Neulasta: adverse event reports filed with FDA

80,512

reports as suspect product

0.4% of all reports · about 3,579 a year

1,521

reports, 12 months to June 2026

3,128 in the 12 months before

15.8%

marked serious by the reporter

32.6% across the class

3%

record death among outcomes, as reported

2,386 reports · not verified by FDA

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 Neulasta reports recording the termmedian drug in leukocyte growth factor

1. Device adhesion issue14.4%11,632
2. Wrong technique in product usage processthe product was used in the wrong way12.7%10,203
3. Unintentional medical device removal11.2%8,989
4. Device malfunctionthe device did not work properly8.4%6,764
5. Device use errora mistake in using the device7.5%6,041
6. Device issuea problem with the device6.3%5,088
7. Accidental exposure to product6.1%4,946
8. Device occlusionthe device blocked4%3,253
9. Off label useused for a purpose or in a way not on the label3.3%2,696
10. Bone painbone pain3.3%2,660
11. Drug dose omissiona dose was missed2.6%2,089
12. Drug dose omission by device2.5%2,007
13. Deaththe patient died; cause not stated by this term2.3%1,827
14. Intercepted product preparation error2%1,572
15. Occupational exposure to product1.8%1,411
16. Application site haemorrhage1.7%1,389
17. Device physical property issuea physical problem with the device1.7%1,374
18. Device leakagethe device leaked1.7%1,344
19. Febrile neutropeniafever with low white blood cells1.6%1,326
20. Fatiguetiredness1.6%1,265
21. Application site pain1.6%1,260
22. Pyrexiafever1.5%1,208
23. Painpain, site not specified1.4%1,160
24. Nauseafeeling sick1.4%1,132
25. Neutropenialow neutrophils, a type of white blood cell1.4%1,089
26. Hyperhidrosisexcessive sweating1.3%1,042
27. Underdoseless than the intended dose1.3%1,034
28. Circumstance or information capable of leading to medication errora situation that could lead to a medication error1.1%881
29. White blood cell count decreasedlow white cell count1.1%880
30. Product storage errorthe product was stored wrongly1.1%858

Top 30 of 1,384 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

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 91% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 80,512 reports.

Drugs most often listed in the same reports

Other products listed in reports where Neulasta 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

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

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.

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 Neulasta as a suspect or interacting product; reports listing it only as a concomitant medication (5,978) 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.