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 mediastinal22.09.03.006; 01.09.01.0250.000245%Not Available
Malignant pleural effusion22.05.04.001; 16.32.03.0140.000245%Not Available
Mesenteric artery embolism24.01.08.002; 07.15.02.0070.001101%Not Available
Neurologic neglect syndrome06.02.06.018; 19.21.01.009; 17.02.03.0170.000856%Not Available
Normal pressure hydrocephalus17.07.01.0020.000245%Not Available
Pancreatic cyst07.18.03.003; 16.05.01.0050.000245%Not Available
Pneumothorax spontaneous22.05.02.0070.000612%Not Available
Pulmonary artery thrombosis24.01.06.005; 22.06.02.0050.000489%Not Available
Renal haematoma20.01.02.018; 12.01.05.006; 24.07.07.0040.000367%Not Available
Ruptured cerebral aneurysm24.02.04.005; 17.08.01.0590.000367%Not Available
Splenic haematoma01.09.02.014; 12.01.17.019; 24.07.01.0790.000245%Not Available
Splenic haemorrhage12.01.17.020; 24.07.01.080; 01.09.02.0150.000856%Not Available
Strangulated hernia24.04.02.025; 08.01.04.0050.002324%Not Available
Ureteric stenosis20.06.01.0100.000245%Not Available
Urinary bladder haemorrhage24.07.01.086; 20.03.01.0230.001468%Not Available
Urinary bladder rupture20.03.01.024; 12.01.05.0070.000245%Not Available
Varicose vein ruptured24.10.04.0050.000367%Not Available
Vertebral artery stenosis24.04.06.044; 17.08.02.0270.000245%Not Available
Aneurysm ruptured24.02.01.0020.000856%Not Available
Atrial thrombosis02.11.01.002; 24.01.05.0050.021065%Not Available
Basilar artery occlusion24.04.06.030; 17.08.01.0420.000489%Not Available
Vertebral artery occlusion24.04.06.043; 17.08.01.0640.000367%Not Available
Subclavian vein thrombosis24.01.02.0130.000367%Not Available
Tongue haemorrhage24.07.02.058; 07.14.01.0150.001076%Not Available
Mediastinal haematoma24.07.01.074; 22.09.03.0070.000367%Not Available
Skin ulcer haemorrhage23.07.03.021; 24.07.01.0780.000367%Not Available
Carotid artery dissection24.02.04.004; 17.08.06.0030.000245%Not Available
Tongue biting12.01.17.023; 17.02.05.064; 07.14.01.0130.000245%Not Available
Soft tissue haemorrhage24.07.01.043; 15.03.02.0110.001199%Not Available
Mechanical ileus07.13.01.0140.000245%Not Available
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