Drugs › Radiographic contrast agent
Brand name · Iopamidol
Isovue: adverse event reports filed with FDA
1,139 reports list it as a suspect or interacting product, 2010–2026. Class: Radiographic contrast agent. Also reported as Isovue 370, Isovue 300, Isovue 200.
- 1,139
- reports as suspect product
- 0% of all reports · about 72 a year
- 162
- reports, 12 months to June 2026
- 63 in the 12 months before
- 56.5%
- marked serious by the reporter
- 77% across the class
- 4.7%
- record death among outcomes, as reported
- 54 reports · not verified by FDA
1,139 adverse event reports received by FDA list the brand name Isovue (iopamidol) as a suspect or interacting product, from September 2010 to June 2026. A further 128 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, 162 reports listed it, up 157% from 63 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 72 reports a year and 0% of the 20,646,523 reports in the database, and 4.2% 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.
The reactions recorded most often are no adverse event (10.7%), urticaria (10.6%) and anaphylactic reaction (9.8%). A report can list several reactions, so shares add to more than 100%; 190 different terms appear across these reports. No adverse event is recorded in 10.7% of these reports, with no counterpart in the median radiographic contrast agent drug (0%).
56.5% of the reports are marked serious by the reporter (77% across the class); 4.7% record death among the outcomes and 23.7% record hospitalisation, as reported. 57% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (29.5%). 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 Isovue reports recording the termmedian drug in radiographic contrast agent
- No adverse eventno adverse event was reported10.7%122
- Urticariahives10.6%121
- Anaphylactic reactiona severe, sudden allergic reaction9.8%112
- Pruritusitching8%91
- Contrast media reaction7.4%84
- Dyspnoeashortness of breath7.1%81
- Product physical issuea physical defect in the product4.3%49
- Hypersensitivityan allergic-type reaction4.2%48
- Sneezing3.3%38
- Erythemaskin redness3.2%36
- Acute kidney injurysudden loss of kidney function3.1%35
- Nauseafeeling sick3.1%35
- Extravasation2.6%30
- Throat irritationan irritated throat2.4%27
- Cardiac arrestthe heart stopped2.3%26
- Coughcough2.3%26
- Vomitingbeing sick1.8%20
- Anaphylactic shocka severe allergic reaction with collapse1.7%19
- Throat tightnessa tight throat1.7%19
- Cardio-respiratory arrestthe heart and breathing stopped1.6%18
- Chest discomfortchest discomfort1.6%18
- Dizzinesslight-headedness or unsteadiness1.6%18
- Wrong drug administeredthe wrong medicine was given1.6%18
- Chest painchest pain1.4%16
- Maternal exposure during pregnancythe mother took the medicine during pregnancy1.3%15
- Contrast media allergy1.2%14
- Rashskin rash1.2%14
- Drug ineffectivethe medicine did not work as expected1.1%13
Top 30 of 190 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. 93.6% 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 | 356 | 31.3% |
| Diagnostic procedure | 118 | 10.4% |
| Computerised tomogram abdomen | 81 | 7.1% |
| Angiogram | 66 | 5.8% |
| Catheterisation cardiac | 42 | 3.7% |
| Mammogram | 40 | 3.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,139 reports.
In context
| Measure | Isovue | Radiographic contrast agent | All reports |
|---|---|---|---|
| Reports as suspect product | 1,139 | 26,987 | 20,646,523 |
| Share of that pool | — | 4.2% | 0% |
| Reports, latest 12 months | 162 | — | 1,332,454 |
| Marked serious | 56.5% | 77% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 47 | 63 | 91 |
| Hospitalisation recorded, per 1,000 reports | 237 | 296 | 213 |
| Consumer-filed share | 16.3% | 6.7% | 45.8% |
| Top term, share of reports | No adverse event 10.7% | median 0% | 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% |
| Ioversol | generic | 1,389 | 54 | 74.5% |
| Iomeron | brand | 1,257 | 301 | 99.8% |
| 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 Isovue reports
How many adverse event reports has FDA received for Isovue?
1,139 reports list Isovue as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 162 of them arrived in the latest 12 months. Another 128 list it only as a concomitant medication.
What reactions are recorded in Isovue reports?
no adverse event (10.7%), urticaria (10.6%), anaphylactic reaction (9.8%), pruritus (8%) and contrast media reaction (7.4%). 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 Isovue was responsible.
How serious are the reports?
56.5% are marked serious by the reporter. Among the outcomes recorded, 4.7% of reports include death and 23.7% 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 (57%), consumer or non-health professional (16.3%) and pharmacist (12.7%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Isovue rising?
162 reports in the 12 months to June 2026, up 157% from 63 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 Isovue 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 Isovue?
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 Isovue as a suspect or interacting product; reports listing it only as a concomitant medication (128) 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.