OBJECTIVE: To study the general regularity and clinical characteristics of adverse drug reaction (ADR) caused by azithromycin, and to provide reference for rational use of drugs in the clinic. METHODS: A case reported a child of 10 years old suffered from cholecystolithiasis due to azithromycin therapy. Retrieved from Wanfang database, publicly issued literatures about azithromycin-induced ADR reported in domestic pharmaceutical journals from 2001 to 2010 were collected and analyzed. RESULTS: Azithromycin-inducing ADR mainly was anaphylactic shock, followed by the damage of dermal system and digestive system. Azithromycin-inducing ADR often occurred in children under 10 years of age. CONCLUSION: We should pay more attention to azithromycin-inducing ADR, select the appropriate route of administration and ensure the safety of drug use.