The safety of Sonovue in abdominal applications: retrospective analysis of 23188 investigations

Ultrasound Med Biol. 2006 Sep;32(9):1369-75. doi: 10.1016/j.ultrasmedbio.2006.05.031.


The aim of the present retrospective study was to assess the incidence of adverse events (AE) of a second-generation ultrasound contrast agent in real clinical practice. A total of 28 Italian Centres provided data on the postmarketing use of SonoVue (Bracco Spa, Milan, Italy) in abdominal examination performed between December 2001 and December 2004. A total of 23 188 investigations were reported. No fatal event occurred. AEs were reported in 29 cases, of which only two were graded as serious; the rest, 27, were nonserious (23 mild, three moderate and one severe). The overall reporting rate of serious AE was 0.0086%. Overall, only four AEs required treatment (two serious, two nonserious including one moderate and one severe AEs). In conclusion, the present large-scale retrospective analysis showed that SonoVue has a good safety profile in abdominal applications, with an AE reporting rate lower than or similar to that reported for radiologic and magnetic resonance contrast agents.

Publication types

  • Multicenter Study

MeSH terms

  • Abdomen / diagnostic imaging*
  • Adverse Drug Reaction Reporting Systems
  • Contrast Media / adverse effects*
  • Humans
  • Liver / diagnostic imaging
  • Phospholipids / adverse effects*
  • Retrospective Studies
  • Sulfur Hexafluoride / adverse effects*
  • Ultrasonography


  • Contrast Media
  • Phospholipids
  • contrast agent BR1
  • Sulfur Hexafluoride