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Important: This site presents data from the FDA Adverse Event Reporting System (FAERS). A report does not mean the drug caused the event. Full disclaimer.

FILGRASTIM-AAFI: 439 Adverse Event Reports & Safety Profile

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439
Total FAERS Reports
80 (18.2%)
Deaths Reported
117
Hospitalizations
439
As Primary/Secondary Suspect
3
Life-Threatening
1
Disabilities
Prescription
Status

FDA Application: 761080 ·

First Report: 201611 · Latest Report: 20250812

What Are the Most Common FILGRASTIM-AAFI Side Effects?

#1 Most Reported
Off label use
63 reports (14.4%)
#2 Most Reported
Death
63 reports (14.4%)
#3 Most Reported
White blood cell count decreased
28 reports (6.4%)

All FILGRASTIM-AAFI Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Death 63 14.4% 62 3
Off label use 63 14.4% 9 4
White blood cell count decreased 28 6.4% 0 8
Hospitalisation 17 3.9% 1 16
Bone pain 15 3.4% 0 1
Malaise 15 3.4% 1 4
Needle issue 15 3.4% 0 0
Pyrexia 15 3.4% 1 12
Pain 14 3.2% 0 2
Device leakage 11 2.5% 0 0
Drug dose omission by device 11 2.5% 0 0
Illness 11 2.5% 1 1
Neoplasm malignant 11 2.5% 5 3
Drug ineffective 10 2.3% 1 1
Diarrhoea 9 2.1% 2 5
Therapy interrupted 9 2.1% 0 8
Device defective 8 1.8% 0 0
Device mechanical issue 8 1.8% 0 0
Asthenia 7 1.6% 0 1
Drug hypersensitivity 7 1.6% 0 3

Who Reports FILGRASTIM-AAFI Side Effects? Age & Gender Data

Gender: 60.0% female, 40.0% male. Average age: 54.8 years. Most reports from: US. View detailed demographics →

Is FILGRASTIM-AAFI Getting Safer? Reports by Year

YearReportsDeathsHosp.
2016 1 0 1
2018 2 1 1
2019 15 2 6
2020 16 6 7
2021 19 10 6
2022 29 9 9
2023 18 8 2
2024 18 1 5
2025 13 4 5

View full timeline →

What Is FILGRASTIM-AAFI Used For?

IndicationReports
Neutropenia 53
Agranulocytosis 19
White blood cell count decreased 16
Breast cancer 11
Plasma cell myeloma 11
Breast cancer female 9
Product used for unknown indication 7
Chemotherapy 6
Colon cancer 6
Neoplasm malignant 6

FILGRASTIM-AAFI vs Alternatives: Which Is Safer?

FILGRASTIM-AAFI vs FILGRASTIM-SNDZ FILGRASTIM-AAFI vs FINASTERIDE FILGRASTIM-AAFI vs FINASTERIDE\TAMSULOSIN FILGRASTIM-AAFI vs FINERENONE FILGRASTIM-AAFI vs FINGOLIMOD FILGRASTIM-AAFI vs FINGOLIMOD LAURYL FILGRASTIM-AAFI vs FISH OIL FILGRASTIM-AAFI vs FISH OIL\MEDIUM-CHAIN TRIGLYCERIDES\OLIVE OIL\SOYBEAN OIL FILGRASTIM-AAFI vs FLAGYL FILGRASTIM-AAFI vs FLECAINIDE

Official FDA Label for FILGRASTIM-AAFI

Official prescribing information from the FDA-approved drug label.