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)
Lower gastrointestinal haemorrhage07.12.03.011; 24.07.02.0300.017175%
Deep vein thrombosis24.01.02.0030.052283%Not Available
Lacunar infarction24.04.06.009; 17.08.01.0160.001468%Not Available
Cardiopulmonary failure22.02.06.004; 02.05.01.0040.001835%Not Available
Catheter site haemorrhage08.02.02.002; 24.07.01.003; 12.07.02.0020.000979%Not Available
Puncture site haemorrhage24.07.01.034; 12.07.04.006; 08.02.04.0070.000856%Not Available
Facial paresis17.04.03.0020.001468%
Exercise tolerance decreased08.01.03.0360.000367%Not Available
Systemic inflammatory response syndrome24.06.03.008; 10.02.01.008; 08.01.05.0050.000489%Not Available
Prostatomegaly21.04.01.0020.000367%Not Available
Large intestine polyp16.05.02.006; 07.20.01.0100.002544%Not Available
Acute coronary syndrome24.04.04.011; 02.02.02.0150.004526%Not Available
Haemodynamic instability24.03.02.0060.004771%Not Available
Gastrointestinal hypomotility07.02.02.0050.000245%Not Available
Oesophageal rupture12.01.17.015; 07.04.05.0050.000367%Not Available
Gastrointestinal hypermotility07.02.04.0050.000538%Not Available
Large intestinal haemorrhage24.07.02.026; 07.12.03.0030.003303%
Epigastric discomfort07.01.02.0040.001076%Not Available
Organ failure08.01.03.0410.000734%Not Available
Vascular rupture24.03.02.023; 12.01.11.0060.000367%Not Available
Cerebral haematoma24.07.04.006; 17.08.01.0140.007829%Not Available
Vessel puncture site haemorrhage24.07.01.061; 12.07.04.014; 08.02.04.0140.000734%Not Available
Haemorrhoidal haemorrhage24.10.02.001; 07.15.03.0020.005578%
Cerebral disorder17.02.10.0170.001346%Not Available
Pelvic haematoma24.07.03.010; 21.07.04.0010.001223%Not Available
Haemorrhagic transformation stroke24.07.04.018; 17.08.01.0360.005872%Not Available
Haemorrhage24.07.01.0020.137693%Not Available
Haemorrhage urinary tract24.07.01.007; 20.02.03.0050.002373%Not Available
Varices oesophageal09.01.06.009; 07.15.05.001; 24.10.02.0040.000856%Not Available
Faecaloma07.01.03.0040.000612%Not Available
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