ABSTRACT Objective:To detect and analyze the safe signals induced by empagliflozin and to provide references for clinic. Methods: Data Mining was used to find the safe signals of empagliflozin from the AERS submitted to the FDA, and the age, sex and doses of medication of patients with digestive system ADRs was statistical analyzed. Results: A totel of 163 safe signals related to empagliflozin were mined in 12 468 235 reports, the digestive system signals were 12. Among the patients with digestive system ADRs, the ratio of male to female was almost equal, the patient aged 40 75 years old were the most, most of the ADRs occurred within six months, all ADRs were used recommended dose. Conclusion:Empagliflozin might cause abdominal pain, gastroenteritis, pancreatitis, cirrhosis, hepatic cirrhosis and the other digestive system ADRs, it was recommended to strengthen pharmaceutical care on empagliflozin to prevent ADRs occur. |