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)
Lymphadenopathy mediastinal01.09.01.025; 22.09.03.0060.000245%-
Malignant pleural effusion16.32.03.014; 22.05.04.0010.000245%-
Mesenteric artery embolism07.15.02.007; 24.01.08.0020.001101%-
Neurologic neglect syndrome06.02.06.018; 17.02.03.017; 19.21.01.0090.000856%-
Normal pressure hydrocephalus17.07.01.0020.000245%-
Pancreatic cyst07.18.03.003; 16.05.01.0050.000245%-
Pneumothorax spontaneous22.05.02.0070.000612%-
Pulmonary artery thrombosis22.06.02.005; 24.01.06.0050.000489%-
Renal haematoma12.01.05.006; 20.01.02.018; 24.07.07.0040.000367%-
Ruptured cerebral aneurysm17.08.01.059; 24.02.04.0050.000367%-
Splenic haematoma01.09.02.014; 12.01.17.019; 24.07.01.0790.000245%-
Splenic haemorrhage01.09.02.015; 12.01.17.020; 24.07.01.0800.000856%-
Strangulated hernia08.01.04.005; 24.04.02.0250.002324%-
Ureteric stenosis20.06.01.0100.000245%-
Urinary bladder haemorrhage20.03.01.023; 24.07.01.0860.001468%-
Urinary bladder rupture12.01.05.007; 20.03.01.0240.000245%-
Varicose vein ruptured24.10.04.0050.000367%-
Vertebral artery stenosis17.08.02.027; 24.04.06.0440.000245%-
Aneurysm ruptured24.02.01.0020.000856%-
Atrial thrombosis02.11.01.002; 24.01.05.0050.021065%-
Basilar artery occlusion17.08.01.042; 24.04.06.0300.000489%-
Vertebral artery occlusion17.08.01.064; 24.04.06.0430.000367%-
Subclavian vein thrombosis24.01.02.0130.000367%-
Tongue haemorrhage07.14.01.015; 24.07.02.0580.001076%-
Mediastinal haematoma22.09.03.007; 24.07.01.0740.000367%-
Skin ulcer haemorrhage23.07.03.021; 24.07.01.0780.000367%-
Carotid artery dissection17.08.06.003; 24.02.04.0040.000245%-
Tongue biting07.14.01.013; 12.01.17.023; 17.02.05.0640.000245%-
Soft tissue haemorrhage15.03.02.011; 24.07.01.0430.001199%-
Mechanical ileus07.13.01.0140.000245%-
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