Gadobenate Dimeglumine side effects: what 4,377 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Multihance
Who reports
4,377 reports · 62% serious · 206 with death outcome · 61% female
Used for
magnetic resonance imaging (MRI) of the central nervous system (CNS) in adults and pediatric patients (including term neonates), to visualize lesions with abnormal blood-brain barrier or abnormal vascularity of the brain, spine, and associated tissues (1.1) magnetic resonance angiography (MRA) to evaluate adults with known or suspected renal or aorto-ilio-femoral occlusive vascular disease.
What it is
MultiHance injection is supplied as a sterile, nonpyrogenic, clear, colorless to slightly yellow aqueous solution intended for intravenous use only.
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. MultiHance is not approved for intrathecal use [see Warnings and Precautions (5.1) ] .
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.
- 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. 100 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 |
|---|---|---|---|---|---|---|
| Mass | 156 | 53.9 46.1–62.9ROR 55.8 · χ² 7,959 / p <1e-300 | 53.0 EB05 46.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious PRR 71.6 · 96% consumer | no trial data cached |
| Scar | 164 | 46.2 39.7–53.7ROR 48.0 · χ² 7,144 / p <1e-300 | 45.5 EB05 40.0 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious PRR 47.2 | no trial data cached |
| Joint range of motion decreased | 121 | 43.7 36.6–52.2ROR 44.9 · χ² 4,966 / p <1e-300 | 43.1 EB05 37.0 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious PRR 49.9 | no trial data cached |
| Deformity | 82 | 42.2 34.1–52.4ROR 43.0 · χ² 3,233 / p <1e-300 | 41.5 EB05 34.5 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 43.1 | no trial data cached |
| Anhedonia | 188 | 34.2 29.7–39.4ROR 35.7 · χ² 5,993 / p <1e-300 | 33.9 EB05 30.0 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious PRR 29.5 | no trial data cached |
| Sneezing | 135 | 29.1 24.6–34.3ROR 30.0 · χ² 3,613 / p <1e-300 | 28.8 EB05 24.9 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 25.5 | no trial data cached |
| Injury | 356 | 24.2 21.9–26.8ROR 26.3 · χ² 7,894 / p <1e-300 | 24.1 EB05 22.1 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 22.2 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 254 | 22.2 19.7–25.1ROR 23.5 · χ² 5,120 / p <1e-300 | 22.1 EB05 19.9 · IC025 +4.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 20.8 | no trial data cached |
| Burning sensation | 272 | 18.6 16.6–20.9ROR 19.8 · χ² 4,520 / p <1e-300 | 18.5 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.2 | no trial data cached |
| Mobility decreased | 264 | 17.7 15.8–19.9ROR 18.8 · χ² 4,144 / p <1e-300 | 17.6 EB05 15.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 | no trial data cached |
| Anaphylactic shock | 92 | 17.2 14.1–21.1ROR 17.6 · χ² 1,388 / p <1e-300 | 17.1 EB05 14.4 · IC025 +3.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 16.1 · 93% clinician | no trial data cached |
| Joint stiffness | 91 | 16.7 13.6–20.4ROR 17.0 · χ² 1,321 / p 2e-289 | 16.5 EB05 13.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 26.7 | no trial data cached |
| Mental impairment | 81 | 16.0 12.9–19.9ROR 16.3 · χ² 1,124 / p 1e-246 | 15.9 EB05 13.2 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · 97% consumer | no trial data cached |
| Mental status changes | 90 | 15.5 12.7–19.1ROR 15.9 · χ² 1,208 / p 5e-265 | 15.4 EB05 12.9 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 16.0 | no trial data cached |
| Inflammation | 163 | 15.2 13.1–17.7ROR 15.8 · χ² 2,154 / p <1e-300 | 15.2 EB05 13.3 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious PRR 19.0 · 94% consumer | no trial data cached |
| Throat tightness | 81 | 14.4 11.6–17.9ROR 14.6 · χ² 995 / p 1e-218 | 14.3 EB05 11.8 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 11.6 | no trial data cached |
