ProHance: adverse event reports filed with FDA

1,646

reports as suspect product

0% of all reports · about 74 a year

77

reports, 12 months to June 2026

85 in the 12 months before

82.7%

marked serious by the reporter

89.3% across the class

8.6%

record death among outcomes, as reported

142 reports · not verified by FDA

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 ProHance reports recording the termmedian drug in paramagnetic contrast agent

1. Nephrogenic systemic fibrosis34.1%561
2. Painpain, site not specified24%395
3. Anxietyanxiety15%247
4. Emotional distressemotional distress13.2%217
5. General physical health deteriorationgeneral decline in health10.9%180
6. Mobility decreasedreduced ability to move about10.9%180
7. Fibrosis10.9%179
8. Injurya physical injury10.7%176
9. Scara scar9.6%158
10. Skin hypertrophy9.2%151
11. Skin induration8.9%146
12. Pruritusitching8.4%139
13. Skin tightness8.1%133
14. Dyspnoeashortness of breath7.7%126
15. Nauseafeeling sick7.5%124
16. Oedema peripheralswelling of the legs, ankles or hands7.5%123
17. Joint range of motion decreasedreduced movement of a joint7%115
18. Anhedonia6.7%110
19. Skin fibrosis6.7%110
20. Pain in extremitypain in an arm or leg5.8%96
21. Anaphylactic reactiona severe, sudden allergic reaction5.7%93
22. Arthralgiajoint pain5.7%93
23. Urticariahives5.4%89
24. Musculoskeletal stiffnessstiffness in muscles or joints5.2%85
25. Joint contracture5.1%84
26. Hypoaesthesianumbness5%83
27. Muscular weaknessmuscle weakness5%83
28. Erythemaskin redness4.8%79
29. Hypersensitivityan allergic-type reaction4.8%79
30. Joint stiffnessa stiff joint4.7%78

Top 30 of 390 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 71.8% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 1,646 reports.

Drugs most often listed in the same reports

Other products listed in reports where ProHance is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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

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.

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 ProHance as a suspect or interacting product; reports listing it only as a concomitant medication (50) 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.