TBO-FILGRASTIM: 300 Adverse Event Reports & Safety Profile
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300
Total FAERS Reports
54 (18.0%)
Deaths Reported
72
Hospitalizations
300
As Primary/Secondary Suspect
5
Life-Threatening
Prescription
Status
FDA Application: 125294 ·
First Report: 20140107 · Latest Report: 20250801
What Are the Most Common TBO-FILGRASTIM Side Effects?
#1 Most Reported
Death
46 reports (15.3%)
#2 Most Reported
Drug ineffective
22 reports (7.3%)
#3 Most Reported
Hospitalisation
19 reports (6.3%)
All TBO-FILGRASTIM Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Death | 46 | 15.3% | 46 | 1 |
| Drug ineffective | 22 | 7.3% | 0 | 1 |
| Hospitalisation | 19 | 6.3% | 1 | 18 |
| White blood cell count decreased | 17 | 5.7% | 0 | 3 |
| Fatigue | 16 | 5.3% | 0 | 3 |
| Bone pain | 13 | 4.3% | 0 | 1 |
| Malaise | 11 | 3.7% | 0 | 3 |
| Nausea | 11 | 3.7% | 0 | 1 |
| Pyrexia | 11 | 3.7% | 0 | 6 |
| Off label use | 9 | 3.0% | 0 | 0 |
| Headache | 8 | 2.7% | 0 | 1 |
| Diarrhoea | 7 | 2.3% | 0 | 1 |
| Febrile neutropenia | 7 | 2.3% | 0 | 5 |
| Illness | 7 | 2.3% | 1 | 2 |
| Neutropenia | 7 | 2.3% | 0 | 2 |
| Neutrophil count abnormal | 7 | 2.3% | 0 | 0 |
| Rash | 7 | 2.3% | 0 | 0 |
| Arthralgia | 6 | 2.0% | 0 | 0 |
| Back pain | 6 | 2.0% | 0 | 0 |
| Sepsis | 6 | 2.0% | 2 | 4 |
Who Reports TBO-FILGRASTIM Side Effects? Age & Gender Data
Gender: 62.4% female, 37.6% male. Average age: 54.0 years. Most reports from: US. View detailed demographics →
Is TBO-FILGRASTIM Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2014 | 6 | 0 | 0 |
| 2015 | 11 | 1 | 3 |
| 2016 | 21 | 1 | 5 |
| 2017 | 18 | 6 | 5 |
| 2018 | 21 | 7 | 9 |
| 2019 | 17 | 2 | 3 |
| 2020 | 15 | 1 | 7 |
| 2021 | 7 | 1 | 2 |
| 2022 | 8 | 2 | 3 |
| 2023 | 4 | 1 | 2 |
| 2024 | 3 | 1 | 0 |
| 2025 | 1 | 0 | 0 |
What Is TBO-FILGRASTIM Used For?
| Indication | Reports |
|---|---|
| Product used for unknown indication | 60 |
| Neutropenia | 47 |
| Agranulocytosis | 11 |
| White blood cell count decreased | 9 |
| Acute myeloid leukaemia | 7 |
| Breast cancer | 6 |
TBO-FILGRASTIM vs Alternatives: Which Is Safer?
TBO-FILGRASTIM vs TEBENTAFUSP-TEBN
TBO-FILGRASTIM vs TECFIDERA
TBO-FILGRASTIM vs TECHNETIUM TC-99M
TBO-FILGRASTIM vs TECHNETIUM TC-99M MEDRONATE
TBO-FILGRASTIM vs TECHNETIUM TC-99M OXIDRONATE
TBO-FILGRASTIM vs TECHNETIUM TC-99M PERTECHNETATE
TBO-FILGRASTIM vs TECHNETIUM TC-99M SESTAMIBI
TBO-FILGRASTIM vs TECHNETIUM TC-99M TETROFOSMIN
TBO-FILGRASTIM vs TECHNETIUM TC-99M TILMANOCEPT
TBO-FILGRASTIM vs TECLISTAMAB
Official FDA Label for TBO-FILGRASTIM
Official prescribing information from the FDA-approved drug label.