Gadoteridol side effects: what 1,793 FDA adverse event reports show
Drug class
Paramagnetic Contrast Agent
Who reports
1,793 reports · 84% serious · 160 with death outcome · 57% female
Used for
Gadoteridol Injection is a gadolinium-based contrast agent indicated for magnetic resonance imaging (MRI) to visualize: lesions with disrupted blood brain barrier and/or abnormal vascularity in the brain (intracranial lesions), spine and associated tis.
What it is
Gadoteridol Injection, USP, a gadolinium-based paramagnetic MRI contrast agent, is a colorless to slightly yellow aqueous, sterile, non-pyrogenic injectable solution for intravenous use.
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.
Causality screen of the 40 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.
- 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.
- 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. 52 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 |
|---|---|---|---|---|---|---|
| Scar | 159 | 109.3 94.1–126.9ROR 119.8 · χ² 16,806 / p <1e-300 | 106.9 EB05 93.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 82.9 | no trial data cached |
| Joint range of motion decreased | 119 | 104.9 88.1–124.9ROR 112.3 · χ² 12,044 / p <1e-300 | 102.3 EB05 87.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 88.3 | no trial data cached |
| Deformity | 75 | 94.2 75.4–117.7ROR 98.3 · χ² 6,772 / p <1e-300 | 91.3 EB05 75.3 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious PRR 70.8 | no trial data cached |
| Anhedonia | 112 | 49.6 41.4–59.4ROR 52.8 · χ² 5,269 / p <1e-300 | 49.0 EB05 41.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Joint stiffness | 80 | 35.7 28.8–44.3ROR 37.3 · χ² 2,660 / p <1e-300 | 35.3 EB05 29.3 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 42.4 | no trial data cached |
| Mobility decreased | 186 | 30.4 26.5–34.9ROR 33.8 · χ² 5,266 / p <1e-300 | 30.3 EB05 26.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 | no trial data cached |
| Injury | 178 | 29.5 25.7–33.9ROR 32.6 · χ² 4,876 / p <1e-300 | 29.3 EB05 25.9 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.0 | no trial data cached |
| Anaphylactic shock | 55 | 25.1 19.4–32.6ROR 25.9 · χ² 1,249 / p 8e-274 | 24.9 EB05 19.8 · IC025 +3.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 17.4 | no trial data cached |
| Muscle tightness | 34 | 24.6 17.6–34.3ROR 25.1 · χ² 745 / p 2e-164 | 24.3 EB05 18.1 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 32.7 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 107 | 22.8 19.0–27.4ROR 24.2 · χ² 2,210 / p <1e-300 | 22.7 EB05 19.3 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.9 | no trial data cached |
| Shock | 42 | 21.5 16.0–29.1ROR 22.0 · χ² 802 / p 1e-176 | 21.3 EB05 16.4 · IC025 +3.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 14.9 · 100% clinician | no trial data cached |
| Emotional distress | 223 | 21.5 19.0–24.3ROR 24.4 · χ² 4,351 / p <1e-300 | 21.4 EB05 19.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Skin discolouration | 83 | 21.1 17.1–26.1ROR 22.1 · χ² 1,573 / p <1e-300 | 21.0 EB05 17.5 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 27.9 | no trial data cached |
| Motor dysfunction | 18 | 20.8 13.1–33.0ROR 21.0 · χ² 320 / p 9e-72 | 20.3 EB05 13.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 17.0 | no trial data cached |
| General physical health deterioration | 184 | 18.7 16.3–21.5ROR 20.8 · χ² 3,084 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
| Quality of life decreased | 19 | 16.5 10.6–25.9ROR 16.7 · χ² 262 / p 3e-59 | 16.0 EB05 10.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.3 | no trial data cached |
