Abstract: Objective To analyze the risk to safety posed by misoprostol tablets used in obstetrics and gynecology in China in order to provide reference for clinical rational drug use. Methods The individual cases of adverse drug reactions reported in China adverse drug reaction database between January 1, 2015 and October 31, 2019 were analyzed, domestic and foreign literature published from the inception of the database to December 31, 2021 was retrieved, and precautions taken in China were outlined. Results and Conclusion The adverse reactions of misoprostol tablets are generally mild, and most of them do not require special treatment. But more serious adverse reactions are worthy of attention. Medical institutions should use misoprostol tablets strictly in accordance with the instructions and be alert to the serious adverse reactions. Drug manufacturers should make more effort to monitor and evaluate adverse drug reactions of their products, improve the safety information in drug instructions and take the initiative to carry out post-marketing safety studies when necessary.

Key words: misoprostol tablets, obstetrics and gynecology, adverse drug reaction, regulatory measures