Pharmacologic class (EPC) · 9 drug pages

Parenteral iron replacement: adverse event reports filed with FDA

16,234 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event." The information in these reports "cannot be used to estimate the incidence of these events."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

16,234
reports across the class: 0.1% of all reports; 1,668
reports, 12 months to June 2026: 1,302 in the 12 months before; 57.1%
marked serious by the reporter: 57.4% across all reports; 9
drugs with a page: brand and generic names counted separately

Parenteral iron replacement is a pharmacologic class (an FDA Established Pharmacologic Class) with 9 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 16,234 adverse event reports received by FDA, 0.1% of the database, from January 2004 to June 2026.

1,668 reports arrived in the 12 months to June 2026, up 28% from 1,302 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 57.1% of the class's reports are marked serious, 5.1% record death among the outcomes and 18.8% record hospitalisation, as reported.

Across the class the reactions recorded most often are nausea (11.6%), dyspnoea (11.3%) and drug hypersensitivity (6.6%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
Venofer (iron sucrose)	generic	5,417	390	73.4%	Drug hypersensitivity
InjectaferFerric carboxymaltose injection	brand	2,813	14	41.3%	Nausea
AuryxiaFerric citrate	brand	1,660	29	24.1%	Diarrhoea
FerahemeFerumoxytol	brand	1,541	20	60.9%	Dyspnoea
Ferric carboxymaltose	generic	1,395	225	67.6%	Hypophosphataemia
FerrlecitSodium ferric gluconate complex	brand	1,174	77	72.4%	Nausea
AccruferFerric maltol	brand	951	567	13.8%	Constipation
InfedIron dextran	brand	665	100	50.1%	Dyspnoea
Iron sucrose	generic	618	246	86.2%	Nausea

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Nauseafeeling sick11.6%1,878
Dyspnoeashortness of breath11.3%1,839
Drug hypersensitivityan allergic-type reaction to a medicine6.6%1,075
Dizzinesslight-headedness or unsteadiness6.3%1,022
Vomitingbeing sick6.2%1,013
Pruritusitching5.9%956
Urticariahives5.6%905
Hypophosphataemia5.5%894
Infusion related reactiona reaction during or soon after an infusion5.2%852
Hypotensionlow blood pressure5.1%832
Diarrhoealoose or frequent stools4.9%795
Back painback pain4.9%789
Headachehead pain4.6%749
Flushingsudden reddening or warmth of the skin4.4%716
Painpain, site not specified4.4%710
Chest painchest pain4.1%669
Rashskin rash4%650
Chest discomfortchest discomfort3.9%631
Hypersensitivityan allergic-type reaction3.7%600
Abdominal painstomach or belly pain3.6%582
Arthralgiajoint pain3.4%559
Off label useused for a purpose or in a way not on the label3.4%557
Product quality issuea problem with the product itself3.2%518
Anaphylactic reactiona severe, sudden allergic reaction3.1%508
Malaisegeneral feeling of being unwell2.9%465

Solid bar: share of all class reports. Hollow bar: the median share across the 9 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death5.1%821

Life-threatening6.8%1,097

Hospitalisation (initial or prolonged)18.8%3,055

Disability3%490

Congenital anomaly0.2%36

Other serious36.1%5,854

Not serious42.9%6,966

Patient age

Under 20.3%51

2 to 110.4%71

12 to 171%167

18 to 4421.5%3,490

45 to 6417.7%2,867

65 to 749.3%1,515

75 and over10.9%1,770

Age not given38.8%6,303

Who reported

Physician13.1%2,127

Pharmacist16%2,598

Other health professional41.9%6,806

Lawyer0.8%127

Consumer or non-health professional24.9%4,043

Not given3.3%533

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Parenteral iron replacement reports

Which drugs are in the Parenteral iron replacement class on this site?

Venofer (iron sucrose), Injectafer, Auryxia, Feraheme, Ferric carboxymaltose and Ferrlecit and 3 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

16,234 reports through June 2026, 1,668 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

nausea (11.6%), dyspnoea (11.3%), drug hypersensitivity (6.6%), dizziness (6.3%) and vomiting (6.2%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.