FIBRINOGEN HUMAN\THROMBIN HUMAN: 1,003 Adverse Event Reports & Safety Profile
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1,003
Total FAERS Reports
45 (4.5%)
Deaths Reported
171
Hospitalizations
1,003
As Primary/Secondary Suspect
39
Life-Threatening
14
Disabilities
First Report: 20050122 · Latest Report: 20240921
What Are the Most Common FIBRINOGEN HUMAN\THROMBIN HUMAN Side Effects?
#1 Most Reported
Off label use
225 reports (22.4%)
#2 Most Reported
Drug ineffective
132 reports (13.2%)
#3 Most Reported
Product use in unapproved indication
95 reports (9.5%)
All FIBRINOGEN HUMAN\THROMBIN HUMAN Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Off label use | 225 | 22.4% | 11 | 30 |
| Drug ineffective | 132 | 13.2% | 5 | 14 |
| Product use in unapproved indication | 95 | 9.5% | 3 | 10 |
| Cerebrospinal fluid leakage | 57 | 5.7% | 2 | 23 |
| Haemorrhage | 50 | 5.0% | 8 | 3 |
| Seroma | 49 | 4.9% | 0 | 5 |
| Drug ineffective for unapproved indication | 42 | 4.2% | 3 | 7 |
| Product physical consistency issue | 31 | 3.1% | 0 | 0 |
| Wound infection | 29 | 2.9% | 0 | 3 |
| Post procedural complication | 26 | 2.6% | 1 | 8 |
| Haematoma | 23 | 2.3% | 1 | 2 |
| Graft complication | 22 | 2.2% | 0 | 0 |
| Procedural complication | 19 | 1.9% | 2 | 5 |
| Product adhesion issue | 19 | 1.9% | 0 | 2 |
| Product quality issue | 19 | 1.9% | 1 | 3 |
| Pyrexia | 19 | 1.9% | 3 | 7 |
| Urticaria | 19 | 1.9% | 1 | 3 |
| Post procedural haemorrhage | 17 | 1.7% | 2 | 7 |
| Inflammation | 16 | 1.6% | 0 | 5 |
| Anaphylactic reaction | 15 | 1.5% | 0 | 1 |
Who Reports FIBRINOGEN HUMAN\THROMBIN HUMAN Side Effects? Age & Gender Data
Gender: 51.1% female, 48.9% male. Average age: 52.0 years. Most reports from: US. View detailed demographics →
Is FIBRINOGEN HUMAN\THROMBIN HUMAN Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2005 | 1 | 0 | 1 |
| 2008 | 1 | 1 | 0 |
| 2009 | 2 | 1 | 1 |
| 2010 | 3 | 0 | 2 |
| 2011 | 1 | 0 | 0 |
| 2012 | 11 | 1 | 5 |
| 2013 | 24 | 0 | 12 |
| 2014 | 50 | 1 | 8 |
| 2015 | 36 | 1 | 12 |
| 2016 | 37 | 0 | 12 |
| 2017 | 47 | 4 | 9 |
| 2018 | 41 | 0 | 12 |
| 2019 | 30 | 1 | 8 |
| 2020 | 21 | 0 | 5 |
| 2021 | 27 | 8 | 1 |
| 2022 | 6 | 0 | 0 |
| 2023 | 13 | 0 | 2 |
| 2024 | 8 | 0 | 2 |
What Is FIBRINOGEN HUMAN\THROMBIN HUMAN Used For?
| Indication | Reports |
|---|---|
| Tissue sealing | 226 |
| Haemostasis | 171 |
| Product used for unknown indication | 146 |
| Off label use | 39 |
| Prophylaxis | 33 |
| Hernia repair | 28 |
| Surgery | 26 |
| Pterygium operation | 25 |
| Abdominal hernia repair | 19 |
| Cerebrospinal fluid leakage | 19 |
FIBRINOGEN HUMAN\THROMBIN HUMAN vs Alternatives: Which Is Safer?
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FIDAXOMICIN
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FILGOTINIB
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FILGRASTIM
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FILGRASTIM-AAFI
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FILGRASTIM-SNDZ
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FINASTERIDE
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FINASTERIDE\TAMSULOSIN
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FINERENONE
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FINGOLIMOD
FIBRINOGEN HUMAN\THROMBIN HUMAN vs FINGOLIMOD LAURYL
Official FDA Label for FIBRINOGEN HUMAN\THROMBIN HUMAN
Official prescribing information from the FDA-approved drug label.