Ethiodized Oil side effects: what 1,281 FDA adverse event reports show
Drug class
Brand names
Lipiodol
Who reports
1,281 reports · 97% serious · 152 with death outcome · 36% female
Used for
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).
What it is
Lipiodol, ethiodized oil injection, is a sterile injectable radio-opaque agent. Each milliliter contains 480 mg of Iodine organically combined with ethyl esters of fatty acids of poppy seed oil. The precise structure of Lipiodol is unknown. Lipiodol is a sterile, clear, pale yellow to amber colored oil.
Boxed 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 ).
Causality screen of the 21 strongest signals
What the badges mean
- Labeled — boxed warning The term (or its clinical synonym) appears in the FDA boxed warning: causality is regulator-recognised and considered serious.
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only and flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 23 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Metastases to central nervous system | 16 | 20.5 12.6–33.3ROR 20.7 · χ² 277 / p 2e-62 | 19.9 EB05 12.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Product use in unapproved indication | 291 | 19.5 17.6–21.6ROR 25.0 · χ² 5,149 / p <1e-300 | 19.5 EB05 17.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.5 · 99% clinician | no trial data cached |
| Hyperthyroidism | 14 | 15.9 9.4–26.7ROR 16.0 · χ² 180 / p 2e-41 | 14.9 EB05 8.7 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.1 | no trial data cached |
| Metastases to liver | 16 | 14.9 9.2–24.3ROR 15.1 · χ² 195 / p 2e-44 | 14.1 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Cerebral infarction | 22 | 14.7 9.7–22.3ROR 15.0 · χ² 268 / p 1e-60 | 14.2 EB05 9.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 100% clinician | no trial data cached |
| Hypothyroidism | 26 | 13.4 9.1–19.6ROR 13.6 · χ² 286 / p 2e-64 | 12.9 EB05 8.9 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.7 · ♀ 76% (drug 36%) · 100% clinician | no trial data cached |
| Ascites | 23 | 12.8 8.5–19.2ROR 13.0 · χ² 239 / p 4e-54 | 12.2 EB05 8.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 100% clinician | no trial data cached |
| Disseminated intravascular coagulation | 11 | 12.8 7.1–23.0ROR 12.9 · χ² 108 / p 2e-25 | 11.0 EB05 5.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.6 | no trial data cached |
| Acute respiratory distress syndrome | 13 | 12.0 7.0–20.7ROR 12.1 · χ² 121 / p 2e-28 | 10.5 EB05 5.9 · IC025 +2.2 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 7.1 | no trial data cached |
| Aspartate aminotransferase increased | 37 | 11.4 8.3–15.7ROR 11.7 · χ² 342 / p 1e-76 | 11.0 EB05 8.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 36 | 10.6 7.7–14.6ROR 10.9 · χ² 303 / p 3e-68 | 10.1 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 7% (drug 36%) · 91% clinician | no trial data cached |
| Hepatic steatosis | 12 | 10.6 6.0–18.6ROR 10.7 · χ² 95 / p 1e-22 | 8.8 EB05 4.9 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 7.1 | no trial data cached |
| Bone marrow failure | 13 | 10.4 6.1–17.9ROR 10.5 · χ² 101 / p 4e-24 | 8.8 EB05 5.1 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 16 | 10.3 6.3–16.7ROR 10.4 · χ² 125 / p 3e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Hepatic failure | 17 | 9.2 5.7–14.8ROR 9.3 · χ² 116 / p 2e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Transaminases increased | 12 | 8.8 5.0–15.5ROR 8.9 · χ² 76 / p 2e-18 | 7.2 EB05 4.2 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Skin ulcer | 13 | 8.2 4.8–14.2ROR 8.3 · χ² 76 / p 2e-18 | 6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Pulmonary embolism (lung blood clot) | 48 | 8.2 6.2–10.9ROR 8.5 · χ² 299 / p 3e-67 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 · 100% clinician | no trial data cached |
| Pneumonitis | 12 | 7.3 4.1–12.8ROR 7.3 · χ² 59 / p 9e-15 | 5.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.5 | no trial data cached |
