Drugs › Parenteral iron replacement
Brand name · Iron dextran
Infed: adverse event reports filed with FDA
665 reports list it as a suspect or interacting product, 2004–2026. Class: Parenteral iron replacement.
- 665
- reports as suspect product
- 0% of all reports · about 30 a year
- 100
- reports, 12 months to June 2026
- 86 in the 12 months before
- 50.1%
- marked serious by the reporter
- 57.1% across the class
- 3.6%
- record death among outcomes, as reported
- 24 reports · not verified by FDA
Between February 2004 and June 2026, 665 adverse event reports received by FDA list the brand name Infed (iron dextran) as a suspect or interacting product. Reports that mention it only as a concomitant medication (159) are left out of every figure here.
In the 12 months to June 2026, 100 reports listed it, up 16% from 86 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 4.1% 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 reactions recorded most often are dyspnoea (20.6%), infusion related reaction (12.8%) and flushing (10.8%). A report can list several reactions, so shares add to more than 100%; 160 different terms appear across these reports. Dyspnoea is recorded in 20.6% of these reports, a larger share than in the median parenteral iron replacement drug (11.1%).
50.1% of the reports are marked serious by the reporter (57.1% across the class); 3.6% record death among the outcomes and 11.6% record hospitalisation, as reported. 48.4% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (22.7%). 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 Infed reports recording the termmedian drug in parenteral iron replacement
- Dyspnoeashortness of breath20.6%137
- Infusion related reactiona reaction during or soon after an infusion12.8%85
- Flushingsudden reddening or warmth of the skin10.8%72
- Chest painchest pain8.6%57
- Chest discomfortchest discomfort8.4%56
- Back painback pain8.3%55
- Anaphylactic reactiona severe, sudden allergic reaction7.5%50
- Nauseafeeling sick7.2%48
- Throat irritationan irritated throat6.2%41
- Off label useused for a purpose or in a way not on the label5.3%35
- Dizzinesslight-headedness or unsteadiness4.8%32
- Pruritusitching4.7%31
- Throat tightnessa tight throat4.2%28
- Hypersensitivityan allergic-type reaction3.9%26
- Urticariahives3.8%25
- Wrong technique in product usage processthe product was used in the wrong way3.8%25
- Blood pressure increaseda raised blood pressure reading3.5%23
- Hyperhidrosisexcessive sweating3%20
- Coughcough2.9%19
- Abdominal painstomach or belly pain2.7%18
- Adverse drug reactiona harmful or unpleasant reaction reported to a medicine2.7%18
- Product preparation issuea problem preparing the product2.6%17
- Erythemaskin redness2.4%16
- Feeling hotfeeling hot2.4%16
- Swelling facea swollen face2.4%16
- Hypotensionlow blood pressure2%13
- Heart rate increaseda fast heart rate reading1.8%12
- Blood pressure decreaseda low blood pressure reading1.7%11
Top 30 of 160 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. 95.9% 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 | 171 | 25.7% |
| Iron deficiency | 80 | 12% |
| Anaemia | 60 | 9% |
| Microcytic anaemia | 4 | 0.6% |
| Blood disorder | 2 | 0.3% |
| Haemorrhage | 2 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 665 reports.
In context
| Measure | Infed | Parenteral iron replacement | All reports |
|---|---|---|---|
| Reports as suspect product | 665 | 16,234 | 20,646,523 |
| Share of that pool | — | 4.1% | 0% |
| Reports, latest 12 months | 100 | — | 1,332,454 |
| Marked serious | 50.1% | 57.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 36 | 51 | 91 |
| Hospitalisation recorded, per 1,000 reports | 116 | 188 | 213 |
| Consumer-filed share | 12.8% | 24.9% | 45.8% |
| Top term, share of reports | Dyspnoea 20.6% | median 11.1% | 2.7% |
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% |
| Iron sucrose | generic | 618 | 246 | 86.2% |
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 Infed reports
How many adverse event reports has FDA received for Infed?
665 reports list Infed as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 100 of them arrived in the latest 12 months. Another 159 list it only as a concomitant medication.
What reactions are recorded in Infed reports?
dyspnoea (20.6%), infusion related reaction (12.8%), flushing (10.8%), chest pain (8.6%) and chest discomfort (8.4%). 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 Infed was responsible.
How serious are the reports?
50.1% are marked serious by the reporter. Among the outcomes recorded, 3.6% of reports include death and 11.6% 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?
other health professional (48.4%), pharmacist (28.7%) and consumer or non-health professional (12.8%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Infed rising?
100 reports in the 12 months to June 2026, up 16% from 86 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 Infed 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 Infed?
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 Infed as a suspect or interacting product; reports listing it only as a concomitant medication (159) 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.