Drug · FAERS side-effect profile with label screen

Iomeprol side effects: what 1,328 FDA adverse event reports show

Iomeprol Injection · 34 reaction terms · 1,107 drug–reaction co-reports · data 2026-09-14

Drug class

Radiographic Contrast Agent

FDA label (Established Pharmacologic Class) of the closest related product

Label matched

Iomeprol Injection (Iomervu)

closest FDA label found for this product string; brand list suppressed because the label is a related product, not an exact match

Who reports

1,328 reports · 100% serious · 115 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

IOMERVU is a radiographic contrast agent indicated for: Intra-arterial Procedures † ( 1.1 ) Cerebral arteriography, includingintra-arterial digital subtraction angiography (IA-DSA), in adults and pediatric patients Visceral and peripheral arteriography.

FDA label, Indications and Usage

What it is

IOMERVU (iomeprol) injection is a tri-iodinated, non-ionic radiographic contrast agent for intra-arterial or intravenous use. It is provided as a sterile, nonpyrogenic, clear, colorless to pale yellow solution.

FDA label, Description section

Boxed warning

RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

FDA label

How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation. Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)? That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.

Causality screen of the 22 strongest signals

Labeled — boxed warning 4Labeled adverse reaction 5Labeled (related wording) 1Reporting / coding artifact 1Lab value / disease marker 1Not in label — unassessed 10

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.
Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
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. 12 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Rash maculo-papular	218	156.9 138.9–177.3ROR 187.5 · χ² 33,313 / p <1e-300	153.3 EB05 136.9 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 98.5 · 98% clinician	no trial data cached
Toxic skin eruption	97	153.0 126.2–185.5ROR 165.0 · χ² 14,365 / p <1e-300	147.2 EB05 124.2 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 87.8 · 98% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	167	103.9 90.1–119.8ROR 118.7 · χ² 16,820 / p <1e-300	102.0 EB05 89.7 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 59.6 · 98% clinician	no trial data cached
Eosinophilia	110	100.0 83.6–119.7ROR 109.0 · χ² 10,627 / p <1e-300	97.8 EB05 83.4 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 60.1 · ♀ 70% (drug 50%) · 98% clinician	no trial data cached
Hepatic cytolysis	24	31.1 20.9–46.2ROR 31.6 · χ² 668 / p 2e-147	30.3 EB05 21.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · ♀ 78% (drug 50%) · 100% clinician	no trial data cached
Anaphylactic shock	41	25.3 18.7–34.2ROR 26.1 · χ² 932 / p 4e-205	25.0 EB05 19.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.6 · 95% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	22	23.1 15.2–34.9ROR 23.4 · χ² 442 / p 2e-98	22.6 EB05 15.7 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.3 · 91% clinician	no trial data cached
Neutrophil count increased	14	21.5 12.8–36.3ROR 21.8 · χ² 254 / p 2e-57	20.8 EB05 12.9 · IC025 +2.8 3/3 methods agree	Lab value / disease marker	serious PRR 13.7	no trial data cached
Hyperthyroidism	19	20.8 13.3–32.5ROR 21.0 · χ² 338 / p 1e-75	20.3 EB05 13.6 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 12.9	no trial data cached
Face oedema	18	16.8 10.6–26.6ROR 17.0 · χ² 252 / p 6e-57	16.2 EB05 10.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Renal tubular necrosis	10	16.1 8.7–29.8ROR 16.2 · χ² 127 / p 1e-29	14.5 EB05 7.3 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Acute kidney injury (sudden kidney damage)	136	14.1 12.0–16.5ROR 15.6 · χ² 1,654 / p <1e-300	14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.2 · 96% clinician	no trial data cached
Hepatocellular injury	10	11.1 6.0–20.6ROR 11.2 · χ² 82 / p 6e-20	9.0 EB05 4.7 · IC025 +1.8 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Angioedema (deep swelling of face/throat)	24	8.6 5.8–12.8ROR 8.7 · χ² 154 / p 1e-35	7.7 EB05 5.3 · IC025 +2.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.2 · 96% clinician	no trial data cached
Multiple organ dysfunction syndrome	15	8.5 5.1–14.0ROR 8.6 · χ² 92 / p 5e-22	7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.9	no trial data cached
Cholestasis (bile flow blockage)	10	8.3 4.5–15.3ROR 8.3 · χ² 57 / p 2e-14	6.4 EB05 3.6 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 4.8	no trial data cached
Cardio-respiratory arrest	21	7.9 5.2–12.0ROR 8.0 · χ² 120 / p 4e-28	7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6 · 95% clinician	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	11	7.8 4.3–14.0ROR 7.9 · χ² 59 / p 1e-14	6.2 EB05 3.6 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5	no trial data cached
Anaphylactic reaction (severe allergic reaction)	27	7.8 5.3–11.3ROR 7.9 · χ² 153 / p 2e-35	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 4.6 · 100% clinician	no trial data cached
Palmar-plantar erythrodysaesthesia syndrome	11	7.4 4.1–13.4ROR 7.5 · χ² 55 / p 6e-14	5.9 EB05 3.5 · IC025 +1.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.7	no trial data cached
Lactic acidosis	14	6.9 4.1–11.6ROR 7.0 · χ² 65 / p 4e-16	5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	no trial data cached
Contraindicated product administered	13	6.8 4.0–11.7ROR 6.9 · χ² 59 / p 9e-15	5.6 EB05 3.5 · IC025 +1.5 3/3 methods agree	Reporting / coding artifact	serious PRR 4.9	no trial data cached

Trial evidence (ClinicalTrials.gov)

Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).

