Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Dabigatran
Drug ID BADD_D00563
Description Dabigatran is the active form of the orally bioavailable prodrug [dabigatran etexilate].
Indications and Usage Not Available
Marketing Status approved; investigational
ATC Code B01AE07
DrugBank ID DB14726
KEGG ID D09707
MeSH ID D000069604
PubChem ID 216210
TTD Drug ID D0M7JT
NDC Product Code 51869-0030
UNII I0VM4M70GC
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 C25H25N7O3
CAS Registry Number 211914-51-1
SMILES CN1C2=C(C=C(C=C2)C(=O)N(CCC(=O)O)C3=CC=CC=N3)N=C1CNC4=CC=C(C=C4)C(=N)N
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)
Intra-abdominal haematoma24.07.02.034; 07.12.02.0050.000734%Not Available
Gaze palsy17.02.05.044; 06.05.02.0140.000489%Not Available
Gastrointestinal ulcer haemorrhage24.07.02.023; 07.04.04.0060.000367%Not Available
Rectal tenesmus15.05.03.011; 07.03.03.0010.000367%Not Available
Urine odour abnormal20.02.01.0200.000905%Not Available
Vascular dementia17.03.01.003; 24.04.06.017; 19.20.04.0010.000245%Not Available
Pulseless electrical activity02.03.04.0200.001346%Not Available
Retroperitoneal haematoma24.07.01.060; 07.07.02.0050.001713%Not Available
Hypoperfusion24.06.02.0190.000367%Not Available
Aortic disorder24.03.04.0040.000245%Not Available
Venous occlusion24.04.02.0090.000245%Not Available
Intestinal mass07.11.01.0100.000489%Not Available
Intestinal haemorrhage24.07.02.031; 07.12.03.0050.008441%Not Available
Angiopathy24.03.02.0070.000489%Not Available
Extremity necrosis24.04.03.0120.000367%Not Available
Ischaemic cerebral infarction24.04.06.013; 17.08.01.0220.001590%Not Available
Aortic rupture24.03.04.009; 12.01.11.0070.000489%Not Available
General symptom08.01.03.0210.000245%Not Available
Abdominal neoplasm16.16.02.002; 07.21.04.0010.000245%Not Available
Allergic oedema10.01.03.025; 08.01.07.014--Not Available
Abdominal hernia07.16.06.0050.000538%Not Available
Biliary tract disorder09.02.03.0010.000367%Not Available
Brain neoplasm17.20.01.003; 16.30.01.0030.001346%Not Available
Colon neoplasm16.13.02.001; 07.21.10.0010.001884%Not Available
Embolism24.01.01.0090.013823%
Gastrointestinal neoplasm16.13.11.001; 07.21.04.0020.000979%Not Available
Infarction24.04.02.0170.003963%Not Available
Intra-abdominal haemorrhage12.01.17.011; 24.07.02.035; 07.12.02.0080.003548%
Ischaemia24.04.02.0040.004453%Not Available
Ischaemic stroke24.04.06.010; 17.08.01.0180.157437%Not Available
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