Abstract: Objective To analyze the risk of haloperidol preparations so as to provide reference for clinical rational drug use. Methods The reports about adverse drug reactions (ADR) induced by haloperidol that were collected in China adverse drug reaction database from, January 1, 2004 to December 31, 2019 as well as those collected in domestic and foreign database from inception to May 31, 2020, and the relevant risk control measures for haloperidol issued by domestic and foreign drug regulatory agencies were retrieved and analyzed. Results A total of 13 936 reports of adverse drug reactions involving haloperidol preparations were received the China Adverse Drug Reaction Monitoring Database for suspected and concurrent use of drugs including 624 cases involving the cardiovascular system and 111 cases of serious adverse reactions. The risk of cardiovascular-related adverse reactions of haloperidol preparations was suggested by domestic and foreign literature reports. Conclusion It is recommended that regulatory authorities urge the drug marketing authorization holders to strengthen the monitoring and evaluation of adverse reactions of haloperidol preparations, revise product instructions in a timely manner, and promote the rational use of drugs by medical staff and patients.

Key words: haloperidol, cardiovascular-related adverse reactions, adverse drug reaction, regulatory measures