Gadoterate Meglumine side effects: what 3,653 FDA adverse event reports show

Gadoterate Meglumine · 163 reaction terms · 8,625 drug–reaction co-reports · data 2026-09-14

Drug class

Gadolinium-based contrast agent

FDA label, Indications wording

Who reports

3,653 reports · 71% serious · 72 with death outcome · 69% female

openFDA FAERS counts, all years, deduplication not applied

Used for

Gadoterate Meglumine Injection is a gadolinium-based contrast agent indicated for intravenous use with magnetic resonance imaging (MRI) in brain (intracranial), spine and associated tissues in adult and pediatric patients (including term neonates) to detect and visualize areas with disruption of the blood brain barrier (BBB) and/or abnormal vascularity.

FDA label, Indications and Usage

What it is

Gadoterate Meglumine Injection, USP is a paramagnetic macrocyclic ionic contrast agent administered for magnetic resonance imaging.

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.

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 40 strongest signals

Labeled — boxed warning 1Labeled adverse reaction 11Labeled (related wording) 5Likely indication confounding 1Not in label — unassessed 22

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.
Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
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. 123 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
Sneezing	130	33.6 28.3–39.8ROR 34.8 · χ² 4,054 / p <1e-300	33.2 EB05 28.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 44.1 · 98% clinician	no trial data cached
Urticaria (hives)	648	22.4 20.9–24.1ROR 27.1 · χ² 13,303 / p <1e-300	22.3 EB05 20.9 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.9 · 98% clinician	no trial data cached
Throat irritation	163	21.0 18.1–24.4ROR 21.9 · χ² 3,080 / p <1e-300	20.9 EB05 18.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 26.9 · 96% clinician	no trial data cached
Throat tightness	92	19.6 16.0–24.0ROR 20.1 · χ² 1,603 / p <1e-300	19.5 EB05 16.4 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 19.2 · 94% clinician	no trial data cached
Pharyngeal swelling	32	19.2 13.6–27.2ROR 19.4 · χ² 534 / p 2e-118	19.0 EB05 14.0 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious n=28 · 97% clinician	no trial data cached
Eyelid oedema	35	17.2 12.4–23.9ROR 17.4 · χ² 517 / p 9e-115	17.0 EB05 12.7 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.6 · 100% clinician	no trial data cached
Bronchospasm (airway tightening)	40	16.1 11.8–21.9ROR 16.2 · χ² 550 / p 8e-122	15.9 EB05 12.1 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.0 · 100% clinician	no trial data cached
Muscle twitching	61	15.2 11.8–19.5ROR 15.4 · χ² 793 / p 9e-175	15.0 EB05 12.1 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 17.5	no trial data cached
Paraesthesia oral	36	14.4 10.4–20.0ROR 14.5 · χ² 435 / p 6e-97	14.1 EB05 10.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.7 · 97% clinician	no trial data cached
Rash maculo-papular	50	13.0 9.9–17.1ROR 13.1 · χ² 540 / p 8e-120	12.7 EB05 9.9 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 11.6 · ♀ 48% (drug 69%) · 100% clinician	no trial data cached
Face oedema	38	12.9 9.4–17.7ROR 13.0 · χ² 405 / p 3e-90	12.5 EB05 9.3 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 11.6 · 95% clinician	no trial data cached
Erythema (skin redness)	422	11.8 10.8–12.9ROR 13.2 · χ² 4,203 / p <1e-300	11.8 EB05 10.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.3 · 97% clinician	no trial data cached
Anaphylactic shock	51	11.4 8.7–15.0ROR 11.6 · χ² 475 / p 1e-105	11.1 EB05 8.7 · IC025 +2.9 3/3 methods agree	Not in label — unassessed	serious PRR 9.3	no trial data cached
Cold sweat	33	10.8 7.7–15.1ROR 10.8 · χ² 282 / p 1e-63	10.2 EB05 7.4 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 12.3 · 97% clinician	no trial data cached
