Reported Reactions

Drugs › Leukocyte growth factor

Brand name · Filgrastim

Neupogen: adverse event reports filed with FDA

7,128 reports list it as a suspect or interacting product, 2004–2026. Class: Leukocyte growth factor.

7,128
reports as suspect product
0% of all reports · about 317 a year
66
reports, 12 months to June 2026
149 in the 12 months before
64.6%
marked serious by the reporter
32.6% across the class
14.9%
record death among outcomes, as reported
1,062 reports · not verified by FDA

7,128 adverse event reports received by FDA list the brand name Neupogen (filgrastim) as a suspect or interacting product, from January 2004 to June 2026. A further 7,974 reports list it only as a concomitant medication, and those are not counted in the figures on this page.

In the 12 months to June 2026, 66 reports listed it, down 56% from 149 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Over its reporting history that is about 317 reports a year and 0% of the 20,646,523 reports in the database, and 6.5% of the reports for the leukocyte growth factor class. How many people take it is not in the data, so a count is not a rate of occurrence.

The MedDRA terms listed most often are off label use (10.3%), bone pain (7.2%) and death (7.1%). A report can list several reactions, so shares add to more than 100%; 949 different terms appear across these reports. Off label use is recorded in 10.3% of these reports, a larger share than in the median leukocyte growth factor drug (6.7%).

64.6% of the reports are marked serious by the reporter (32.6% across the class); 14.9% record death among the outcomes and 29.5% record hospitalisation, as reported. 33.8% of the reports came from physicians, and the largest patient age group is 45 to 64 (21.5%). FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event."

Reports by month, five years

02346Jul 2021: 14Aug 2021: 14Sep 2021: 15Oct 2021: 12Nov 2021: 15Dec 2021: 132022Jan 2022: 15Feb 2022: 28Mar 2022: 21Apr 2022: 15May 2022: 14Jun 2022: 11Jul 2022: 14Aug 2022: 26Sep 2022: 34Oct 2022: 30Nov 2022: 32Dec 2022: 262023Jan 2023: 28Feb 2023: 25Mar 2023: 14Apr 2023: 15May 2023: 17Jun 2023: 21Jul 2023: 18Aug 2023: 23Sep 2023: 18Oct 2023: 14Nov 2023: 41Dec 2023: 172024Jan 2024: 28Feb 2024: 20Mar 2024: 12Apr 2024: 14May 2024: 14Jun 2024: 15Jul 2024: 46Aug 2024: 22Sep 2024: 8Oct 2024: 23Nov 2024: 8Dec 2024: 92025Jan 2025: 5Feb 2025: 1Mar 2025: 8Apr 2025: 10May 2025: 4Jun 2025: 5Jul 2025: 10Aug 2025: 2Sep 2025: 3Oct 2025: 5Nov 2025: 9Dec 2025: 32026Jan 2026: 11Feb 2026: 2Mar 2026: 4Apr 2026: 4May 2026: 7Jun 2026: 6

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

02935862004: 13520042005: 1452006: 1292007: 27120072008: 3352009: 3252010: 34120102011: 4022012: 5022013: 35520132014: 4622015: 4782016: 58620162017: 4742018: 5542019: 31720192020: 2982021: 1842022: 26620222023: 2512024: 2192025: 6520252026: 34

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Neupogen reports recording the termmedian drug in leukocyte growth factor

  1. Off label useused for a purpose or in a way not on the label10.3%736
  2. Bone painbone pain7.2%512
  3. Deaththe patient died; cause not stated by this term7.1%507
  4. Pyrexiafever6.1%432
  5. Febrile neutropeniafever with low white blood cells5.8%415
  6. Product storage errorthe product was stored wrongly5.7%408
  7. Neutropenialow neutrophils, a type of white blood cell5.5%395
  8. Fatiguetiredness4.7%335
  9. White blood cell count decreasedlow white cell count4.5%319
  10. Nauseafeeling sick4.4%315
  11. Drug ineffectivethe medicine did not work as expected3.9%280
  12. Dyspnoeashortness of breath3.9%275
  13. Circumstance or information capable of leading to medication errora situation that could lead to a medication error3.5%253
  14. Painpain, site not specified3%213
  15. Back painback pain2.8%199
  16. Diarrhoealoose or frequent stools2.7%193
  17. Vomitingbeing sick2.7%189
  18. Rashskin rash2.6%182
  19. Hospitalisationadmission to hospital2.5%175
  20. Headachehead pain2.4%169
  21. Malaisegeneral feeling of being unwell2.4%168
  22. Thrombocytopenialow platelets2.3%166
  23. Arthralgiajoint pain2.2%158
  24. Astheniaweakness or lack of energy2.2%156
  25. Pneumonialung infection2.1%147
  26. Anaemialow red blood cells2%144
  27. Sepsisa severe body-wide response to infection2%144
  28. Infectionan infection, type not specified2%141
  29. Platelet count decreasedlow platelet count1.9%136
  30. Chest painchest pain1.9%134

