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)
Gallbladder cancer16.07.05.001; 09.04.02.0050.000245%Not Available
Gastric cancer16.13.03.001; 07.21.02.0010.002202%Not Available
Gastric haemorrhage24.07.02.007; 07.12.01.0010.007927%
Gastric perforation12.02.03.007; 07.04.03.0010.001101%
Gastric polyps16.05.03.001; 07.20.01.0030.000245%Not Available
Gastric ulcer07.04.03.0020.004037%
Gastric ulcer haemorrhage24.07.02.003; 07.04.03.0050.003229%Not Available
Gastric ulcer perforation07.04.03.0060.000245%Not Available
Gastritis07.08.02.0010.005798%
Gastritis erosive07.04.03.0030.002814%Not Available
Gastritis haemorrhagic24.07.02.008; 07.08.02.0020.001223%Not Available
Gastrooesophageal reflux disease07.02.02.003--
Gastrointestinal carcinoma16.13.04.001; 07.21.03.0010.001957%Not Available
Gastrointestinal haemorrhage24.07.02.009; 07.12.02.0010.237586%Not Available
Gastrointestinal necrosis07.15.01.003; 24.04.08.0060.002447%
Gastrointestinal pain07.01.05.0050.000734%
Gastrointestinal perforation07.04.04.0010.001346%Not Available
Gingival bleeding24.07.02.010; 07.09.07.0010.005187%Not Available
Gouty arthritis15.01.06.004; 14.09.01.0040.000245%Not Available
Groin pain15.03.02.0040.001076%Not Available
Haemangioma24.03.06.004; 16.02.01.0020.000245%Not Available
Haemarthrosis15.01.01.004; 12.04.03.001; 24.07.01.0460.003278%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.017835%Not Available
Haematochezia24.07.02.012; 07.12.02.0030.019597%Not Available
Haematoma24.07.01.0010.029065%
Haematuria24.07.01.047; 20.02.01.006; 21.10.01.0180.040246%
Haemoglobin13.01.05.018--Not Available
Haemoptysis02.11.04.009; 24.07.01.006; 22.02.03.0040.014655%Not Available
Haemorrhage intracranial24.07.04.003; 17.08.01.0080.065201%
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.001223%Not Available
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