Neulasta (pegfilgrastim) adverse event reports that FDA received

Name: Reaction terms in FDA adverse event reports that name Neulasta
Creator: Reported Reactions
License: https://creativecommons.org/publicdomain/zero/1.0/

Name type: Brand name
Generic name: Pegfilgrastim
Class: Leukocyte growth factor

What a report is

A report is not proof that the drug was the cause of the event.

FDA says:

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview, section "Responsible use of the data". The site read the page on 2 Oct 2026. The data have the reports that FDA received through 30 Jun 2026.

FDA also says:

There is no certainty that the reported event (adverse event or medication error) was actually due to the product. FDA does not require that a causal relationship between a product and event be proven, and reports do not always contain enough detail to properly evaluate an event. The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.
Source: openFDA, Response of the drug event API (meta.disclaimer). The site read the page on 2 Oct 2026.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

Drug reports received through 30 Jun 2026. Device reports have a separate cutoff, 30 Sep 2026. Why a report count is not a rate.

Reports on file

From January 2004 to June 2026, FDA received 80,512 adverse event reports that name Neulasta. In these reports the drug is a suspect or interacting product.

In the same period, 5,978 further reports name it only as a concomitant medicine. The counts on this page do not include these reports.

FDA received 1,521 reports in the 12 months to June 2026 and 3,128 in the 12 months before. FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Of the 1,332,454 drug reports that FDA received in the 12 months to June 2026, 1,521 (0.1%) name Neulasta. Reports from consumers or other non-health professionals were 12.9% of the reports that name Neulasta and 45.8% of all drug reports.

The number of people who use the product is not in the data. A count is not a rate. A count of reports is not a count of events or of patients, because one event can have more than one report.

There are many instances of duplicative reports and some reports do not contain all the necessary information.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Suspect product

FDA records each drug in a report as suspect, concomitant or interacting. This page counts the reports in which Neulasta is suspect or interacting. FDA says:

Any number of the drugs may be marked as suspect if thought to be responsible for one or more of the reactions, but that information is not validated.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Data version

openFDA FAERS release of 29 Oct 2026. Reports received through 30 Jun 2026.

Since the last update

FDA says:

Many factors can influence whether or not an event will be reported, such as the time a product has been marketed and publicity about an event.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The information in these reports cannot be used to estimate the incidence (occurrence rates) of the events reported.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

The latest update of the FDA data, recorded on 28 Oct 2026, changed no count of this page.

In April to June 2026, FDA received 332 reports that name Neulasta.
In January to March 2026, FDA received 323.
In April to June 2025, FDA received 494.

April to June 2026 is the latest closed quarter in the data. A closed quarter is a quarter for which the FDA files have most of the reports.

All updates Feed of updates (RSS)

Reaction lookup

These are the reaction terms that the reports record, with the number of reports for each term. Type a term or a plain word to find its count.

What this list leaves out

The table lists the 855 reaction terms that 5 or more reports record. A term with fewer than 5 reports is not in the table.

The site keeps reaction terms for all 80,512 reports.

The site keeps a term for a year only if two or more reports of that year record it.

So a count in the table can be lower than the count of FDA.

Find a reaction term

The table shows the first 50 of 855 terms.

