Pharmacologic class (EPC) · 4 drug pages

Gadolinium-based contrast agent: adverse event reports filed with FDA

11,772 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

11,772
reports across the class: 0.1% of all reports; 641
reports, 12 months to June 2026: 556 in the 12 months before; 55.4%
marked serious by the reporter: 57.4% across all reports; 4
drugs with a page: brand and generic names counted separately

Gadolinium-based contrast agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 4 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 11,772 adverse event reports received by FDA, 0.1% of the database, from March 2004 to June 2026.

641 reports arrived in the 12 months to June 2026, up 15% from 556 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 55.4% of the class's reports are marked serious, 3.3% record death among the outcomes and 16.7% record hospitalisation, as reported.

Across the class the reactions recorded most often are urticaria (18.5%), nausea (16%) and vomiting (13.4%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
MultiHanceGadobenate dimeglumine	brand	4,147	126	60.3%	Pain
GadavistGadobutrol	brand	3,653	115	28.8%	Urticaria
DotaremGadoterate meglumine	brand	2,954	216	69%	Urticaria
Gadobutrol	generic	1,018	184	91.4%	Dyspnoea

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Urticariahives18.5%2,177
Nauseafeeling sick16%1,882
Vomitingbeing sick13.4%1,574
Pruritusitching12.4%1,456
Dyspnoeashortness of breath10.6%1,247
Erythemaskin redness8.1%952
Painpain, site not specified6.6%780
Rashskin rash6%710
Nephrogenic systemic fibrosis5.3%626
Hypersensitivityan allergic-type reaction5.2%610
Coughcough5.1%606
Paraesthesiatingling or pins and needles4.6%539
Dizzinesslight-headedness or unsteadiness4.4%519
Headachehead pain4.2%489
Arthralgiajoint pain4%465
Anaphylactic reactiona severe, sudden allergic reaction3.8%450
Anxietyanxiety3.8%449
Burning sensationa burning feeling3.7%431
Throat irritationan irritated throat3.4%404
Hypoaesthesianumbness3.4%397
Fatiguetiredness3.2%382
Sneezing3.2%382
Injurya physical injury3.1%364
Contrast media reaction3%353
Gadolinium deposition disease3%352

Solid bar: share of all class reports. Hollow bar: the median share across the 4 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death3.3%394

Life-threatening6.5%761

Hospitalisation (initial or prolonged)16.7%1,967

Disability3.9%464

Congenital anomaly0.1%7

Other serious36.8%4,332

Not serious44.6%5,249

Patient age

Under 20.2%29

2 to 111.3%154

12 to 172.2%262

18 to 4425.4%2,995

45 to 6430.8%3,621

65 to 7410.6%1,253

75 and over5.7%672

Age not given23.7%2,786

Who reported

Physician9.8%1,155

Pharmacist4.2%489

Other health professional60.4%7,112

Lawyer3.6%419

Consumer or non-health professional18.5%2,181

Not given3.5%416

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Gadolinium-based contrast agent reports

Which drugs are in the Gadolinium-based contrast agent class on this site?

MultiHance, Gadavist, Dotarem and Gadobutrol. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

11,772 reports through June 2026, 641 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

urticaria (18.5%), nausea (16%), vomiting (13.4%), pruritus (12.4%) and dyspnoea (10.6%).

Can the members table be used to rank the drugs?

No. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. See the guide on how to report.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.