Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Prasugrel hydrochloride
Drug ID BADD_D01823
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 10158453
TTD Drug ID D07IRF
NDC Product Code 0713-0882; 82245-0102; 65862-809; 53747-048; 65597-601; 65015-809; 14501-0072; 24196-177; 68180-795; 0713-0881; 66039-887; 65597-602; 68180-796; 55111-928; 65977-0076
UNII G89JQ59I13
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 C20H21ClFNO3S
CAS Registry Number 389574-19-0
SMILES CC(=O)OC1=CC2=C(S1)CCN(C2)C(C3=CC=CC=C3F)C(=O)C4CC4.Cl
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)
Anaemia01.03.02.001--
Anaphylactic reaction10.01.07.001; 24.06.03.006--
Angioedema10.01.05.009; 22.04.02.008; 23.04.01.001---
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bradycardia02.03.02.002---
Cardiac tamponade02.06.01.001--
Cough22.02.03.001--
Diarrhoea07.02.01.001--
Dizziness02.11.04.006; 17.02.05.003; 24.06.02.007--
Dyspnoea02.11.05.003; 22.02.01.004--
Epistaxis22.04.03.001; 24.07.01.005--
Fatigue08.01.01.002--
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.009---
Haemoptysis02.11.04.009; 22.02.03.004; 24.07.01.006---
Headache17.14.01.001--
Hepatic function abnormal09.01.02.001---
Hypercholesterolaemia14.08.01.001---
Hypersensitivity10.01.03.003--
Hypertension24.08.02.001--
Hypotension24.06.03.002--
Leukopenia01.02.02.001---
Nausea07.01.07.001--
Neoplasm malignant16.16.01.001---
Oedema peripheral02.05.04.007; 08.01.07.007; 14.05.06.011--
Pain in extremity15.03.04.010--
Pericardial effusion02.06.01.002--
Pericardial haemorrhage02.06.01.003; 24.07.01.013---
Pyrexia08.05.02.003--
Rash23.03.13.001---
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