Reaction terms in the reports that name Neulasta, most reports first
Reaction term (MedDRA) and plain meaning	Reports	Share of the 80,512 reports
Device adhesion issue	11,632	14.4%
Wrong technique in product usage processthe product was used in the wrong way	10,203	12.7%
Unintentional medical device removal	8,989	11.2%
Device malfunctionthe device did not work properly	6,764	8.4%
Device use errora mistake in using the device	6,041	7.5%
Device issuea problem with the device	5,088	6.3%
Accidental exposure to product	4,946	6.1%
Device occlusionthe device blocked	3,253	4%
Off label useused for a purpose or in a way not on the label	2,696	3.3%
Bone pain	2,660	3.3%
Drug dose omissiona dose was missed	2,089	2.6%
Drug dose omission by device	2,007	2.5%
Deaththe patient died; cause not stated by this term	1,827	2.3%
Intercepted product preparation error	1,572	2%
Occupational exposure to product	1,411	1.8%
Application site haemorrhage	1,389	1.7%
Device physical property issuea physical problem with the device	1,374	1.7%
Device leakagethe device leaked	1,344	1.7%
Febrile neutropeniafever with low white blood cells	1,326	1.6%
Fatiguetiredness	1,265	1.6%
Application site pain	1,260	1.6%
Pyrexiafever	1,208	1.5%
Painpain, site not specified	1,160	1.4%
Nauseafeeling sick	1,132	1.4%
Neutropenialow neutrophils, a type of white blood cell	1,089	1.4%
Hyperhidrosisexcessive sweating	1,042	1.3%
Underdoseless than the intended dose	1,034	1.3%
Circumstance or information capable of leading to medication errora situation that could lead to a medication error	881	1.1%
White blood cell count decreasedlow white cell count	880	1.1%
Product storage errorthe product was stored wrongly	858	1.1%
Dyspnoeashortness of breath	847	1.1%
Device failurethe device failed	821	1%
Hospitalisationadmission to hospital	766	1%
Arthralgiajoint pain	756	0.9%
Diarrhoealoose or frequent stools	731	0.9%
Malaisegeneral feeling of being unwell	712	0.9%
Drug ineffectivethe medicine did not work as expected	703	0.9%
Back pain	679	0.8%
Astheniaweakness or lack of energy	598	0.7%
Headachehead pain	580	0.7%
Pain in extremitypain in an arm or leg	579	0.7%
Vomitingbeing sick	577	0.7%
Product preparation error	517	0.6%
Device power source issue	485	0.6%
Needle issuea problem with the needle	482	0.6%
Incorrect dose administered by devicethe device gave the wrong dose	478	0.6%
Myalgiamuscle pain	463	0.6%
Product dose omissiona dose was missed	459	0.6%
Inappropriate schedule of drug administrationthe medicine was taken at the wrong times	448	0.6%
Alopeciahair loss	443	0.6%

Download all 855 terms of Neulasta (CSV)

The counts add to more than 80,512 reports, because one report can record more than one term. FDA says:

No individual drug is connected to any individual reaction. When a report lists multiple drugs and multiple reactions, there is no way to conclude from the data therein that a given drug is responsible for a given reaction.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The CSV file has the same rows and the same limits. Its last row is a note that says so.

MedDRA term

The person who codes a report selects the preferred term that agrees best with the description of the reporter. The words under a term are the plain meaning that this site gives.

Not the label

The FDA-approved label of a product lists its adverse reactions. See the official pages at the end of this page.

Same ingredient, other names

Reporters write a brand name or a generic name. Each name has its own page and its own count.

Names of Pegfilgrastim with a page, in the order generic names, brand names, names as reported
Name	Name type	Reports
Pegfilgrastim	Generic name	7,127
Neulasta (this page)	Brand name	80,512

Sum of the separately reported names: 87,639. A report that names two of these names is in the sum two times. The sum is not the number of reports for the ingredient.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Outcomes by year

The table gives the outcomes that the reporters gave, in the terms of FDA.

Outcomes in the reports that name Neulasta, by the year of the openFDA file that holds the report

The table continues to the right.

Year of the openFDA file	Reports	Serious	Death	Life-threatening	Hospitalization (initial or prolonged)	Disability or Permanent Damage	Congenital Anomaly/Birth Defect	Other Serious (Important Medical Events)	Not serious
2004	266	158	16	21	122	7	0	28	108
2005	179	153	28	7	115	2	0	30	26
2006	384	204	22	5	153	8	0	46	180
2007	398	261	35	14	178	3	0	83	137
2008	666	507	36	26	330	18	0	181	159
2009	638	549	43	22	292	4	0	296	89
2010	597	509	52	27	250	1	0	290	88
2011	542	517	73	22	293	6	0	250	25
2012	552	525	72	16	313	2	0	225	27
2013	803	583	154	8	258	6	0	240	220
2014	2,041	1,943	689	14	1,006	7	0	406	98
2015	1,172	1,034	277	13	469	6	0	538	138
2016	4,459	1,660	256	9	673	13	0	1,319	2,799
2017	7,211	1,068	200	20	486	7	0	784	6,143
2018	12,521	880	136	13	416	8	0	630	11,641
2019	6,672	565	57	15	314	6	1	380	6,107
2020	10,318	517	68	22	300	3	0	324	9,801
2021	9,343	289	41	19	154	11	0	188	9,054
2022	8,114	224	34	6	114	4	0	139	7,890
2023	6,378	206	23	28	106	4	0	149	6,172
2024	4,386	187	36	6	101	1	0	111	4,199
2025	2,085	163	30	10	87	1	0	86	1,922
2026	787	59	8	2	41	1	0	25	728

