Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Bivalirudin
Drug ID BADD_D00279
Description Bivalirudin is a synthetic 20 residue peptide (thrombin inhibitor) which reversibly inhibits thrombin. Once bound to the active site, thrombin cannot activate fibrinogen into fibrin, the crucial step in the formation of thrombus. It is administered intravenously. Because it can cause blood stagnation, it is important to monitor changes in hematocrit, activated partial thromboplastin time, international normalized ratio and blood pressure.
Indications and Usage For treatment of heparin-induced thrombocytopenia and for the prevention of thrombosis. Bivalirudin is indicated for use in patients undergoing percutaneous coronary intervention (PCI), in patients at moderate to high risk acute coronary syndromes due to unstable angina or non-ST segment elevation in whom a PCI is planned.
Marketing Status approved; investigational
ATC Code B01AE06
DrugBank ID DB00006
KEGG ID D03136
MeSH ID C074619
PubChem ID 16129704
TTD Drug ID D09HVL
NDC Product Code 68225-041; 76177-001; 63323-562; 0781-3453; 32861-0001; 52958-112; 55111-918; 55463-0029; 55111-652; 0781-3447; 0781-9158; 36974-0066; 41524-0001; 70511-141; 0781-3158; 65129-1225; 52958-034; 55150-210; 0409-8300; 16729-275; 42023-622; 67457-256; 70860-402; 70860-403; 70436-025; 71288-427; 72572-035
UNII TN9BEX005G
Synonyms bivalirudin | Phe-Pro-Arg-Pro-(Gly)4-desulfohirudin-(53-64) | Phe-Pro-Arg-Pro-(Gly)4 desulfato-Tyr63'-hirugen | Phe-Pro-Arg-Pro-(Gly)4-Asn-Gly-Asp-Phe-Glu-Glu-Ile-Pro-Glu-Glu-Tyr-Leu | CTB-001 | Hirulog | Hirulog-1 | Angiomax | BG 8967 | BG8967 | BG-8967
Chemical Information
Molecular Formula C98H138N24O33
CAS Registry Number 128270-60-0
SMILES CCC(C)C(C(=O)N1CCCC1C(=O)NC(CCC(=O)O)C(=O)NC(CCC(=O)O)C(=O)NC(CC2=CC=C(C=C2)O)C( =O)NC(CC(C)C)C(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CCC(=O)O)NC(=O)C(CC3=CC=CC=C3)NC(=O )C(CC(=O)O)NC(=O)CNC(=O)C(CC(=O)N)NC(=O)CNC(=O)CNC(=O)CNC(=O)CNC(=O)C4CCCN4C(=O) C(CCCNC(=N)N)NC(=O)C5CCCN5C(=O)C(CC6=CC=CC=C6)N
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
Urticaria23.04.02.001; 10.01.06.001--
Ventricular fibrillation02.03.04.008--
Ventricular tachycardia02.03.04.010--
Vomiting07.01.07.003--
Vascular pseudoaneurysm12.02.01.001; 24.03.02.010--Not Available
Anal haemorrhage24.07.02.029; 07.12.03.004--
Contusion24.07.06.001; 23.03.11.002; 12.01.06.001; 15.03.05.007--
Post procedural haemorrhage24.07.01.014; 12.02.05.004--
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Puncture site reaction12.07.04.013; 08.02.04.013--Not Available
Injection site discomfort12.07.03.019; 08.02.03.018--Not Available
Haemorrhage24.07.01.002--Not Available
Retroperitoneal haematoma24.07.01.060; 07.07.02.005--Not Available
Angiopathy24.03.02.007--Not Available
Cardiac disorder02.11.01.003--Not Available
Connective tissue disorder10.04.04.026; 15.06.01.006--Not Available
Mediastinal disorder22.09.03.001--Not Available
Inner ear disorder04.04.02.002--Not Available
Blood disorder01.05.01.004--Not Available
Thrombosis in device24.01.01.018; 27.01.02.006--Not Available
Reperfusion injury24.03.02.012; 12.02.01.003--Not Available
Vascular stent thrombosis08.07.05.002; 24.01.01.044--Not Available
Vessel puncture site haematoma24.07.01.018; 12.07.04.003; 08.02.04.002--Not Available
Vascular malformation24.03.03.014; 03.07.03.004--Not Available
Device related thrombosis24.01.01.027; 08.07.05.001--Not Available
Haemoperitoneum24.07.02.065; 12.01.17.007; 07.07.02.007--Not Available
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