Abstract: ObjectiveTo explore the regularity and characteristics of adverse drug reaction/event (ADR/ADE) induced by azithromycin and search for risk factors in order to provide a reference for safe clinical use. Methods1 353 cases of azithromycin ADR/ADE reports were analyzed in terms of the patient's condition, original disease, ADR/ADE occurring time, organ function, clinical manifestation and outcome by using retrospective study method. Results 81.95% cases of azithromycin ADR/ADE occurred for the treatment of infectious diseases, 18.05% for non-infectious diseases. 75.16% cases of ADR/ADE occurred between 14~55 years old. 55.82% cases with intravenous drip occurred within 1 h after using medicine, 50.73% cases with oral medicine occurred in 10 min~24 h after drug use. The involved systems and organs included digestive system (56.05%), skin and accessories (15.78%), systemic damage (10.91%), nervous system (6.71%), cardiovascular system (4.87%), not in detail (2.61%), respiratory system (1.69%), auditory and vestibular apparatus(0.51%), kinetic system apparatus (0.46%) and urogenital system (0.41%). After active symptomatic treatment, recovery and improvement rate was 98.57%. ConclusionThe unreasonable use of azithromycin is one of the important factors of ADR/ADE. During the period of clinical application of azithromycin, we should strengthen the monitoring of ADR/ADE involving nervous system and cardiovascular system in order to reduce or avoid the occurrence of severe ADR/ADE.

Key words: azithromycin, adverse reactions/events, analysis, rational use of drugs