Drugs › Paramagnetic contrast agent
Brand name · Gadodiamide
Omniscan: adverse event reports filed with FDA
3,251 reports list it as a suspect or interacting product, 2004–2026. Class: Paramagnetic contrast agent.
- 3,251
- reports as suspect product
- 0% of all reports · about 145 a year
- 23
- reports, 12 months to June 2026
- 23 in the 12 months before
- 92.7%
- marked serious by the reporter
- 89.3% across the class
- 11.2%
- record death among outcomes, as reported
- 365 reports · not verified by FDA
Between January 2004 and June 2026, 3,251 adverse event reports received by FDA list the brand name Omniscan (gadodiamide) as a suspect or interacting product. Reports that mention it only as a concomitant medication (66) are left out of every figure here.
In the 12 months to June 2026, 23 reports listed it, close to the 23 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 145 reports a year and 0% of the 20,646,523 reports in the database, and 66.4% of the reports for the paramagnetic contrast agent class. How many people take it is not in the data, so a count is not a rate of occurrence.
The MedDRA terms listed most often are nephrogenic systemic fibrosis (68%), pain (23%) and anxiety (13.1%). A report can list several reactions, so shares add to more than 100%; 534 different terms appear across these reports. Nephrogenic systemic fibrosis is recorded in 68% of these reports, a larger share than in the median paramagnetic contrast agent drug (51.1%).
92.7% of the reports are marked serious by the reporter (89.3% across the class); 11.2% record death among the outcomes and 8.4% record hospitalisation, as reported. 33.3% of the reports came from other health professionals, and the largest patient age group is 45 to 64 (27.2%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."
Reports by month, five years
Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.
By year received
2026 covers reports received through June 2026 only.
Reactions recorded in the reports
share of Omniscan reports recording the termmedian drug in paramagnetic contrast agent
- Nephrogenic systemic fibrosis68%2,211
- Painpain, site not specified23%747
- Anxietyanxiety13.1%427
- Emotional distressemotional distress12%391
- Injurya physical injury12%390
- Mobility decreasedreduced ability to move about10.7%349
- Arthralgiajoint pain10.5%342
- Fibrosis8.3%271
- Skin hypertrophy8.2%266
- General physical health deteriorationgeneral decline in health8.2%265
- Oedema peripheralswelling of the legs, ankles or hands8%260
- Skin induration8%260
- Rashskin rash7.8%255
- Hypoaesthesianumbness7.7%251
- Astheniaweakness or lack of energy7.6%248
- Skin tightness6.9%225
- Fatiguetiredness6.9%223
- Paraesthesiatingling or pins and needles6.9%223
- Scara scar6.8%220
- Anhedonia6.7%219
- Burning sensationa burning feeling6.6%213
- Skin fibrosis6.2%201
- Gadolinium deposition disease6.1%197
- Joint range of motion decreasedreduced movement of a joint6.1%197
- Pain in extremitypain in an arm or leg5.6%181
- Pruritusitching5.5%178
- Muscle spasmsmuscle cramps5.3%173
- Confusional stateconfusion5.3%172
- Erythemaskin redness4.8%157
- Joint contracture4.8%156
Top 30 of 534 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 2 drugs in the paramagnetic contrast agent class; it describes the reports, not the patients. 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."
Outcomes recorded
Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 4,897 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."
Patients and reporters
Patient age
Patient sex
Who reported
Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 76.8% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Nuclear magnetic resonance imaging | 447 | 13.7% |
| Diagnostic procedure | 192 | 5.9% |
| Angiogram | 102 | 3.1% |
| Magnetic resonance imaging | 74 | 2.3% |
| Renal transplant | 60 | 1.8% |
| Nuclear magnetic resonance imaging brain | 42 | 1.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 3,251 reports.
In context
| Measure | Omniscan | Paramagnetic contrast agent | All reports |
|---|---|---|---|
| Reports as suspect product | 3,251 | 4,897 | 20,646,523 |
| Share of that pool | — | 66.4% | 0% |
| Reports, latest 12 months | 23 | — | 1,332,454 |
| Marked serious | 92.7% | 89.3% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 112 | 104 | 91 |
| Hospitalisation recorded, per 1,000 reports | 84 | 121 | 213 |
| Consumer-filed share | 15.5% | 15.7% | 45.8% |
| Top term, share of reports | Nephrogenic systemic fibrosis 68% | median 51.1% | 0% |
Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. 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."
Other drugs in the paramagnetic contrast agent class
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| ProHance | brand | 1,646 | 77 | 82.7% |
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." A brand and its generic are separate rows because reporters name them separately.
Questions about Omniscan reports
How many adverse event reports has FDA received for Omniscan?
3,251 reports list Omniscan as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 23 of them arrived in the latest 12 months. Another 66 list it only as a concomitant medication.
What reactions are recorded in Omniscan reports?
nephrogenic systemic fibrosis (68%), pain (23%), anxiety (13.1%), emotional distress (12%) and injury (12%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Omniscan was responsible.
How serious are the reports?
92.7% are marked serious by the reporter. Among the outcomes recorded, 11.2% of reports include death and 8.4% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.
Who files these reports?
lawyer (33.3%), other health professional (23.2%) and physician (18.9%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Omniscan rising?
23 reports in the 12 months to June 2026, close to the 23 of the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.
Do these reports show that Omniscan was responsible for these reactions?
No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.
Is this a list of the side effects of Omniscan?
No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.
How do I report an adverse event?
Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Omniscan as a suspect or interacting product; reports listing it only as a concomitant medication (66) are excluded. 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.