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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.

APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN: 12 Adverse Event Reports & Safety Profile

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12
Total FAERS Reports
0
Deaths Reported
0
Hospitalizations
12
As Primary/Secondary Suspect
11
Life-Threatening

Active Ingredient: APROTININ\CALCIUM CHLORIDE\FIBRINOGEN HUMAN\HUMAN THROMBIN ·

First Report: 20231124 · Latest Report: 20240611

What Are the Most Common APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN Side Effects?

#1 Most Reported
Shock haemorrhagic
11 reports (91.7%)
#2 Most Reported
Haemothorax
11 reports (91.7%)
#3 Most Reported
Anaphylactic reaction
11 reports (91.7%)

All APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN Side Effects by Frequency

Side Effect Reports % of Total Deaths Hosp.
Anaphylactic reaction 11 91.7% 0 0
Haemothorax 11 91.7% 0 0
Shock haemorrhagic 11 91.7% 0 0
Adverse reaction 9 75.0% 0 0
Anaphylactic shock 9 75.0% 0 0
Angiopathy 9 75.0% 0 0
Back pain 9 75.0% 0 0
Blood pressure increased 9 75.0% 0 0
Emphysema 9 75.0% 0 0
Epistaxis 9 75.0% 0 0
Face oedema 9 75.0% 0 0
Flatulence 9 75.0% 0 0
Haemorrhage 9 75.0% 0 0
Hypersensitivity 9 75.0% 0 0
Hypotension 9 75.0% 0 0
Hypovolaemia 9 75.0% 0 0
Inspiratory capacity decreased 9 75.0% 0 0
Mechanical ventilation complication 9 75.0% 0 0
Pleural effusion 9 75.0% 0 0
Pneumothorax 9 75.0% 0 0

Who Reports APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN Side Effects? Age & Gender Data

Gender: 0.0% female, 100.0% male. Average age: 14.0 years. Most reports from: CA. View detailed demographics →

Is APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN Getting Safer? Reports by Year

YearReportsDeathsHosp.
2023 3 0 0
2024 1 0 0

View full timeline →

What Is APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN Used For?

IndicationReports
Tissue sealing 8
Surgery 5

Official FDA Label for APROTININ\CALCIUM\FIBRINOGEN HUMAN\HUMAN THROMBIN

Official prescribing information from the FDA-approved drug label.