Gadodiamide side effects: what 3,355 FDA adverse event reports show

Gadodiamide · Omniscan · 105 reaction terms · 8,877 drug–reaction co-reports · data 2026-09-14

Drug class

Paramagnetic Contrast Agent

FDA label (Established Pharmacologic Class)

Brand names

Omniscan

openFDA label

Who reports

3,355 reports · 93% serious · 373 with death outcome · 50% female

openFDA FAERS counts, all years, deduplication not applied

Used for

OMNISCAN is a gadolinium-based contrast agent for diagnostic magnetic resonance imaging (MRI) indicated for intravenous use to: Visualize lesions with abnormal vascularity in the brain, spine, and associated tissues ( 1.1 ) Facilitate the visualization.

FDA label, Indications and Usage

What it is

OMNISCAN (gadodiamide) Injection is the formulation of the gadolinium complex of diethylenetriamine pentaacetic acid bismethylamide, and is an injectable, nonionic extracellular enhancing agent for magnetic resonance imaging. OMNISCAN is administered by intravenous injection.

FDA label, Description section

Boxed warning

RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intr.

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 4Labeled (related wording) 5Reporting / coding artifact 1Not in label — unassessed 29

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. 65 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
Joint range of motion decreased	200	94.9 82.9–108.7ROR 100.9 · χ² 18,226 / p <1e-300	92.7 EB05 82.4 · IC025 +6.0 3/3 methods agree	Not in label — unassessed	serious PRR 71.9	no trial data cached
Deformity	126	85.2 71.7–101.2ROR 88.4 · χ² 10,258 / p <1e-300	83.0 EB05 71.5 · IC025 +5.7 3/3 methods agree	Not in label — unassessed	serious PRR 57.9	no trial data cached
Scar	222	81.9 72.1–93.1ROR 87.7 · χ² 17,451 / p <1e-300	80.3 EB05 71.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 60.1	no trial data cached
Mass	150	67.6 57.8–79.1ROR 70.7 · χ² 9,679 / p <1e-300	66.4 EB05 57.9 · IC025 +5.5 3/3 methods agree	Not in label — unassessed	serious PRR 60.2 · 97% consumer	no trial data cached
Anhedonia	223	53.1 46.7–60.3ROR 56.8 · χ² 11,256 / p <1e-300	52.4 EB05 46.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.1	no trial data cached
Injury	397	35.3 32.2–38.7ROR 39.9 · χ² 13,170 / p <1e-300	35.1 EB05 32.3 · IC025 +4.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 21.7	no trial data cached
Joint stiffness	142	34.0 28.9–40.0ROR 35.5 · χ² 4,496 / p <1e-300	33.7 EB05 29.3 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 36.6	no trial data cached
Mobility decreased	355	31.1 28.2–34.4ROR 34.7 · χ² 10,306 / p <1e-300	30.9 EB05 28.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial data cached
Mental impairment	81	20.9 16.9–26.0ROR 21.4 · χ² 1,514 / p <1e-300	20.8 EB05 17.2 · IC025 +3.8 3/3 methods agree	Not in label — unassessed	serious PRR 16.3 · 97% consumer	no trial data cached
Emotional distress	398	20.5 18.7–22.5ROR 23.2 · χ² 7,396 / p <1e-300	20.5 EB05 18.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Inflammation	162	19.8 17.0–23.0ROR 20.7 · χ² 2,868 / p <1e-300	19.7 EB05 17.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 16.4 · 92% consumer	no trial data cached
Burning sensation	218	19.5 17.1–22.2ROR 20.8 · χ² 3,806 / p <1e-300	19.4 EB05 17.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 26.0 · 74% consumer	no trial data cached
Skin discolouration	139	19.0 16.1–22.3ROR 19.7 · χ² 2,345 / p <1e-300	18.9 EB05 16.4 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 23.1	no trial data cached
Mental status changes	80	18.0 14.5–22.4ROR 18.5 · χ² 1,268 / p 4e-278	17.9 EB05 14.8 · IC025 +3.7 3/3 methods agree	Not in label — unassessed	serious PRR 12.4	no trial data cached
Abasia	71	17.8 14.1–22.4ROR 18.1 · χ² 1,104 / p 2e-242	17.6 EB05 14.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Muscle tightness	45	17.4 13.0–23.3ROR 17.7 · χ² 679 / p 5e-150	17.2 EB05 13.4 · IC025 +3.4 3/3 methods agree	Not in label — unassessed	serious PRR 20.8	no trial data cached
