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 Nevertheless, the drug was formally withdrawn worldwide in May of 2008 after studies confirmed that its use enhanced the risk of complications or death.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Marketing Status approved; investigational; withdrawn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)
Urinary retention20.02.02.011--
Urinary tract disorder20.08.01.001--Not Available
Urinary tract infection20.08.02.001; 11.01.14.004--
Urticaria23.04.02.001; 10.01.06.001--
Ventricular arrhythmia02.03.04.006--
Ventricular extrasystoles02.03.04.007--Not Available
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.010--
Vomiting07.01.07.003--
Musculoskeletal disorder15.03.05.025--Not Available
Deep vein thrombosis24.01.02.003--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Vascular occlusion24.04.02.015--Not Available
Infusion site reaction12.07.05.006; 08.02.05.005--Not Available
Haemorrhage24.07.01.002--Not Available
Angiopathy24.03.02.007--Not Available
Cardiac disorder02.11.01.003--Not Available
Embolism24.01.01.009--
Infarction24.04.02.017--Not Available
Ischaemia24.04.02.004--Not Available
Blood disorder01.05.01.004--Not Available
Renal impairment20.01.03.010--Not Available
Acute kidney injury20.01.03.016--
Multiple organ dysfunction syndrome08.01.03.057--
Haemoperitoneum07.07.02.007; 24.07.02.065; 12.01.17.007--Not Available
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