Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Aprotinin (bovine)
Drug ID BADD_D00158
Description Aprotinin is a protein-based drug that is also known as bovine pancreatic trypsin inhibitor (BPTI). Since it demonstrates the capacity to slow fibrinolysis, it has been employed to reduce bleeding during complex surgery such as heart and liver surgery. For this use, it is typically administered by injection. The goal of using of aprotinin was subsequently to minimize end-organ damage resulting from hypotension due to blood loss in surgery and to reduce the necessity for blood transfusions during surgery. Nevertheless, the drug was formally withdrawn worldwide in May of 2008 after studies confirmed that its use enhanced the risk of complications or death. The substance is consequently made available only for very restricted research use.
Indications and Usage For prophylactic use to reduce perioperative blood loss and the need for blood transfusion in patients undergoing cardiopulmonary bypass in the course of coronary artery bypass graft surgery who are at an increased risk for blood loss and blood transfusion.
Marketing Status approved; investigational; withdrawn
ATC Code B02AB01
DrugBank ID DB06692
KEGG ID D02971
MeSH ID D007611
PubChem ID 16130295
TTD Drug ID D08XYX
NDC Product Code 55463-0031
UNII 04XPW8C0FL
Synonyms Aprotinin | Trypsin Inhibitor, Basic, Pancreatic | Bovine Kunitz Pancreatic Trypsin Inhibitor | BPTI, Basic Pancreatic Trypsin Inhibitor | Kallikrein-Trypsin Inactivator | Inactivator, Kallikrein-Trypsin | Kallikrein Trypsin Inactivator | Kunitz Pancreatic Trypsin Inhibitor | Trypsin Inhibitor, Kunitz, Pancreatic | Basic Pancreatic Trypsin Inhibitor | Bovine Pancreatic Trypsin Inhibitor | Pulmin | Traskolan | Dilmintal | Zymofren | Antilysin | Contrykal | Kontrykal | Kontrikal | Contrical | Iniprol | Trasylol
Chemical Information
Molecular Formula C284H432N84O79S7
CAS Registry Number 9050-74-2
SMILES CCC(C)C1C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC( C(=O)NCC(=O)NC(C(=O)NC2CSSCC3C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(CSSCC(C(=O)NC(C(=O) NC(C(=O)N4CCCC4C(=O)N5CCCC5C(=O)NC(C(=O)NC(C(=O)NCC(=O)N6CCCC6C(=O)NC(CSSCC(C(=O )NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O)NC(C(=O )NC(C(=O)NC(C(=O)N3)CC(=O)O)CCC(=O)O)C)CO)CCCCN)CC7=CC=CC=C7)CC(=O)N)CC(=O)N)CCC NC(=N)N)CCCCN)C)CCCNC(=N)N)NC(=O)CNC(=O)CNC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C(NC(=O)C (NC2=O)CCC(=O)N)C(C)O)CC8=CC=CC=C8)C(C)C)CC9=CC=C(C=C9)O)C(=O)NC(C(=O)NC(C(=O)NC (C(=O)N1)CCCNC(=N)N)C)CCCCN)C(C)O)CC1=CC=C(C=C1)O)CCC(=O)O)CC(C)C)NC(=O)C(CC1=CC =CC=C1)NC(=O)C(CC(=O)O)NC(=O)C1CCCN1C(=O)C(CCCNC(=N)N)N)C(=O)NCC(=O)NCC(=O)NC(C) C(=O)O)C(C)O)CCCNC(=N)N)CCSC)CC(C)C)C)CCCCN)C)CC(=O)N)CC1=CC=C(C=C1)O)CC1=CC=CC= C1)CC1=CC=C(C=C1)O)CCCNC(=N)N)C(C)CC
Chemical Structure
ADRs Induced by Drug
*The priority for ADR severity classification is based on FAERS assessment, followed by the most severe level in CTCAE rating. If neither is available, it will be displayed as 'Not available'.
**The 'Not Available' level is hidden by default and can be restored by clicking on the legend twice.
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Acidosis14.01.03.002--
Agitation19.06.02.001; 17.02.05.012--
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002---
Anaphylactoid reaction10.01.07.003; 24.06.03.007---
Anxiety19.06.02.002--
Apnoea22.02.01.001--
Arrhythmia02.03.02.001---
Arrhythmia supraventricular02.03.03.001---
Arterial thrombosis24.01.01.002---
Arthralgia15.01.02.001--
Asthenia08.01.01.001---
Asthma22.03.01.002; 10.01.03.010---
Atelectasis22.01.02.001--
Atrial fibrillation02.03.03.002--
Atrial flutter02.03.03.003--
Atrioventricular block02.03.01.002---
Blood creatine phosphokinase increased13.04.01.001--
Body temperature increased13.15.01.001---
Bradycardia02.03.02.002---
Bronchospasm22.03.01.004; 10.01.03.012--
Bundle branch block02.03.01.009---
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
Cardiac failure congestive02.05.01.002---
Cerebral artery embolism24.01.04.001; 17.08.01.001---
Cerebrovascular accident24.03.05.001; 17.08.01.007--
Chest pain22.12.02.003; 08.01.08.002; 02.02.02.011---
Coagulopathy01.01.02.001---
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