Objective: To evaluate the safety and efficacy of real-world generic and original levetiracetam levetiracetam ( LEV). Methods: Clinical data of 600 children with epilepsy received LEV in the Second Affiliated Hospital of Xi’an Jiaotong University from Apr. 2019 to May 2020 were retrospectively analyzed. Blood concentration of generic and original LEV was determined by high performance liquid chromatography. Correlation between the dose of two drugs and blood concentration

therapeutic effect and incidence of adverse drug reactions were analyzed. Results: Among the 600 patients with epilepsy

125 cases received generic LEV

including 71 cases of monotherapy and 54 cases of additive therapy. Totally 475 patients received original LEV

including 266 cases of monotherapy and 209 cases of additive therapy. Blood concentrations were (9. 31±3. 34) μg / mL for LEV generic monotherapy

(10. 26±4. 72) μg / mL and (11. 05±2. 41) μg / mL when combined with liver enzyme inducers (oxcarbazepine and phenobarbital)

(10. 69±5. 78) μg / mL and (8. 16±4. 37) μg / mL when combined with liver enzyme inhibitors ( valproic acid and topiramate)

and ( 8. 74 ± 5. 56) μg / mL in combination with liver enzyme inducers and liver enzyme inhibitors ( oxcarbazepine + valproic acid)

with no statistically significant differences compared with the original LEV. The effective rate of LEV generic drug was 78. 9%

and that of the original drug was 74. 1%. The effective rate of the generic LEV combined with liver enzyme inducers was 64. 3%

and that of the original drug was 62. 7%. The effective rate of generic LEV combined with liver enzyme inhibitors was 59. 3%

and that of the original drug was 78. 2%. The effective rate of generic LEV combined with liver enzyme inducers and liver enzyme inhibitors was 69. 2%

and that of the original drug was 71. 4%. There was no significant difference in clinical efficacy between generic and original LEV. The incidence of adverse drug reactions of generic LEV was similar to that of the original LEV

and the most common adverse drug reactions were abnormal behavior and sleep difficulty. Conclusion: There is no significant difference between the generic and original LEV in clinical efficacyand adverse drug reactions. Generic LEV are safe and effective to replace the original LEV.