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Gadoterate Side Effects

The most commonly reported side effects of gadoterate include urticaria, dyspnoea, and nausea, based on 3,535 FDA adverse event reports from 2004 to 2025.

Gadoterate side effects

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

1
Urticaria17.5%620
2
Dyspnoea15.0%529
3
Nausea14.4%508
4
Pruritus12.9%456
5
Vomiting11.5%408
6
Erythema11.4%402
7
Cough7.9%281
8
Rash7.3%257
9
Headache5.9%207
10
Dizziness5.7%200
11
Product Use In Unapproved Indication5.3%186
12
Paraesthesia4.7%166
13
Throat Irritation4.4%157
14
Sneezing3.6%127
15
Fatigue3.6%126

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

Report severity

71.5%Serious2,527 reports
25.5%Hospitalizations900 reports
2.0%Fatal69 reports

Seriousness is determined by the reporter, not by OpenClaim.

Gadoterate drug interactions

Other drugs that appear in adverse event reports alongside gadoterate. 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-dimeglumine1.7%60
2
Gadodiamide1.4%51
3
Gadobenate-dimeglumine1.3%46
4
Gadoteridol1.2%42
5
Gadobutrol0.9%32
6
Enoxaparin-sodium0.8%29
7
Dexamethasone0.8%27
8
Glucagon0.6%21
9
Cyclophosphamide0.5%19
10
Metformin0.5%18
11
Iodixanol0.5%17
12
Fludarabine-phosphate0.5%17
13
Amoxicillin0.5%16
14
Pantoprazole-sodium0.4%15
15
Iohexol0.4%15

Taken alongside

1
Acetaminophen3.5%123
2
Sodium-chloride2.2%77
3
Levothyroxine-sodium2.1%74
4
Furosemide1.8%63
5
Atorvastatin-calcium1.6%57
6
Ondansetron1.5%54
7
Methylprednisolone1.5%53
8
Ergocalciferol1.4%51
9
Pantoprazole-sodium1.4%49
10
Prednisone1.3%47
11
Omeprazole1.2%43
12
Lidocaine1.2%41
13
Aspirin1.2%41
14
Levetiracetam1.2%41
15
Amlodipine1.1%39

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 gadoterate side effects

64.5% of gadoterate adverse event reports involve female patients and 28.8% involve male patients. The largest age group is adult at 73%. These figures reflect who reports side effects, not underlying risk.

Sex

Female64.5%
Male28.8%
Unknown6.7%

Age group

< 20.3%
2–112.6%
12–173.4%
18–6473.2%
65+20.5%

What is gadoterate used for

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

Abdomen ScanAbdominal PainAccidental Exposure To ProductAngiogramAngioplastyAnkylosing SpondylitisArteritisArthritisArthrogramArthroscopyAbdominal PainAcoustic NeuromaAdenomyosisAdrenal MassAllergy Test

Showing 15 of 266 indications

Gadoterate brand names and reporting trend

Gadoterate is sold under the brand name Gadoterate Meglumine.

Brand names

Gadoterate Meglumine160

Quarterly reports (20042025)

20042010201520202025

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

Taking gadoterate with another medication?

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