Gadobutrol side effects: what 4,851 FDA adverse event reports show
Drug class
Gadolinium-based Contrast Agent
Who reports
4,851 reports · 44% serious · 187 with death outcome · 67% female
Used for
Gadobutrol Injection is indicated for: Magnetic resonance imaging (MRI) of the central nervous system (CNS) to detect and visualize areas with disrupted blood brain barrier and/or abnormal vascularity in adult and pediatric patients including term neon.
What it is
Gadobutrol Injection is a paramagnetic macrocyclic gadolinium-based contrast agent 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. 109 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 |
|---|---|---|---|---|---|---|
| Urticaria (hives) | 1,178 | 30.8 29.3–32.4ROR 40.4 · χ² 33,974 / p <1e-300 | 30.6 EB05 29.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.0 | no trial data cached |
| Sneezing | 140 | 27.2 23.1–32.1ROR 28.0 · χ² 3,492 / p <1e-300 | 27.0 EB05 23.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.3 | no trial data cached |
| Throat tightness | 119 | 19.1 16.0–22.8ROR 19.6 · χ² 2,019 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 | no trial data cached |
| Throat irritation | 183 | 17.8 15.4–20.5ROR 18.4 · χ² 2,872 / p <1e-300 | 17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 | no trial data cached |
| Eye swelling | 98 | 11.5 9.4–14.0ROR 11.7 · χ² 927 / p 7e-204 | 11.3 EB05 9.5 · IC025 +3.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 16.5 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 139 | 11.0 9.3–12.9ROR 11.3 · χ² 1,249 / p 8e-274 | 10.8 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.5 | no trial data cached |
| Anaphylactic shock | 63 | 10.6 8.3–13.6ROR 10.8 · χ² 541 / p 7e-120 | 10.3 EB05 8.3 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.9 | no trial data cached |
| Feeling hot | 141 | 10.0 8.5–11.7ROR 10.2 · χ² 1,127 / p 2e-247 | 9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Unresponsive to stimuli | 59 | 9.9 7.7–12.8ROR 10.0 · χ² 465 / p 2e-103 | 9.6 EB05 7.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 13.2 | no trial data cached |
| Muscle twitching | 47 | 8.8 6.6–11.7ROR 8.9 · χ² 317 / p 3e-71 | 8.3 EB05 6.4 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 14.8 · 81% consumer | no trial data cached |
| Lip swelling | 67 | 8.7 6.9–11.1ROR 8.8 · χ² 451 / p 3e-100 | 8.4 EB05 6.8 · IC025 +2.6 3/3 methods agree | Labeled (related wording) related wording | serious PRR 10.9 | no trial data cached |
| Salivary hypersecretion | 20 | 8.7 5.6–13.4ROR 8.7 · χ² 128 / p 6e-30 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.4 | no trial data cached |
| Renal pain | 21 | 8.6 5.6–13.2ROR 8.6 · χ² 133 / p 4e-31 | 7.6 EB05 5.1 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 13.4 · 90% consumer | no trial data cached |
| Pharyngeal swelling | 19 | 8.6 5.5–13.5ROR 8.6 · χ² 120 / p 3e-28 | 7.5 EB05 4.9 · IC025 +2.1 3/3 methods agree | Labeled adverse reaction exact term | serious n=15 | no trial data cached |
| Eyelid oedema | 23 | 8.5 5.7–12.8ROR 8.5 · χ² 145 / p 1e-33 | 7.6 EB05 5.2 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 · ♀ 87% (drug 67%) · 91% clinician | no trial data cached |
| Pruritus (itching) | 723 | 8.3 7.7–8.9ROR 9.6 · χ² 4,699 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Erythema (skin redness) | 373 | 7.9 7.1–8.7ROR 8.4 · χ² 2,247 / p <1e-300 | 7.8 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Paraesthesia oral | 26 | 7.8 5.3–11.5ROR 7.9 · χ² 148 / p 2e-34 | 7.1 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 7.7 | no trial data cached |
