Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Idarucizumab
Drug ID BADD_D01129
Description Idarucizumab is a humanized monoclonal antibody fragment (Fab) derived from an immunoglobulin G1 isotype molecule that binds to and inactivates the oral anticoagulant dabigatran, thereby reversing its anticoagulant effect. As a direct acting oral anticoagulant (DOAC), one of the risks associated with the use of dabigatran includes bleeding, espeically when given to patients at increased risk (elderly, chronic kidney disease, concomitant NSAID or warfarin use, etc). Approved under the tradename Praxbind (FDA), idarucizumab is indicated for the emergency treatment of dabigatran-associated bleeding in life-threatening or surgically induced situations. Its use is associated with immediate, complete and sustained reversal of the anticoagulant effects of dabigatran. Idarucizumab protein structure can be viewed below, with disulfide bridges at the following points: H22-H95, H149-H205, H225-L-219, L23-L93, L139-L199.
Indications and Usage For use in patients treated with Dabigatran when reversal of the anticoagulant effects of dabigatran is needed for emergency surgery/urgent procedures and in life-threatening or uncontrolled bleeding.
Marketing Status approved
ATC Code V03AB37
DrugBank ID DB09264
KEGG ID D10741
MeSH ID C000594745
PubChem ID Not Available
TTD Drug ID D0B9FW
NDC Product Code 0597-0197; 12714-195; 12714-196
UNII 97RWB5S1U6
Synonyms idarucizumab | Praxbind | BI-655075 | BI655075 | BI 655075 | ADABI-FAB
Chemical Information
Molecular Formula Not Available
CAS Registry Number 1362509-93-0
SMILES Not Available
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)
Bronchospasm10.01.03.012; 22.03.01.004--
Constipation07.02.02.001--
Delirium19.13.02.001--
Headache17.14.01.001--
Hypersensitivity10.01.03.003--
Hyperventilation19.01.02.004; 22.02.01.006---
Hypokalaemia14.05.03.002--
Pneumonia11.01.09.003; 22.07.01.003---
Pruritus23.03.12.001--
Pyrexia08.05.02.003--
Rash23.03.13.001---
Thrombocytopenia01.08.01.002---
Adverse reaction08.06.01.018---
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