An outcome in a report is not proof that the drug was the cause. The reporter gives the outcome, and FDA does not verify it. FDA says:

The information in these reports has not been scientifically or otherwise verified as to a cause and effect relationship and cannot be used to estimate the incidence of these events.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

The six headings with the names of FDA are the outcome terms of FDA. A report can have more than one outcome. The columns Serious and Not serious are the two values of the openFDA field serious. For the value serious, openFDA gives this description:

The adverse event resulted in death, a life threatening condition, hospitalization, disability, congenital anomaly, or other serious condition
Source: openFDA, Drug adverse event fields (YAML reference). The site read the page on 2 Oct 2026.

The year is the year of the openFDA file that holds the latest version of the report. It is not always the year in which FDA first received the report. The chart of the next section uses the year of first receipt. The latest year is not complete.

Reports by year and month

Reports that name Neulasta, by the year in which FDA received them

The column of 2026 has an outline, because the year is not complete. It has the reports that FDA received through June 2026 only.

Show the figures of the chart as a table

Reports that name Neulasta, by the year in which FDA received them
Year	Reports
2004	193
2005	216
2006	234
2007	430
2008	677
2009	679
2010	609
2011	633
2012	628
2013	822
2014	2,067
2015	1,213
2016	4,558
2017	7,232
2018	12,438
2019	7,221
2020	10,490
2021	10,136
2022	7,149
2023	6,012
2024	4,289
2025	1,931
2026	655

Reports that name Neulasta, by month, five years to June 2026

FDA releases FAERS data every quarter, so the newest months are not complete. They grow in later releases.

Why a count moves

A count moves for many reasons. The guide gives FDA's words about them.

Patients and reporters

Age of the patient in the reports that name Neulasta
Age	Reports	Share
Under 2	39	under 0.1%
2 to 11	164	0.2%
12 to 17	169	0.2%
18 to 44	5,815	7.2%
45 to 64	21,441	26.6%
65 to 74	14,772	18.3%
75 and over	7,783	9.7%
Age not given	30,329	37.7%

Sex of the patient in the reports that name Neulasta
Sex	Reports	Share
Female	43,653	54.2%
Male	21,898	27.2%
Unknown or not given	14,961	18.6%

Type of reporter in the reports that name Neulasta
Reporter	Reports	Share
Physician	34,455	42.8%
Pharmacist	14,408	17.9%
Other health professional	20,511	25.5%
Lawyer	25	under 0.1%
Consumer or non-health professional	10,364	12.9%
Not given	749	0.9%

Age and sex are as the report gives them. The reporter is the primary source in the report. 91% of the reports give the United States as the country.

Reason for use

Reason for use (indication) that the reports of Neulasta record
Indication as recorded (MedDRA)	Reports	Share
Neutropenia	16,294	20.2%
Prophylaxis	7,270	9%
Chemotherapy	2,780	3.5%
Breast cancer	648	0.8%
Breast cancer female	572	0.7%
Agranulocytosis	234	0.3%

The reporter fills in the indication, and the field is often empty. Each share is of all 80,512 reports.

