ObjectiveTo analyze the clinical application and safety of Shenmai injection.MethodsWe collected clinical data of 30 012 patients using Shenmai injection from 26 hospitals nationwide from September, 2009 to June, 2013. The SPSS 15.0 software was used to analyze demographic characteristics, diagnostic information, and clinical application of the injection.ResultsAmong all patients, 14 270 were females (47.55%), 8 218 were aged 45-60 (27.38%), and 10 452 were aged 61-75 (34.83%). The primary use of Shenmai injection was as an adjuvant treatment of chemotherapy for cancer patients, and the top 3 cancers were lung cancer (1 533, 5.11%), breast cancer (1 509, 5.03%) and gastric cancer (847, 2.82%). The second important use of Shenmai injection was the treatment of coronary heart disease (5 703, 19.00%), of which the most common single dose was 50 mL (14 406, 48.00%), followed by 100 mL (10 804, 36.00%) and 200 mL (600, 2.00%). The solvents were used in 18 902 patients (62.98%), and the 5% glucose injection was used most frequently (84.64%). The adverse effects (AEs) rate was 0.15%, and 57.78% AEs occurred within 24 hours of infusion. The most common AEs were damage of the cardiovascular system, followed by damaging of blood system and respiratory system.ConclusionsShenmai injection has a wide range of applications and can be used in treatment of numerous diseases in the real-world, and the AEs have been linked to off-label uses.