FDA — authorised 10 October 2014
- Application: NDA203684
- Marketing authorisation holder: BRACCO
- Local brand name: LUMASON
- Indication: FOR SUSPENSION — INTRAVENOUS
- Status: approved
🇺🇸 Lumason in United States
FDA authorised Lumason on 10 October 2014 · 1,410 US adverse-event reports
Marketing authorisations
FDA
- Status: approved
Safety signals — FAERS
Adverse reaction reports describe suspected side effects. A report does not mean the drug caused the event — co-medications, underlying disease and coincidence all contribute.
- Window: 27 March 2025 – 27 March 2026
- Total reports: 1,410
Most-reported reactions
- Dyspnoea — 231 reports (16.38%)
- Nausea — 190 reports (13.48%)
- Anaphylactic Reaction — 182 reports (12.91%)
- Hyperhidrosis — 165 reports (11.7%)
- Flushing — 132 reports (9.36%)
- Dizziness — 114 reports (8.09%)
- Hypersensitivity — 109 reports (7.73%)
- Hypotension — 102 reports (7.23%)
- Paraesthesia — 93 reports (6.6%)
- Blood Pressure Decreased — 92 reports (6.52%)
Other Other approved in United States
Frequently asked questions
Is Lumason approved in United States?
Yes. FDA authorised it on 10 October 2014; FDA has authorised it.
Who is the marketing authorisation holder for Lumason in United States?
BRACCO holds the US marketing authorisation.