Abstract: Objective To analyze the safety risks of human rabies immunoglobulin so as to provide a reference for rational clinical use of drugs. Methods Data on adverse reactions caused by human rabies immunoglobulin was retrieved from China’s Adverse Drug Reaction Monitoring Database (collected from inception to February 13, 2023) and FAERS database (collected from inception to December 31, 2024). Domestic literature published from inception to December 31, 2024 and foreign literature published between 2019 and 2024 on cases of adverse drug reactions caused by human rabies immunoglobulin were also retrieved from related databases. Package inserts of the drug were also analyzed. Results Adverse drug reactions of human rabies immunoglobulin involved multiple systems or organs. The clinical manifestations included dizziness, pyrexia, nausea, chest discomfort, rash, hypodynamia, pruritus and anaphylactic shock. The package inserts of human rabies immunoglobulin were upgraded as required by the National Medical Products Administration (NMPA) on October 20, 2023. Conclusion Medical institutions should be alert to such serious risks as anaphylactic shock and thromboembolism associated with this drug. Close observation is essential during medication. In case of allergic reactions or other serious adverse reactions, the drug must be discontinued immediately and quick treatment should be provided.

Key words: Human Rabies Immunoglobulin, Adverse Drug Reactions, Anaphylactic Shock, Safety, Risk