toxicity of ferric carboxymaltose. We did a retrospective analysis of data made available to public by the FDA regarding the occurrence of hypophosphatemia in various intravenous iron formulations.

Methods: The FDA has made the data on adverse effects of various treatments available to public through the FDA Adverse Events Reports System (FAERS) public dashboard. We investigated the hypophosphatemia toxicities of intravenous iron formulations available at FDAERS for the years 2020-2022.

Results: A total of 547 reports of hypophosphatemia were reported in the year 2021 across all drugs. Out of them 114 were related to ferric carboxymaltose use. Out of 1017 reactions reported for ferric carboxymaltose, 220 were hypophosphatemia and 5 were hypophosphatemia osteomalacia. There were no reports hypophosphatemia with use of ferric derisomaltose, ferric gluconate, and iron dextran. Iron sucrose and ferumoxytol had five and one report of hypophosphatemia, respectively

Conclusions: Out of various iron formulations, ferric carboxymaltose has highest rate of hypophosphatemia and can even lead to hypophosphatemia osteomalacia. 21% of all reported adverse events of ferric carboxymaltose were hypophosphatemia. The rate hypophosphatemia with other iron formulations is negligible. This data is helpful to remind clinicians to monitor phosphorus levels in patients on ferric carboxymaltose

Master:Cardinal Health: Membership on an entity's Board of Directors or advisory committees; Aptitude health: Membership on an entity's Board of Directors or advisory committees; curio sciences: Membership on an entity's Board of Directors or advisory committees; Blue Bird Bio: Current holder of stock options in a privately-held company; Toxicity: Current holder of stock options in a privately-held company; Gilead: Current holder of stock options in a privately-held company; Jasper: Current holder of stock options in a privately-held company.

Author notes

*Asterisk with author names denotes non-ASH members.

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