| Skin disorder | 47 | 16.5 12.5–21.9ROR 16.9 · χ² 670 / p 5e-148 | 16.4 EB05 12.7 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 19.2 | no trial data cached |
| Sneezing | 30 | 15.7 11.0–22.4ROR 15.9 · χ² 398 / p 8e-89 | 15.4 EB05 11.1 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 20.7 | no trial data cached |
| Pain of skin | 34 | 14.7 10.6–20.5ROR 15.0 · χ² 421 / p 6e-94 | 14.4 EB05 10.6 · IC025 +3.0 3/3 methods agree | Labeled (related wording) related wording | serious PRR 31.9 | no trial data cached |
| Skin lesion | 33 | 14.2 10.1–19.9ROR 14.4 · χ² 391 / p 2e-87 | 13.8 EB05 10.1 · IC025 +3.0 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 13.3 | no trial data cached |
| Abasia | 28 | 13.1 9.0–18.9ROR 13.3 · χ² 300 / p 2e-67 | 12.6 EB05 8.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 10.8 · ♀ 36% (drug 57%) | no trial data cached |
| Cold sweat | 19 | 12.6 8.0–19.7ROR 12.7 · χ² 191 / p 9e-44 | 11.7 EB05 7.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Musculoskeletal stiffness | 91 | 12.1 9.9–14.8ROR 12.7 · χ² 922 / p 9e-203 | 12.0 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 125 | 11.9 10.1–14.2ROR 12.8 · χ² 1,249 / p 6e-274 | 11.8 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Burning sensation | 71 | 11.8 9.4–14.9ROR 12.3 · χ² 695 / p 2e-153 | 11.6 EB05 9.5 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 15.9 | no trial data cached |
| Rash papular | 21 | 10.9 7.1–16.7ROR 11.0 · χ² 180 / p 3e-41 | 10.0 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 18.9 | no trial data cached |
| Unresponsive to stimuli | 24 | 10.9 7.3–16.2ROR 11.0 · χ² 206 / p 5e-47 | 10.1 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Pallor | 25 | 10.7 7.3–15.8ROR 10.9 · χ² 211 / p 5e-48 | 9.9 EB05 6.8 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Muscle twitching | 21 | 10.6 6.9–16.3ROR 10.7 · χ² 174 / p 6e-40 | 9.7 EB05 6.3 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 · ♀ 90% (drug 57%) | no trial data cached |
| Anxiety | 254 | 10.4 9.3–11.7ROR 12.0 · χ² 2,179 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Throat tightness | 24 | 10.4 7.0–15.5ROR 10.5 · χ² 194 / p 2e-44 | 9.5 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.4 · ♀ 79% (drug 57%) | no trial data cached |
| Paraesthesia oral | 12 | 9.8 5.6–17.2ROR 9.8 · χ² 86 / p 1e-20 | 8.0 EB05 4.6 · IC025 +1.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 11.0 | no trial data cached |
| Pharyngeal oedema | 13 | 9.7 5.7–16.8ROR 9.8 · χ² 93 / p 2e-22 | 8.1 EB05 4.7 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.8 | no trial data cached |
| Circulatory collapse | 14 | 9.6 5.7–16.1ROR 9.6 · χ² 99 / p 1e-23 | 8.1 EB05 4.8 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Peripheral coldness | 11 | 9.3 5.2–16.8ROR 9.4 · χ² 74 / p 5e-18 | 7.5 EB05 4.2 · IC025 +1.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Muscular weakness | 87 | 8.9 7.3–11.0ROR 9.4 · χ² 609 / p 8e-135 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Pruritus generalised | 16 | 8.5 5.2–13.9ROR 8.6 · χ² 99 / p 1e-23 | 7.3 EB05 4.6 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 12.2 | no trial data cached |
| Cardio-respiratory arrest | 30 | 8.3 5.8–11.9ROR 8.5 · χ² 187 / p 9e-43 | 7.6 EB05 5.5 · IC025 +2.3 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 · 100% clinician | no trial data cached |
| Neuralgia | 17 | 8.2 5.1–13.2ROR 8.3 · χ² 100 / p 6e-24 | 7.0 EB05 4.5 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Rash macular | 24 | 8.1 5.4–12.0ROR 8.2 · χ² 141 / p 6e-33 | 7.2 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | 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 |
