Drugs › Parenteral iron replacement
Generic name
Iron sucrose: adverse event reports filed with FDA
618 reports list it as a suspect or interacting product, 2005–2026. Class: Parenteral iron replacement.
- 618
- reports as suspect product
- 0% of all reports · about 30 a year
- 246
- reports, 12 months to June 2026
- 57 in the 12 months before
- 86.2%
- marked serious by the reporter
- 57.1% across the class
- 11.7%
- record death among outcomes, as reported
- 72 reports · not verified by FDA
618 adverse event reports received by FDA list iron sucrose, a generic name as a suspect or interacting product, from September 2005 to June 2026. A further 976 reports list it only as a concomitant medication, and those are not counted in the figures on this page.
In the 12 months to June 2026, 246 reports listed it, up 332% from 57 in 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 30 reports a year and 0% of the 20,646,523 reports in the database, and 3.8% of the reports for the parenteral iron replacement 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 nausea (15%), dyspnoea (13.3%) and infusion related reaction (10.8%). A report can list several reactions, so shares add to more than 100%; 189 different terms appear across these reports. Nausea is recorded in 15% of these reports, a larger share than in the median parenteral iron replacement drug (11.2%).
86.2% of the reports are marked serious by the reporter (57.1% across the class); 11.7% record death among the outcomes and 33.7% record hospitalisation, as reported. 38.2% of the reports came from pharmacists, and the largest patient age group is 18 to 44 (24.9%). 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 Iron sucrose reports recording the termmedian drug in parenteral iron replacement
- Nauseafeeling sick15%93
- Dyspnoeashortness of breath13.3%82
- Infusion related reactiona reaction during or soon after an infusion10.8%67
- Rashskin rash10.8%67
- Arthralgiajoint pain8.9%55
- Drug ineffectivethe medicine did not work as expected8.7%54
- Hypotensionlow blood pressure8.7%54
- Deaththe patient died; cause not stated by this term8.4%52
- Dizzinesslight-headedness or unsteadiness8.3%51
- Diarrhoealoose or frequent stools8.1%50
- Urticariahives7.3%45
- Headachehead pain7.1%44
- Painpain, site not specified7.1%44
- Pruritusitching7.1%44
- Abdominal discomfortstomach discomfort7%43
- Abdominal pain upperupper stomach pain7%43
- Drug hypersensitivityan allergic-type reaction to a medicine7%43
- Malaisegeneral feeling of being unwell6.8%42
- Hypertensionhigh blood pressure6.6%41
- Hypersensitivityan allergic-type reaction6.3%39
- Cardiac failureheart failure5.8%36
- Cardiac failure congestivecongestive heart failure5.7%35
- Coughcough5.7%35
- Drug intolerancethe medicine was not tolerated5.7%35
- Hepatic steatosisfatty liver5.7%35
- Liver disorder5.2%32
- Back painback pain5%31
Top 30 of 189 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
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. 56.1% of reports give the United States as the country of the event or reporter.
Reason for use recorded
| Indication as recorded (MedDRA) | Reports | Share |
|---|---|---|
| Iron deficiency anaemia | 123 | 19.9% |
| Anaemia | 53 | 8.6% |
| Iron deficiency | 35 | 5.7% |
| Foetal exposure during pregnancy | 4 | 0.6% |
| Uterine contractions during pregnancy | 4 | 0.6% |
| Anaemia postoperative | 3 | 0.5% |
The indication field is filled in by the reporter and is often blank; shares are of all 618 reports.
In context
| Measure | Iron sucrose | Parenteral iron replacement | All reports |
|---|---|---|---|
| Reports as suspect product | 618 | 16,234 | 20,646,523 |
| Share of that pool | — | 3.8% | 0% |
| Reports, latest 12 months | 246 | — | 1,332,454 |
| Marked serious | 86.2% | 57.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 117 | 51 | 91 |
| Hospitalisation recorded, per 1,000 reports | 337 | 188 | 213 |
| Consumer-filed share | 10.5% | 24.9% | 45.8% |
| Top term, share of reports | Nausea 15% | median 11.2% | 3.8% |
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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Venofer (iron sucrose) | generic | 5,417 | 390 | 73.4% |
| Injectafer | brand | 2,813 | 14 | 41.3% |
| Auryxia | brand | 1,660 | 29 | 24.1% |
| Feraheme | brand | 1,541 | 20 | 60.9% |
| Ferric carboxymaltose | generic | 1,395 | 225 | 67.6% |
| Ferrlecit | brand | 1,174 | 77 | 72.4% |
| Accrufer | brand | 951 | 567 | 13.8% |
| Infed | brand | 665 | 100 | 50.1% |
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 Iron sucrose reports
How many adverse event reports has FDA received for Iron sucrose?
618 reports list Iron sucrose as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 246 of them arrived in the latest 12 months. Another 976 list it only as a concomitant medication.
What reactions are recorded in Iron sucrose reports?
nausea (15%), dyspnoea (13.3%), infusion related reaction (10.8%), rash (10.8%) and arthralgia (8.9%). 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 Iron sucrose was responsible.
How serious are the reports?
86.2% are marked serious by the reporter. Among the outcomes recorded, 11.7% of reports include death and 33.7% 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?
pharmacist (38.2%), other health professional (37.2%) and physician (12%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Iron sucrose rising?
246 reports in the 12 months to June 2026, up 332% from 57 in 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 Iron sucrose 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 Iron sucrose?
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 Iron sucrose as a suspect or interacting product; reports listing it only as a concomitant medication (976) 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.