Epogen (epoetin alfa) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Epogen
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Epoetin alfa
Class: Erythropoiesis-stimulating agent

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

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 has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

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.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

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

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 4,317 adverse event reports that name Epogen. In these reports the drug is a suspect or interacting product.

In the same period, 4,466 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 27 reports in the 12 months to June 2026 and 181 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 27 (under 0.1%) name Epogen. Reports for female patients were 30% of the reports that name Epogen and 52.7% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Epogen is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 7 reports that name Epogen.
In January to March 2026, FDA received 10.
In April to June 2025, FDA received 4.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 193 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 4,317 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 193 terms.

Reaction terms in the reports that name Epogen, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 4,317 reports
Product storage errorthe product was stored wrongly	1,121	26%
Circumstance or information capable of leading to medication errora situation that could lead to a medication error	537	12.4%
Therapeutic response decreasedthe medicine worked less well	401	9.3%
Haemoglobin decreasedlow haemoglobin	337	7.8%
Intercepted product administration error	282	6.5%
Anaemialow red blood cells	229	5.3%
Drug ineffectivethe medicine did not work as expected	192	4.4%
Aplasia pure red cell	187	4.3%
Incorrect product storagethe product was stored wrongly	181	4.2%
Off label useused for a purpose or in a way not on the label	161	3.7%
Deaththe patient died; cause not stated by this term	139	3.2%
Wrong technique in product usage processthe product was used in the wrong way	97	2.2%
Hospitalisationadmission to hospital	96	2.2%
Haemoglobin abnormal	95	2.2%
Hypertensionhigh blood pressure	94	2.2%
Dyspnoeashortness of breath	91	2.1%
Anti-erythropoietin antibody positive	76	1.8%
Rashskin rash	70	1.6%
Product administration errora mistake in giving the product	69	1.6%
Pruritusitching	66	1.5%
Nauseafeeling sick	65	1.5%
Medication errora mistake in prescribing, dispensing or taking a medicine	64	1.5%
Fatiguetiredness	63	1.5%
Hypersensitivityan allergic-type reaction	59	1.4%
Astheniaweakness or lack of energy	56	1.3%
Injection site painpain where the injection was given	56	1.3%
Pyrexiafever	56	1.3%
Malaisegeneral feeling of being unwell	52	1.2%
Vomitingbeing sick	48	1.1%
Chest pain	47	1.1%
Therapy non-responderthe treatment did not work	43	1%
Diarrhoealoose or frequent stools	40	0.9%
Pneumonialung infection	39	0.9%
Headachehead pain	36	0.8%
Sepsisa severe body-wide response to infection	33	0.8%
Bone marrow failure	32	0.7%
Blood pressure increaseda raised blood pressure reading	31	0.7%
Cardiac failure congestivecongestive heart failure	31	0.7%
Thrombocytopenialow platelets	31	0.7%
Convulsion	30	0.7%
Cerebrovascular accidentstroke	28	0.6%
Drug hypersensitivityan allergic-type reaction (the term names a medicine)	26	0.6%
Hypotensionlow blood pressure	26	0.6%
Painpain, site not specified	26	0.6%
Condition aggravatedthe condition being treated got worse	25	0.6%
Drug dose omissiona dose was missed	25	0.6%
Platelet count decreasedlow platelet count	25	0.6%
Arthralgiajoint pain	23	0.5%
Dizzinesslight-headedness or unsteadiness	23	0.5%
Drug effect decreasedthe medicine had less effect	23	0.5%

Download all 193 terms of Epogen (CSV)

The counts add to more than 4,317 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Epoetin alfa with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Epoetin alfa	Generic name	945
Epogen (this page)	Brand name	4,317

Sum of the separately reported names: 5,262. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Epogen, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	153	150	41	2	91	4	0	51	3
2005	132	62	8	0	44	0	0	29	70
2006	204	87	13	2	68	0	0	28	117
2007	164	82	10	3	51	1	0	44	82
2008	151	102	3	4	62	1	0	68	49
2009	156	115	21	4	46	1	1	87	41
2010	177	154	23	0	36	1	0	126	23
2011	178	142	15	1	58	1	0	101	36
2012	199	143	13	3	61	0	0	106	56
2013	201	125	7	0	46	1	0	96	76
2014	198	98	11	0	29	1	0	75	100
2015	242	75	9	2	25	0	0	59	167
2016	208	81	7	3	23	3	0	65	127
2017	271	68	7	3	31	0	0	55	203
2018	185	79	17	3	29	0	10	58	106
2019	172	51	10	0	20	0	5	36	121
2020	105	50	10	0	23	0	0	30	55
2021	114	46	11	2	21	0	0	30	68
2022	416	29	2	0	10	3	0	17	387
2023	346	18	5	1	11	0	0	5	328
2024	303	18	1	0	12	0	0	9	285
2025	24	16	4	2	6	1	0	9	8
2026	18	14	4	0	7	0	0	3	4

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Epogen, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Epogen, by the year in which FDA received them
Year	Reports
2004	140
2005	63
2006	218
2007	185
2008	175
2009	154
2010	200
2011	152
2012	250
2013	189
2014	207
2015	241
2016	207
2017	263
2018	186
2019	168
2020	109
2021	108
2022	416
2023	344
2024	302
2025	23
2026	17

Reports that name Epogen, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Epogen
Age	Reports	Share
Under 2	32	0.7%
2 to 11	37	0.9%
12 to 17	59	1.4%
18 to 44	284	6.6%
45 to 64	473	11%
65 to 74	267	6.2%
75 and over	255	5.9%
Age not given	2,910	67.4%

Sex of the patient in the reports that name Epogen
Sex	Reports	Share
Female	1,296	30%
Male	1,352	31.3%
Unknown or not given	1,669	38.7%

Type of reporter in the reports that name Epogen
Reporter	Reports	Share
Physician	1,149	26.6%
Pharmacist	498	11.5%
Other health professional	1,517	35.1%
Lawyer	5	0.1%
Consumer or non-health professional	1,063	24.6%
Not given	85	2%

Age and sex are as the report gives them. The reporter is the primary source in the report. 93.5% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Epogen record
Indication as recorded (MedDRA)	Reports	Share
Dialysis	550	12.7%
Renal failure chronic	542	12.6%
Anaemia	325	7.5%
Nephrogenic anaemia	246	5.7%
Chronic kidney disease	152	3.5%
Anaemia of malignant disease	59	1.4%

The reporter fills in the indication, and the field is often empty. Each share is of all 4,317 reports.

Drugs in the same reports

Other drugs that the reports of Epogen name, in any role, in order of name
Drug	Reports that name the two
Aranesp	380
Aspirin	125
Folic acid	101
Iron	126
Lasix	82
Norvasc	92
Prednisone	103
Procrit	84
Venofer (iron sucrose)	95
Zemplar	82

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

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.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Epoetin alfa same ingredient
Erythropoietin same class
Darbepoetin alfa same class
Methoxy polyethylene glycol-epoetin beta same class
Aranesp same class
Mircera same class
Epoetin Beta next in the A to Z list
Epoprostenol next in the A to Z list
Epoprostenol Act next in the A to Z list
Eplontersen sodium next in the A to Z list
Epoprostenol sodium next in the A to Z list
Eplerenone next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for EpogenThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Reported Reactions. Epogen: adverse event reports that FDA received. https://reportedreactions.com/drug/epogen/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Epogen as a suspect or interacting product. The 4,466 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Epogen was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Epogen?

No. It is a count of what people reported to FDA: 4,317 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Other health professional (35.1%), physician (26.6%) and consumer or non-health professional (24.6%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

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