Definity: adverse event reports filed with FDA

5,416

reports as suspect product

0% of all reports · about 241 a year

415

reports, 12 months to June 2026

548 in the 12 months before

31.1%

marked serious by the reporter

38.6% across the class

1.8%

record death among outcomes, as reported

96 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Definity reports recording the termmedian drug in contrast agent for ultrasound imaging

1. Back painback pain43.7%2,367
2. Dyspnoeashortness of breath14.1%761
3. Muscle spasmsmuscle cramps13.8%746
4. Pain in extremitypain in an arm or leg9%490
5. Flushingsudden reddening or warmth of the skin7.2%391
6. Chest painchest pain7.1%385
7. Headachehead pain6.8%366
8. Dizzinesslight-headedness or unsteadiness5.7%309
9. Urticariahives5.5%297
10. Neck painneck pain5.4%295
11. Nauseafeeling sick4.7%253
12. Arthralgiajoint pain4.4%240
13. Pruritusitching3.9%209
14. Erythemaskin redness3.6%194
15. Anaphylactic reactiona severe, sudden allergic reaction3.5%192
16. Blood pressure increaseda raised blood pressure reading3.5%192
17. Chest discomfortchest discomfort3.2%175
18. Painpain, site not specified2.9%156
19. Feeling abnormalfeeling odd or not right2.8%151
20. Feeling hotfeeling hot2.7%144
21. Hyperhidrosisexcessive sweating2.7%144
22. Unresponsive to stimuli2.6%143
23. Oxygen saturation decreased2.6%140
24. Heart rate increaseda fast heart rate reading2.5%136
25. Loss of consciousnesspassing out2.4%130
26. Musculoskeletal painpain in muscles or bones2.2%120
27. Rashskin rash2.2%119
28. Hypotensionlow blood pressure2.1%115
29. Anxietyanxiety1.9%104
30. Coughcough1.9%104

Top 30 of 313 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the contrast agent for ultrasound imaging class; it describes the reports, not the patients. 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."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 6,955 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 97.1% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 5,416 reports.

Drugs most often listed in the same reports

Other products listed in reports where Definity is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."

Other drugs in the contrast agent for ultrasound imaging class

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." A brand and its generic are separate rows because reporters name them separately.

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 report counts here when it lists Definity as a suspect or interacting product; reports listing it only as a concomitant medication (95) are excluded. 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.