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
Rash maculo-papular	218	156.9 138.9–177.3ROR 187.5 · χ² 33,313 / p <1e-300	153.3 EB05 136.9 · IC025 +6.6 3/3 methods agree	Not in label — unassessed	serious PRR 98.5 · 98% clinician	no trial data cached
Drug reaction with eosinophilia and systemic symptoms	167	103.9 90.1–119.8ROR 118.7 · χ² 16,820 / p <1e-300	102.0 EB05 89.7 · IC025 +6.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 59.6 · 98% clinician	no trial data cached
Acute kidney injury (sudden kidney damage)	136	14.1 12.0–16.5ROR 15.6 · χ² 1,654 / p <1e-300	14.0 EB05 12.2 · IC025 +3.5 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.2 · 96% clinician	no trial data cached
Eosinophilia	110	100.0 83.6–119.7ROR 109.0 · χ² 10,627 / p <1e-300	97.8 EB05 83.4 · IC025 +5.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 60.1 · ♀ 70% (drug 50%) · 98% clinician	no trial data cached
Toxic skin eruption	97	153.0 126.2–185.5ROR 165.0 · χ² 14,365 / p <1e-300	147.2 EB05 124.2 · IC025 +6.1 3/3 methods agree	Not in label — unassessed	serious PRR 87.8 · 98% clinician	no trial data cached
Anaphylactic shock	41	25.3 18.7–34.2ROR 26.1 · χ² 932 / p 4e-205	25.0 EB05 19.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 14.6 · 95% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	27	7.8 5.3–11.3ROR 7.9 · χ² 153 / p 2e-35	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 4.6 · 100% clinician	no trial data cached
Angioedema (deep swelling of face/throat)	24	8.6 5.8–12.8ROR 8.7 · χ² 154 / p 1e-35	7.7 EB05 5.3 · IC025 +2.2 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 5.2 · 96% clinician	no trial data cached
Hepatic cytolysis	24	31.1 20.9–46.2ROR 31.6 · χ² 668 / p 2e-147	30.3 EB05 21.5 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 17.9 · ♀ 78% (drug 50%) · 100% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	22	23.1 15.2–34.9ROR 23.4 · χ² 442 / p 2e-98	22.6 EB05 15.7 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 13.3 · 91% clinician	no trial data cached
Cardio-respiratory arrest	21	7.9 5.2–12.0ROR 8.0 · χ² 120 / p 4e-28	7.0 EB05 4.7 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.6 · 95% clinician	no trial data cached
Hyperthyroidism	19	20.8 13.3–32.5ROR 21.0 · χ² 338 / p 1e-75	20.3 EB05 13.6 · IC025 +3.0 3/3 methods agree	Labeled — boxed warning synonym match	serious PRR 12.9	no trial data cached
Face oedema	18	16.8 10.6–26.6ROR 17.0 · χ² 252 / p 6e-57	16.2 EB05 10.5 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 10.8	no trial data cached
Multiple organ dysfunction syndrome	15	8.5 5.1–14.0ROR 8.6 · χ² 92 / p 5e-22	7.2 EB05 4.5 · IC025 +1.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.9	no trial data cached
Lactic acidosis	14	6.9 4.1–11.6ROR 7.0 · χ² 65 / p 4e-16	5.8 EB05 3.6 · IC025 +1.6 3/3 methods agree	Not in label — unassessed	serious PRR 4.0	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.

Rash maculo-papular — n=218, PRR 156.9
Toxic skin eruption — n=97, PRR 153.0
Hepatic cytolysis — n=24, PRR 31.1
Anaphylactic shock — n=41, PRR 25.3

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 Iomeprol?

In FDA FAERS, the most frequently co-reported reaction terms for Iomeprol are rash maculo-papular, drug reaction with eosinophilia and systemic symptoms, acute kidney injury, eosinophilia, toxic skin eruption, anaphylactic shock. 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 Iomeprol have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISKS ASSOCIATED WITH INTRATHECAL ADMINISTRATION Intrathecal administration, even if inadvertent, may cause death, convulsions, cerebral hemorrhage, coma, paralysis, arachnoiditis, acute renal failure, cardiac arrest, seizures, rhabdomyolysis, hyperthermia, and brain edema.

Do FAERS signals prove that Iomeprol 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 cb2e0e00-7c93-0fb4-89a5-861641662a5a, effective 20260205; matched on openfda.generic_name.exact:"IOMEPROL INJECTION")
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, field patient.drug.openfda.generic_name.exact, 34 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.