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)
Haemorrhagic disorder01.01.03.004; 24.07.01.0210.001223%-
Haemorrhagic stroke17.08.01.011; 24.07.04.0140.017371%-
Haemorrhoids07.15.03.001; 24.10.02.0020.006753%
Haemothorax12.01.18.005; 22.05.02.001; 24.07.01.0080.007951%
Hemianopia06.02.07.004; 17.17.01.0120.000856%-
Hemiparesis17.01.04.0010.018472%
Hemiplegia17.01.04.0020.009664%-
Hepatic cyst09.01.08.008; 16.06.02.0010.000245%-
Hepatic failure09.01.03.0020.005382%
Hepatic haemorrhage09.01.06.008; 12.01.17.009; 24.07.01.0270.001101%
Hepatic neoplasm09.04.03.001; 16.07.03.0010.000367%-
Hepatitis09.01.07.0040.003156%-
Hepatitis acute09.01.07.0050.001101%-
Hepatitis cholestatic09.01.01.0020.000979%-
Hepatorenal syndrome09.01.03.007; 20.01.03.0120.000612%-
Hiatus hernia07.16.01.001; 22.09.02.0040.000979%-
Hydrocephalus17.07.01.0010.001468%
Hydronephrosis20.01.05.0010.000856%-
Hypercapnia14.01.04.001; 22.02.02.0020.000367%-
Hypercoagulation01.01.02.0070.001272%-
Hypersensitivity10.01.03.003--
Hypersensitivity vasculitis01.01.04.008; 10.02.02.017; 23.06.02.005; 24.12.04.0130.000734%-
Hypertensive crisis24.08.01.0010.002691%-
Hypochloraemia14.05.08.0030.000245%-
Hypochromic anaemia01.03.02.0040.000367%-
Hypocoagulable state01.01.02.0040.001957%-
Hypoprothrombinaemia01.01.01.0010.000489%-
Hypotension24.06.03.002--
Hypovolaemia14.05.05.0020.001957%-
Hypovolaemic shock24.06.02.0170.008196%-
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