| Cold sweat | 31 | 7.6 5.4–10.8ROR 7.6 · χ² 171 / p 2e-39 | 7.0 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 13.0 · ♀ 37% (drug 67%) | no trial data cached |
| Pharyngeal oedema | 27 | 7.5 5.1–10.9ROR 7.5 · χ² 145 / p 9e-34 | 6.8 EB05 4.8 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.6 | no trial data cached |
| Pruritus generalised | 37 | 7.3 5.3–10.1ROR 7.3 · χ² 195 / p 1e-44 | 6.8 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.0 | no trial data cached |
| Presyncope (near-fainting) | 40 | 7.2 5.3–9.7ROR 7.2 · χ² 206 / p 6e-47 | 6.7 EB05 5.1 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.7 | no trial data cached |
| Pallor | 44 | 7.0 5.2–9.4ROR 7.0 · χ² 219 / p 6e-50 | 6.6 EB05 5.1 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 8.9 | no trial data cached |
| Cyanosis (blue skin from low oxygen) | 25 | 6.9 4.6–10.2ROR 6.9 · χ² 119 / p 4e-28 | 6.2 EB05 4.4 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.5 | no trial data cached |
| Vomiting | 737 | 6.8 6.4–7.3ROR 7.8 · χ² 3,721 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Incorrect route of product administration | 26 | 6.7 4.6–9.8ROR 6.7 · χ² 120 / p 3e-28 | 6.1 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 12.1 | no trial data cached |
| Eye pruritus | 51 | 6.7 5.1–8.8ROR 6.8 · χ² 241 / p 1e-54 | 6.3 EB05 5.0 · IC025 +2.2 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.1 | no trial data cached |
| Hypoaesthesia oral | 23 | 6.6 4.4–9.9ROR 6.6 · χ² 104 / p 1e-24 | 5.9 EB05 4.1 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Tachypnoea | 20 | 6.4 4.1–9.9ROR 6.4 · χ² 86 / p 1e-20 | 5.6 EB05 3.8 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Swelling face | 91 | 6.1 4.9–7.4ROR 6.2 · χ² 380 / p 7e-85 | 5.9 EB05 4.9 · IC025 +2.2 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 | no trial data cached |
| Burning sensation | 97 | 6.0 4.9–7.3ROR 6.1 · χ² 399 / p 5e-89 | 5.8 EB05 4.9 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 13.3 | no trial data cached |
| Muscle tightness | 21 | 5.6 3.7–8.6ROR 5.6 · χ² 75 / p 2e-18 | 5.0 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 11.4 | no trial data cached |
| Retching | 26 | 5.3 3.6–7.8ROR 5.3 · χ² 86 / p 8e-21 | 4.9 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 3.7 | no trial data cached |
| Acute respiratory distress syndrome | 21 | 5.1 3.4–7.9ROR 5.2 · χ² 66 / p 2e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.7 · 90% clinician | no trial data cached |
| Dry throat | 12 | 5.1 2.9–9.0ROR 5.1 · χ² 36 / p 1e-9 | 4.3 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious n=7 | no trial data cached |
| Sensory disturbance | 19 | 5.1 3.3–8.0ROR 5.1 · χ² 59 / p 1e-14 | 4.6 EB05 3.1 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.7 | no trial data cached |
| Brain fog | 17 | 5.0 3.1–8.1ROR 5.1 · χ² 51 / p 4e-13 | 4.5 EB05 3.0 · IC025 +1.4 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 11.9 | no trial data cached |
| Respiratory distress | 32 | 5.0 3.5–7.1ROR 5.0 · χ² 99 / p 1e-23 | 4.7 EB05 3.5 · IC025 +1.6 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 6.6 | no trial data cached |
| Ocular hyperaemia | 54 | 5.0 3.8–6.5ROR 5.0 · χ² 169 / p 6e-39 | 4.8 EB05 3.8 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 9.6 | no trial data cached |
| Lacrimation increased | 34 | 4.9 3.5–6.9ROR 5.0 · χ² 102 / p 2e-24 | 4.6 EB05 3.5 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | 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 |
