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)
Dermatitis23.03.04.002--Not Available
Dermatitis exfoliative23.03.07.001; 10.01.01.0040.000783%
Diabetic retinopathy24.03.07.004; 14.07.01.002; 06.10.02.002; 05.07.01.0020.000245%Not Available
Diarrhoea07.02.01.001--
Diarrhoea haemorrhagic24.07.02.004; 07.02.01.0020.000856%Not Available
Disseminated intravascular coagulation01.01.02.002; 24.01.01.0100.005015%
Diverticulum07.10.01.0010.001590%Not Available
Diverticulum intestinal07.10.01.0020.001713%Not Available
Drug hypersensitivity10.01.01.001--Not Available
Drug interaction08.06.03.0010.019621%Not Available
Duodenal ulcer07.04.02.0020.001713%
Duodenal ulcer haemorrhage24.07.02.020; 07.04.02.0040.001223%Not Available
Duodenal ulcer perforation07.04.02.0030.001223%Not Available
Duodenitis07.08.03.0010.000856%Not Available
Dysarthria19.19.03.001; 17.02.08.0010.009762%
Dyspepsia07.01.02.0010.020722%
Ear haemorrhage12.01.14.004; 24.07.01.004; 04.03.01.0020.001028%Not Available
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.0010.004061%Not Available
Embolic stroke24.01.04.010; 17.08.01.0320.021897%Not Available
Embolism arterial24.01.01.0140.002202%
Embolism venous24.01.01.0030.003401%Not Available
Emphysema22.01.02.0020.000612%Not Available
Endometrial cancer21.07.02.002; 16.12.02.0010.000245%Not Available
Epistaxis24.07.01.005; 22.04.03.0010.029065%
Eructation07.01.02.0030.001321%
Extensor plantar response17.02.01.0050.000489%Not Available
Eye haemorrhage06.07.02.001; 12.02.02.012; 24.07.05.0020.003034%Not Available
Eyelid ptosis17.17.02.004; 06.05.01.0020.000661%Not Available
Facial paralysis17.04.03.0080.002862%Not Available
Faeces discoloured07.01.03.0020.011156%Not Available
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