Eye swelling	69	10.7 8.5–13.6ROR 10.9 · χ² 599 / p 1e-132	10.5 EB05 8.5 · IC025 +2.9 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.8 · 94% clinician	no trial data cached
Feeling hot	107	10.0 8.3–12.1ROR 10.3 · χ² 861 / p 1e-189	9.8 EB05 8.3 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.8 · 92% clinician	no trial data cached
Anaphylactic reaction (severe allergic reaction)	94	9.8 8.1–12.0ROR 10.1 · χ² 738 / p 7e-163	9.6 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 8.1 · 94% clinician	no trial data cached
Pharyngeal oedema	25	9.2 6.2–13.6ROR 9.3 · χ² 175 / p 3e-40	8.4 EB05 5.8 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 8.6 · 100% clinician	no trial data cached
Eosinophilia	28	9.2 6.4–13.3ROR 9.3 · χ² 197 / p 6e-45	8.5 EB05 6.0 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.8 · 96% clinician	no trial data cached
Spinal pain	17	8.3 5.2–13.4ROR 8.4 · χ² 103 / p 2e-24	7.2 EB05 4.6 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.8	no trial data cached
Cyanosis (blue skin from low oxygen)	22	8.0 5.3–12.2ROR 8.1 · χ² 128 / p 5e-30	7.1 EB05 4.9 · IC025 +2.1 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.9 · 90% clinician	no trial data cached
Lip swelling	46	8.0 6.0–10.6ROR 8.0 · χ² 273 / p 1e-61	7.5 EB05 5.8 · IC025 +2.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.9 · 98% clinician	no trial data cached
Retching	29	7.8 5.5–11.3ROR 7.9 · χ² 166 / p 3e-38	7.1 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.7	no trial data cached
Skin reaction	19	7.8 5.0–12.2ROR 7.8 · χ² 105 / p 6e-25	6.8 EB05 4.5 · IC025 +2.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.7	no trial data cached
Swelling face	84	7.4 6.0–9.2ROR 7.6 · χ² 461 / p 1e-102	7.2 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 8.9 · 95% clinician	no trial data cached
Burning sensation	90	7.4 6.0–9.0ROR 7.5 · χ² 491 / p 5e-109	7.1 EB05 6.0 · IC025 +2.5 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 11.0	no trial data cached
Lacrimation increased	38	7.3 5.3–10.0ROR 7.4 · χ² 201 / p 7e-46	6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.1	no trial data cached
Pruritus (itching)	479	7.3 6.7–7.9ROR 8.2 · χ² 2,634 / p <1e-300	7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9 · 93% clinician	no trial data cached
Feeling cold	35	7.2 5.2–10.0ROR 7.3 · χ² 181 / p 1e-41	6.7 EB05 5.0 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 9.0	no trial data cached
Chest discomfort	127	7.2 6.0–8.5ROR 7.4 · χ² 669 / p 9e-148	7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 94% clinician	no trial data cached
Pallor	33	7.0 4.9–9.8ROR 7.0 · χ² 162 / p 2e-37	6.4 EB05 4.7 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.3 · ♀ 47% (drug 69%) · 94% clinician	no trial data cached
Respiratory distress	32	6.7 4.7–9.4ROR 6.7 · χ² 148 / p 2e-34	6.1 EB05 4.5 · IC025 +2.0 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.5 · 96% clinician	no trial data cached
Dysphonia	67	6.6 5.2–8.4ROR 6.7 · χ² 313 / p 3e-70	6.3 EB05 5.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 9.0 · 94% clinician	no trial data cached
Disturbance in attention	62	6.6 5.1–8.4ROR 6.7 · χ² 289 / p 5e-65	6.3 EB05 5.1 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.8	no trial data cached
Head discomfort	20	6.5 4.2–10.1ROR 6.6 · χ² 88 / p 3e-21	5.8 EB05 3.9 · IC025 +1.8 3/3 methods agree	Labeled (related wording) related wording	serious PRR 8.0	no trial data cached
Ocular hyperaemia	53	6.5 5.0–8.5ROR 6.6 · χ² 242 / p 6e-55	6.2 EB05 4.9 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 12.0	no trial data cached
Brain fog	16	6.3 3.9–10.3ROR 6.3 · χ² 66 / p 2e-16	5.4 EB05 3.5 · IC025 +1.6 3/3 methods agree	Likely indication confounding term in indications; also in warnings	serious PRR 9.2	no trial data cached
Unresponsive to stimuli	28	6.3 4.3–9.0ROR 6.3 · χ² 118 / p 7e-28	5.7 EB05 4.1 · IC025 +1.9 3/3 methods agree	Not in label — unassessed	serious PRR 5.0 · 92% clinician	no trial data cached
Motor dysfunction	11	6.2 3.5–11.3ROR 6.3 · χ² 43 / p 2e-11	5.1 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 6.4	no trial data cached
