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)
Vascular encephalopathy24.04.06.042; 19.20.04.002; 17.08.02.0250.000245%Not Available
Accidental death12.01.08.040; 08.04.01.0130.000245%Not Available
Renal ischaemia20.01.07.015; 24.04.11.0050.000245%Not Available
Multimorbidity08.01.03.0750.000612%Not Available
Mucosal exfoliation08.01.06.0210.000245%Not Available
Thalamic infarction24.04.06.041; 17.08.01.0610.000612%Not Available
Eyelid haematoma24.07.05.013; 23.06.07.007; 12.01.04.025; 06.07.05.0020.000245%Not Available
Oesophageal fistula07.11.05.0130.000245%
Basal ganglia haemorrhage17.08.01.039; 24.07.04.0210.001346%Not Available
Carotid arteriosclerosis24.04.06.031; 17.08.02.0150.000367%Not Available
Thrombotic cerebral infarction24.01.04.017; 17.08.01.0630.000367%Not Available
Abdominal wall haematoma24.07.02.039; 07.16.05.0050.001590%Not Available
Apparent death08.01.03.0620.000367%Not Available
Inguinal hernia strangulated24.04.08.016; 07.16.02.0040.000612%Not Available
Dieulafoy's vascular malformation24.03.03.025; 07.15.04.0020.000856%Not Available
Haemorrhagic hepatic cyst24.07.01.070; 16.06.02.003; 09.01.08.0130.000367%Not Available
Aortic intramural haematoma24.02.03.0040.000734%Not Available
Cerebral amyloid angiopathy24.03.05.010; 17.08.02.017; 10.02.05.0030.000245%Not Available
Cardiorenal syndrome02.05.01.012; 20.01.03.0180.000245%Not Available
Femoral artery embolism24.01.02.0120.000905%Not Available
Cerebellar ischaemia17.08.01.047; 24.04.06.0330.000245%Not Available
Splenic embolism24.01.08.005; 01.09.02.0120.000245%Not Available
Basal ganglia infarction24.04.06.028; 17.08.01.0400.000489%Not Available
Oesophageal mucosal dissection07.11.02.0070.000245%Not Available
Prerenal failure24.06.02.025; 20.01.03.0220.000783%Not Available
Spontaneous haemorrhage24.07.01.081; 01.01.03.0070.000245%Not Available
Internal haemorrhage24.07.01.0720.002495%Not Available
Chest wall haematoma15.03.05.005; 24.07.01.0650.000245%Not Available
Cerebral vascular occlusion24.04.06.035; 17.08.01.0490.000734%Not Available
Lacunar stroke24.04.06.037; 17.08.01.0540.000612%Not Available
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