|---|---|---|---|---|---|---|
| Pain | 405 | 7.7 7.1–8.4ROR 9.6 · χ² 2,422 / p <1e-300 | 7.6 EB05 7.0 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Anxiety | 254 | 10.4 9.3–11.7ROR 12.0 · χ² 2,179 / p <1e-300 | 10.3 EB05 9.3 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.3 | no trial data cached |
| Emotional distress | 223 | 21.5 19.0–24.3ROR 24.4 · χ² 4,351 / p <1e-300 | 21.4 EB05 19.1 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious PRR 11.3 | no trial data cached |
| Mobility decreased | 186 | 30.4 26.5–34.9ROR 33.8 · χ² 5,266 / p <1e-300 | 30.3 EB05 26.8 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 25.1 | no trial data cached |
| General physical health deterioration | 184 | 18.7 16.3–21.5ROR 20.8 · χ² 3,084 / p <1e-300 | 18.7 EB05 16.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 11.9 | no trial data cached |
| Injury | 178 | 29.5 25.7–33.9ROR 32.6 · χ² 4,876 / p <1e-300 | 29.3 EB05 25.9 · IC025 +4.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 15.0 | no trial data cached |
| Scar | 159 | 109.3 94.1–126.9ROR 119.8 · χ² 16,806 / p <1e-300 | 106.9 EB05 93.7 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious PRR 82.9 | no trial data cached |
| Oedema peripheral (swelling of legs/feet) | 125 | 11.9 10.1–14.2ROR 12.8 · χ² 1,249 / p 6e-274 | 11.8 EB05 10.2 · IC025 +3.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.2 | no trial data cached |
| Joint range of motion decreased | 119 | 104.9 88.1–124.9ROR 112.3 · χ² 12,044 / p <1e-300 | 102.3 EB05 87.8 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious PRR 88.3 | no trial data cached |
| Anhedonia | 112 | 49.6 41.4–59.4ROR 52.8 · χ² 5,269 / p <1e-300 | 49.0 EB05 41.9 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 27.6 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 107 | 22.8 19.0–27.4ROR 24.2 · χ² 2,210 / p <1e-300 | 22.7 EB05 19.3 · IC025 +4.0 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 15.9 | no trial data cached |
| Urticaria (hives) | 99 | 7.0 5.7–8.4ROR 7.3 · χ² 502 / p 1e-111 | 6.8 EB05 5.7 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | no trial data cached |
| Hypoaesthesia (numbness) | 91 | 7.1 5.8–8.7ROR 7.4 · χ² 474 / p 2e-105 | 6.9 EB05 5.8 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 7.8 | no trial data cached |
| Musculoskeletal stiffness | 91 | 12.1 9.9–14.8ROR 12.7 · χ² 922 / p 9e-203 | 12.0 EB05 10.0 · IC025 +3.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.5 | no trial data cached |
| Erythema (skin redness) | 90 | 5.1 4.2–6.3ROR 5.3 · χ² 297 / p 6e-67 | 5.0 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.2 | 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.
- Scar — n=159, PRR 109.3
- Joint range of motion decreased — n=119, PRR 104.9
- Deformity — n=75, PRR 94.2
- Anhedonia — n=112, PRR 49.6
- Joint stiffness — n=80, PRR 35.7
- Mobility decreased — n=186, PRR 30.4
- Muscle tightness — n=34, PRR 24.6
- Emotional distress — n=223, PRR 21.5
- Skin discolouration — n=83, PRR 21.1
- Abasia — n=28, PRR 13.1
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 Gadoteridol?
In FDA FAERS, the most frequently co-reported reaction terms for Gadoteridol are pain, anxiety, emotional distress, mobility decreased, injury, scar. 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 Gadoteridol 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 Gadoteridol 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 538a70e0-061c-40d2-8447-5b7a4e61a55f, effective 20250924; matched on
openfda.generic_name.exact:"GADOTERIDOL") - 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, 92 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.