Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Prasugrel
Drug ID BADD_D01822
Description Prasugrel, a thienopyridine derivative, is a platelet activation and aggregation inhibitor structurally and pharmacologically related to clopidogrel and ticlopidine. Similar to clopidogrel, prasugrel is a prodrug that requires enzymatic transformation in the liver to its active metabolite, R-138727. R-138727 irreversibly binds to P2Y12 type ADP receptors on platelets thus preventing activation of the GPIIb/IIIa receptor complex. As a result, inhibition of ADP-mediated platelet activation and aggregation occurs. Prasugrel was developed by Daiichi Sankyo Co. and is currently marketed in the United States and Canada in cooperation with Eli Lilly and Company for acute coronary syndromes planned for percutaneous coronary intervention (PCI). FDA approved in 2009.
Indications and Usage Indicated in combination with acetylsalicylic acid (ASA) to prevent atherothrombotic events in patients with acute coronary syndrome (ACS) who are to be managed with percutaneous coronary intervention (PCI). May be used in patients with unstable angina (UA), non-ST elevation myocardial infarction (NSTEMI), ST-elevation myocardial infarction (STEMI) who are to be managed with PCI. Prasugrel is not recommended in patients 75 years of age or greater, those that weigh<60kg, and patients with a history of stroke or transient ischemic attack due to increased risk of fatal and intracranial bleeding.
Marketing Status approved
ATC Code B01AC22
DrugBank ID DB06209
KEGG ID D05597
MeSH ID D000068799
PubChem ID 6918456
TTD Drug ID D07IRF
NDC Product Code 43817-240; 51407-444; 0378-5185; 65862-829; 43817-239; 50090-5169; 65162-002; 66003-602; 66003-601; 60505-4643; 16729-272; 0378-5186; 65162-001; 65862-830; 14501-0084; 51407-445; 60505-4642; 16729-273
UNII 34K66TBT99
Synonyms Prasugrel Hydrochloride | Hydrochloride, Prasugrel | Prasugrel HCl | HCl, Prasugrel | CS 747 | 747, CS | CS-747 | CS747 | Prasugrel | Efient | Effient | LY 640315 | 640315, LY | LY640315 | LY-640315
Chemical Information
Molecular Formula C20H20FNO3S
CAS Registry Number 150322-43-3
SMILES CC(=O)OC1=CC2=C(S1)CCN(C2)C(C3=CC=CC=C3F)C(=O)C4CC4
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)
Pulmonary embolism24.01.06.001; 22.06.02.0010.000577%Not Available
Rash23.03.13.001--Not Available
Rectal haemorrhage24.07.02.018; 07.12.03.001--
Renal disorder20.01.02.0020.000384%Not Available
Respiratory failure22.02.06.002; 14.01.04.0030.000384%
Retinal haemorrhage06.10.01.001; 24.07.05.003--Not Available
Retroperitoneal haemorrhage24.07.01.017; 12.01.17.018; 07.07.02.002--
Shock24.06.02.0020.000384%Not Available
Skin disorder23.03.03.007--Not Available
Skin necrosis23.03.03.0110.000384%Not Available
Stupor19.02.05.004; 17.02.04.0070.000384%Not Available
Subarachnoid haemorrhage24.07.04.004; 17.08.01.010; 12.01.10.0110.001345%Not Available
Subcutaneous haematoma23.06.07.003; 12.01.06.005; 24.07.01.033--Not Available
Sudden death08.04.01.003; 02.03.04.0130.000384%
Surgery25.01.02.003--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.000384%
Thrombocytopenia01.08.01.0020.001153%Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.003--Not Available
Thrombosis24.01.01.0060.000961%Not Available
Thrombotic thrombocytopenic purpura24.07.06.014; 23.06.01.011; 01.08.01.0050.000769%
Transient ischaemic attack24.04.06.005; 17.08.04.0010.000384%
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.000961%
Urethral disorder20.07.01.002--Not Available
Urinary tract disorder20.08.01.001--Not Available
Ventricular fibrillation02.03.04.0080.000384%
Vomiting07.01.07.0030.003306%
Tumour haemorrhage24.07.01.028; 16.32.03.0080.000384%
Shock haemorrhagic24.06.02.014; 14.05.05.0030.000384%Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Post procedural haemorrhage12.02.05.004; 24.07.01.014--
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