Abstract: Objective To probe into the status,characterstics and influencing factors of ADR/ADE cases induced by Ambroxol Hydrochloride injection. Methods We analyzed 40 ADR/ADE cases induced by ambroxol hydrochloride injection which were collected by Shandong ADR monitoring network from Jan. to Dec. of 2011. Results 95% of the patients were under 14 or more than 45 years old. The symptoms of serious ADR were mainly anaphylactoid reactions. 92.5% of ADR/ADE appeared within 30 min. Conclusion Serious ADR/ADE can be caused by a variety of factors. High attention should be paid to acute anaphylactoid reactions. Ambroxol hydrochloride injection should be used with more caution and exact monitoring.

Key words: ambroxol hydrochloride injection, adverse drug reactions/event(ADR/ADE）, analysis