Drugs › Parenteral iron replacement
Generic name
Ferric carboxymaltose: adverse event reports filed with FDA
1,395 reports list it as a suspect or interacting product, 2014–2026. Class: Parenteral iron replacement.
- 1,395
- reports as suspect product
- 0% of all reports · about 113 a year
- 225
- reports, 12 months to June 2026
- 180 in the 12 months before
- 67.6%
- marked serious by the reporter
- 57.1% across the class
- 1.1%
- record death among outcomes, as reported
- 15 reports · not verified by FDA
1,395 adverse event reports received by FDA list ferric carboxymaltose, a generic name as a suspect or interacting product, from March 2014 to June 2026. A further 222 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, 225 reports listed it, up 25% from 180 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 113 reports a year and 0% of the 20,646,523 reports in the database, and 8.6% 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 hypophosphataemia (39.6%), pain (18.4%) and product quality issue (16.1%). A report can list several reactions, so shares add to more than 100%; 292 different terms appear across these reports. Hypophosphataemia is recorded in 39.6% of these reports, a larger share than in the median parenteral iron replacement drug (0.5%).
67.6% of the reports are marked serious by the reporter (57.1% across the class); 1.1% record death among the outcomes and 12.3% record hospitalisation, as reported. 37.3% of the reports came from other health professionals, and the largest patient age group is 18 to 44 (20.6%). 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 Ferric carboxymaltose reports recording the termmedian drug in parenteral iron replacement
- Hypophosphataemia39.6%552
- Painpain, site not specified18.4%256
- Product quality issuea problem with the product itself16.1%225
- Anxietyanxiety14.4%201
- Emotional distressemotional distress14.1%197
- Anhedonia14.1%196
- Arthralgiajoint pain12%167
- Astheniaweakness or lack of energy10.7%149
- Headachehead pain9.9%138
- Nauseafeeling sick9%126
- Dizzinesslight-headedness or unsteadiness9%125
- Dyspnoeashortness of breath8.9%124
- Myalgiamuscle pain8.9%124
- Chest painchest pain5.4%76
- Ill-defined disordera condition that was not clearly described5.2%73
- Muscle spasmsmuscle cramps5%70
- Blood phosphorus decreased4.9%68
- Pain in extremitypain in an arm or leg4.9%68
- Palpitationsawareness of the heartbeat4.7%65
- Urticariahives4.7%65
- Back painback pain4.4%62
- Pruritusitching4.3%60
- Vomitingbeing sick4.2%58
- Paraesthesiatingling or pins and needles3.9%55
- Rashskin rash3.9%55
- Stressstress3.9%54
- Malaisegeneral feeling of being unwell3.7%51
- Fatiguetiredness3.6%50
- Maternal exposure during pregnancythe mother took the medicine during pregnancy2.9%41
- Chest discomfortchest discomfort2.7%37
Top 30 of 292 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. 91% 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 | 463 | 33.2% |
| Anaemia | 56 | 4% |
| Iron deficiency | 36 | 2.6% |
| Blood iron decreased | 19 | 1.4% |
| Microcytic anaemia | 7 | 0.5% |
| Heavy menstrual bleeding | 4 | 0.3% |
The indication field is filled in by the reporter and is often blank; shares are of all 1,395 reports.
In context
| Measure | Ferric carboxymaltose | Parenteral iron replacement | All reports |
|---|---|---|---|
| Reports as suspect product | 1,395 | 16,234 | 20,646,523 |
| Share of that pool | — | 8.6% | 0% |
| Reports, latest 12 months | 225 | — | 1,332,454 |
| Marked serious | 67.6% | 57.1% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 11 | 51 | 91 |
| Hospitalisation recorded, per 1,000 reports | 123 | 188 | 213 |
| Consumer-filed share | 15.2% | 24.9% | 45.8% |
| Top term, share of reports | Hypophosphataemia 39.6% | median 0.5% | 0% |
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% |
| Ferrlecit | brand | 1,174 | 77 | 72.4% |
| Accrufer | brand | 951 | 567 | 13.8% |
| Infed | brand | 665 | 100 | 50.1% |
| 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 Ferric carboxymaltose reports
How many adverse event reports has FDA received for Ferric carboxymaltose?
1,395 reports list Ferric carboxymaltose as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 225 of them arrived in the latest 12 months. Another 222 list it only as a concomitant medication.
What reactions are recorded in Ferric carboxymaltose reports?
hypophosphataemia (39.6%), pain (18.4%), product quality issue (16.1%), anxiety (14.4%) and emotional distress (14.1%). 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 Ferric carboxymaltose was responsible.
How serious are the reports?
67.6% are marked serious by the reporter. Among the outcomes recorded, 1.1% of reports include death and 12.3% 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 (37.3%), physician (30.9%) and consumer or non-health professional (15.2%). Most reports reach FDA through the manufacturer, which must forward reports it receives.
Are reports for Ferric carboxymaltose rising?
225 reports in the 12 months to June 2026, up 25% from 180 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 Ferric carboxymaltose 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 Ferric carboxymaltose?
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 Ferric carboxymaltose as a suspect or interacting product; reports listing it only as a concomitant medication (222) 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.