Feraheme: adverse event reports filed with FDA

1,541

reports as suspect product

0% of all reports · about 92 a year

20

reports, 12 months to June 2026

45 in the 12 months before

60.9%

marked serious by the reporter

57.1% across the class

6.2%

record death among outcomes, as reported

95 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 Feraheme reports recording the termmedian drug in parenteral iron replacement

1. Dyspnoeashortness of breath26.5%408
2. Flushingsudden reddening or warmth of the skin14.1%218
3. Nauseafeeling sick13.4%207
4. Hypotensionlow blood pressure12.5%192
5. Back painback pain11.9%184
6. Anaphylactic reactiona severe, sudden allergic reaction10.6%163
7. Dizzinesslight-headedness or unsteadiness10.3%159
8. Hypersensitivityan allergic-type reaction9.8%151
9. Chest discomfortchest discomfort9.7%149
10. Unresponsive to stimuli9.1%141
11. Infusion related reactiona reaction during or soon after an infusion9%139
12. Chest painchest pain8.4%130
13. Vomitingbeing sick6.9%106
14. Hyperhidrosisexcessive sweating6.5%100
15. Pruritusitching5.3%82
16. Erythemaskin redness4.9%75
17. Oxygen saturation decreased4.7%72
18. Headachehead pain4.2%64
19. Loss of consciousnesspassing out4%62
20. Hypertensionhigh blood pressure4%61
21. Abdominal painstomach or belly pain3.4%53
22. Blood pressure increaseda raised blood pressure reading3.4%52
23. Chillschills or shivering3.4%52
24. Coughcough3.2%50
25. Feeling abnormalfeeling odd or not right3.1%48
26. Anxietyanxiety3%46
27. Blood pressure decreaseda low blood pressure reading2.9%44
28. Infusion site extravasationinfusion fluid leaked into surrounding tissue2.9%44
29. Malaisegeneral feeling of being unwell2.9%44
30. Feeling hotfeeling hot2.7%42

Top 30 of 240 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 9 drugs in the parenteral iron replacement 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 16,234 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. 97.9% 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 1,541 reports.

Drugs most often listed in the same reports

Other products listed in reports where Feraheme 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 parenteral iron replacement 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 Feraheme as a suspect or interacting product; reports listing it only as a concomitant medication (193) 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.