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)
IIIrd nerve paralysis06.05.02.011; 17.04.02.0030.000245%-
Ileus07.13.01.0010.006116%
Inguinal hernia07.16.02.0010.001223%-
Injection site haemorrhage08.02.03.005; 12.07.03.005; 24.07.01.0100.000612%-
Intestinal infarction07.15.02.006; 24.04.08.0080.001101%-
Intestinal ischaemia07.15.02.001; 24.04.08.0010.006899%-
Intestinal obstruction07.13.01.0020.006361%-
Intestinal perforation07.04.06.0020.004037%-
Intestinal ulcer07.04.06.0030.000612%-
Intracranial aneurysm17.08.06.001; 24.02.04.0010.000489%-
Intracranial pressure increased17.07.02.0020.001468%-
Intraventricular haemorrhage17.08.01.017; 24.07.04.0080.003792%-
Iron deficiency14.13.02.0020.000612%-
Iron deficiency anaemia01.03.01.002; 14.13.02.0010.003841%-
Joint effusion15.01.02.0050.000367%
Large intestinal ulcer07.04.06.0040.000245%
Large intestine perforation07.04.06.005; 12.02.03.0050.002080%
Left ventricular failure02.05.02.0010.000367%-
Lung consolidation22.01.02.0100.000367%-
Lymphoma01.12.01.001; 16.20.01.0010.001468%-
Mallory-Weiss syndrome07.12.01.004; 24.07.02.0380.000979%-
Megacolon07.02.05.0020.000245%-
Melaena07.12.02.004; 24.07.02.0130.041102%-
Mesenteric artery thrombosis07.15.02.008; 24.01.08.0030.000612%-
Metastatic malignant melanoma16.03.01.002; 23.08.01.0020.000367%-
Microcytic anaemia01.03.02.0080.001101%-
Mitral valve incompetence02.07.01.0020.001884%-
Monoparesis17.01.04.0110.001713%-
Monoplegia17.01.04.0030.000979%-
Mouth haemorrhage07.05.02.001; 24.07.02.0140.004306%
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