Abstract: Objective To explore the characters of the serious adverse reactions caused by Gugua extracts injection. Methods 208 reports of the serious adverse reactions caused by Gugua extracts injection were analyzed via retrospective study. Results Gugua extracts injection may lead to serious adverse reactions such as anaphylactic shock, anaphylactoid reaction,rigors,dyspnea,fever, etc. The serious adverse reactions occurred within 30 min, and anaphylactic shock occurred within 15 min. Conclusion It is necessary to re-evaluate the risk of serious adverse reactions caused by Gugua extracts injection and modify the drug instructions on this basis.

Key words: Gugua extracts, serious adverse reactions, anaphylactic shock