Pharmacologic class (EPC) · 2 drug pages

Contrast agent for ultrasound imaging: adverse event reports filed with FDA

6,955 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

6,955
reports across the class: 0% of all reports; 823
reports, 12 months to June 2026: 754 in the 12 months before; 38.6%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Contrast agent for ultrasound imaging is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 6,955 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

823 reports arrived in the 12 months to June 2026, close to the 754 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 38.6% of the class's reports are marked serious, 2.3% record death among the outcomes and 9.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are back pain (34.7%), dyspnoea (14.9%) and muscle spasms (10.8%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
DefinityPerflutren	brand	5,416	415	31.1%	Back pain
LumaSonSulfur hexafluoride	brand	1,539	408	65.2%	Dyspnoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Back painback pain34.7%2,412
Dyspnoeashortness of breath14.9%1,035
Muscle spasmsmuscle cramps10.8%751
Flushingsudden reddening or warmth of the skin7.9%550
Pain in extremitypain in an arm or leg7.1%495
Nauseafeeling sick6.9%482
Chest painchest pain6.8%470
Dizzinesslight-headedness or unsteadiness6.4%445
Headachehead pain6.2%432
Anaphylactic reactiona severe, sudden allergic reaction5.8%400
Hyperhidrosisexcessive sweating4.9%339
Urticariahives4.8%331
Pruritusitching4.5%310
Erythemaskin redness4.4%303
Neck painneck pain4.3%298
Feeling hotfeeling hot3.8%266
Unresponsive to stimuli3.5%242
Arthralgiajoint pain3.5%240
Hypotensionlow blood pressure3.3%230
Blood pressure increaseda raised blood pressure reading3.1%219
Hypersensitivityan allergic-type reaction3.1%218
Oxygen saturation decreased3.1%218
Chest discomfortchest discomfort3%211
Heart rate increaseda fast heart rate reading2.9%199
Feeling abnormalfeeling odd or not right2.8%197

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death2.3%160

Life-threatening8.5%591

Hospitalisation (initial or prolonged)9.2%643

Disability0.3%22

Congenital anomaly0%0

Other serious30.4%2,117

Not serious61.4%4,270

Patient age

Under 20.1%5

2 to 110%1

12 to 170%3

18 to 4413.7%956

45 to 6433.2%2,306

65 to 7418.7%1,300

75 and over15.1%1,050

Age not given19.2%1,334

Who reported

Physician2.9%203

Pharmacist3.4%238

Other health professional29.3%2,037

Lawyer0%0

Consumer or non-health professional63.2%4,396

Not given1.2%81

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Contrast agent for ultrasound imaging reports

Which drugs are in the Contrast agent for ultrasound imaging class on this site?

Definity and LumaSon. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

6,955 reports through June 2026, 823 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

back pain (34.7%), dyspnoea (14.9%), muscle spasms (10.8%), flushing (7.9%) and pain in extremity (7.1%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.