Drugs › Radiographic contrast agent
Brand name · Ethiodized oil
Lipiodol: adverse event reports filed with FDA
1,069 reports list it as a suspect or interacting product, 2006–2026. Class: Radiographic contrast agent.
- 1,069
- reports as suspect product
- 0% of all reports · about 52 a year
- 158
- reports, 12 months to June 2026
- 101 in the 12 months before
- 96.9%
- marked serious by the reporter
- 77% across the class
- 11.3%
- record death among outcomes, as reported
- 121 reports · not verified by FDA
Between February 2006 and June 2026, 1,069 adverse event reports received by FDA list the brand name Lipiodol (ethiodized oil) as a suspect or interacting product. Reports that mention it only as a concomitant medication (124) are left out of every figure here.
In the 12 months to June 2026, 158 reports listed it, up 56% from 101 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 52 reports a year and 0% of the 20,646,523 reports in the database, and 4% 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 product use in unapproved indication (26.7%), off label use (13%) and liver abscess (6.4%). A report can list several reactions, so shares add to more than 100%; 243 different terms appear across these reports. Product use in unapproved indication is recorded in 26.7% of these reports, with no counterpart in the median radiographic contrast agent drug (0%).
96.9% of the reports are marked serious by the reporter (77% across the class); 11.3% record death among the outcomes and 19.6% record hospitalisation, as reported. 64% of the reports came from physicians, and the largest patient age group is 45 to 64 (25.9%). 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 Lipiodol reports recording the termmedian drug in radiographic contrast agent
- Product use in unapproved indicationused for a purpose not on the label26.7%285
- Off label useused for a purpose or in a way not on the label13%139
- Liver abscess6.4%68
- Pyrexiafever4.2%45
- Pulmonary embolisma blood clot in the lung3.7%40
- Product use issuea problem in how the product was used3.1%33
- Cerebral artery embolism2.8%30
- Hepatic artery stenosis2.8%30
- Cholecystitis acute2.6%28
- Overdosea dose above the recommended amount2.6%28
- Aspartate aminotransferase increasedraised liver enzyme (AST)2.5%27
- Alanine aminotransferase increasedraised liver enzyme (ALT)2.2%23
- Acute kidney injurysudden loss of kidney function1.9%20
- Cerebral infarction1.8%19
- Ascitesfluid in the abdomen1.6%17
- Hypothyroidismunderactive thyroid1.6%17
- Post embolisation syndrome1.6%17
- Abdominal painstomach or belly pain1.5%16
- Biloma1.5%16
- Device dislocationthe device moved out of position1.5%16
- Drug reaction with eosinophilia and systemic symptomsDRESS, a severe reaction with rash, fever and organ involvement1.4%15
- Splenic infarction1.3%14
- Nauseafeeling sick1.2%13
- Sepsisa severe body-wide response to infection1.2%13
- Tumour lysis syndrome1.2%13
- Drug ineffectivethe medicine did not work as expected1.1%12
- Dyspnoeashortness of breath1.1%12
- Hyperthyroidismoveractive thyroid1.1%12
Top 30 of 243 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. 11.7% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Therapeutic embolisation | 314 | 29.4% |
| Transcatheter arterial chemoembolisation | 314 | 29.4% |
| Hepatocellular carcinoma | 90 | 8.4% |
| Hysterosalpingogram | 54 | 5.1% |
| Lymphangiogram | 38 | 3.6% |
| Sclerotherapy | 28 | 2.6% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,069 reports.
In context
| Measure | Lipiodol | Radiographic contrast agent | All reports |
|---|---|---|---|
| Reports as suspect product | 1,069 | 26,987 | 20,646,523 |
| Share of that pool | — | 4% | 0% |
| Reports, latest 12 months | 158 | — | 1,332,454 |
| Marked serious | 96.9% | 77% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 113 | 63 | 91 |
| Hospitalisation recorded, per 1,000 reports | 196 | 296 | 213 |
| Consumer-filed share | 1% | 6.7% | 45.8% |
| Top term, share of reports | Product use in unapproved indication 26.7% | median 0% | 1.2% |
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% |
| Isovue | brand | 1,139 | 162 | 56.5% |
| Iopamidol | generic | 1,081 | 89 | 80.9% |
| 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 Lipiodol reports
How many adverse event reports has FDA received for Lipiodol?
1,069 reports list Lipiodol as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 158 of them arrived in the latest 12 months. Another 124 list it only as a concomitant medication.
What reactions are recorded in Lipiodol reports?
product use in unapproved indication (26.7%), off label use (13%), liver abscess (6.4%), pyrexia (4.2%) and pulmonary embolism (3.7%). 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 Lipiodol was responsible.
How serious are the reports?
96.9% are marked serious by the reporter. Among the outcomes recorded, 11.3% of reports include death and 19.6% 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?
physician (64%), other health professional (23.9%) and not given (10.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Lipiodol rising?
158 reports in the 12 months to June 2026, up 56% from 101 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 Lipiodol 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 Lipiodol?
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 Lipiodol as a suspect or interacting product; reports listing it only as a concomitant medication (124) 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.