OBJECTIVE: To investigate the occurrence regularity and characteristics of adverse drug reactions（ ADR）based on the data of ADR in Shanghai Fifth People ’s Hospital

Fudan University（ hereinafter referred to as “our hospital”）

so as to to promote the rational application of clinical drugs. METHODS: Totally 1 167 reports of ADR collected and reported by our hospital from 2017 to 2020 were retrospectively analyzed in terms of patients’ age and gender

types of drugs involved in ADR

organs and（ or） systems involved

route of administration

causality and occupation of the reporter. RESULTS: Among 1 167 ADR cases

the highest number of ADR were reported by pharmacists（ 779 cases

66. 75%）. The proportion of female patients with ADR（ 651 cases

55. 78%） was slightly higher than that of male patients（ 516 cases

44. 22%）. A total of 621 patients were over 60 years

accounting for 53. 21%.The main route of administration was oral administration（ 580 cases

49. 70%）

followed by intravenous administration（ 502 cases

43. 02%）. There were 364 kinds of drugs that caused ADR

among which 395 cases（ 33. 85%） were caused by anti-infective drugs

including 39 kinds of anti-infective drugs

with fluoroquinolones

cephalosporins and macrolides as the most common antibiotics that caused ADR. The clinical manifestations of ADR were mainly digestive system damage（ 396 cases

33. 93%） and skin and accessory damage（ 284 cases

24. 34%）. CONCLUSIONS: Our hospital should continue to strengthen the monitoring of ADR

pay attention to the safety of medication for the elderly

and rationally select drugs and routes of administration in order to avoid or reduce the occurrence of ADR.