Abstract: Objective To provide reference for the rational use of drugs in clinic and the development of their dosage forms through analyzing 45 cases of adverse drug reactions (ADRs) induced by Lamiophlomis rotata Kudo. Methods A descriptive study was used to retrospectively analyze 45 cases of adverse drug reactions reported from 2007 to 2016 in Gansu province. Results There were four kinds of dosage forms related to the side effects, which were Lamiophlomis rotata capsule, soft capsule, dispersible tablet and granule.45 cases of adverse reactions occurred in the preparations of Lamiophlomis rotata Kudo, of which Lamiophlomis rotata capsule had 28 cases, accounting for 62.22%; 13 cases of Lamiophlomis rotata soft capsules, accounting for 28.89%; 2 cases of Lamiophlomis rotata dispersible tablet and granule respectively, accounting for 4.44%. Lamiophlomis rotata capsule 's and Lamiophlomis rotata soft capsule 's main adverse reactions were gastrointestinal tract reaction, nausea and abdominal pain. The common adverse reactions of the four formulations were gastrointestinal reaction and pruritus. The sequence of adverse reactions in the four formulations is as follows: Lamiophlomis rotata capsule > Lamiophlomis rotata soft capsule > Lamiophlomis rotata granule > Lamiophlomis rotata dispersible tablet. Conclusion The paper is aimed at strengthening the monitoring and reporting of adverse reactions, grasping the possible adverse reactions timely and effectively. Through the study, it is significant to find out the risk so that maximization of the prevention of risk expansion can be reached, improve the safety of clinical drug use, and provide a new idea for the rational development of the drug. According to the adverse reactions of Lamiophlomis rotata capsule and soft capsule, it can be used with gastrointestinal protection drugs to reduce the stimulation of gastrointestinal tract caused by Lamiophlomis rotata capsule.

Key words: Lamiophhmis rotate, Lamiophhmis rotata capsule, adverse drug reactions