Pharmacologic class (EPC) · 2 drug pages

Paramagnetic contrast agent: adverse event reports filed with FDA

4,897 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.

4,897
reports across the class: 0% of all reports; 100
reports, 12 months to June 2026: 108 in the 12 months before; 89.3%
marked serious by the reporter: 57.4% across all reports; 2
drugs with a page: brand and generic names counted separately

Paramagnetic contrast agent is a pharmacologic class (an FDA Established Pharmacologic Class) with 2 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 4,897 adverse event reports received by FDA, 0% of the database, from January 2004 to June 2026.

100 reports arrived in the 12 months to June 2026, close to the 108 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 89.3% of the class's reports are marked serious, 10.4% record death among the outcomes and 12.1% record hospitalisation, as reported.

Across the class the reactions recorded most often are nephrogenic systemic fibrosis (56.6%), pain (23.3%) and anxiety (13.8%). 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
OmniscanGadodiamide	brand	3,251	23	92.7%	Nephrogenic systemic fibrosis
ProHanceGadoteridol	brand	1,646	77	82.7%	Nephrogenic systemic fibrosis

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

Nephrogenic systemic fibrosis56.6%2,772
Painpain, site not specified23.3%1,142
Anxietyanxiety13.8%674
Emotional distressemotional distress12.4%608
Injurya physical injury11.6%566
Mobility decreasedreduced ability to move about10.8%529
Fibrosis9.2%450
General physical health deteriorationgeneral decline in health9.1%445
Arthralgiajoint pain8.9%435
Skin hypertrophy8.5%417
Skin induration8.3%406
Oedema peripheralswelling of the legs, ankles or hands7.8%383
Scara scar7.7%378
Skin tightness7.3%358
Hypoaesthesianumbness6.8%334
Anhedonia6.7%329
Pruritusitching6.5%317
Joint range of motion decreasedreduced movement of a joint6.4%312
Skin fibrosis6.4%311
Rashskin rash6.3%310
Astheniaweakness or lack of energy6.1%299
Paraesthesiatingling or pins and needles6%294
Fatiguetiredness5.7%280
Pain in extremitypain in an arm or leg5.7%277
Burning sensationa burning feeling5.6%274

Solid bar: share of all class reports. Hollow bar: the median share across the 2 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death10.4%507

Life-threatening5.6%273

Hospitalisation (initial or prolonged)12.1%592

Disability22.6%1,107

Congenital anomaly0%2

Other serious60.1%2,941

Not serious10.7%523

Patient age

Under 20.2%8

2 to 110.6%30

12 to 171%47

18 to 4415.6%764

45 to 6427.7%1,358

65 to 749.5%467

75 and over4.1%202

Age not given41.3%2,021

Who reported

Physician17.7%866

Pharmacist1.8%86

Other health professional30.4%1,489

Lawyer27.6%1,354

Consumer or non-health professional15.7%769

Not given6.8%333

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 Paramagnetic contrast agent reports

Which drugs are in the Paramagnetic contrast agent class on this site?

Omniscan and ProHance. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

4,897 reports through June 2026, 100 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?

nephrogenic systemic fibrosis (56.6%), pain (23.3%), anxiety (13.8%), emotional distress (12.4%) and injury (11.6%).

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.