Procrit: adverse event reports filed with FDA

8,224

reports as suspect product

0% of all reports · about 366 a year

66

reports, 12 months to June 2026

91 in the 12 months before

57%

marked serious by the reporter

78.3% across the class

23.8%

record death among outcomes, as reported

1,961 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 Procrit reports recording the termmedian drug in erythropoiesis-stimulating agent

1. Deaththe patient died; cause not stated by this term20%1,641
2. Haemoglobin decreasedlow haemoglobin7.7%634
3. Fatiguetiredness5.4%443
4. Anaemialow red blood cells4.6%378
5. Drug ineffectivethe medicine did not work as expected4.2%345
6. Astheniaweakness or lack of energy3.9%321
7. Hospitalisationadmission to hospital3.5%285
8. Therapeutic response decreasedthe medicine worked less well3.3%273
9. Aplasia pure red cell3.2%261
10. Dyspnoeashortness of breath2.9%240
11. Drug dose omissiona dose was missed2.9%238
12. Nauseafeeling sick2.7%219
13. Off label useused for a purpose or in a way not on the label2.5%204
14. Malaisegeneral feeling of being unwell2.3%193
15. Headachehead pain2.2%178
16. Diarrhoealoose or frequent stools2.1%176
17. Injection site painpain where the injection was given2.1%176
18. Product storage errorthe product was stored wrongly2.1%170
19. Oedema peripheralswelling of the legs, ankles or hands1.9%153
20. Rashskin rash1.9%153
21. Dizzinesslight-headedness or unsteadiness1.8%150
22. Incorrect product storagethe product was stored wrongly1.7%140
23. Painpain, site not specified1.7%137
24. Pneumonialung infection1.7%137
25. Pain in extremitypain in an arm or leg1.7%136
26. Arthralgiajoint pain1.6%132
27. Haemoglobin abnormal1.6%131
28. Weight decreasedweight loss1.6%130
29. Hypertensionhigh blood pressure1.5%126
30. Pruritusitching1.5%125

Top 30 of 746 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. 96.6% 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 8,224 reports.

Drugs most often listed in the same reports

Other products listed in reports where Procrit 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 Procrit as a suspect or interacting product; reports listing it only as a concomitant medication (7,696) 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.