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%-
Lacunar infarction17.08.01.016; 24.04.06.0090.001468%-
Cardiopulmonary failure02.05.01.004; 22.02.06.0040.001835%-
Catheter site haemorrhage08.02.02.002; 12.07.02.002; 24.07.01.0030.000979%-
Puncture site haemorrhage08.02.04.007; 12.07.04.006; 24.07.01.0340.000856%-
Facial paresis17.04.03.0020.001468%
Exercise tolerance decreased08.01.03.0360.000367%-
Systemic inflammatory response syndrome08.01.05.005; 10.02.01.008; 24.06.03.0080.000489%-
Prostatomegaly21.04.01.0020.000367%-
Large intestine polyp07.20.01.010; 16.05.02.0060.002544%-
Acute coronary syndrome02.02.02.015; 24.04.04.0110.004526%-
Haemodynamic instability24.03.02.0060.004771%-
Gastrointestinal hypomotility07.02.02.0050.000245%-
Oesophageal rupture07.04.05.005; 12.01.17.0150.000367%-
Gastrointestinal hypermotility07.02.04.0050.000538%-
Large intestinal haemorrhage07.12.03.003; 24.07.02.0260.003303%
Epigastric discomfort07.01.02.0040.001076%-
Organ failure08.01.03.0410.000734%-
Vascular rupture12.01.11.006; 24.03.02.0230.000367%-
Cerebral haematoma17.08.01.014; 24.07.04.0060.007829%-
Vessel puncture site haemorrhage08.02.04.014; 12.07.04.014; 24.07.01.0610.000734%-
Haemorrhoidal haemorrhage07.15.03.002; 24.10.02.0010.005578%
Cerebral disorder17.02.10.0170.001346%-
Pelvic haematoma21.07.04.001; 24.07.03.0100.001223%-
Haemorrhagic transformation stroke17.08.01.036; 24.07.04.0180.005872%-
Haemorrhage24.07.01.0020.137693%-
Haemorrhage urinary tract20.02.03.005; 24.07.01.0070.002373%-
Varices oesophageal07.15.05.001; 09.01.06.009; 24.10.02.0040.000856%-
Faecaloma07.01.03.0040.000612%-
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