What the label lists and what reports show
Sulfur hexafluoride side effects
Sulfur hexafluoride's FDA label: “Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ).” FAERS holds 1,865 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is dyspnoea (312 reports).
- No generic listed
- Boxed warning
Check it at the source: the sulfur hexafluoride FDA label on DailyMed (effective July 22, 2025); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| Reaction | *occurring in at least 0.2% of patients Table 1. Adverse Reactions in Adult Patients* n = 6856 |
|---|---|
| Number (%) of Patients with Adverse Reactions | 340 (5%) |
| Headache | 65 (1%) |
| Nausea | 37 (0.5%) |
| Dysgeusia | 29 (0.4%) |
| Injection site pain | 23 (0.3%) |
| Feeling Hot | 18 (0.3%) |
| Chest discomfort | 17 (0.2%) |
| Chest pain | 12 (0.2%) |
| Dizziness | 11 (0.2%) |
| Injection Site Warmth | 11 (0.2%) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following serious adverse reactions are discussed elsewhere in the labeling: Cardiopulmonary reactions [see Warnings and Precautions ( 5.1 )] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 )] Most common adverse reactions (incidence ≥ 0.5%) are headache and nausea ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Bracco Diagnostics Inc at 1-800-257-5181 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. Adults In completed clinical trials, a total of 6984 adult subjects (128 healthy volunteers and 6856 patients) received Lumason at cumulative doses ranging from 0.2 to 161 mL (mean 9.8 mL). Lumason was administered mainly as single or multiple injections; however, some subjects received infusion dosing. The majority (75%) of subjects received Lumason at cumulative doses of 10 mL or less. There were 64% men and 36% women, with an average age of 59 years (range 17 to 99 years). A total of 79% subjects were White; 4% were Black; 16% were Asian; <1% were Hispanic; and <1% were in other racial groups or race was not reported. …
Source: FDA drug label, BRACCO DIAGNOSTICS INC, effective July 22, 2025 (SPL set 7c679424-c3f7-ed02-892f-20ca0d775089), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,865 reports list sulfur hexafluoride among the medicines taken, 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. Of the 24 reactions below, 10 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Sulfur hexafluoride: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions