Drug · FAERS side-effect profile with label screen

Gadoxetate side effects: what 440 FDA adverse event reports show

Gadoxetate Disodium · 15 reaction terms · 1,663 drug–reaction co-reports · data 2026-09-14

Drug class

Gadolinium-based contrast agent

FDA label, Indications wording of the closest related product

Label matched

Gadoxetate Disodium (Eovist)

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

Who reports

440 reports · 55% serious · 2 with death outcome · 70% female

openFDA FAERS counts, all years, deduplication not applied

Used for

EOVIST is indicated for use in magnetic resonance imaging (MRI) of the liver to detect and characterize lesions in adult and pediatric patients, including term neonates, with known or suspected focal liver disease. EOVIST is a gadolinium-based contrast.

FDA label, Indications and Usage

What it is

EOVIST (gadoxetate disodium) injection is a paramagnetic gadolinium-based contrast agent for intravenous use. Gadoxetate disodium (Gd-EOB-DTPA) is a highly water-soluble, hydrophilic compound with a lipophilic moiety, the ethoxybenzyl group (EOB).

FDA label, Description section

Boxed warning

RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ].

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 15 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 2Labeled (related wording) 1Not in label — unassessed 11

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.
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. 0 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
Mass	147	505.2 442.3–577.1ROR 758.2 · χ² 72,740 / p <1e-300	469.2 EB05 408.9 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 754.5 · 100% consumer	no trial data cached
Mental impairment	73	143.8 116.6–177.4ROR 172.2 · χ² 10,188 / p <1e-300	138.2 EB05 113.6 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 188.3 · 100% consumer	no trial data cached
Inflammation	150	139.7 122.6–159.1ROR 211.4 · χ² 20,501 / p <1e-300	136.9 EB05 119.4 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 193.9 · 100% consumer	no trial data cached
Anhedonia	74	133.5 108.4–164.4ROR 160.3 · χ² 9,585 / p <1e-300	128.8 EB05 106.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 153.5 · 100% consumer	no trial data cached
Mental status changes	74	127.2 103.3–156.6ROR 152.7 · χ² 9,128 / p <1e-300	122.9 EB05 101.2 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 146.4	no trial data cached
Movement disorder	73	108.1 87.6–133.3ROR 129.4 · χ² 7,631 / p <1e-300	104.9 EB05 86.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 143.9	no trial data cached
Burning sensation	153	104.2 91.7–118.5ROR 159.2 · χ² 15,554 / p <1e-300	102.7 EB05 89.7 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 233.4 · 96% consumer	no trial data cached
Injury	152	102.7 90.3–116.9ROR 156.4 · χ² 15,229 / p <1e-300	101.2 EB05 88.4 · IC025 +6.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 132.5 · 100% consumer	no trial data cached
Hypoaesthesia (numbness)	153	48.7 42.9–55.4ROR 74.1 · χ² 7,145 / p <1e-300	48.4 EB05 42.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 81.3 · 96% consumer	no trial data cached
Mobility decreased	73	48.6 39.4–60.0ROR 58.1 · χ² 3,366 / p <1e-300	48.0 EB05 39.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 74.7 · 100% consumer	no trial data cached
Paraesthesia (tingling/numbness)	154	46.6 41.0–52.9ROR 71.1 · χ² 6,868 / p <1e-300	46.3 EB05 40.5 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 85.3 · 96% consumer	no trial data cached
Confusional state (confusion)	150	44.2 38.8–50.3ROR 66.5 · χ² 6,332 / p <1e-300	43.9 EB05 38.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 58.6 · 100% consumer	no trial data cached
Muscle spasms	153	39.8 35.0–45.2ROR 60.4 · χ² 5,788 / p <1e-300	39.5 EB05 34.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 80.2 · 96% consumer	no trial data cached
Emotional distress	79	31.0 25.4–37.9ROR 37.6 · χ² 2,276 / p <1e-300	30.8 EB05 25.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 100% consumer	no trial data cached
Injection site extravasation	5	19.1 8.0–45.7ROR 19.3 · χ² 69 / p 6e-17	14.8 EB05 4.7 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious n=2	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
Paraesthesia (tingling/numbness)	154	46.6 41.0–52.9ROR 71.1 · χ² 6,868 / p <1e-300	46.3 EB05 40.5 · IC025 +5.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 85.3 · 96% consumer	no trial data cached
Muscle spasms	153	39.8 35.0–45.2ROR 60.4 · χ² 5,788 / p <1e-300	39.5 EB05 34.6 · IC025 +4.9 3/3 methods agree	Not in label — unassessed	serious PRR 80.2 · 96% consumer	no trial data cached
Hypoaesthesia (numbness)	153	48.7 42.9–55.4ROR 74.1 · χ² 7,145 / p <1e-300	48.4 EB05 42.3 · IC025 +5.1 3/3 methods agree	Not in label — unassessed	serious PRR 81.3 · 96% consumer	no trial data cached
Burning sensation	153	104.2 91.7–118.5ROR 159.2 · χ² 15,554 / p <1e-300	102.7 EB05 89.7 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 233.4 · 96% consumer	no trial data cached
Injury	152	102.7 90.3–116.9ROR 156.4 · χ² 15,229 / p <1e-300	101.2 EB05 88.4 · IC025 +6.0 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 132.5 · 100% consumer	no trial data cached
Confusional state (confusion)	150	44.2 38.8–50.3ROR 66.5 · χ² 6,332 / p <1e-300	43.9 EB05 38.3 · IC025 +5.0 3/3 methods agree	Not in label — unassessed	serious PRR 58.6 · 100% consumer	no trial data cached
Inflammation	150	139.7 122.6–159.1ROR 211.4 · χ² 20,501 / p <1e-300	136.9 EB05 119.4 · IC025 +6.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 193.9 · 100% consumer	no trial data cached
Mass	147	505.2 442.3–577.1ROR 758.2 · χ² 72,740 / p <1e-300	469.2 EB05 408.9 · IC025 +7.3 3/3 methods agree	Not in label — unassessed	serious PRR 754.5 · 100% consumer	no trial data cached
Emotional distress	79	31.0 25.4–37.9ROR 37.6 · χ² 2,276 / p <1e-300	30.8 EB05 25.5 · IC025 +4.3 3/3 methods agree	Not in label — unassessed	serious PRR 36.4 · 100% consumer	no trial data cached
Mental status changes	74	127.2 103.3–156.6ROR 152.7 · χ² 9,128 / p <1e-300	122.9 EB05 101.2 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 146.4	no trial data cached
Anhedonia	74	133.5 108.4–164.4ROR 160.3 · χ² 9,585 / p <1e-300	128.8 EB05 106.0 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 153.5 · 100% consumer	no trial data cached
Mobility decreased	73	48.6 39.4–60.0ROR 58.1 · χ² 3,366 / p <1e-300	48.0 EB05 39.5 · IC025 +4.8 3/3 methods agree	Not in label — unassessed	serious PRR 74.7 · 100% consumer	no trial data cached
Movement disorder	73	108.1 87.6–133.3ROR 129.4 · χ² 7,631 / p <1e-300	104.9 EB05 86.2 · IC025 +5.6 3/3 methods agree	Not in label — unassessed	serious PRR 143.9	no trial data cached
Mental impairment	73	143.8 116.6–177.4ROR 172.2 · χ² 10,188 / p <1e-300	138.2 EB05 113.6 · IC025 +5.8 3/3 methods agree	Not in label — unassessed	serious PRR 188.3 · 100% consumer	no trial data cached
Injection site extravasation	5	19.1 8.0–45.7ROR 19.3 · χ² 69 / p 6e-17	14.8 EB05 4.7 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious n=2	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.

Mass — n=147, PRR 505.2
Mental impairment — n=73, PRR 143.8
Anhedonia — n=74, PRR 133.5
Mental status changes — n=74, PRR 127.2
Movement disorder — n=73, PRR 108.1
Burning sensation — n=153, PRR 104.2
Hypoaesthesia — n=153, PRR 48.7
Mobility decreased — n=73, PRR 48.6
Confusional state — n=150, PRR 44.2
Muscle spasms — n=153, PRR 39.8

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 Gadoxetate?

In FDA FAERS, the most frequently co-reported reaction terms for Gadoxetate are paraesthesia, muscle spasms, hypoaesthesia, burning sensation, injury, confusional state. 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 Gadoxetate have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS Risk Associated with Intrathecal Use Intrathecal administration of gadolinium-based contrast agents (GBCAs) can cause serious adverse reactions including death, coma, encephalopathy, and seizures. EOVIST is not approved for intrathecal use [see Warnings and Precautions (5.1) ].

Do FAERS signals prove that Gadoxetate 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 6218b1e1-cbc3-4c14-bec7-528ac163a561, effective 20260302; matched on openfda.generic_name.exact:"GADOXETATE DISODIUM")
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, 15 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.