Abstract: Objective To analyze the occurrence of adverse drug reactions (ADRs) induced by quinolone drugs in China. Methods Based on the National Science Data Sharing Platform for Population and Health, 481 case reports of quinolone drugs-induced ADRs were collected. The fields in each case report were standardized, and the ADR symptoms were extracted and standardized by using Jieba word segmentation module and WHO adverse reaction terminology. In addition, gender, age, routes of administration and organs/systems involved in ADRs were retrospectively analyzed. Results In these reports, male patients slightly outnumbered female ones and the proportion of patients aged 20 to 59 was higher. ADRs induced by intravenous drip were the most common and tended to occur within 10 minutes of administration. The ADRs recorded in most of these case reports were relatively mild. The most common serious ADRs were life-threatening, and levofloxacin caused most of the serious adverse reactions. Quinolone drugs were involved in a total of 184 adverse drug reactions, the dominating ones of which were chest pain and palpitation. The main organ system involved was the skin and its appendages, with such clinical manifestations as pruritus and rash. Conclusion This study has effectively analyzed ADRs caused by quinolone drugs by extracting the adverse reaction symptoms from case reports and standardizing the terms, providing a novel approach to retrospective analysis of adverse reactions. Health care workers should pay close attention to adverse reactions that may occur along with the use of quinolone drugs to ensure safe and rational clinical use.

Key words: quinolone drug, adverse drug reaction, case report, rational drug use