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)
Rectal polyp07.20.01.005; 16.05.02.0030.000245%-
Rectal ulcer07.04.01.0020.000783%
Renal artery thrombosis20.01.07.010; 24.01.11.0010.000856%-
Renal failure20.01.03.0050.044772%-
Renal haemorrhage12.01.05.004; 20.01.02.013; 24.07.07.0020.001468%
Renal infarct20.01.07.008; 24.01.11.0040.002691%-
Renal pain20.02.03.0030.001492%-
Renal tubular necrosis20.01.07.0030.001101%-
Renal vein thrombosis20.01.07.011; 24.01.11.0020.000245%-
Respiratory tract haemorrhage22.02.07.011; 24.07.01.0360.000367%-
Retinal artery occlusion06.10.01.005; 24.01.07.0030.000979%-
Retinal artery thrombosis06.10.01.007; 24.01.07.0050.000612%-
Retinal detachment06.09.03.003; 12.01.04.0040.000734%
Retinal haemorrhage06.10.01.001; 24.07.05.0030.001884%-
Retinal vascular occlusion06.10.01.008; 24.04.10.0040.000245%-
Retinal vein occlusion06.10.01.010; 24.01.07.0060.001321%-
Retrograde amnesia17.03.02.006; 19.20.01.0060.000245%-
Retroperitoneal fibrosis07.07.03.003; 10.02.01.026; 20.06.01.0060.000245%-
Retroperitoneal haemorrhage07.07.02.002; 12.01.17.018; 24.07.01.0170.003425%
Shock24.06.02.0020.008196%-
Shock symptom24.06.02.0210.000245%-
Sinus arrest02.03.03.0070.000367%-
Skin erosion23.07.03.0020.000538%-
Skin fragility23.03.03.0090.000832%-
Skin necrosis23.03.03.0110.001395%-
Skin odour abnormal23.03.03.0120.001370%
Skin warm23.03.03.0140.000245%-
Small intestinal obstruction07.13.06.0010.001835%
Small intestinal perforation07.04.06.0060.000612%
Speech disorder17.02.08.003; 19.19.02.002; 22.12.03.0270.005872%-
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