Iopamidol adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Iopamidol
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Generic name
Class: Radiographic contrast agent
Also reported as: Iopamidol Injection, Iopamidol 370

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Reports on file

From February 2004 to June 2026, FDA received 1,081 adverse event reports that name Iopamidol. In these reports the drug is a suspect or interacting product.

In the same period, 572 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 89 reports in the 12 months to June 2026 and 55 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Iopamidol is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 1 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

No update is on record for this page. The record starts when FDA adds the reports of July to September 2026.

In April to June 2026, FDA received 33 reports that name Iopamidol.
In January to March 2026, FDA received 26.
In April to June 2025, FDA received 9.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 83 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for 1,067 of the 1,081 reports (98.7%).

The reports of the other years are not in the counts.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 83 terms.

Reaction terms in the reports that name Iopamidol, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 1,081 reports
Anaphylactic reactiona severe, sudden allergic reaction	66	6.1%
Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement	62	5.7%
Off label useused for a purpose or in a way not on the label	59	5.5%
Dyspnoeashortness of breath	53	4.9%
Nauseafeeling sick	53	4.9%
Contrast media reaction	51	4.7%
Anaphylactic shocka severe allergic reaction with collapse	48	4.4%
Urticariahives	48	4.4%
Pruritusitching	47	4.3%
Maternal exposure during pregnancythe mother took the medicine during pregnancy	43	4%
Hypersensitivityan allergic-type reaction	40	3.7%
Vomitingbeing sick	36	3.3%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	30	2.8%
Rashskin rash	30	2.8%
Hepatic artery stenosis	25	2.3%
Contrast media allergy	24	2.2%
Cardio-respiratory arrestthe heart and breathing stopped	23	2.1%
Erythemaskin redness	22	2%
Cardiac arrestthe heart stopped	21	1.9%
Flushingsudden reddening or warmth of the skin	21	1.9%
Nephropathy toxic	20	1.9%
Dizzinesslight-headedness or unsteadiness	19	1.8%
Blood pressure decreaseda low blood pressure reading	18	1.7%
Contrast encephalopathy	18	1.7%
Hypotensionlow blood pressure	17	1.6%
Chest discomfort	16	1.5%
Oxygen saturation decreased	15	1.4%
Pyrexiafever	15	1.4%
Acute kidney injurysudden loss of kidney function	14	1.3%
Loss of consciousnesspassing out	14	1.3%
Blood pressure increaseda raised blood pressure reading	13	1.2%
Chillschills or shivering	13	1.2%
Cough	13	1.2%
Extravasation	13	1.2%
Headachehead pain	13	1.2%
Sepsisa severe body-wide response to infection	13	1.2%
Angioedemadeep swelling of skin or mucous membranes	12	1.1%
Blood creatinine increasedraised creatinine, a kidney test	12	1.1%
Infusion site extravasationinfusion fluid leaked into surrounding tissue	12	1.1%
Throat irritationan irritated throat	12	1.1%
Unresponsive to stimuli	12	1.1%
Abdominal painstomach or belly pain	11	1%
Product use in unapproved indicationused for a purpose not on the label	11	1%
Renal failurekidney failure	11	1%
Sneezing	11	1%
Anaphylactoid reaction	9	0.8%
Neurotoxicity	9	0.8%
Depressed level of consciousness	8	0.7%
Hyperhidrosisexcessive sweating	8	0.7%
Kounis syndrome	8	0.7%

Download all 83 terms of Iopamidol (CSV)

The counts add to more than 1,081 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Iopamidol with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Iopamidol (this page)	Generic name	1,081
Isovue	Brand name	1,139

Sum of the separately reported names: 2,220. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Iopamidol, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	24	23	6	2	11	3	0	5	1
2005	28	27	5	8	15	0	0	11	1
2006	13	13	1	0	5	1	0	7	0
2007	8	8	4	4	3	0	0	1	0
2008	20	20	3	7	12	5	0	7	0
2009	19	17	3	3	11	0	0	5	2
2010	51	50	10	10	17	5	0	20	1
2011	69	63	13	18	28	2	0	33	6
2012	49	40	7	7	18	1	1	16	9
2013	51	43	3	5	9	1	0	34	8
2014	44	28	2	5	7	0	0	17	16
2015	54	28	2	8	11	1	0	13	26
2016	36	30	2	5	16	0	0	14	6
2017	49	41	0	3	28	2	0	13	8
2018	63	43	1	0	14	0	0	29	20
2019	102	40	2	5	11	0	0	29	62
2020	37	30	3	4	12	0	0	22	7
2021	54	45	5	8	23	1	1	27	9
2022	56	53	5	14	28	1	0	32	3
2023	54	50	7	9	32	5	0	38	4
2024	70	67	11	9	27	0	0	59	3
2025	51	48	7	9	24	0	0	37	3
2026	79	67	1	12	25	3	0	56	12

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Iopamidol, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Iopamidol, by the year in which FDA received them
Year	Reports
2004	21
2005	31
2006	4
2007	16
2008	21
2009	19
2010	51
2011	68
2012	51
2013	50
2014	45
2015	54
2016	37
2017	47
2018	69
2019	101
2020	35
2021	85
2022	56
2023	43
2024	65
2025	53
2026	59

Reports that name Iopamidol, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Iopamidol
Age	Reports	Share
Under 2	4	0.4%
2 to 11	13	1.2%
12 to 17	4	0.4%
18 to 44	120	11.1%
45 to 64	311	28.8%
65 to 74	237	21.9%
75 and over	133	12.3%
Age not given	259	24%

Sex of the patient in the reports that name Iopamidol
Sex	Reports	Share
Female	541	50%
Male	442	40.9%
Unknown or not given	98	9.1%

Type of reporter in the reports that name Iopamidol
Reporter	Reports	Share
Physician	299	27.7%
Pharmacist	225	20.8%
Other health professional	423	39.1%
Lawyer	3	0.3%
Consumer or non-health professional	52	4.8%
Not given	79	7.3%

Age and sex are as the report gives them. The reporter is the primary source in the report. 49.4% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Iopamidol record
Indication as recorded (MedDRA)	Reports	Share
Computerised tomogram	186	17.2%
Diagnostic procedure	66	6.1%
Angiogram pulmonary	43	4%
Angiogram	42	3.9%
Scan with contrast	34	3.1%
Covid-19	33	3.1%

The reporter fills in the indication, and the field is often empty. Each share is of all 1,081 reports.

Pages near this one

Isovue same ingredient
Iomeron same class
Iopromide same class
Iohexol same class
Ioversol same class
Iodixanol same class
Iopamiro next in the A to Z list
Iopamiron next in the A to Z list
Iodine next in the A to Z list
Iobitridol next in the A to Z list
Ioxitalamate next in the A to Z list
Invokana next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for IopamidolThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Iopamidol: adverse event reports that FDA received. https://reportedreactions.com/drug/iopamidol/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 1 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 1 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Oct 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Iopamidol as a suspect or interacting product. The 572 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Iopamidol was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Iopamidol?

No. It is a count of what people reported to FDA: 1,081 reports from February 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (39.1%), physician (27.7%) and pharmacist (20.8%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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