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
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 Neupogen reports recording the termmedian drug in leukocyte growth factor
- Off label useused for a purpose or in a way not on the label10.3%736
- Bone painbone pain7.2%512
- Deaththe patient died; cause not stated by this term7.1%507
- Pyrexiafever6.1%432
- Febrile neutropeniafever with low white blood cells5.8%415
- Product storage errorthe product was stored wrongly5.7%408
- Neutropenialow neutrophils, a type of white blood cell5.5%395
- Fatiguetiredness4.7%335
- White blood cell count decreasedlow white cell count4.5%319
- Nauseafeeling sick4.4%315
- Drug ineffectivethe medicine did not work as expected3.9%280
- Dyspnoeashortness of breath3.9%275
- Circumstance or information capable of leading to medication errora situation that could lead to a medication error3.5%253
- Painpain, site not specified3%213
- Back painback pain2.8%199
- Diarrhoealoose or frequent stools2.7%193
- Vomitingbeing sick2.7%189
- Rashskin rash2.6%182
- Hospitalisationadmission to hospital2.5%175
- Headachehead pain2.4%169
- Malaisegeneral feeling of being unwell2.4%168
- Thrombocytopenialow platelets2.3%166
- Arthralgiajoint pain2.2%158
- Astheniaweakness or lack of energy2.2%156
- Pneumonialung infection2.1%147
- Anaemialow red blood cells2%144
- Sepsisa severe body-wide response to infection2%144
- Infectionan infection, type not specified2%141
- Platelet count decreasedlow platelet count1.9%136
- 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
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
Patient sex
Who reported
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) | Reports | Share |
|---|---|---|
| Neutropenia | 878 | 12.3% |
| Chemotherapy | 597 | 8.4% |
| Haematopoietic stem cell mobilisation | 164 | 2.3% |
| Prophylaxis | 135 | 1.9% |
| Diffuse large b-cell lymphoma | 131 | 1.8% |
| Peripheral blood stem cell apheresis | 108 | 1.5% |
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) | Reports | Share of Neupogen reports |
|---|---|---|
| Neulasta | 986 | 13.8% |
| Cyclophosphamide | 917 | 12.9% |
| Vincristine | 437 | 6.1% |
| Doxorubicin hydrochloride | 431 | 6% |
| Dexamethasone | 378 | 5.3% |
| Prednisone | 377 | 5.3% |
| Rituximab | 368 | 5.2% |
| Etoposide | 341 | 4.8% |
| Cytarabine | 298 | 4.2% |
| Methotrexate | 245 | 3.4% |
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
| Measure | Neupogen | Leukocyte growth factor | All reports |
|---|---|---|---|
| Reports as suspect product | 7,128 | 109,309 | 20,646,523 |
| Share of that pool | — | 6.5% | 0% |
| Reports, latest 12 months | 66 | — | 1,332,454 |
| Marked serious | 64.6% | 32.6% | 57.4% |
| Death recorded among outcomes, per 1,000 reports | 149 | 73 | 91 |
| Hospitalisation recorded, per 1,000 reports | 295 | 153 | 213 |
| Consumer-filed share | 23.3% | 13% | 45.8% |
| Top term, share of reports | Off 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
| Drug | Name type | Reports | Latest 12 months | Marked serious |
|---|---|---|---|---|
| Neulasta | brand | 80,512 | 1,521 | 15.8% |
| Filgrastim | generic | 10,601 | 1,004 | 94.9% |
| Pegfilgrastim | generic | 7,127 | 489 | 89.6% |
| Zarxio | brand | 1,770 | 92 | 59.3% |
| Udenyca | brand | 1,232 | 550 | 17.4% |
| Leukine | brand | 939 | 44 | 62.6% |
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.