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)
Spinal cord compression17.10.01.0060.000783%
Spleen disorder01.09.02.0030.000245%Not Available
Splenic infarction24.04.08.024; 01.09.02.0040.000734%Not Available
Stress ulcer07.04.04.0070.000245%Not Available
Subarachnoid haemorrhage17.08.01.010; 12.01.10.011; 24.07.04.0040.016637%Not Available
Subcutaneous emphysema23.07.04.006; 12.02.06.0020.000367%
Sudden death08.04.01.003; 02.03.04.0130.001468%
Superior vena cava syndrome24.04.09.008; 16.32.03.0190.000245%
Surgery25.01.02.003--Not Available
Syncope02.11.04.015; 24.06.02.012; 17.02.04.0080.013334%
Testicular swelling21.13.01.0030.000538%Not Available
Thrombocytopenia01.08.01.002--Not Available
Thrombocytopenic purpura23.06.01.007; 01.08.01.0030.000245%Not Available
Thrombocytosis01.08.02.0010.000905%Not Available
Thrombophlebitis24.01.02.0010.000856%Not Available
Thrombosis24.01.01.0060.031243%Not Available
Thrombosis mesenteric vessel24.01.08.001; 07.15.02.0040.000367%Not Available
Thrombotic stroke24.01.04.006; 17.08.01.0210.001223%Not Available
Thyroid neoplasm16.24.01.002; 05.02.05.0020.000245%Not Available
Transient ischaemic attack24.04.06.005; 17.08.04.0010.045555%
Transitional cell carcinoma20.08.01.010; 16.08.04.0020.000245%Not Available
Ulcer08.03.06.0010.003205%Not Available
Upper gastrointestinal haemorrhage24.07.02.024; 07.12.02.0060.020527%
Ureteric obstruction20.06.01.0050.000245%Not Available
Urine flow decreased20.02.02.0120.000538%Not Available
Urticaria23.04.02.001; 10.01.06.001--
Uterine haemorrhage24.07.03.004; 21.07.01.0050.000979%
Varicose vein24.10.04.0010.002447%Not Available
Vasculitis24.12.04.027; 10.02.02.0060.002642%
Vena cava thrombosis24.01.10.0010.000856%Not Available
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