Pharmacologic class (EPC) · 7 drug pages

Leukocyte growth factor: adverse event reports filed with FDA

109,309 reports list a drug in this class as a suspect or interacting product, 2004–2026.

Read first · FDA's statement on these data

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. openFDA, FDA

FDA adds: "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 "cannot be used to estimate the incidence of these events."

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.

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

109,309
reports across the class: 0.5% of all reports; 3,766
reports, 12 months to June 2026: 6,154 in the 12 months before; 32.6%
marked serious by the reporter: 57.4% across all reports; 7
drugs with a page: brand and generic names counted separately

Leukocyte growth factor is a pharmacologic class (an FDA Established Pharmacologic Class) with 7 drug pages on this site. Together those drugs are listed as a suspect or interacting product in 109,309 adverse event reports received by FDA, 0.5% of the database, from January 2004 to June 2026.

3,766 reports arrived in the 12 months to June 2026, down 39% from 6,154 in the 12 months before. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases. 32.6% of the class's reports are marked serious, 7.3% record death among the outcomes and 15.3% record hospitalisation, as reported.

Across the class the reactions recorded most often are device adhesion issue (10.7%), wrong technique in product usage process (9.5%) and unintentional medical device removal (8.2%). The class median share shown beside each term is the middle value across the member drugs; it is the comparison used on every drug page in this class.

The members table is 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."

Drugs in the class

Drug	Name type	Reports	Latest 12 months	Marked serious	Top term recorded
NeulastaPegfilgrastim	brand	80,512	1,521	15.8%	Device adhesion issue
Filgrastim	generic	10,601	1,004	94.9%	Febrile neutropenia
NeupogenFilgrastim	brand	7,128	66	64.6%	Off label use
Pegfilgrastim	generic	7,127	489	89.6%	Febrile neutropenia
ZarxioFilgrastim-sndz	brand	1,770	92	59.3%	Death
UdenycaPegfilgrastim-cbqv	brand	1,232	550	17.4%	Device malfunction
LeukineSargramostim	brand	939	44	62.6%	Dyspnoea

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."

Reports by month, five years

FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

Reactions recorded across the class

share of class reports recording the termmedian drug in the class

Device adhesion issue10.7%11,741
Wrong technique in product usage processthe product was used in the wrong way9.5%10,347
Unintentional medical device removal8.2%8,992
Device malfunctionthe device did not work properly7.1%7,735
Device use errora mistake in using the device5.6%6,070
Off label useused for a purpose or in a way not on the label4.8%5,281
Device issuea problem with the device4.8%5,251
Accidental exposure to product4.6%5,079
Febrile neutropeniafever with low white blood cells4.1%4,461
Deaththe patient died; cause not stated by this term3.8%4,177
Bone painbone pain3.5%3,865
Neutropenialow neutrophils, a type of white blood cell3.2%3,527
Device occlusionthe device blocked3.1%3,338
Pyrexiafever2.9%3,169
Nauseafeeling sick2.3%2,545
Fatiguetiredness2.2%2,387
Drug dose omissiona dose was missed2%2,145
Drug dose omission by device2%2,142
Diarrhoealoose or frequent stools1.8%1,984
Dyspnoeashortness of breath1.7%1,804
Painpain, site not specified1.6%1,720
Drug ineffectivethe medicine did not work as expected1.5%1,694
White blood cell count decreasedlow white cell count1.5%1,685
Intercepted product preparation error1.4%1,574
Vomitingbeing sick1.4%1,513

Solid bar: share of all class reports. Hollow bar: the median share across the 7 member drugs, the reference used on each member's page. One report can record several terms.

Outcomes, patients and reporters

Outcomes recorded

Death7.3%8,020

Life-threatening1.8%1,933

Hospitalisation (initial or prolonged)15.3%16,761

Disability0.4%420

Congenital anomaly0.1%96

Other serious20%21,848

Not serious67.4%73,644

Patient age

Under 20.2%263

2 to 110.9%1,036

12 to 170.5%532

18 to 448.2%8,967

45 to 6425.2%27,599

65 to 7416.5%18,016

75 and over8.5%9,326

Age not given39.9%43,570

Who reported

Physician40.9%44,655

Pharmacist16%17,442

Other health professional28.7%31,418

Lawyer0%34

Consumer or non-health professional13%14,242

Not given1.4%1,518

Grey bar: all 20,646,523 reports in the database. Outcome flags are as the reporter set them and are not verified by FDA.

Questions about Leukocyte growth factor reports

Which drugs are in the Leukocyte growth factor class on this site?

Neulasta, Filgrastim, Neupogen, Pegfilgrastim, Zarxio and Udenyca and 1 more. Class membership comes from the pharmacologic class (EPC) on the drug's FDA label.

How many reports does the class have?

109,309 reports through June 2026, 3,766 of them in the latest 12 months. A report listing two drugs of the class counts once for each.

What reactions are recorded most often?

device adhesion issue (10.7%), wrong technique in product usage process (9.5%), unintentional medical device removal (8.2%), device malfunction (7.1%) and device use error (5.6%).

Can the members table be used to rank the drugs?

No. 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." Drugs differ in how many people take them, in the conditions they treat, in time on the market and in how diligently reports are collected.

How do I report an adverse event?

Through FDA MedWatch (Form FDA 3500, or 1-800-FDA-1088) or to the manufacturer. 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 class is the Established Pharmacologic Class most often attached to a drug's reports by openFDA's label harmonisation, or from the NDC Directory where reports carry none. 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.