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)
Embolism arterial24.01.01.014--
Epistaxis22.04.03.001; 24.07.01.005--
Eye disorder06.08.03.001---
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.002---
Facial paralysis17.04.03.008---
Feeling abnormal08.01.09.014---
Gastrointestinal disorder07.11.01.001---
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Gastrointestinal pain07.01.05.005--
Gingival bleeding07.09.07.001; 24.07.02.010---
Groin pain15.03.02.004---
Haematemesis07.12.02.002; 24.07.02.011---
Haematoma24.07.01.001--
Haematuria20.02.01.006; 21.10.01.018; 24.07.01.047--
Haemoglobin13.01.05.018---
Haemoglobin decreased13.01.05.003---
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Haemorrhage intracranial17.08.01.008; 24.07.04.003--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Immune system disorder10.02.01.001---
Increased tendency to bruise01.01.03.005; 23.06.01.009; 24.07.06.012---
Infection11.01.08.002---
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.010---
Injection site pain08.02.03.010; 12.07.03.011---
Injection site reaction08.02.03.014; 12.07.03.015--
Insomnia17.15.03.002; 19.02.01.002--
International normalised ratio increased13.01.02.008--
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