Abstract: Objective To explore the general characteristics and risk factors of serious adverse drug reaction (ADR) induced by fat-soluble vitamin for injection, so as to provide reference for rational and safe clinical drug use. Methods 491 serious ADR reports of fat-soluble vitamin for injection were collected based on Shandong adverse drug reaction database and the data were analyzed statistically. Results Serious adverse reactions of fat-soluble vitamins for injection could affect multiple systems. Allergic reactions were the main adverse reactions, and severe ones could lead to anaphylactic shock risk in clinic. Conclusion The manufacturer should carry out the safety monitoring of fat-soluble vitamin for injection, update the safety information contents of the drug instruction and warn drug risk in time. Drugs should be used reasonably following the indications, and dosage and administration to reduce the risk of ADRs.

Key words: fat-soluble vitamin for injection, adverse reaction, analysis