Drug class · FAERS comparison

Leukocyte Growth Factor side effects compared: 8 drugs, 143,489 FDA adverse event reports

Class as assigned in the FDA label (Established Pharmacologic Class) · data 2026-09-14

How to read this page. Report counts are not incidence rates: a drug with more reports is usually older, more widely used or more publicised, not more dangerous. Signals are screened against each product's FDA label on its own page; a term flagged across most of a class usually reflects the shared mechanism or the shared patient population.

Members

Drug	FAERS reports	Serious	Death outcome	Boxed warning	Top labeled signals	Unlabeled (unassessed)
Pegfilgrastim (Neulasta)	98,102	29%	5,274	–	Occupational exposure to product; Application site haemorrhage; Application site discomfort	Unintentional medical device removal; Intercepted product preparation error
Filgrastim (Releuko)	37,395	88%	8,445	–	Secondary immunodeficiency; Acute myeloid leukaemia recurrent; Aortitis	Cytomegalovirus viraemia; Staphylococcal bacteraemia
Filgrastim-Sndz (Zarxio)	3,286	57%	740	–	White blood cell count decreased; Bone pain; Platelet count decreased	Neoplasm malignant; Neuropathy peripheral
Sargramostim (Leukine)	1,703	73%	250	–	Hypotension; Chills; Syncope	Colitis
Pegfilgrastim-Cbqv (Udenyca)	1,328	21%	127	–	Neutrophil count decreased	–
Filgrastim-Aafi (Nivestym)	640	60%	112	–	–	–
Pegfilgrastim-Bmez (Ziextenzo)	598	83%	183	–	–	Candida infection; Restlessness
Pegfilgrastim-Jmdb (Fulphila)	437	66%	84	–	–	–

Class-wide signals (flagged in at least 4 of 8 members)

Reaction	Members flagged	Median PRR	Reports (sum)	In label
Needle issue	4/8	13.0	65	0/4 members' labels

Member-specific signals (flagged in exactly one drug)

Reaction	Drug	Reports	PRR	Label screen
Lymphoid tissue hypoplasia	Filgrastim	145	40,045.7	Not in label — unassessed
Thymus hypoplasia	Filgrastim	143	2,925.4	Not in label — unassessed
Human bocavirus infection	Filgrastim	124	1,070.2	Not in label — unassessed
Unintentional medical device removal	Pegfilgrastim	8,992	742.6	Not in label — unassessed
Blood stem cell harvest failure	Filgrastim	66	450.1	Not in label — unassessed
Cystitis bacterial	Filgrastim	110	268.8	Not in label — unassessed
Application site haemorrhage	Pegfilgrastim	1,397	220.8	Labeled adverse reaction
Mycobacterium chelonae infection	Filgrastim	165	162.2	Not in label — unassessed
Disseminated aspergillosis	Filgrastim	100	152.2	Not in label — unassessed
Meningitis tuberculous	Filgrastim	116	145.6	Not in label — unassessed
Secondary immunodeficiency	Filgrastim	233	136.0	Labeled (related wording)
Abscess bacterial	Filgrastim	68	131.8	Not in label — unassessed
Corona virus infection	Filgrastim	59	87.8	Not in label — unassessed
Application site bruise	Pegfilgrastim	277	85.4	Labeled adverse reaction
Pseudomonal sepsis	Filgrastim	231	84.6	Not in label — unassessed
Parainfluenzae virus infection	Filgrastim	162	65.5	Not in label — unassessed
Application site discomfort	Pegfilgrastim	417	64.2	Labeled adverse reaction
Occupational exposure to product	Pegfilgrastim	1,412	59.6	Labeled (related wording)
Enterobacter infection	Filgrastim	148	54.2	Not in label — unassessed
Human herpesvirus 6 infection	Filgrastim	166	53.5	Not in label — unassessed
Acute myeloid leukaemia recurrent	Filgrastim	185	53.3	Labeled (related wording)
Viraemia	Filgrastim	106	46.2	Not in label — unassessed
Neutropenic infection	Filgrastim	73	45.8	Likely indication confounding
Diffuse alveolar damage	Filgrastim	79	41.2	Not in label — unassessed
Cytomegalovirus viraemia	Filgrastim	257	34.9	Not in label — unassessed

Common questions

Which leukocyte growth factor has the most FDA adverse event reports?

Pegfilgrastim has the most FAERS co-reports in this class (98,102), followed by Filgrastim (37,395). Report volume tracks how widely and how long a drug has been used, and how much attention it has had, far more than its risk.

Which side effects are shared across leukocyte growth factor drugs?

Reaction terms flagged in at least half of the 8 members include needle issue. A term shared across a class usually reflects the shared mechanism (or the shared patient population) rather than one product.

Does a FAERS signal mean the drug causes the reaction?

No. These are disproportionality signals from voluntary reports with no denominator. Each is screened against the FDA label (known vs unlabeled) on the drug pages; causality needs temporality, dose-response, plausibility and trial or cohort evidence.

Sources: openFDA FAERS pair statistics (OpenPV build 2026-09-14), FDA labels via openFDA, seriousness and death counts from openFDA count queries. Generated 2026-10-08. Not medical advice.