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🏅 FDA Orphan Designation

Lipiodol

ethiodized oil injection

Manufacturer: Guerbet LLC

Indicated for:
Pediatric hepatocellular carcinomaOrphanInfantile neuroaxonal dystrophyAcute lymphoblastic leukemia
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Black Box Warning (Boxed Warning)

A Boxed Warning is the FDA's strongest safety warning — it indicates serious or life-threatening risks identified during clinical trials or post-market surveillance. It does not mean the medication is unsafe for all patients; your prescriber weighs these risks against the benefits for your specific situation. Source: FDA-approved prescribing information.

View full prescribing information on DailyMed (NLM) ↗

FDA-Approved Indications (3)

Selective hepatic intra-arterial use for imaging tumors in adults with known hepatocellular carcinoma (HCC)

hysterosalpingography in adults

Population: adults

lymphography in adult and pediatric patients

Population: adult and pediatric patients

Indications & Usage

1 INDICATIONS AND USAGE Lipiodol 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)

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Lipiodol
Guerbet LLC

Where shown, WAC (Wholesale Acquisition Cost) is an estimate only — your actual cost depends on your insurance plan. Always verify pricing with your pharmacy or insurer.

Medical disclaimer: This information is for educational purposes only. Always consult a qualified healthcare provider before making treatment decisions. Data sourced from FDA and current as of our last update.