To analyze the characteristics and relative factors of adverse drug reactions (ADR) induced by sanqizongzaogan injection, in order to provide reference for the clinical use of sanqizongzaogan injection properly. The 103 reported cases of ADR induced by sanqizongzaogan injection in China over 15 years were retrospectively analyzed. The 103 ADR cases, 41.7% occurred in patients aged above 60. The most common presentation of ADR was drug eruption, followed by allergic reactions (20.4%) and allergic shock (9.7%). The occurrence of ADR is affected by many factors. We should control the drug indication strictly, check patients drug allergy history carefully before prescription, monitor ADR afterwards, promote clinical rational drug-usage.