Pharmacologic class (EPC) · 9 drug pages

Erythropoiesis-stimulating agent: adverse event reports filed with FDA

66,386 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.

66,386
reports across the class: 0.3% of all reports; 1,713
reports, 12 months to June 2026: 2,443 in the 12 months before; 78.3%
marked serious by the reporter: 57.4% across all reports; 9
drugs with a page: brand and generic names counted separately

Erythropoiesis-stimulating agent 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 66,386 adverse event reports received by FDA, 0.3% of the database, from January 2004 to June 2026.

1,713 reports arrived in the 12 months to June 2026, down 30% from 2,443 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 78.3% of the class's reports are marked serious, 34% record death among the outcomes and 34.2% record hospitalisation, as reported.

Across the class the reactions recorded most often are death (28.4%), hospitalisation (10%) and drug hypersensitivity (4.9%). 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
AranespDarbepoetin alfa	brand	37,277	826	88.2%	Death
MirceraMethoxy polyethylene glycol-epoetin beta	brand	8,865	281	65.8%	Drug hypersensitivity
ProcritErythropoietin	brand	8,224	66	57%	Death
EpogenEpoetin alfa	brand	4,317	27	41.8%	Product storage error
Darbepoetin alfa	generic	3,770	299	93.6%	Hospitalisation
RetacritEpoetin alfa-epbx	brand	1,429	106	61%	Death
Epoetin alfa	generic	945	43	91.5%	Off label use
Methoxy polyethylene glycol-epoetin beta	generic	911	1	99.7%	Death
Erythropoietin	generic	648	64	97.2%	Foetal exposure during pregnancy

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

Deaththe patient died; cause not stated by this term28.4%18,853
Hospitalisationadmission to hospital10%6,613
Drug hypersensitivityan allergic-type reaction to a medicine4.9%3,283
Product storage errorthe product was stored wrongly4.4%2,944
Haemoglobin decreasedlow haemoglobin4.2%2,774
Off label useused for a purpose or in a way not on the label4%2,668
Dyspnoeashortness of breath3.2%2,141
Anaemialow red blood cells3.2%2,119
Nauseafeeling sick2.5%1,655
Circumstance or information capable of leading to medication errora situation that could lead to a medication error2.5%1,642
Aplasia pure red cell2.3%1,529
Drug ineffectivethe medicine did not work as expected2.2%1,465
Vomitingbeing sick2%1,348
Pneumonialung infection1.9%1,236
Therapeutic response decreasedthe medicine worked less well1.8%1,167
Pruritusitching1.8%1,165
Malaisegeneral feeling of being unwell1.7%1,142
Fatiguetiredness1.7%1,129
Hypertensionhigh blood pressure1.6%1,064
Falla fall1.6%1,054
Haemodialysis1.5%966
Astheniaweakness or lack of energy1.4%937
Sepsisa severe body-wide response to infection1.2%792
Diarrhoealoose or frequent stools1.2%773
Dialysisdialysis1.2%764

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

Death34%22,554

Life-threatening3.1%2,083

Hospitalisation (initial or prolonged)34.2%22,683

Disability1%680

Congenital anomaly0.2%161

Other serious45.1%29,957

Not serious21.7%14,389

Patient age

Under 20.2%128

2 to 110.3%188

12 to 170.4%235

18 to 445.1%3,374

45 to 6413.6%9,042

65 to 7411.8%7,841

75 and over25.4%16,872

Age not given43.2%28,706

Who reported

Physician19.9%13,184

Pharmacist6.6%4,392

Other health professional49.7%32,995

Lawyer0%25

Consumer or non-health professional22.3%14,809

Not given1.5%981

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 Erythropoiesis-stimulating agent reports

Which drugs are in the Erythropoiesis-stimulating agent class on this site?

Aranesp, Mircera, Procrit, Epogen, Darbepoetin alfa and Retacrit and 3 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

66,386 reports through June 2026, 1,713 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?

death (28.4%), hospitalisation (10%), drug hypersensitivity (4.9%), product storage error (4.4%) and haemoglobin decreased (4.2%).

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.