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 etexilate is available in both oral pellet and capsule form. Dabigatran etexilate pellets are indicated for the treatment of venous thromboembolic events (VTE) in pediatric patients between three months and 12 years of age who have been treated with a parenteral anticoagulant for at least 5 days. They are also indicated in the same age group to reduce the risk of recurrence of VTE in patients who have been previously treated.[L34675] In capsule form, dabigatran etexilate is indicated in adults to reduce the risk of stroke and systemic embolism associated with non-valvular atrial fibrillation and for the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in patients who have been treated with a parenteral anticoagulant for 5-10 days. It is also indicated in adults to reduce the risk of recurrence of DVT and PE in patients who have been previously treated and for the prophylaxis of DVT and PE in patients who have undergone hip replacement surgery. Lastly, it is indicated in pediatric patients between eight and 18 years of age for the treatment of venous thromboembolic events (VTE) in patients who have been treated with a parenteral anticoagulant for at least 5 days and to reduce the risk of recurrence of VTE in patients who have been previously treated.[L34680]
Marketing Status approved
ATC Code B01AE07
DrugBank ID DB06695
KEGG ID D07144
MeSH ID D000069604
PubChem ID 135565674
TTD Drug ID D0KI5R
NDC Product Code 67877-475; 67877-474; 31722-621; 60687-744; 60687-752; 0597-0430; 0597-0445; 31722-622; 0597-0425; 0597-0435; 0597-0440; 0597-0450
UNII 2E18WX195X
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
SMILES CCCCCCOC(=O)NC(=N)C1=CC=C(C=C1)NCC2=NC3=C(N2C)C=CC(=C3)C(=O)N(CCC(=O)OCC)C4=CC=C C=N4
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)
Abdominal discomfort07.01.06.001--Not Available
Abdominal pain07.01.05.002--
Abdominal pain upper07.01.05.003--
Acute myocardial infarction02.02.02.001; 24.04.04.001--Not Available
Alanine aminotransferase increased13.03.04.005--
Anaemia01.03.02.001--
Anaphylactic shock24.06.02.004; 10.01.07.002--Not Available
Angina pectoris24.04.04.002; 02.02.02.002--
Angina unstable24.04.04.004; 02.02.02.004--Not Available
Angioedema22.04.02.008; 23.04.01.001; 10.01.05.009--Not Available
Aortic aneurysm24.02.03.001--Not Available
Aortic aneurysm rupture24.02.03.003--Not Available
Aortic dissection24.02.03.002--Not Available
Aphasia17.02.03.001; 19.21.01.001--
Arterial thrombosis24.01.01.002--Not Available
Arthralgia15.01.02.001--
Aspartate aminotransferase increased13.03.04.011--
Asthenia08.01.01.001--Not Available
Atrial fibrillation02.03.03.002--
Back pain15.03.04.005--
Bladder cancer16.08.01.001; 20.03.04.001--Not Available
Blindness06.02.10.003; 17.17.01.003--Not Available
Blindness unilateral06.02.10.007; 17.17.01.016--Not Available
Blood bilirubin increased13.03.04.018--
Bone disorder15.02.04.004--Not Available
Brain stem haemorrhage17.08.01.031; 24.07.04.015--Not Available
Bronchitis11.01.09.001; 22.07.01.001--
Bronchospasm22.03.01.004; 10.01.03.012--
Cardiac arrest02.03.04.001--
Cardiac failure02.05.01.001--
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