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)
Vasculitis10.02.02.006; 24.12.04.027--
Ventricular tachycardia02.03.04.010--
Vomiting07.01.07.003--
Intracardiac thrombus02.11.01.017; 24.01.05.003--Not Available
Wound secretion12.01.08.007; 08.01.03.035--Not Available
Anaemia postoperative12.02.05.032; 01.03.02.014--Not Available
Spinal cord haemorrhage24.07.04.010; 17.08.01.030; 12.01.13.003--Not Available
Tumour haemorrhage24.07.01.028; 16.32.03.008--
Balance disorder08.01.03.081; 17.02.02.007--Not Available
Lung cancer metastatic22.08.01.004; 16.19.02.003--Not Available
Urogenital haemorrhage24.07.01.044; 21.10.05.008; 20.08.01.006--Not Available
Contusion15.03.05.007; 24.07.06.001; 23.03.11.002; 12.01.06.001--
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.030--
Deep vein thrombosis24.01.02.003--Not Available
Post procedural haemorrhage24.07.01.014; 12.02.05.004--
Catheter site haemorrhage24.07.01.003; 12.07.02.002; 08.02.02.002--Not Available
Incision site haemorrhage24.07.01.022; 12.02.05.014--Not Available
Wound haemorrhage24.07.01.029; 12.01.08.017--Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.015--Not Available
Lymphatic disorder01.09.01.003--Not Available
Wound23.03.11.043; 12.01.08.009--Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.003--
Epigastric discomfort07.01.02.004--Not Available
Musculoskeletal discomfort15.03.04.001--Not Available
Traumatic haemorrhage24.07.01.056; 12.01.08.029--Not Available
Vascular occlusion24.04.02.015--Not Available
Cerebral haematoma24.07.04.006; 17.08.01.014--Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.002--
Transaminases increased13.03.04.036--Not Available
Haemorrhagic transformation stroke17.08.01.036; 24.07.04.018--Not Available
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