OBJECTIVE: To conduct an analysis based on the U.S. Adverse Event Database (FAERS) to mine the adverse drug event signals of the ultrasound contrast agent sulphur hexafluoride (SonoVue) for safe clinical use. METHODS: All reported SonoVue adverse drug event reports (ADEs) from 2015 to 2023 in the FAERS database were extracted, and the ADEs were analysed using the report-to-ratio (ROR) method, the proportionate report-to-ratio (PRR) method, and the BCPNN method, to obtain ADEs occurring in the real world and to uncover ADEs whose drug ADEs that were not labelled in the specification. RESULTS: A total of 12,178,164 adverse event reports from the FAERS database were extracted. Of these ADEs, SonoVue was identified as the first suspected drug in 1079 ADEs. Patient gender was predominantly male (56.35%) and reported nationality was predominantly American (86.28%). The resulting ADEs were mainly for 16 system-organ classifications, with various neurological disorders, systemic disorders and various reactions at the site of administration, respiratory system, immune system disorders, and cardiac organ disorders being the main ones, and the ADE risk signals were generally consistent with the drug inserts. Adverse reactions not included in the specification, including eye organ diseases (ROR=0.61), renal and urinary system diseases (ROR=0.36), ear and labyrinthine disorders (ROR=7.2), and infections and invasive diseases (ROR=0.03), were also discovered, but the high risk signals were low. Severe ADE outcomes were mostly life-threatening (23.2%) and hospitalisation (23.04%), and there were 4.69% of fatal ADEs reported. CONCLUSION: Sulfur hexafluoride microbubbles, an ultrasound contrast agent, are relatively safe, and the actual application of some of the instructions are not included in the adverse reactions, and it is recommended that contraindications, precautions, and supervision should be strictly grasped in the process of actual clinical application.