Omnipaque: adverse event reports filed with FDA

7,562

reports as suspect product

0% of all reports · about 336 a year

661

reports, 12 months to June 2026

637 in the 12 months before

80.7%

marked serious by the reporter

77% across the class

5.9%

record death among outcomes, as reported

448 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 Omnipaque reports recording the termmedian drug in radiographic contrast agent

1. Urticariahives13.5%1,019
2. Pruritusitching11.7%883
3. Dyspnoeashortness of breath10%757
4. Sneezing8.1%609
5. Erythemaskin redness7.6%576
6. Nauseafeeling sick6.1%463
7. Vomitingbeing sick5.6%421
8. Rashskin rash4.9%368
9. Chillschills or shivering4.5%344
10. Coughcough3.9%298
11. Contrast media reaction3.7%279
12. Anaphylactic reactiona severe, sudden allergic reaction3.4%259
13. Hypotensionlow blood pressure3.3%247
14. Chest discomfortchest discomfort3.2%245
15. Dizzinesslight-headedness or unsteadiness3.2%244
16. Throat irritationan irritated throat3.2%243
17. Hypersensitivityan allergic-type reaction3.2%241
18. Contrast media allergy3.1%235
19. Pyrexiafever2.7%204
20. Throat tightnessa tight throat2.7%202
21. Anaphylactic shocka severe allergic reaction with collapse2.7%201
22. Blood pressure decreaseda low blood pressure reading2.6%193
23. Headachehead pain2.5%192
24. Loss of consciousnesspassing out2.5%188
25. Acute kidney injurysudden loss of kidney function2.2%169
26. Extravasation2%152
27. Dysphagiadifficulty swallowing1.9%140
28. Malaisegeneral feeling of being unwell1.8%138
29. Flushingsudden reddening or warmth of the skin1.8%137
30. Hyperhidrosisexcessive sweating1.7%131

Top 30 of 656 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 11 drugs in the radiographic contrast agent 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 26,987 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. 37% 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 7,562 reports.

Drugs most often listed in the same reports

Other products listed in reports where Omnipaque 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 radiographic contrast agent 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 Omnipaque as a suspect or interacting product; reports listing it only as a concomitant medication (809) 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.