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What the label lists and what reports show

Pegfilgrastim side effects

Pegfilgrastim's FDA label: “Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.” FAERS holds 100,402 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is device adhesion issue (11,741 reports).

  • No generic listed

Check it at the source: the pegfilgrastim FDA label on DailyMed (effective August 10, 2026, Amgen, Inc); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are possible side effects of Neulasta?

Neulasta can cause serious side effects, including: Spleen rupture. Your spleen may become enlarged and can rupture. A ruptured spleen can cause death. Tell your healthcare provider right away if you develop pain in the left upper stomach area or your left shoulder. A serious lung problem called Acute Respiratory Distress Syndrome (ARDS). Tell your healthcare provider or get emergency help right away if you develop shortness of breath with or without a fever, trouble breathing, or a fast rate of breathing. Serious allergic reactions. Allergic reactions can cause a rash over your whole body, shortness of breath, wheezing, dizziness, swelling around your mouth or eyes, fast heart rate, and sweating. If you develop any of these symptoms, stop using Neulasta and tell your healthcare provider or get emergency medical help right away. Sickle cell crises in people with sickle cell disorder. […]

Source: FDA drug label, Amgen, Inc, effective August 10, 2026 (SPL set fdfe5d72-6b80-435a-afa4-c5d74dd852ce), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity.

From the label: adverse reactions, continued

The following clinically significant adverse reactions are discussed in greater detail in other sections of the labeling: Splenic Rupture [see Warnings and Precautions (5.1) ] Acute Respiratory Distress Syndrome [see Warnings and Precautions (5.2) ] Serious Hypersensitivity Reactions [see Warnings and Precautions (5.3) ] Allergies to Acrylics [see Warnings and Precautions (5.4) ] Use in Patients with Sickle Cell Disorders [see Warnings and Precautions (5.5) ] Glomerulonephritis [see Warnings and Precautions (5.6) ] Leukocytosis [see Warnings and Precautions (5.7) ] Thrombocytopenia [see Warnings and Precautions (5.8) ] Capillary Leak Syndrome [see Warnings and Precautions (5.9) ] Potential for Tumor Growth Stimulatory Effects on Malignant Cells [see Warnings and Precautions (5.10) ] Myelodysplastic syndrome [see Warnings and Precautions (5.11) ] Acute myeloid leukemia [see Warnings and Precautions (5.11) ] Large and Medium Vessel Arteritis [see Warnings and Precautions (5.13) ] Most common adverse reactions (≥ 5% difference in incidence compared to placebo) are bone pain and pain in extremity. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Amgen Inc. at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Amgen, Inc, effective August 10, 2026 (SPL set fdfe5d72-6b80-435a-afa4-c5d74dd852ce), via openFDA; the full label on DailyMed

What do FAERS reports show?

100,402 reports list pegfilgrastim among the medicines taken, each a report of something that happened, not proof the medicine caused it; 5,662 are coded as a death and 15,826 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 18 reactions below, 1 is named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

  • Device Adhesion Issue11,741
  • Wrong Technique In Product Usage Process (a use or a product term, not a reaction)10,262
  • Unintentional Medical Device Removal8,992
  • Device Malfunction7,728
  • Device Use Error6,057
  • Device Issue5,176
  • Accidental Exposure To Product5,039
  • Off Label Use (a use or a product term, not a reaction)3,854
  • Febrile Neutropenia (a use or a product term, not a reaction)3,840
  • Device Occlusion3,335
  • Death (an outcome recorded in the report)3,078
  • Bone Pain (named in the label)2,983
  • Neutropenia (a use or a product term, not a reaction)2,744
  • Fatigue2,690
  • Pyrexia2,562
  • Nausea2,545
  • Drug Dose Omission By Device (a use or a product term, not a reaction)2,107
  • Drug Dose Omission (a use or a product term, not a reaction)2,104
  • Diarrhoea2,028
  • Pain1,794
  • Alopecia1,748
  • Dyspnoea1,663
  • Intercepted Product Preparation Error1,575
  • Vomiting1,483
  • Anaemia1,455

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Pegfilgrastim: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions