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)
Pelvic haemorrhage24.07.03.016; 21.07.04.007; 12.01.09.0130.000612%Not Available
Vascular stent thrombosis08.07.05.002; 24.01.01.0440.000856%Not Available
Skin haemorrhage24.07.01.103; 23.06.07.0010.002202%Not Available
Tumour invasion16.16.01.0080.000538%Not Available
Spontaneous haematoma24.07.01.054; 01.01.03.0060.000734%Not Available
Cerebral hypoperfusion24.03.05.008; 17.08.02.011; 12.02.01.0140.000245%Not Available
Urethral stenosis20.07.03.0030.000367%Not Available
Bronchial haemorrhage24.07.01.045; 22.03.02.0070.000367%Not Available
Cardiovascular insufficiency02.11.01.011; 24.06.03.0050.000905%Not Available
Mixed liver injury09.01.07.0150.000245%Not Available
Liver injury12.01.17.012; 09.01.07.0220.002447%Not Available
Organising pneumonia22.01.02.0080.000612%Not Available
Haemorrhagic erosive gastritis24.07.02.037; 07.04.03.0080.000245%Not Available
Brain injury19.07.03.007; 17.11.01.0030.001713%Not Available
Cholestatic liver injury09.01.07.0160.000367%Not Available
Anal pruritus07.03.03.0020.001248%Not Available
Anorectal discomfort07.03.03.0030.001370%Not Available
Neurological decompensation17.02.05.0300.001346%Not Available
Brain stem stroke24.04.06.024; 17.08.01.0330.000367%Not Available
Acute kidney injury20.01.03.0160.054436%
Hypoxic-ischaemic encephalopathy17.13.02.006; 24.04.06.021; 22.02.02.0110.000489%Not Available
Gastrointestinal tract irritation07.08.03.0080.001076%Not Available
Central nervous system haemorrhage24.07.04.016; 17.08.01.0350.000734%Not Available
Peripheral artery thrombosis24.01.02.0100.002691%Not Available
Granulomatosis with polyangiitis10.02.02.018; 24.12.04.011; 22.01.01.015; 20.05.01.0130.000245%Not Available
Application site haemorrhage24.07.01.048; 12.07.01.040; 08.02.01.0400.000245%Not Available
Mesenteric vascular occlusion24.04.08.014; 07.15.02.0110.000245%Not Available
Language disorder19.19.01.006; 17.02.08.0150.000367%Not Available
Sinus node dysfunction02.03.03.0170.000489%
Spinal cord haematoma17.08.01.037; 12.01.13.005; 24.07.04.0190.000734%Not Available
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