Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dabigatran etexilate
Drug ID BADD_D00564
Description Dabigatran etexilate is an oral prodrug that is hydrolyzed to the competitive and reversible direct thrombin inhibitor [dabigatran].[A177463, A6970, L34675, L34680] Dabigatran etexilate may be used to decrease the risk of venous thromboembolic events in patients in whom anticoagulation therapy is indicated.[A177463] In contrast to warfarin, because its anticoagulant effects are predictable, lab monitoring is not necessary.[A177463] Dabigatran etexilate was approved by the FDA in 2010.[L6022]
Indications and Usage Dabigatran is indicated for the prevention of venous thromboembolic events in patients who have undergone elective hip or knee replacement surgery (based on RE-NOVATE, RE-MODEL, and RE-MOBILIZE trials). In 2010, it was approved in the US and Canada for prevention of stroke and systemic embolism in patients with atrial fibrillation (approval based on the RE-LY trial). Contraindications: severe renal impairment (CrCL < 30 ml/min); haemorrhagic manifestations, bleeding diathesis or spontaneous or pharmacologic impairment of haemostasis; lesions at risk of clinically significant bleeding (e.g. extensive cerebral infarction (haemorrhagic or ischemic) in the last 6 months, active peptic ulcer disease); concomitant treatment with P-glycoprotein inhibitors (e.g. oral ketoconazole, verapamil); and those with known hypersensitivity to dabigatran, dabigatran etexilate or any ingredient used in the formulation or component of the container. As of December 2012, dabigatran is contraindicated in patients with mechanical prosthetic heart valves.
Marketing Status Prescription
ATC Code B01AE07
DrugBank ID DB06695
KEGG ID D07144
MeSH ID D000069604
PubChem ID 135565674
NDC Product Code 31722-621; 0597-0445; 0597-0425; 31722-622; 0597-0435; 0597-0450; 0597-0430; 0597-0440
Synonyms Dabigatran | N-((2-(((4-(aminoiminomethyl)phenyl)amino)methyl)-1-methyl-1H-benzimidazol-5-yl)carbonyl)-N-2-pyridinyl-beta-alanine | BIBR 1048 | Pradaxa | Dabigatran Etexilate | Etexilate, Dabigatran | Dabigatran Etexilate Mesylate | Etexilate Mesylate, Dabigatran | Mesylate, Dabigatran Etexilate
Chemical Information
Molecular Formula C34H41N7O5
CAS Registry Number 211915-06-9
Chemical Structure
ADR Related Proteins Induced by Drug
ADR Term Protein Name UniProt AC TTD Target ID PMID
Not AvailableNot AvailableNot AvailableNot AvailableNot Available
ADRs Induced by Drug
ADR Term ADReCS ID ADR Frequency (FAERS) ADR Severity Grade (FAERS) ADR Severity Grade (CTCAE)
Abdominal discomfort07.01.06.001--Not Available
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Abdominal pain lower07.01.05.010--Not Available
Abdominal pain upper07.01.05.003--
Abnormal dreams19.02.03.001; Available
Abnormal faeces07.01.03.0010.001582%Not Available
Abscess11.01.08.001--Not Available
Activated partial thromboplastin time13.01.02.0330.002110%Not Available
Activated partial thromboplastin time abnormal13.01.02.0190.006329%Not Available
Activated partial thromboplastin time prolonged13.01.02.0010.073839%
Activated partial thromboplastin time shortened13.01.02.0200.003165%Not Available
Acute abdomen07.01.06.0150.018987%Not Available
Acute hepatic failure09.01.03.001--Not Available
Acute myeloid leukaemia16.01.05.001; Available
Acute myocardial infarction02.02.02.001; Available
Acute prerenal failure24.06.02.003; Available
Acute pulmonary oedema22.01.03.005; Available
Acute respiratory distress syndrome22.01.03.001--
Acute respiratory failure22.02.06.001; Available
Adenocarcinoma16.16.01.0040.000275%Not Available
Adrenal haemorrhage24.07.01.023;; Available
Ageusia07.14.03.003; Available
Aggression19.05.01.001--Not Available
Agranulocytosis01.02.03.001--Not Available
Alanine aminotransferase increased13.03.01.003--
Altered state of consciousness19.07.01.003; Available
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