Filgrastim: adverse event reports filed with FDA

10,601

reports as suspect product

0.1% of all reports · about 473 a year

1,004

reports, 12 months to June 2026

1,489 in the 12 months before

94.9%

marked serious by the reporter

32.6% across the class

26.7%

record death among outcomes, as reported

2,833 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 Filgrastim reports recording the termmedian drug in leukocyte growth factor

1. Febrile neutropeniafever with low white blood cells13.4%1,424
2. Off label useused for a purpose or in a way not on the label12.1%1,281
3. Neutropenialow neutrophils, a type of white blood cell11.8%1,248
4. Deaththe patient died; cause not stated by this term8.8%934
5. Pyrexiafever8.3%883
6. Thrombocytopenialow platelets6.3%671
7. Diarrhoealoose or frequent stools6.2%658
8. Anaemialow red blood cells5.6%590
9. Pneumonialung infection5.2%549
10. Nauseafeeling sick5.2%548
11. Sepsisa severe body-wide response to infection4.7%503
12. Drug ineffectivethe medicine did not work as expected4.6%490
13. Infectionan infection, type not specified4.3%452
14. Vomitingbeing sick4.1%438
15. Bacterial infectiona bacterial infection4.1%430
16. Bone painbone pain3.9%418
17. Pancytopenialow counts of all blood cells3.5%373
18. Fatiguetiredness3.5%367
19. Product use in unapproved indicationused for a purpose not on the label3.5%367
20. Disease progressionthe disease advanced3.3%349
21. Mucosal inflammation3.2%339
22. Clostridium difficile colitisa bowel infection with C. difficile2.9%308
23. Dyspnoeashortness of breath2.8%293
24. White blood cell count decreasedlow white cell count2.7%286
25. Rashskin rash2.5%270
26. Platelet count decreasedlow platelet count2.5%265
27. Viral infectiona viral infection2.4%259
28. Hypotensionlow blood pressure2.3%246
29. Leukopenialow white blood cells2.2%234
30. Fungal infectiona fungal infection2.2%230

Top 30 of 1,662 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 7 drugs in the leukocyte growth factor 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 109,309 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. 21.6% 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 10,601 reports.

Drugs most often listed in the same reports

Other products listed in reports where Filgrastim 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 leukocyte growth factor 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 Filgrastim as a suspect or interacting product; reports listing it only as a concomitant medication (12,321) 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.