Drugs › Radiographic contrast agent
Generic name
Ioversol: adverse event reports filed with FDA
1,389 reports list it as a suspect or interacting product, 2004–2026. Class: Radiographic contrast agent.
- 1,389
- reports as suspect product
- 0% of all reports · about 62 a year
- 54
- reports, 12 months to June 2026
- 42 in the 12 months before
- 74.5%
- marked serious by the reporter
- 77% across the class
- 5.7%
- record death among outcomes, as reported
- 79 reports · not verified by FDA
1,389 adverse event reports received by FDA list ioversol, a generic name as a suspect or interacting product, from April 2004 to June 2026. A further 126 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 54 reports listed it, up 29% from 42 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 62 reports a year and 0% of the 20,646,523 reports in the database, and 5.1% of the reports for the radiographic contrast agent class. How many people take it is not in the data, so a count is not a rate of occurrence.
Reporters most often recorded urticaria (13%), dyspnoea (10.7%) and pruritus (10.4%). A report can list several reactions, so shares add to more than 100%; 211 different terms appear across these reports. Urticaria is recorded in 13% of these reports, a larger share than in the median radiographic contrast agent drug (7.2%).
74.5% of the reports are marked serious by the reporter (77% across the class); 5.7% record death among the outcomes and 28.1% record hospitalisation, as reported. 58.7% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (26%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
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 Ioversol reports recording the termmedian drug in radiographic contrast agent
- Urticariahives13%180
- Dyspnoeashortness of breath10.7%148
- Pruritusitching10.4%144
- Rashskin rash6.3%87
- Throat irritationan irritated throat5.6%78
- Sneezing5.4%75
- Anaphylactic shocka severe allergic reaction with collapse4.9%68
- Erythemaskin redness4.5%62
- Coughcough4.4%61
- Nauseafeeling sick4.1%57
- Chest discomfortchest discomfort3.8%53
- Throat tightnessa tight throat3.5%49
- Hypersensitivityan allergic-type reaction3%42
- Acute kidney injurysudden loss of kidney function2.9%40
- Vomitingbeing sick2.8%39
- Rash maculo-papulara rash of flat and raised spots2.6%36
- Cardiac arrestthe heart stopped2.4%33
- Anaphylactic reactiona severe, sudden allergic reaction2.3%32
- Loss of consciousnesspassing out2.2%31
- Renal failure acute2.2%30
- Nephropathy toxic2.1%29
- Blood pressure decreaseda low blood pressure reading2%28
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement1.9%27
- Eosinophilia1.7%24
- Pharyngeal oedemaswelling of the throat1.7%23
- Headachehead pain1.6%22
- Hypotensionlow blood pressure1.6%22
- Malaisegeneral feeling of being unwell1.6%22
- Dizzinesslight-headedness or unsteadiness1.5%21
Top 30 of 211 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
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 39.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Computerised tomogram | 640 | 46.1% |
| Computerised tomogram abdomen | 100 | 7.2% |
| Angiogram | 57 | 4.1% |
| Arteriogram coronary | 30 | 2.2% |
| Urogram | 27 | 1.9% |
| Computerised tomogram head | 24 | 1.7% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,389 reports.
In context
| Measure | Ioversol | Radiographic contrast agent | All reports |
|---|---|---|---|
| Reports as suspect product | 1,389 | 26,987 | 20,646,523 |
| Share of that pool | — | 5.1% | 0% |
| Reports, latest 12 months | 54 | — | 1,332,454 |
| Marked serious | 74.5% | 77% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 57 | 63 | 91 |
| Hospitalisation recorded, per 1,000 reports | 281 | 296 | 213 |
| Consumer-filed share | 7.1% | 6.7% | 45.8% |
| Top term, share of reports | Urticaria 13% | median 7.2% | 0.8% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Omnipaque | brand | 7,562 | 661 | 80.7% |
| Ultravist | brand | 7,221 | 470 | 63% |
| Visipaque | brand | 2,877 | 214 | 91.6% |
| Optiray | brand | 2,247 | 56 | 72.8% |
| Iomeron | brand | 1,257 | 301 | 99.8% |
| Isovue | brand | 1,139 | 162 | 56.5% |
| Iopamidol | generic | 1,081 | 89 | 80.9% |
| Lipiodol | brand | 1,069 | 158 | 96.9% |
| Iopromide | generic | 622 | 21 | 94.7% |
| Iohexol | generic | 523 | 47 | 81.5% |
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.
Questions about Ioversol reports
How many adverse event reports has FDA received for Ioversol?
1,389 reports list Ioversol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 54 of them arrived in the latest 12 months. Another 126 list it only as a concomitant medication.
What reactions are recorded in Ioversol reports?
urticaria (13%), dyspnoea (10.7%), pruritus (10.4%), rash (6.3%) and throat irritation (5.6%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Ioversol was responsible.
How serious are the reports?
74.5% are marked serious by the reporter. Among the outcomes recorded, 5.7% of reports include death and 28.1% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
other health professional (58.7%), physician (25.2%) and pharmacist (7.1%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ioversol rising?
54 reports in the 12 months to June 2026, up 29% from 42 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Ioversol was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Ioversol?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Ioversol as a suspect or interacting product; reports listing it only as a concomitant medication (126) 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.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.