Abstract: Objective To study using rules and safety of oxiracetam injection and provide reference for clinically reasonable application. Methods In twelve sentinel hospital of Hubei province, all hospitalized patients using oxiracetam injection were monitored centralizedly in observation period (September 1, 2016 to March 31, 2017). The patient's demographic information, clinical diagnosis, drug usage and dosage, course of treatment, solvent, combination and incidence of adverse drug reactions (ADRs) were analyzed, and the risk factors influencing ADRs were studied. Results A total of 6 519 cases were recorded. There were 19 cases of ADRs (0.29%). Patients aged 40 to 90 years accounted for 90.31%. ADRs occur mostly in 3 days after medication (57.89%). 17 ADRs are mild (89.47%), and 2 ADRs are new and serious. Skin and appendages disorders (pruritus) are the most common (36.84%). Statistical analysis showed no significant difference (P>0.05) in incidence rate of ADR between different genders, age groups, allergic history, diseases and dosage form. Conclusion The drug instructions and clinical medication need to further improved. In clinical use of oxiracetam injection, particular attention should be paid to the course of treatment, dosage and solvent. To avoid or reduce ADRs, it is important to closely observe patients' drug reactions and dispose immediately.

Key words: oxiracetam injection, adverse reactions, drug safety, centralized monitoring