Neulastapegfilgrastim
According to the FDA label: FYLNETRA is a leukocyte growth factor indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. (1.1) Increase survival in patients acutely exposed to myelosuppressive doses of radiation (Hematopoietic Subsyndrome of Acute Radiation Syndrome).
97,395 adverse event reports submitted to the FDA (2004–2026)
Top Reported Adverse Events
The most frequently reported events in association with Neulasta in the FAERS database. These are events reported by patients taking this medication, not necessarily caused by it. A single report may include multiple events.
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Device Adhesion Issue 11,595 reports
A report that a device meant to stick to the skin did not adhere properly. This is a product-performance category.
Full definition in the glossary →Wrong Technique in Product Usage Process 10,244 reports
A report that the medication was used or administered with the wrong technique, such as an incorrect injection or inhaler method. This is a usage category, not a sign of a problem with the drug itself.
Full definition in the glossary →- Unintentional Medical Device Removal 8,985 reports
Device Malfunction 6,868 reports
A report that a medical device did not work as intended.
Full definition in the glossary →- Device Use Error 6,041 reports
Device Issue 5,127 reports
A general report of a problem with a medical device, used when no more specific issue is named.
Full definition in the glossary →Accidental Exposure to Product 4,990 reports
A report that someone was unintentionally exposed to a medication, for example a child or another person who was not the patient. This is a safety-tracking category.
Full definition in the glossary →Off Label Use 3,777 reports
Using a medication for a condition or in a way that the FDA has not officially approved. This is common and often legal, and a report of it does not mean something went wrong. Doctors sometimes prescribe drugs off label based on their judgment.
Full definition in the glossary →Febrile Neutropenia 3,740 reports
A fever occurring together with a low level of neutrophils, a type of infection-fighting white blood cell. It is taken seriously because infection is harder to fight when these cells are low.
Full definition in the glossary →- Device Occlusion 3,307 reports
Bone Pain 2,943 reports
Pain felt in or coming from the bones.
Full definition in the glossary →Death 2,751 reports
A report that the person died. A death appearing in reports for a drug does not mean the drug caused it. Reports record that a death occurred while the medication was being used, which can happen for many unrelated reasons.
Full definition in the glossary →Neutropenia 2,635 reports
A low level of neutrophils, a type of white blood cell that fights infection.
Full definition in the glossary →Fatigue 2,610 reports
Extreme tiredness or lack of energy that does not improve with rest.
Full definition in the glossary → See all drugs reporting this event →Pyrexia 2,492 reports
The medical term for fever, meaning a raised body temperature.
Full definition in the glossary → See all drugs reporting this event →
Ranked by frequency of reports, not severity. The most-reported event is not necessarily the most dangerous or the most common in patients taking this drug.
Who Is Reporting
Demographics of patients in FAERS reports that included this information. Not all reports include patient demographics.
By Sex
View reporter sex data as a table
| Sex | Reports |
|---|---|
| Female | 52,412 |
| Male | 27,211 |
| Unknown | 323 |
By Age Group
View age group data as a table
| Age group | Reports |
|---|---|
| 0-17 | 767 |
| 18-34 | 2,511 |
| 35-49 | 9,275 |
| 50-64 | 21,915 |
| 65-74 | 17,575 |
| 75+ | 9,125 |
This shows who filed reports, reflecting who takes this drug and who tends to report, not who is at greatest risk.
Reported Outcomes
Outcomes recorded in FAERS reports that included Neulasta. A single report may involve multiple reactions, each with a different outcome. These categories are defined by FDA reporting guidelines, not by PillSignal.
View outcome data as a table
| Outcome | Reports |
|---|---|
| Non-Serious | 69,131 |
| Other Serious | 15,714 |
| Hospitalization | 15,166 |
| Death | 5,200 |
| Life-Threatening | 1,630 |
| Disability | 499 |
Serious outcomes are far more likely to be reported than mild ones, so this overstates how often outcomes are serious. A recorded death does not mean the drug caused it.
Report Volume Over Time
Number of FAERS reports received per quarter for Neulasta. Changes in volume may reflect shifts in prescribing rates, media attention, or reporting behavior, not changes in the medication's safety profile.
View report trend as a table
| Year | Reports |
|---|---|
| 2004 | 346 |
| 2005 | 350 |
| 2006 | 391 |
| 2007 | 595 |
| 2008 | 909 |
| 2009 | 945 |
| 2010 | 882 |
| 2011 | 1,103 |
| 2012 | 1,560 |
| 2013 | 1,529 |
| 2014 | 2,667 |
| 2015 | 2,065 |
| 2016 | 5,281 |
| 2017 | 8,064 |
| 2018 | 14,149 |
| 2019 | 8,391 |
| 2020 | 11,660 |
| 2021 | 11,386 |
| 2022 | 8,427 |
| 2023 | 7,319 |
| 2024 | 5,723 |
| 2025 | 3,094 |
| 2026 (partial) | 559 |
The steep increase around 2004 reflects the FDA's move to electronic submission, not a change in this drug's safety. Trends track reporting volume, not risk.
Medications commonly reported with Neulasta
In FDA adverse event reports that mention Neulasta, these medications appeared most often in the same report.
- Cyclophosphamide (8,136 reports)
- Cyclophosphamide For (8,136 reports)
- Doxorubicin (4,643 reports)
- Dexamethasone (4,631 reports)
- Rituximab (4,547 reports)
This reflects co-occurrence in submitted reports, not evidence of drug interaction or combined risk. People often report several medications taken for the same condition or for unrelated reasons. Talk to a doctor or pharmacist about your specific medications.
Related Drugs
Other medications with similar adverse event profiles in FDA FAERS reports.
Data Source
This data is sourced from the FDA's Adverse Event Monitoring System (AEMS), formerly FAERS, via the OpenFDA API. PillSignal is not affiliated with the FDA.
View this data on the FDA website →Data last updated: June 2026