Ethiodized oil
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From MedlinePlus, U.S. National Library of Medicine
Boxed warning
WARNING: 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 ).
Radiographic Contrast Agent
Dosing in kidney impairment
Renal Impairment Prior to an intra-arterial administration of Lipiodol screen all patients for renal dysfunction by obtaining history and/or laboratory tests. Consider follow-up renal function assessments for patients with a history of renal dysfunction.
Preparation and administration
Drug Handling Inspect Lipiodol visually for particulate matter and discoloration before administration. Do not use the solution if particulate matter is present or if the container appears damaged. Lipiodol is a clear, pale yellow to amber colored oil; do not use if the color has darkened. Draw Lipiodol into a disposable syringe and use promptly.
Discard any unused portion of Lipiodol.
Drug interactions
Check ethiodized oil against a medication listLabel text (2 paragraphs)
Lipiodol may interfere with thyroid function testing and with radioactive iodine uptake by the thyroid tissue during diagnostic or therapeutic procedures. ( 7.1 )
7.1 Interference with Iodine-Based Diagnostic Tests and Iodine-Based Radiotherapy Following Lipiodol administration, ethiodized oil remains in the body for several months. Ethiodized oil interferes with radioactive iodine uptake by the thyroid for several weeks to months may impair visualization of thyroid scintigraphy and reduce effectiveness of iodine 131 treatment.
Contraindications
Lipiodol is contraindicated in patients with hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding. Hysterosalpingography Lipiodol hysterosalpingography is contraindicated in pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. [see Use in Specific Populations ( 8.1 ) .
] Lymphography Lipiodol Lymphography is contraindicated in patients with a right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage advanced neoplastic disease with expected lymphatic obstruction, previous surgery interrupting the lymphatic system, radiation therapy to the examined area. Selective Hepatic Intra-arterial Use Patients with HCC Lipiodol use is contraindicated in areas of the liver where the bile ducts are dilated unless external biliary drainage was performed before injection. Hypersensitivity to Lipiodol, hyperthyroidism, traumatic injuries, recent hemorrhage or bleeding.
Lipiodol Hysterosalpingography is contraindicated in: pregnancy, acute pelvic inflammatory disease, marked cervical erosion, endocervicitis and intrauterine bleeding, in the immediate pre-or postmenstrual phase, and within 30 days of curettage or conization or patients with known or suspected reproductive tract neoplasia due to the risk of peritoneal spread of neoplasm. Lipiodol Lymphography is contraindicated in: right to left cardiac shunt, advanced pulmonary disease, tissue trauma or hemorrhage, advanced neoplastic disease with expected lymphatic obstruction, previous surgery interrupting the lymphatic system, or radiation therapy to the examined area.
Lipiodol Selective Hepatic Intra-arterial Injection is contraindicated in: the presence of dilated bile ducts unless external biliary drainage was performed before injection.
Safety data
Reported adverse events (FAERS)
Liver injury (LiverTox)
LiverTox has no chapter for ethiodized oil. Check the label's hepatic warnings.
Pregnancy and lactation
Pregnancy
8.1 Pregnancy Risk Summary Hysterosalpingography is contraindicated in pregnant women due to the potential risk to the fetus from an intrauterine procedure [see Contraindications ( 4 ) ]. The use of Lipiodol before or during pregnancy may interfere with thyroid function in both the pregnant woman and her fetus and may affect fetal development. There are maternal, fetal, and neonatal clinical considerations for women who are exposed to Lipiodol either before or during pregnancy (see Clinical Considerations).
Rare pregnancy outcomes reported in the post marketing setting with Lipiodol use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects or miscarriage (see Data). Animal reproduction studies have not been conducted using the indicated routes of administration of Lipiodol, it was not embryotoxic or teratogenic in animal studies with oral administration. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of major birth defects, loss, or other adverse outcomes. In the U.S.
general population, the estimated background risk of major birth defects and miscarriages in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Clinical Considerations Maternal adverse reactions The use of Lipiodol before or during pregnancy may interfere with the thyroid function of the pregnant woman. Untreated hypothyroidism in pregnancy is associated with adverse perinatal outcomes, such as spontaneous abortion, preeclampsia, preterm birth, abruptio placentae, and fetal death. Consider thyroid function testing during pregnancy if a woman was exposed to Lipiodol either before or during pregnancy or if clinically indicated [see Warnings and Precautions ( 5.4 ) ].
Fetal / Neonatal adverse reactions The use of Lipiodol before or during pregnancy causes iodide transfer across the placenta which may interfere with fetal thyroid function and may affect fetal development. Untreated hypothyroidism is associated with increased fetal risk of low birth weight, fetal distress, and impaired neuropsychological development. Consider thyroid function testing in infants whose mothers were exposed to Lipiodol before and during pregnancy or if clinically indicated [see Warnings and Precautions ( 5.4 ) ].
Data Human Data In a prospective study, twenty-two euthyroid women with infertility underwent hysterosalpingography, and thyroid stimulating hormone, serum iodine concentration, and urinary iodide/creatine excretion were evaluated at 4, 8, 12, 24…
Breastfeeding (LactMed)
Ethiodized oil use causes large increases milk iodine concentrations, which may interfere with the thyroid function of the breastfed infant. interfere with the thyroid function of the breastfed infant. Breastfeeding should be suspended until concentrations normalize. The time for milk iodine levels to normalize is unknown, but may be 2 weeks or longer, depending on the dose. Consider thyroid function testing in a breastfed infant whose mother was exposed to ethiodized oil.
Supply and cost
Drug shortage status
Recalls (last 24 months)
Therapeutic equivalence (Orange Book)
Price ladder
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