Top 30 of 949 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

Death14.9%1,062
Life-threatening3.4%241
Hospitalisation (initial or prolonged)29.5%2,103
Disability1.1%81
Congenital anomaly0.2%13
Other serious37.5%2,674
Not serious35.4%2,523

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

Patient age

Under 20.9%65
2 to 112.2%160
12 to 171.3%92
18 to 4410.5%749
45 to 6421.5%1,534
65 to 749.1%647
75 and over4.9%350
Age not given49.5%3,531

Patient sex

Female46.7%3,329
Male33.2%2,366
Not given20.1%1,433

Who reported

Physician33.8%2,411
Pharmacist12.9%920
Other health professional26%1,855
Lawyer0.1%5
Consumer or non-health professional23.3%1,661
Not given3.9%276

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 62.6% of reports give the United States as the country of the event or reporter.

Reason for use recorded

Indication as recorded (MedDRA)ReportsShare
Neutropenia87812.3%
Chemotherapy5978.4%
Haematopoietic stem cell mobilisation1642.3%
Prophylaxis1351.9%
Diffuse large b-cell lymphoma1311.8%
Peripheral blood stem cell apheresis1081.5%

The indication field is filled in by the reporter and is often blank; shares are of all 7,128 reports.

Drugs most often listed in the same reports

Drug (any role in the report)ReportsShare of Neupogen reports
Neulasta98613.8%
Cyclophosphamide91712.9%
Vincristine4376.1%
Doxorubicin hydrochloride4316%
Dexamethasone3785.3%
Prednisone3775.3%
Rituximab3685.2%
Etoposide3414.8%
Cytarabine2984.2%
Methotrexate2453.4%

Other products listed in reports where Neupogen 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

MeasureNeupogenLeukocyte growth factorAll reports
Reports as suspect product7,128109,30920,646,523
Share of that pool—6.5%0%
Reports, latest 12 months66—1,332,454
Marked serious64.6%32.6%57.4%
Death recorded among outcomes, per 1,000 reports1497391
Hospitalisation recorded, per 1,000 reports295153213
Consumer-filed share23.3%13%45.8%
Top term, share of reportsOff label use 10.3%median 6.7%4.1%

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

DrugName typeReportsLatest 12 monthsMarked serious
Neulastabrand80,5121,52115.8%
Filgrastimgeneric10,6011,00494.9%
Pegfilgrastimgeneric7,12748989.6%
Zarxiobrand1,7709259.3%
Udenycabrand1,23255017.4%
Leukinebrand9394462.6%

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.

Questions about Neupogen reports

How many adverse event reports has FDA received for Neupogen?

7,128 reports list Neupogen as a suspect or interacting product in the openFDA FAERS release of 28 Sep 2026, covering reports received through June 2026. 66 of them arrived in the latest 12 months. Another 7,974 list it only as a concomitant medication.

What reactions are recorded in Neupogen reports?

off label use (10.3%), bone pain (7.2%), death (7.1%), pyrexia (6.1%) and febrile neutropenia (5.8%). These are MedDRA preferred terms coded from what the reporter described; a report can list several, and a term's presence is not a finding that Neupogen was responsible.

How serious are the reports?

64.6% are marked serious by the reporter. Among the outcomes recorded, 14.9% of reports include death and 29.5% include hospitalisation. FDA has not verified these outcomes and states that the reports "cannot be used to estimate the incidence" of the events.

Who files these reports?

physician (33.8%), other health professional (26%) and consumer or non-health professional (23.3%). Most reports reach FDA through the manufacturer, which must forward reports it receives.

Are reports for Neupogen rising?

66 reports in the 12 months to June 2026, down 56% from 149 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. Counts also move with how many people take a product, its time on the market and publicity.

Do these reports show that Neupogen was responsible for these reactions?

No. FDA states that "a causal relationship cannot be established between product and reactions listed in a report" and that for any given report "there is no certainty that a suspected drug caused the event." The reaction may relate to the condition being treated, to other medicines, or to something else.

Is this a list of the side effects of Neupogen?

No. It is a count of what was reported to FDA. The adverse reactions observed in clinical studies are printed on the FDA-approved label, which a pharmacist or clinician can go through with you.

How do I report an adverse event?

Consumers and health professionals can report to FDA through MedWatch (Form FDA 3500 online, or 1-800-FDA-1088), or to the manufacturer, which must pass reports on. 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 report counts here when it lists Neupogen as a suspect or interacting product; reports listing it only as a concomitant medication (7,974) 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.

Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.