Motor dysfunction	28	17.3 12.0–25.1ROR 17.5 · χ² 414 / p 2e-92	17.0 EB05 12.2 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 13.1 · 90% clinician	no trial data cached
Movement disorder	89	17.3 14.1–21.2ROR 17.7 · χ² 1,348 / p 3e-295	17.2 EB05 14.4 · IC025 +3.6 3/3 methods agree	Not in label — unassessed	serious PRR 13.6	no trial data cached
Quality of life decreased	37	17.3 12.5–23.8ROR 17.4 · χ² 549 / p 9e-122	17.0 EB05 12.8 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Skin disorder	91	17.1 14.0–21.0ROR 17.6 · χ² 1,365 / p 4e-299	17.0 EB05 14.3 · IC025 +3.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.9	no trial data cached
Skin lesion	72	16.6 13.2–20.8ROR 16.9 · χ² 1,036 / p 1e-227	16.4 EB05 13.5 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 13.6	no trial data cached
Dialysis	36	15.9 11.5–22.0ROR 16.0 · χ² 485 / p 7e-108	15.6 EB05 11.7 · IC025 +3.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0 · 96% clinician	no trial data cached
Pain of skin	64	14.8 11.6–18.9ROR 15.1 · χ² 812 / p 7e-179	14.7 EB05 11.9 · IC025 +3.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 31.9	no trial data cached
General physical health deterioration	271	14.8 13.2–16.6ROR 16.0 · χ² 3,478 / p <1e-300	14.7 EB05 13.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Oedema peripheral (swelling of legs/feet)	263	13.5 12.0–15.1ROR 14.5 · χ² 3,034 / p <1e-300	13.4 EB05 12.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.5	no trial data cached
Rash papular	40	11.1 8.2–15.2ROR 11.3 · χ² 359 / p 2e-80	10.7 EB05 8.0 · IC025 +2.8 3/3 methods agree	Not in label — unassessed	serious PRR 16.9	no trial data cached
Hypoaesthesia (numbness)	258	10.8 9.6–12.1ROR 11.6 · χ² 2,291 / p <1e-300	10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Musculoskeletal stiffness	140	10.0 8.5–11.8ROR 10.4 · χ² 1,127 / p 2e-247	9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 10.0	no trial data cached
Skin ulcer	40	9.7 7.1–13.2ROR 9.8 · χ² 303 / p 3e-68	9.2 EB05 6.9 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.6	no trial data cached
Anxiety	431	9.5 8.7–10.3ROR 10.7 · χ² 3,290 / p <1e-300	9.4 EB05 8.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Paraesthesia (tingling/numbness)	228	9.0 8.0–10.3ROR 9.6 · χ² 1,634 / p <1e-300	8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0	no trial data cached
Muscle atrophy	18	9.0 5.6–14.2ROR 9.0 · χ² 119 / p 4e-28	7.8 EB05 5.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.2	no trial data cached
Oedema	74	8.6 6.8–10.7ROR 8.7 · χ² 487 / p 4e-108	8.3 EB05 6.8 · IC025 +2.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.5	no trial data cached
Muscular weakness	147	8.1 6.9–9.5ROR 8.4 · χ² 911 / p 2e-200	7.9 EB05 6.9 · IC025 +2.7 3/3 methods agree	Not in label — unassessed	serious PRR 7.1	no trial data cached
Pain	758	7.7 7.2–8.2ROR 9.7 · χ² 4,546 / p <1e-300	7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial data cached
Pruritus generalised	27	7.7 5.3–11.2ROR 7.8 · χ² 151 / p 6e-35	7.0 EB05 5.0 · IC025 +2.1 3/3 methods agree	Not in label — unassessed	serious PRR 9.6	no trial data cached
Activities of daily living impaired	23	7.2 4.8–10.8ROR 7.2 · χ² 116 / p 3e-27	6.4 EB05 4.4 · IC025 +2.0 3/3 methods agree	Not in label — unassessed	serious PRR 6.0	no trial data cached
Confusional state (confusion)	182	7.0 6.1–8.1ROR 7.4 · χ² 942 / p 4e-207	6.9 EB05 6.1 · IC025 +2.5 3/3 methods agree	Not in label — unassessed	serious PRR 5.6 · 79% consumer	no trial data cached
Grand mal convulsion	10	6.7 3.6–12.4ROR 6.7 · χ² 43 / p 3e-11	5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree	Labeled (related wording) related wording	serious PRR 4.2	no trial data cached
Arteriosclerosis	10	6.6 3.6–12.3ROR 6.7 · χ² 42 / p 4e-11	5.3 EB05 3.0 · IC025 +1.3 3/3 methods agree	Not in label — unassessed	serious PRR 4.3	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
