SonoVue has been shown to be safe and well tolerated with minimal risk to patients. In clinical trials, the overall incidence of adverse events was relatively low (10.7% overall, 5.2% investigational product-related) in subjects receiving SonoVue. The most frequently reported adverse events were headache (2.1%), nausea (0.9%), chest pain (0.8%), and chest discomfort (0.5%). All other adverse events occurred at a frequency of <0.5%. Most adverse events were mild and resolved spontaneously within a short time without sequelae. Serious adverse events occurred in 0.43% of patients and only 0.08% of events were considered to be of some relationship to the administration of SonoVue (probable, possible, or unlikely). No product- related deaths were reported within MAH-sponsored trials.