Prescription medicine
Ethiodized oil Brand names: Lipiodol
Ethiodized oil (Lipiodol) is a prescription medicine with an FDA approval on record since 1954. No generic is listed in FDA's NDC Directory.
- No generic listed
- Boxed warning
Check it at the source: the ethiodized oil FDA label on DailyMed (effective December 16, 2025, Guerbet LLC); the NDA 9190 record on Drugs@FDA; every ethiodized oil label on DailyMed.
Highlights of the record
FDA label of December 16, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY.
Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ). WARNING: FOR INTRALYMPHATIC, INTRAUTERINE AND SELECTIVE HEPATIC INTRA-ARTERIAL USE ONLY See Full Prescribing Information for complete Boxed Warning Pulmonary and cerebral embolism can result from inadvertent intravascular injection or intravasation of Lipiodol. Inject Lipiodol slowly with radiologic monitoring; do not exceed recommended dose ( 5.1 ).
Used for
From the label: indications and usageLipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-
Forms and strengths
- 480 mg/ml
Injection.
On the market
- Earliest approval on file
- March 31, 1954 Lipiodol, Guerbet; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,281 through July 30, 2026
What is ethiodized oil used for?
From the label: indications and usageLipiodol is an oil-based radio-opaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC) Lipiodol is an oil-based radiopaque contrast agent indicated for: hysterosalpingography in adults lymphography in adult and pediatric patients selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)
FDA pharmacologic class: Radiographic Contrast Agent.
Source: FDA drug label (LIPIODOL), Guerbet LLC, effective December 16, 2025 (SPL set 511d1f64-5cb9-4baa-a123-96205467e59a), via openFDA; the full label on DailyMed
Is there a generic for ethiodized oil (Lipiodol)?
No generic ethiodized oil is approved (Drugs@FDA, October 8, 2026).
- 1954 earliest approval on file
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do FAERS reports show for ethiodized oil?
The FDA Adverse Event Reporting System holds 1,281 reports that list ethiodized oil among the medicines taken, through July 30, 2026, 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.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Other radiographic contrast agents
- the pharmacologic class, with prices and generics
- Ethiodized oil side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other