Pain	758	7.7 7.2–8.2ROR 9.7 · χ² 4,546 / p <1e-300	7.7 EB05 7.2 · IC025 +2.8 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 6.6	no trial data cached
Anxiety	431	9.5 8.7–10.3ROR 10.7 · χ² 3,290 / p <1e-300	9.4 EB05 8.7 · IC025 +3.1 3/3 methods agree	Not in label — unassessed	serious PRR 7.0	no trial data cached
Emotional distress	398	20.5 18.7–22.5ROR 23.2 · χ² 7,396 / p <1e-300	20.5 EB05 18.8 · IC025 +4.2 3/3 methods agree	Not in label — unassessed	serious PRR 11.5	no trial data cached
Injury	397	35.3 32.2–38.7ROR 39.9 · χ² 13,170 / p <1e-300	35.1 EB05 32.3 · IC025 +4.9 3/3 methods agree	Labeled — boxed warning exact term	serious PRR 21.7	no trial data cached
Mobility decreased	355	31.1 28.2–34.4ROR 34.7 · χ² 10,306 / p <1e-300	30.9 EB05 28.3 · IC025 +4.7 3/3 methods agree	Not in label — unassessed	serious PRR 25.3	no trial data cached
Arthralgia (joint pain)	345	5.2 4.7–5.8ROR 5.7 · χ² 1,191 / p 2e-261	5.2 EB05 4.7 · IC025 +2.2 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.9	no trial data cached
General physical health deterioration	271	14.8 13.2–16.6ROR 16.0 · χ² 3,478 / p <1e-300	14.7 EB05 13.3 · IC025 +3.6 3/3 methods agree	Reporting / coding artifact	serious PRR 8.9	no trial data cached
Oedema peripheral (swelling of legs/feet)	263	13.5 12.0–15.1ROR 14.5 · χ² 3,034 / p <1e-300	13.4 EB05 12.1 · IC025 +3.5 3/3 methods agree	Labeled (related wording) related wording	serious PRR 10.5	no trial data cached
Rash	260	3.7 3.3–4.2ROR 4.0 · χ² 532 / p 5e-118	3.7 EB05 3.4 · IC025 +1.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 5.0	no trial data cached
Hypoaesthesia (numbness)	258	10.8 9.6–12.1ROR 11.6 · χ² 2,291 / p <1e-300	10.7 EB05 9.6 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 10.7	no trial data cached
Asthenia (weakness)	254	4.2 3.8–4.8ROR 4.5 · χ² 633 / p 6e-140	4.2 EB05 3.8 · IC025 +1.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 3.7	no trial data cached
Paraesthesia (tingling/numbness)	228	9.0 8.0–10.3ROR 9.6 · χ² 1,634 / p <1e-300	8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.0	no trial data cached
Anhedonia	223	53.1 46.7–60.3ROR 56.8 · χ² 11,256 / p <1e-300	52.4 EB05 46.9 · IC025 +5.3 3/3 methods agree	Not in label — unassessed	serious PRR 31.1	no trial data cached
Scar	222	81.9 72.1–93.1ROR 87.7 · χ² 17,451 / p <1e-300	80.3 EB05 71.8 · IC025 +5.9 3/3 methods agree	Not in label — unassessed	serious PRR 60.1	no trial data cached
Burning sensation	218	19.5 17.1–22.2ROR 20.8 · χ² 3,806 / p <1e-300	19.4 EB05 17.3 · IC025 +4.0 3/3 methods agree	Not in label — unassessed	serious PRR 26.0 · 74% consumer	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.

Joint range of motion decreased — n=200, PRR 94.9
Deformity — n=126, PRR 85.2
Scar — n=222, PRR 81.9
Mass — n=150, PRR 67.6
Anhedonia — n=223, PRR 53.1
Joint stiffness — n=142, PRR 34.0
Mobility decreased — n=355, PRR 31.1
Mental impairment — n=81, PRR 20.9
Emotional distress — n=398, PRR 20.5
Inflammation — n=162, PRR 19.8

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 Gadodiamide?

In FDA FAERS, the most frequently co-reported reaction terms for Gadodiamide are pain, anxiety, emotional distress, injury, mobility decreased, arthralgia. 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 Gadodiamide have an FDA boxed warning?

Yes. The current FDA label carries a boxed warning: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS WARNING: RISK ASSOCIATED WITH INTRATHECAL USE and NEPHROGENIC SYSTEMIC FIBROSIS See full prescribing information for complete boxed warning. Intr.

Do FAERS signals prove that Gadodiamide 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 1e9a37e2-f28a-4373-bf0f-3e9b60f42d8a, effective 20250418; matched on openfda.generic_name.exact:"GADODIAMIDE")
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, 105 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.