Drugs in the same reports

Other drugs that the reports of Neulasta name, in any role, in order of name
Drug	Reports that name the two
Carboplatin	1,180
Cyclophosphamide	3,021
Cytoxan	852
Dexamethasone	935
Doxorubicin hydrochloride	1,039
Neupogen	1,029
Rituximab	1,061
Taxol	899
Taxotere	1,130
Vincristine	877

The table has the 10 drug names that these reports name most. Two names in one report says only that the report recorded the two. It says nothing about the part of a product in the event.

FDA says:

Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

Importantly, the AEMS data by themselves are not an indicator of the safety profile of the drug or biologic.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

Pages near this one

Pegfilgrastim same ingredient
Leukine same class
Neupogen same class
Granix same class
Nivestym same class
Fulphila same class
Nesp next in the A to Z list
Neulastim next in the A to Z list
Nesina next in the A to Z list
Nerlynx next in the A to Z list
Neupro next in the A to Z list
Neratinib next in the A to Z list

These links are for navigation. No count selected them. The class page lists each drug of the class.

Official pages

DailyMed labels for NeulastaThe labels (prescribing information) that have this name, at the National Library of Medicine.
MedWatch Online Voluntary Reporting FormThe online form of FDA for a voluntary report.
MedWatch: The FDA Safety Information and Adverse Event Reporting ProgramThe page of the FDA program that receives reports about drugs and devices.
FDA Adverse Event Monitoring System (AEMS) Public DashboardThe public dashboard of FDA for adverse event reports on drugs and biologics.

The site checked these addresses on 2 Oct 2026. The links open in a new tab.

Cite this page

Embed this card on your site

Copy this code into your page. The card shows the figures above with their source. A line under the card links to this page.

<iframe src="https://reportedreactions.com/embed/drug/neulasta/" title="Neulasta: adverse event reports that FDA received" width="100%" height="360" style="border:0;max-width:640px" loading="lazy"></iframe>
<p style="margin:4px 0 0;font-size:13px"><a href="https://reportedreactions.com/drug/neulasta/">Neulasta: adverse event reports that FDA received</a>, from reportedreactions.com</p>

How embedding works. It is free. Keep the link in the card and the link line under it.

Reported Reactions. Neulasta: adverse event reports that FDA received. https://reportedreactions.com/drug/neulasta/ Source: U.S. Food and Drug Administration, openFDA Drug Adverse Event (FAERS) files, release of 29 Oct 2026. Reports received through 30 Jun 2026.

Where the data come from

The counts come from the openFDA Drug Adverse Event (FAERS) bulk files, release of 29 Oct 2026. The files have the reports that FDA received through 30 Jun 2026. A drug name is the name on the report. The site matches it to a brand name or a generic name of the National Drug Code Directory of 2 Nov 2026. A class is the pharmacologic class (EPC) of the FDA label.

A report is in the count when it names Neulasta as a suspect or interacting product. The 5,978 reports that name it only as a concomitant medicine are not in the count. The site does not publish a report narrative, a lot number, a detail of a patient or the identity of a reporter. The record of FDA is the authority. See how the site counts reports, the data sources and the corrections page.

Questions

Do these reports show that Neulasta was responsible for the reactions?

No. FDA says:

For any given report, there is no certainty that a suspected drug caused the event.
Source: FDA, FDA Adverse Event Monitoring System (AEMS) Public Dashboard. Content current as of 11 Mar 2026. The site read the page on 2 Oct 2026.

A reaction can relate to the condition that the drug treats, to other medicines, or to something else.

Is this the list of reactions on the label of Neulasta?

No. It is a count of what people reported to FDA: 80,512 reports from January 2004 to June 2026. The FDA-approved label of a product lists its adverse reactions. The official pages at the end of this page link to the labels.

Who sent these reports?

Physician (42.8%), other health professional (25.5%) and pharmacist (17.9%). These are the types of reporter for the reports that name this drug.

If a manufacturer receives an adverse event report, it is normally required to send the report to FDA.
Source: openFDA, Drug Adverse Event Overview. The site read the page on 2 Oct 2026.

How does a person report an adverse event?

FDA runs MedWatch, a program that takes voluntary reports from health professionals, patients and consumers. The guide on how to report has the links.

To the top of the page