What the label lists and what reports show
Ethiodized oil side effects
Ethiodized oil's FDA label: “Selective Hepatic Intra-arterial Injection Abdominal pain, nausea, and vomiting are the most common reactions; other reactions include hepatic vein thrombosis, hepatic ischemia, liver enzymes abnormalities, transitory decrease in liver function, liver …” FAERS holds 1,281 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is liver abscess (73 reports).
- No generic listed
- Boxed warning
Check it at the source: the ethiodized oil FDA label on DailyMed (effective December 16, 2025, Guerbet LLC); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsSelective Hepatic Intra-arterial Injection Abdominal pain, nausea, and vomiting are the most common reactions; other reactions include hepatic vein thrombosis, hepatic ischemia, liver enzymes abnormalities, transitory decrease in liver function, liver decompensation and renal insufficiency.
From the label: adverse reactions, continuedAdverse reactions caused by Lipiodol include hypersensitivity reactions, pulmonary embolism, pulmonary dysfunction, exacerbation of liver disease, procedural complications, abdominal pain, fever, nausea, vomiting, and thyroid dysfunction. To report SUSPECTED ADVERSE REACTIONS, contact GUERBET LLC at 1-877-729-6679 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.2 Postmarketing Experience The following adverse reactions (Table 1) have been identified during post approval use of Lipiodol. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions are described in more detail in other sections of the prescribing information: Pulmonary and cerebral embolism [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity reactions [see Warnings and Precautions ( 5.2 ) ] Exacerbation of chronic liver disease [see Warnings and Precautions ( 5.3 ) ] Thyroid dysfunction [see Warnings and Precautions ( 5.4 ) ].
Source: FDA drug label, Guerbet LLC, effective December 16, 2025 (SPL set 511d1f64-5cb9-4baa-a123-96205467e59a), via openFDA; the full label on DailyMed
What do FAERS reports show?
1,281 reports list ethiodized oil among the medicines taken, each a report of something that happened, not proof the medicine caused it; 152 are coded as a death and 282 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 5 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Ethiodized oil: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions