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 polyp16.05.02.003; 07.20.01.0050.000245%Not Available
Rectal ulcer07.04.01.0020.000783%
Renal artery thrombosis24.01.11.001; 20.01.07.0100.000856%Not Available
Renal failure20.01.03.0050.044772%Not Available
Renal haemorrhage20.01.02.013; 12.01.05.004; 24.07.07.0020.001468%
Renal infarct24.01.11.004; 20.01.07.0080.002691%Not Available
Renal pain20.02.03.0030.001492%Not Available
Renal tubular necrosis20.01.07.0030.001101%Not Available
Renal vein thrombosis24.01.11.002; 20.01.07.0110.000245%Not Available
Respiratory tract haemorrhage24.07.01.036; 22.02.07.0110.000367%Not Available
Retinal artery occlusion24.01.07.003; 06.10.01.0050.000979%Not Available
Retinal artery thrombosis24.01.07.005; 06.10.01.0070.000612%Not Available
Retinal detachment12.01.04.004; 06.09.03.0030.000734%
Retinal haemorrhage24.07.05.003; 06.10.01.0010.001884%Not Available
Retinal vascular occlusion24.04.10.004; 06.10.01.0080.000245%Not Available
Retinal vein occlusion24.01.07.006; 06.10.01.0100.001321%Not Available
Retrograde amnesia19.20.01.006; 17.03.02.0060.000245%Not Available
Retroperitoneal fibrosis20.06.01.006; 10.02.01.026; 07.07.03.0030.000245%Not Available
Retroperitoneal haemorrhage07.07.02.002; 12.01.17.018; 24.07.01.0170.003425%
Shock24.06.02.0020.008196%Not Available
Shock symptom24.06.02.0210.000245%Not Available
Sinus arrest02.03.03.0070.000367%Not Available
Skin erosion23.07.03.0020.000538%Not Available
Skin fragility23.03.03.0090.000832%Not Available
Skin necrosis23.03.03.0110.001395%Not Available
Skin odour abnormal23.03.03.0120.001370%
Skin warm23.03.03.0140.000245%Not Available
Small intestinal obstruction07.13.06.0010.001835%
Small intestinal perforation07.04.06.0060.000612%
Speech disorder22.12.03.027; 19.19.02.002; 17.02.08.0030.005872%Not Available
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