Abstract: Objective To analyze the data on monitoring of post-marketing adverse reactions of Iron Dextran injection, explore the risk factors, recommend risk control measures, and provide a reference for clinical safe medication. Methods The adverse reaction reports retrieved from the National Adverse Drug Reaction Monitoring System (from January 1, 2004 to May 31, 2024) and foreign databases, literature (published from the inception to December 26, 2025), as well as drugs’ package inserts were systematically analyzed. Data was analyzed in terms of demographics, systems and organs involved, manifestations and outcomes before the revision of drug instructions was proposed. Results Among the 2 173 reports, Severe cases accounted for 21.91% of the adverse reactions of Iron Dextran injection from the National Adverse Drug Reaction Monitoring System. Adverse reactions were dominating among adults ages 45 to 64, especially in female patients. The systems and organs involved included general disorders and reactions at the sites of administration, the skin and subcutaneous tissues, the gastrointestinal system, respiratory, thoracic and mediastinal disorders, and the immune system. The allergic shocks caused by this drug were mostly immediate. The adverse reaction profiles reported in databases and literature were basically consistent with those in China. There was a lack of information on safety in the sections of precautions, contraindications and special populations in drug instructions. Conclusion Iron Dextran injection can cause severe adverse reactions such as anaphylactic shock. Marketing authorization holders are to monitor adverse reactions and quickly improve drug instructions based on feedback. Health care providers should inquire about patients’ medication history and allergy history before administration, administer Iron Dextran injection with caution, and control the infusion rate to ensure safe medication.

Key words: Iron Dextran Injection, Anaphylactic Shock, Adverse Drug Reaction, Risk Control, Improve Drug Instructions