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)
Peptic ulcer07.04.07.0010.000905%-
Pericardial effusion02.06.01.0020.019206%
Pericardial haemorrhage02.06.01.003; 24.07.01.0130.010545%-
Pericarditis02.06.02.0010.001884%
Peripheral ischaemia24.04.03.0020.004159%
Petechiae01.01.03.002; 23.06.01.003; 24.07.06.0040.003915%-
Pharyngeal haemorrhage22.04.05.002; 24.07.02.0170.000612%
Pharyngeal ulceration22.04.05.0040.000245%-
Phlebitis12.02.01.002; 24.12.03.0040.002985%
Phlebitis superficial24.12.03.0050.000954%-
Pleural effusion22.05.02.0020.007511%
Pleuritic pain22.12.01.0070.000245%
Pneumothorax22.05.02.0030.003548%
Polymyalgia rheumatica10.04.05.003; 15.06.01.0010.000367%-
Portal vein thrombosis09.01.06.007; 24.01.03.0030.000612%
Proctalgia07.03.02.0010.002031%
Proctitis07.08.04.0010.001615%
Pruritus23.03.12.001--
Pulmonary alveolar haemorrhage22.01.02.005; 24.07.01.0150.002202%-
Pulmonary congestion02.05.02.002; 22.01.03.002; 24.03.08.0010.001101%-
Pulmonary embolism22.06.02.001; 24.01.06.0010.058595%-
Pulmonary haemorrhage22.12.01.009; 24.07.01.0160.007707%
Pulmonary infarction22.06.02.002; 24.04.09.0010.000612%-
Pulmonary oedema02.05.02.003; 22.01.03.0030.004771%
Pupillary disorder06.05.03.008; 17.02.11.0060.000245%-
Quadriplegia17.01.04.0130.000856%-
Rash23.03.13.001---
Rebound effect08.06.02.0090.000979%-
Rectal cancer07.21.05.002; 16.13.01.0030.001713%-
Rectal haemorrhage07.12.03.001; 24.07.02.0180.054338%
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