|---|---|---|---|---|---|---|
| Urticaria (hives) | 1,178 | 30.8 29.3–32.4ROR 40.4 · χ² 33,974 / p <1e-300 | 30.6 EB05 29.1 · IC025 +4.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 19.0 | no trial data cached |
| Nausea | 884 | 4.8 4.6–5.1ROR 5.7 · χ² 2,798 / p <1e-300 | 4.8 EB05 4.6 · IC025 +2.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.9 | no trial data cached |
| Vomiting | 737 | 6.8 6.4–7.3ROR 7.8 · χ² 3,721 / p <1e-300 | 6.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Pruritus (itching) | 723 | 8.3 7.7–8.9ROR 9.6 · χ² 4,699 / p <1e-300 | 8.2 EB05 7.7 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 453 | 3.5 3.2–3.8ROR 3.7 · χ² 813 / p 4e-179 | 3.5 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.8 | no trial data cached |
| Erythema (skin redness) | 373 | 7.9 7.1–8.7ROR 8.4 · χ² 2,247 / p <1e-300 | 7.8 EB05 7.2 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.8 | no trial data cached |
| Dizziness | 243 | 2.1 1.9–2.4ROR 2.2 · χ² 144 / p 2e-33 | 2.1 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Rash | 241 | 2.4 2.1–2.7ROR 2.5 · χ² 200 / p 1e-45 | 2.4 EB05 2.2 · IC025 +1.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Cough | 228 | 3.5 3.1–4.0ROR 3.6 · χ² 415 / p 2e-92 | 3.5 EB05 3.1 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.6 | no trial data cached |
| Throat irritation | 183 | 17.8 15.4–20.5ROR 18.4 · χ² 2,872 / p <1e-300 | 17.7 EB05 15.6 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 26.3 | no trial data cached |
| Feeling hot | 141 | 10.0 8.5–11.7ROR 10.2 · χ² 1,127 / p 2e-247 | 9.8 EB05 8.5 · IC025 +3.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 14.4 | no trial data cached |
| Sneezing | 140 | 27.2 23.1–32.1ROR 28.0 · χ² 3,492 / p <1e-300 | 27.0 EB05 23.4 · IC025 +4.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 30.3 | no trial data cached |
| Anaphylactic reaction (severe allergic reaction) | 139 | 11.0 9.3–12.9ROR 11.3 · χ² 1,249 / p 8e-274 | 10.8 EB05 9.4 · IC025 +3.1 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 14.5 | no trial data cached |
| Paraesthesia (tingling/numbness) | 136 | 3.7 3.2–4.4ROR 3.8 · χ² 271 / p 4e-61 | 3.7 EB05 3.2 · IC025 +1.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Throat tightness | 119 | 19.1 16.0–22.8ROR 19.6 · χ² 2,019 / p <1e-300 | 19.0 EB05 16.3 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious PRR 24.3 | 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.
- Throat tightness — n=119, PRR 19.1
- Throat irritation — n=183, PRR 17.8
- Unresponsive to stimuli — n=59, PRR 9.9
- Muscle twitching — n=47, PRR 8.8
- Salivary hypersecretion — n=20, PRR 8.7
- Eyelid oedema — n=23, PRR 8.5
- Paraesthesia oral — n=26, PRR 7.8
- Cold sweat — n=31, PRR 7.6
- Presyncope — n=40, PRR 7.2
- Hypoaesthesia oral — n=23, PRR 6.6
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 Gadobutrol?
In FDA FAERS, the most frequently co-reported reaction terms for Gadobutrol are urticaria, nausea, vomiting, pruritus, dyspnoea, erythema. 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 Gadobutrol 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 Gadobutrol 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 18c67a70-0c1f-46d4-a123-66080090b71b, effective 20260723; matched on
openfda.generic_name.exact:"GADOBUTROL") - 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, 149 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.