Abstract: Objective To investigate relevant factors of the adverse drug reaction(ADR) induced by Sophora Tonkinensis and related preparations, and provide the scientific reference for the safe and rational use in clinic. Methods With retrospective case study, 111 cases of ADR induced by Sophora Tonkinensis and related preparations were analyzed, which were collected from medical journal database and traditional Chinese medicine database. Results Adverse reaction will occur when orally taken daily dose more than 5 g or intramuscularly injected 4 mL. The damage to digestive and nervous system was the most common, which accounted for 32.21% and 31.46% of total adverse reactions respectively. Conclusion Sophora Tonkinensis as a common traditional Chinese medicine is used for clinical treatment of sore throat and physicians/pharmacists should control the dosage strictly to avoid or reduce the incidence of ADR.

Key words: Sophora Tonkinensis Gagnep., adverse drug reaction, rational drug use