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)
Metastatic neoplasm16.16.01.0070.000734%-
Motor dysfunction15.05.06.006; 17.01.02.0310.000734%-
Mucosal haemorrhage08.01.06.005; 24.07.01.0110.001982%-
Oesophageal disorder07.11.02.0010.001370%-
Peripheral embolism24.01.02.0050.007095%-
Cardiac valve disease02.07.02.0010.000856%-
Venous thrombosis limb24.01.02.0090.001933%-
Gastrointestinal ulcer07.04.04.0020.000856%-
Polyp08.01.06.010; 16.02.02.0050.003132%-
Urinary tract obstruction20.08.01.0040.000856%
Ulcer haemorrhage08.03.06.003; 24.07.01.0400.002080%-
Cardiac fibrillation02.03.02.0210.000367%-
Artery dissection24.02.01.0030.000245%-
Autoimmune disorder10.04.04.0030.000783%
Diverticular perforation07.04.04.0080.000856%-
Obstruction08.01.03.0230.000489%-
Oesophageal neoplasm07.21.04.004; 16.13.08.0010.000245%-
Gastrointestinal obstruction07.13.01.0050.000612%-
Lung neoplasm16.19.04.001; 22.08.01.0060.000489%-
Large intestinal obstruction07.13.03.0030.000734%
Metabolic encephalopathy14.11.01.013; 17.13.01.0010.000612%-
Renal impairment20.01.03.0100.029799%-
Non-cardiac chest pain08.01.08.006; 22.12.02.0090.000489%
Heparin-induced thrombocytopenia01.08.01.004; 10.02.01.007; 24.01.01.0200.000489%-
Peripheral arterial occlusive disease24.04.03.0100.000734%-
Arterial occlusive disease24.04.02.0210.001101%-
Haemorrhagic diathesis01.01.03.003; 24.07.01.0200.001223%-
Effusion08.01.03.0520.000538%-
Cerebral artery stenosis17.08.02.010; 24.04.06.0230.000367%-
Erosive oesophagitis07.04.05.0040.000245%-
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