Epogen: adverse event reports filed with FDA

4,317

reports as suspect product

0% of all reports · about 192 a year

27

reports, 12 months to June 2026

181 in the 12 months before

41.8%

marked serious by the reporter

78.3% across the class

5.8%

record death among outcomes, as reported

252 reports · not verified by FDA

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 Epogen reports recording the termmedian drug in erythropoiesis-stimulating agent

1. Product storage errorthe product was stored wrongly26%1,121
2. Circumstance or information capable of leading to medication errora situation that could lead to a medication error12.4%537
3. Therapeutic response decreasedthe medicine worked less well9.3%401
4. Haemoglobin decreasedlow haemoglobin7.8%337
5. Intercepted product administration error6.5%282
6. Anaemialow red blood cells5.3%229
7. Drug ineffectivethe medicine did not work as expected4.4%192
8. Aplasia pure red cell4.3%187
9. Incorrect product storagethe product was stored wrongly4.2%181
10. Off label useused for a purpose or in a way not on the label3.7%161
11. Deaththe patient died; cause not stated by this term3.2%139
12. Wrong technique in product usage processthe product was used in the wrong way2.2%97
13. Hospitalisationadmission to hospital2.2%96
14. Haemoglobin abnormal2.2%95
15. Hypertensionhigh blood pressure2.2%94
16. Dyspnoeashortness of breath2.1%91
17. Anti-erythropoietin antibody positive1.8%76
18. Rashskin rash1.6%70
19. Product administration errora mistake in giving the product1.6%69
20. Pruritusitching1.5%66
21. Nauseafeeling sick1.5%65
22. Medication errora mistake in prescribing, dispensing or taking a medicine1.5%64
23. Fatiguetiredness1.5%63
24. Hypersensitivityan allergic-type reaction1.4%59
25. Astheniaweakness or lack of energy1.3%56
26. Injection site painpain where the injection was given1.3%56
27. Pyrexiafever1.3%56
28. Malaisegeneral feeling of being unwell1.2%52
29. Vomitingbeing sick1.1%48
30. Chest painchest pain1.1%47

Top 30 of 440 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 erythropoiesis-stimulating agent 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 66,386 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 93.5% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 4,317 reports.

Drugs most often listed in the same reports

Other products listed in reports where Epogen is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

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 erythropoiesis-stimulating agent class

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.

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 Epogen as a suspect or interacting product; reports listing it only as a concomitant medication (4,466) 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.