| Emotional distress | 337 | 13.3 12.0–14.8ROR 14.3 · χ² 3,837 / p <1e-300 | 13.3 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Urticaria (hives) | 419 | 12.1 11.0–13.2ROR 13.3 · χ² 4,271 / p <1e-300 | 12.0 EB05 11.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Movement disorder | 80 | 11.9 9.6–14.8ROR 12.1 · χ² 787 / p 2e-173 | 11.7 EB05 9.6 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 14.0 | no trial data cached |
| Hypersensitivity (allergic reaction) | 436 | 11.3 10.3–12.3ROR 12.4 · χ² 4,104 / p <1e-300 | 11.2 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.1 · 93% clinician | no trial data cached |
| Retching | 50 | 11.3 8.6–14.9ROR 11.4 · χ² 457 / p 8e-102 | 10.9 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.1 | no trial data cached |
| Skin discolouration | 98 | 10.2 8.4–12.4ROR 10.4 · χ² 807 / p 8e-178 | 10.0 EB05 8.4 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious PRR 18.0 | no trial data cached |
| Muscle tightness | 34 | 10.1 7.2–14.1ROR 10.2 · χ² 269 / p 1e-60 | 9.5 EB05 6.9 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 17.6 | no trial data cached |
| Presyncope (near-fainting) | 47 | 9.3 7.0–12.4ROR 9.4 · χ² 340 / p 3e-76 | 8.9 EB05 6.8 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.7 | no trial data cached |
| Unresponsive to stimuli | 49 | 9.1 6.9–12.1ROR 9.2 · χ² 347 / p 1e-77 | 8.7 EB05 6.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 · 93% clinician | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 30 | 9.1 6.4–13.0ROR 9.2 · χ² 209 / p 1e-47 | 8.4 EB05 6.0 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.4 | no trial data cached |
| Throat irritation | 84 | 9.0 7.3–11.1ROR 9.2 · χ² 590 / p 1e-130 | 8.7 EB05 7.2 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Motor dysfunction | 18 | 8.5 5.4–13.5ROR 8.6 · χ² 112 / p 2e-26 | 7.4 EB05 4.8 · IC025 +2.0 3/3 methods agree | Not in label — unassessed | serious PRR 9.5 | no trial data cached |
| Hypoaesthesia (numbness) | 257 | 8.2 7.3–9.3ROR 8.7 · χ² 1,632 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | no trial data cached |
| Skin lesion | 46 | 8.1 6.1–10.8ROR 8.2 · χ² 279 / p 6e-63 | 7.6 EB05 5.9 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 9.7 | no trial data cached |
| General physical health deterioration | 192 | 8.0 7.0–9.2ROR 8.3 · χ² 1,176 / p 5e-258 | 7.9 EB05 7.0 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 6.9 | no trial data cached |
| Paraesthesia (tingling/numbness) | 263 | 8.0 7.1–9.0ROR 8.4 · χ² 1,612 / p <1e-300 | 7.9 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 | no trial data cached |
| Quality of life decreased | 22 | 7.9 5.2–11.9ROR 7.9 · χ² 125 / p 3e-29 | 7.0 EB05 4.8 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Angioedema (deep swelling of face/throat) | 72 | 7.8 6.2–9.8ROR 7.9 · χ² 422 / p 5e-94 | 7.5 EB05 6.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 · 96% clinician | no trial data cached |
| Skin disorder | 54 | 7.8 6.0–10.1ROR 7.9 · χ² 312 / p 3e-70 | 7.4 EB05 5.8 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.3 | no trial data cached |
| Pain of skin | 43 | 7.6 5.7–10.3ROR 7.7 · χ² 241 / p 1e-54 | 7.2 EB05 5.5 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 22.8 | no trial data cached |
| Eyelid oedema | 17 | 7.0 4.3–11.2ROR 7.0 · χ² 81 / p 1e-19 | 6.0 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.0 | no trial data cached |
| Feeling hot | 88 | 6.9 5.6–8.5ROR 7.0 · χ² 436 / p 3e-97 | 6.7 EB05 5.6 · IC025 +2.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 7.6 | no trial data cached |
