APROTININ: 124 Adverse Event Reports & Safety Profile
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124
Total FAERS Reports
46 (37.1%)
Deaths Reported
71
Hospitalizations
124
As Primary/Secondary Suspect
32
Life-Threatening
6
Disabilities
Discontinued
Status
FDA Application: 020304 ·
First Report: 19780527 · Latest Report: 20230428
What Are the Most Common APROTININ Side Effects?
#1 Most Reported
Product use in unapproved indication
88 reports (71.0%)
#2 Most Reported
Off label use
76 reports (61.3%)
#3 Most Reported
Renal impairment
28 reports (22.6%)
All APROTININ Side Effects by Frequency
| Side Effect | Reports | % of Total | Deaths | Hosp. |
|---|---|---|---|---|
| Product use in unapproved indication | 88 | 71.0% | 32 | 60 |
| Off label use | 76 | 61.3% | 26 | 45 |
| Renal impairment | 28 | 22.6% | 11 | 26 |
| Blood creatinine increased | 22 | 17.7% | 2 | 18 |
| Ischaemic stroke | 14 | 11.3% | 4 | 11 |
| Acute kidney injury | 5 | 4.0% | 4 | 5 |
| Anaphylactic reaction | 5 | 4.0% | 1 | 0 |
Who Reports APROTININ Side Effects? Age & Gender Data
Gender: 25.2% female, 74.8% male. Average age: 61.0 years. Most reports from: NL. View detailed demographics →
Is APROTININ Getting Safer? Reports by Year
| Year | Reports | Deaths | Hosp. |
|---|---|---|---|
| 2006 | 1 | 1 | 1 |
| 2013 | 1 | 1 | 0 |
| 2017 | 14 | 2 | 4 |
| 2018 | 7 | 3 | 4 |
| 2019 | 50 | 18 | 36 |
| 2020 | 17 | 11 | 14 |
| 2021 | 12 | 1 | 7 |
| 2022 | 2 | 0 | 1 |
| 2023 | 2 | 0 | 2 |
What Is APROTININ Used For?
| Indication | Reports |
|---|---|
| Aortic dissection | 26 |
| Aortic valve replacement | 19 |
| Heart valve replacement | 12 |
| Heart transplant | 11 |
| Mitral valve replacement | 9 |
| Cardiopulmonary bypass | 7 |
| Coronary artery bypass | 7 |
| Aortic surgery | 5 |
APROTININ vs Alternatives: Which Is Safer?
APROTININ vs ARANESP
APROTININ vs ARAVA
APROTININ vs AREDIA
APROTININ vs ARFORMOTEROL
APROTININ vs ARGATROBAN
APROTININ vs ARGININE
APROTININ vs ARGININE\LYSINE
APROTININ vs ARIMIDEX
APROTININ vs ARIPIPRAZOLE
APROTININ vs ARIPIPRAZOLE LAUROXIL
Official FDA Label for APROTININ
Official prescribing information from the FDA-approved drug label.