| Device dislocation | 17 | 6.4 4.0–10.3ROR 6.5 · χ² 72 / p 8e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Hepatic function abnormal | 14 | 6.2 3.7–10.4ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Product use in unapproved indication | 291 | 19.5 17.6–21.6ROR 25.0 · χ² 5,149 / p <1e-300 | 19.5 EB05 17.7 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious PRR 24.5 · 99% clinician | no trial data cached |
| Pulmonary embolism (lung blood clot) | 48 | 8.2 6.2–10.9ROR 8.5 · χ² 299 / p 3e-67 | 7.8 EB05 6.1 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 4.7 · 100% clinician | no trial data cached |
| Aspartate aminotransferase increased | 37 | 11.4 8.3–15.7ROR 11.7 · χ² 342 / p 1e-76 | 11.0 EB05 8.1 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.8 · 100% clinician | no trial data cached |
| Pancytopenia (all blood cells low) | 36 | 10.6 7.7–14.6ROR 10.9 · χ² 303 / p 3e-68 | 10.1 EB05 7.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 6.3 · ♀ 7% (drug 36%) · 91% clinician | no trial data cached |
| Hypothyroidism | 26 | 13.4 9.1–19.6ROR 13.6 · χ² 286 / p 2e-64 | 12.9 EB05 8.9 · IC025 +2.8 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 8.7 · ♀ 76% (drug 36%) · 100% clinician | no trial data cached |
| Ascites | 23 | 12.8 8.5–19.2ROR 13.0 · χ² 239 / p 4e-54 | 12.2 EB05 8.1 · IC025 +2.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.7 · 100% clinician | no trial data cached |
| Cerebral infarction | 22 | 14.7 9.7–22.3ROR 15.0 · χ² 268 / p 1e-60 | 14.2 EB05 9.5 · IC025 +2.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.7 · 100% clinician | no trial data cached |
| Device dislocation | 17 | 6.4 4.0–10.3ROR 6.5 · χ² 72 / p 8e-18 | 5.6 EB05 3.7 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 4.7 | no trial data cached |
| Hepatic failure | 17 | 9.2 5.7–14.8ROR 9.3 · χ² 116 / p 2e-27 | 8.0 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.5 | no trial data cached |
| Drug reaction with eosinophilia and systemic symptoms | 16 | 10.3 6.3–16.7ROR 10.4 · χ² 125 / p 3e-29 | 9.0 EB05 5.5 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 | no trial data cached |
| Metastases to liver | 16 | 14.9 9.2–24.3ROR 15.1 · χ² 195 / p 2e-44 | 14.1 EB05 8.6 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 | no trial data cached |
| Metastases to central nervous system | 16 | 20.5 12.6–33.3ROR 20.7 · χ² 277 / p 2e-62 | 19.9 EB05 12.7 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 12.3 | no trial data cached |
| Hepatic function abnormal | 14 | 6.2 3.7–10.4ROR 6.2 · χ² 56 / p 4e-14 | 5.2 EB05 3.3 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.0 | no trial data cached |
| Hyperthyroidism | 14 | 15.9 9.4–26.7ROR 16.0 · χ² 180 / p 2e-41 | 14.9 EB05 8.7 · IC025 +2.5 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 10.1 | no trial data cached |
| Skin ulcer | 13 | 8.2 4.8–14.2ROR 8.3 · χ² 76 / p 2e-18 | 6.8 EB05 4.1 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Pancytopenia — n=36, PRR 10.6
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Ethiodized Oil?
In FDA FAERS, the most frequently co-reported reaction terms for Ethiodized Oil are pulmonary embolism, aspartate aminotransferase increased, pancytopenia, hypothyroidism, ascites, cerebral infarction. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Ethiodized Oil have an FDA boxed warning?
Yes. The current FDA label carries a boxed 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 ).
Do FAERS signals prove that Ethiodized Oil causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 511d1f64-5cb9-4baa-a123-96205467e59a, effective 20251216; matched on
openfda.generic_name.exact:"ETHIODIZED OIL") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 44 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath
Page generated 2026-10-08. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.