| Pharyngeal oedema | 21 | 6.5 4.2–9.9ROR 6.5 · χ² 91 / p 6e-22 | 5.7 EB05 3.9 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Anxiety | 384 | 6.5 5.9–7.1ROR 7.0 · χ² 1,785 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | 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 | 623 | 4.9 4.5–5.2ROR 5.5 · χ² 1,957 / p <1e-300 | 4.8 EB05 4.5 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.1 | no trial data cached |
| Nausea | 594 | 3.6 3.3–3.9ROR 4.0 · χ² 1,159 / p 2e-254 | 3.6 EB05 3.4 · IC025 +1.7 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.3 | no trial data cached |
| Vomiting | 510 | 5.2 4.8–5.7ROR 5.8 · χ² 1,770 / p <1e-300 | 5.2 EB05 4.8 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.6 | no trial data cached |
| Hypersensitivity (allergic reaction) | 436 | 11.3 10.3–12.3ROR 12.4 · χ² 4,104 / p <1e-300 | 11.2 EB05 10.4 · IC025 +3.3 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 11.1 · 93% clinician | no trial data cached |
| Urticaria (hives) | 419 | 12.1 11.0–13.2ROR 13.3 · χ² 4,271 / p <1e-300 | 12.0 EB05 11.1 · IC025 +3.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.2 | no trial data cached |
| Anxiety | 384 | 6.5 5.9–7.1ROR 7.0 · χ² 1,785 / p <1e-300 | 6.4 EB05 5.9 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 | no trial data cached |
| Injury | 356 | 24.2 21.9–26.8ROR 26.3 · χ² 7,894 / p <1e-300 | 24.1 EB05 22.1 · IC025 +4.4 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 22.2 | no trial data cached |
| Dyspnoea (shortness of breath) | 355 | 3.0 2.7–3.3ROR 3.2 · χ² 486 / p 5e-108 | 3.0 EB05 2.7 · IC025 +1.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 2.8 | no trial data cached |
| Emotional distress | 337 | 13.3 12.0–14.8ROR 14.3 · χ² 3,837 / p <1e-300 | 13.3 EB05 12.1 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.9 | no trial data cached |
| Pruritus (itching) | 326 | 4.1 3.7–4.6ROR 4.4 · χ² 784 / p 7e-173 | 4.1 EB05 3.7 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.1 | no trial data cached |
| Arthralgia (joint pain) | 293 | 3.4 3.0–3.8ROR 3.6 · χ² 500 / p 5e-111 | 3.4 EB05 3.1 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 5.5 | no trial data cached |
| Burning sensation | 272 | 18.6 16.6–20.9ROR 19.8 · χ² 4,520 / p <1e-300 | 18.5 EB05 16.8 · IC025 +4.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 34.2 | no trial data cached |
| Mobility decreased | 264 | 17.7 15.8–19.9ROR 18.8 · χ² 4,144 / p <1e-300 | 17.6 EB05 15.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 21.1 | no trial data cached |
| Paraesthesia (tingling/numbness) | 263 | 8.0 7.1–9.0ROR 8.4 · χ² 1,612 / p <1e-300 | 7.9 EB05 7.1 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 12.2 | no trial data cached |
| Hypoaesthesia (numbness) | 257 | 8.2 7.3–9.3ROR 8.7 · χ² 1,632 / p <1e-300 | 8.1 EB05 7.3 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 11.8 | 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=156, PRR 53.9
- Scar — n=164, PRR 46.2
- Joint range of motion decreased — n=121, PRR 43.7
- Deformity — n=82, PRR 42.2
- Anhedonia — n=188, PRR 34.2
- Mobility decreased — n=264, PRR 17.7
- Joint stiffness — n=91, PRR 16.7
- Mental impairment — n=81, PRR 16.0
- Mental status changes — n=90, PRR 15.5
- Inflammation — n=163, PRR 15.2
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 Gadobenate Dimeglumine?
In FDA FAERS, the most frequently co-reported reaction terms for Gadobenate Dimeglumine are pain, nausea, vomiting, hypersensitivity, urticaria, anxiety. 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 Gadobenate Dimeglumine 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. MultiHance is not approved for intrathecal use [see Warnings and Precautions (5.1) ] .
Do FAERS signals prove that Gadobenate Dimeglumine 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 f63abe56-46d9-4e32-afb1-f4e22370717d, effective 20250316; matched on
openfda.generic_name.exact:"GADOBENATE DIMEGLUMINE") - 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, 140 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.