Nasal congestion (stuffy nose)	63	6.2 4.8–7.9ROR 6.3 · χ² 269 / p 9e-61	5.9 EB05 4.8 · IC025 +2.2 3/3 methods agree	Not in label — unassessed	serious PRR 7.2 · 92% clinician	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
Urticaria (hives)	648	22.4 20.9–24.1ROR 27.1 · χ² 13,303 / p <1e-300	22.3 EB05 20.9 · IC025 +4.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 16.9 · 98% clinician	no trial data cached
Dyspnoea (shortness of breath)	546	5.5 5.1–6.0ROR 6.3 · χ² 2,084 / p <1e-300	5.5 EB05 5.1 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 5.7 · 95% clinician	no trial data cached
Nausea	523	3.8 3.5–4.1ROR 4.3 · χ² 1,121 / p 4e-246	3.8 EB05 3.5 · IC025 +1.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.6 · 91% clinician	no trial data cached
Pruritus (itching)	479	7.3 6.7–7.9ROR 8.2 · χ² 2,634 / p <1e-300	7.2 EB05 6.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.9 · 93% clinician	no trial data cached
Erythema (skin redness)	422	11.8 10.8–12.9ROR 13.2 · χ² 4,203 / p <1e-300	11.8 EB05 10.9 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 17.3 · 97% clinician	no trial data cached
Vomiting	419	5.1 4.7–5.6ROR 5.7 · χ² 1,421 / p <1e-300	5.1 EB05 4.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.4 · 94% clinician	no trial data cached
Cough	295	6.1 5.4–6.8ROR 6.5 · χ² 1,256 / p 2e-275	6.0 EB05 5.4 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 95% clinician	no trial data cached
Rash	263	3.5 3.1–3.9ROR 3.7 · χ² 473 / p 4e-105	3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 4.5 · 92% clinician	no trial data cached
Product use in unapproved indication	202	4.7 4.2–5.4ROR 5.0 · χ² 601 / p 6e-133	4.7 EB05 4.2 · IC025 +2.0 3/3 methods agree	Reporting / coding artifact	serious PRR 2.7 · 95% clinician	no trial data cached
Paraesthesia (tingling/numbness)	168	6.1 5.3–7.1ROR 6.4 · χ² 719 / p 1e-158	6.0 EB05 5.3 · IC025 +2.3 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 7.7	no trial data cached
Throat irritation	163	21.0 18.1–24.4ROR 21.9 · χ² 3,080 / p <1e-300	20.9 EB05 18.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 26.9 · 96% clinician	no trial data cached
Sneezing	130	33.6 28.3–39.8ROR 34.8 · χ² 4,054 / p <1e-300	33.2 EB05 28.7 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 44.1 · 98% clinician	no trial data cached
Chest discomfort	127	7.2 6.0–8.5ROR 7.4 · χ² 669 / p 9e-148	7.0 EB05 6.0 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 7.1 · 94% clinician	no trial data cached
Hypersensitivity (allergic reaction)	109	3.4 2.8–4.1ROR 3.5 · χ² 181 / p 1e-41	3.3 EB05 2.8 · IC025 +1.4 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 4.3	no trial data cached
Feeling hot	107	10.0 8.3–12.1ROR 10.3 · χ² 861 / p 1e-189	9.8 EB05 8.3 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 12.8 · 92% clinician	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.

Sneezing — n=130, PRR 33.6
Throat irritation — n=163, PRR 21.0
Throat tightness — n=92, PRR 19.6
Muscle twitching — n=61, PRR 15.2
Paraesthesia oral — n=36, PRR 14.4
Rash maculo-papular — n=50, PRR 13.0
Face oedema — n=38, PRR 12.9
Erythema — n=422, PRR 11.8
Anaphylactic shock — n=51, PRR 11.4
Cold sweat — n=33, PRR 10.8

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 Gadoterate Meglumine?

In FDA FAERS, the most frequently co-reported reaction terms for Gadoterate Meglumine are urticaria, dyspnoea, nausea, pruritus, erythema, vomiting. 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 Gadoterate Meglumine 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.

Do FAERS signals prove that Gadoterate Meglumine 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 b4159c07-b114-4256-b9a9-e6af811704fa, effective 20250416; matched on openfda.generic_name.exact:"GADOTERATE MEGLUMINE")
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, 163 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.