Venofer (iron sucrose): adverse event reports filed with FDA

5,417

reports as suspect product

0% of all reports · about 241 a year

390

reports, 12 months to June 2026

488 in the 12 months before

73.4%

marked serious by the reporter

57.1% across the class

5.1%

record death among outcomes, as reported

274 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 Venofer (iron sucrose) reports recording the termmedian drug in parenteral iron replacement

1. Drug hypersensitivityan allergic-type reaction to a medicine17.2%932
2. Nauseafeeling sick11.2%608
3. Dyspnoeashortness of breath11.1%599
4. Pruritusitching8%433
5. Vomitingbeing sick7.7%418
6. Urticariahives6.9%376
7. Dizzinesslight-headedness or unsteadiness6.5%352
8. Hypotensionlow blood pressure6.4%344
9. Off label useused for a purpose or in a way not on the label5.5%298
10. Infusion related reactiona reaction during or soon after an infusion5.4%293
11. Peripheral swellingswelling of the arms or legs4.8%262
12. Rashskin rash4.8%261
13. Headachehead pain4.5%243
14. Back painback pain4.3%235
15. Malaisegeneral feeling of being unwell4.1%220
16. Paraesthesiatingling or pins and needles4%217
17. Erythemaskin redness3.9%211
18. Flushingsudden reddening or warmth of the skin3.9%211
19. Hypersensitivityan allergic-type reaction3.9%211
20. Chest painchest pain3.6%194
21. Abdominal painstomach or belly pain3.5%191
22. Diarrhoealoose or frequent stools3.5%190
23. Chest discomfortchest discomfort3.3%177
24. Hyperhidrosisexcessive sweating3.2%176
25. Painpain, site not specified3.2%176
26. Product quality issuea problem with the product itself3.2%173
27. Burning sensationa burning feeling3.2%171
28. Maternal exposure during pregnancythe mother took the medicine during pregnancy3.1%167
29. Arthralgiajoint pain2.9%158
30. Loss of consciousnesspassing out2.9%157

Top 30 of 717 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. 59.8% 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 5,417 reports.

Drugs most often listed in the same reports

Other products listed in reports where Venofer (iron sucrose) 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 Venofer (iron sucrose) as a suspect or interacting product; reports listing it only as a concomitant medication (2,602) 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.