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Gadobutrol Side Effects

The most commonly reported side effects of gadobutrol include urticaria, nausea, and pruritus, based on 4,716 FDA adverse event reports from 2007 to 2025.

Gadobutrol side effects

Percentages show how often each reaction appears relative to total reports for gadobutrol.

1
Urticaria22.2%1,046
2
Nausea16.2%763
3
Pruritus13.8%652
4
Vomiting13.6%640
5
Dyspnoea8.7%408
6
Erythema7.0%330
7
Dizziness4.7%223
8
Headache4.4%209
9
Cough4.3%204
10
Rash4.3%202
11
Contrast Media Reaction3.4%162
12
Throat Irritation3.4%160
13
Anaphylactic Reaction2.8%134
14
Sneezing2.7%128
15
Paraesthesia2.7%127

These are voluntary reports and do not establish that gadobutrol caused these reactions.

Report severity

43.3%Serious2,042 reports
14.5%Hospitalizations683 reports
3.9%Fatal182 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gadobutrol drug interactions

Other drugs that appear in adverse event reports alongside gadobutrol. Drugs flagged as a suspected cause appear in the first column. Drugs taken at the same time but not suspected appear in the second.

Also suspected

1
Gadopentetate-dimeglumine0.9%42
2
Gadobenate-dimeglumine0.8%39
3
Gadodiamide0.7%34
4
Gadoterate-meglumine0.7%32
5
Gadoteridol0.4%20
6
Erythromycin0.4%17
7
Amlodipine0.4%17
8
Acetaminophen0.4%17
9
Calcium-carbonate0.3%16
10
Sumatriptan0.3%16
11
Perindopril0.3%16
12
Gabapentin0.3%16
13
Penicillin0.3%16
14
Levomepromazine0.3%16
15
Prochlorperazine0.3%16

Taken alongside

1
Acetaminophen3.1%148
2
Ergocalciferol1.9%88
3
Diphenhydramine1.8%85
4
Ondansetron1.8%83
5
Sodium-chloride1.4%67
6
Aspirin1.3%63
7
Albuterol1.3%60
8
Lorazepam1.3%59
9
Amlodipine1.2%57
10
Levothyroxine-sodium1.2%57
11
Omeprazole1.2%56
12
Pantoprazole-sodium1.2%56
13
Oxycodone1.1%54
14
Atorvastatin-calcium1.1%53
15
Dexamethasone1.1%52

Co-occurrence in adverse event reports does not establish a drug interaction. Patients often take multiple medications, and these lists reflect prescribing patterns rather than causal relationships. Consult a healthcare provider about potential drug interactions.

Who reports gadobutrol side effects

56.4% of gadobutrol adverse event reports involve female patients and 27.8% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female56.4%
Male27.8%
Unknown15.8%

Age group

< 20.6%
2–111.9%
12–172.9%
18–6473.0%
65+21.5%

What is gadobutrol used for

Conditions and purposes for which patients were taking gadobutrol when the adverse event was reported.

AbasiaAbdomen ScanAbdominal AbscessAbdominal NeoplasmAbdominal PainAbdominal Pain UpperAbscessAcoustic NeuromaAdenomyosisAdnexa Uteri MassAdrenal MassAdverse EventAmnesiaAngiogramAngiogram Cerebral

Showing 15 of 550 indications

Gadobutrol brand names and reporting trend

Gadobutrol is sold under the brand name Gadavist.

Brand names

Gadavist1,349

Quarterly reports (20072025)

2007201520202025

An upward trend reflects increased FAERS reporting overall, not necessarily increased risk.

Taking gadobutrol with another medication?

Ask OpenClaim about your specific drug combination. Get a sourced report using FDA data, drug labels, and medical literature.