Pharmacologic class (EPC) · 11 drug pages

Radiographic contrast agent: adverse event reports filed with FDA

26,987 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.

26,987
reports across the class: 0.1% of all reports; 2,233
reports, 12 months to June 2026: 1,879 in the 12 months before; 77%
marked serious by the reporter: 57.4% across all reports; 11
drugs with a page: brand and generic names counted separately

Radiographic contrast agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 11 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 26,987 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

2,233 reports arrived in the 12 months to June 2026, up 19% from 1,879 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 77% of the class's reports are marked serious, 6.3% record death among the outcomes and 29.6% record hospitalisation, as reported.

Across the class the reactions recorded most often are urticaria (14.7%), pruritus (11.5%) and dyspnoea (9.8%). 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
OmnipaqueIohexol	brand	7,562	661	80.7%	Urticaria
UltravistIopromide	brand	7,221	470	63%	Urticaria
VisipaqueIodixanol	brand	2,877	214	91.6%	Pruritus
OptirayIoversol	brand	2,247	56	72.8%	Urticaria
Ioversol	generic	1,389	54	74.5%	Urticaria
IomeronIomeprol injection	brand	1,257	301	99.8%	Rash maculo-papular
IsovueIopamidol	brand	1,139	162	56.5%	No adverse event
Iopamidol	generic	1,081	89	80.9%	Anaphylactic reaction
LipiodolEthiodized oil	brand	1,069	158	96.9%	Product use in unapproved indication
Iopromide	generic	622	21	94.7%	Nephropathy toxic
Iohexol	generic	523	47	81.5%	Anaphylactic reaction

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

Urticariahives14.7%3,976
Pruritusitching11.5%3,098
Dyspnoeashortness of breath9.8%2,653
Erythemaskin redness6.6%1,782
Nauseafeeling sick5.6%1,510
Sneezing5%1,355
Vomitingbeing sick4.9%1,313
Rashskin rash4.7%1,281
Anaphylactic shocka severe allergic reaction with collapse3.8%1,030
Coughcough3.2%865
Anaphylactic reactiona severe, sudden allergic reaction3.2%864
Blood pressure decreaseda low blood pressure reading3.1%830
Contrast media reaction3%800
Chest discomfortchest discomfort2.9%789
Hypotensionlow blood pressure2.9%785
Loss of consciousnesspassing out2.8%754
Throat irritationan irritated throat2.6%705
Dizzinesslight-headedness or unsteadiness2.6%701
Chillschills or shivering2.5%688
Acute kidney injurysudden loss of kidney function2.5%664
Hypersensitivityan allergic-type reaction2.4%646
Contrast media allergy2.3%625
Rash maculo-papulara rash of flat and raised spots2.1%564
Throat tightnessa tight throat2%552
Flushingsudden reddening or warmth of the skin2%541

Solid bar: share of all class reports. Hollow bar: the median share across the 11 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death6.3%1,690

Life-threatening13.9%3,745

Hospitalisation (initial or prolonged)29.6%7,998

Disability1.3%347

Congenital anomaly0.1%29

Other serious43.9%11,840

Not serious23%6,208

Patient age

Under 20.4%108

2 to 110.5%148

12 to 170.9%235

18 to 4416%4,327

45 to 6429.8%8,033

65 to 7416.4%4,423

75 and over12.3%3,315

Age not given23.7%6,398

Who reported

Physician23.6%6,379

Pharmacist7.5%2,037

Other health professional58.8%15,876

Lawyer0.1%29

Consumer or non-health professional6.7%1,805

Not given3.2%861

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 Radiographic contrast agent reports

Which drugs are in the Radiographic contrast agent class on this site?

Omnipaque, Ultravist, Visipaque, Optiray, Ioversol and Iomeron and 5 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

26,987 reports through June 2026, 2,233 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?

urticaria (14.7%), pruritus (11.5%), dyspnoea (9.8%), erythema (6.6%) and nausea (5.6%).

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.