Abstract: Objective To investigate the incidence of adverse drug reactions (ADR) caused by multivitamins for injection (12) so as to provide reference for clinical rational drug use. Methods 989 cases of ADR related to multivitamins for injection (12) were collected from the national adverse drug reaction monitoring system in Jiangsu between January 1, 2015 and May 31, 2020 before being analyzed retrospectively. Results 52.88% of these cases involved new ADR. Most of the adverse reactions involved females, and most of the patients ranged from 41 to 70 years old (56.32%). As for SOCs, systemic reactions accounted for 26.95%, skin and its accessories 20.41%, and the gastrointestinal system 10.87%. Serious ADR mainly involved the immune system (27.55%), systemic reactions (21.43%), and skin and its accessories (15.31%). Conclusion Marketing authorization holders should strengthen the post-marketing surveillance of drugs. More attention should be paid to the safe use of drugs and serious adverse reactions such as anaphylactic shock.

Key words: multivitamins for injection (12), adverse drug reaction, report analysis