Prescription medicine
Sulfur hexafluoride Brand names: Lumason
Sulfur hexafluoride (Lumason) is a prescription medicine. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the sulfur hexafluoride FDA label on DailyMed (effective July 22, 2025); every sulfur hexafluoride label on DailyMed.
Highlights of the record
FDA label of July 22, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
SERIOUS CARDIOPULMONARY REACTIONS.
Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres [see Warnings and Precautions ( 5.1 )]. Most serious reactions occur within 30 minutes of administration [see Warnings and Precautions ( 5.1 )]. Assess all patients for the presence of any condition that precludes administration [see Contraindications ( 4 )]. Always have resuscitation equipment and trained personnel readily available [see Warnings and Precautions ( 5.1 )]. WARNING: SERIOUS CARDIOPULMONARY REACTIONS See full prescribing information for complete boxed warning Serious cardiopulmonary reactions, including fatalities, have occurred uncommonly during or following the injection of ultrasound contrast agents, including sulfur hexafluoride lipid microspheres ( 5.1 ). Most serious reactions occur within 30 minutes of administration ( 5.1 ). Assess all patients for the presence of any condition that precludes administration ( 4 ). Always have resuscitation equipment and trained personnel readily available ( 5.1 ).
Used for
From the label: indications and usageEchocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border.
Forms and strengths
Kit.
On the market
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,865 through July 30, 2026
What is sulfur hexafluoride used for?
From the label: indications and usageEchocardiography Lumason is indicated for use in adult and pediatric patients with suboptimal echocardiograms to opacify the left ventricular chamber and to improve the delineation of the left ventricular endocardial border. Ultrasonography of the Liver Lumason is indicated for use with ultrasound of the liver in adult and pediatric patients to characterize focal liver lesions. Ultrasonography of the Urinary Tract Lumason is indicated for use in ultrasonography of the urinary tract in pediatric patients for the evaluation of suspected or known vesicoureteral reflux. […]
Source: FDA drug label (LumaSon), BRACCO DIAGNOSTICS INC, effective July 22, 2025 (SPL set 7c679424-c3f7-ed02-892f-20ca0d775089), via openFDA; the full label on DailyMed
Is there a generic for sulfur hexafluoride (Lumason)?
No generic sulfur hexafluoride is approved (Drugs@FDA, October 8, 2026).
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for sulfur hexafluoride?
The FDA Adverse Event Reporting System holds 1,865 reports that list sulfur hexafluoride among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 91 are coded as a death and 459 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Sulfur hexafluoride side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other