Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Apixaban
Drug ID BADD_D00151
Description Apixaban is an oral, direct, and highly selective factor Xa (FXa) inhibitor of both free and bound FXa, as well as prothrombinase, independent of antithrombin III for the prevention and treatment of thromboembolic diseases[Label,A6897]. It is marketed under the name Eliquis[Label,L6043]. Apixaban was approved by the FDA on December 28, 2012[L6043].
Indications and Usage Apixaban is indicated for reducing the risk of stroke and systemic embolism in patients who have nonvalvular atrial fibrillation, prophylaxis of deep vein thrombosis(DVT) leading to pulmonary embolism(PE) in patients after a hip or knee replacement surgery, and treatment of DVT and PE to reduce the risk of recurrence[Label,A177565,A6897].
Marketing Status approved
ATC Code B01AF02
DrugBank ID DB06605
KEGG ID D03213
MeSH ID C522181
PubChem ID 10182969
TTD Drug ID D0I5HF
NDC Product Code 0003-0893; 52048-0420; 69037-0023; 76397-007; 15308-1221; 24196-190; 58032-2028; 66174-0091; 50193-0893; 65372-1196; 65727-081; 0003-3764; 55154-0612; 59651-051; 70366-001; 14445-149; 12783-0893; 12783-0894; 17381-026; 42765-025; 42816-0894; 58623-0137; 63850-8085; 65129-1344; 66039-925; 66651-921; 69989-0006; 63629-7747; 12658-0440; 53869-0893; 73377-191; 55154-0613; 70518-1861; 71610-662; 67835-0015; 75945-060; 76397-010; 50090-6454; 82982-054; 14501-0089; 16436-0113; 65129-1465; 63629-8432; 14445-014; 53747-062; 53869-0894; 63415-0520; 65015-897; 76072-1017; 14445-150; 42816-0893; 0003-0894; 55111-980; 50090-6451
UNII 3Z9Y7UWC1J
Synonyms apixaban | Eliquis | BMS 562247 | BMS562247 | BMS-562247-01 | BMS-562247
Chemical Information
Molecular Formula C25H25N5O4
CAS Registry Number 503612-47-3
SMILES COC1=CC=C(C=C1)N2C3=C(CCN(C3=O)C4=CC=C(C=C4)N5CCCCC5=O)C(=N2)C(=O)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)
Biliary obstruction09.02.02.0050.000065%-
Blood loss anaemia01.03.02.018; 24.07.01.0880.000855%-
BRASH syndrome02.03.02.030; 14.05.03.0050.000087%-
Cerebellar stroke17.08.01.070; 24.04.06.0460.000065%-
Cerebral mass effect17.11.01.0190.000586%-
Cerebral venous sinus thrombosis17.08.03.006; 24.01.04.0210.000239%-
Cerebrospinal fluid retention17.07.02.0100.000043%-
Cholesteatoma04.03.01.016; 16.02.03.0010.000043%-
Chronic gastrointestinal bleeding07.12.02.009; 24.07.02.0620.000087%-
Colorectal adenoma07.20.01.019; 16.05.02.0090.000065%-
Congestive hepatopathy02.05.04.018; 09.01.06.0270.000087%-
Discoloured vomit07.01.07.0170.000108%-
Dry age-related macular degeneration06.09.03.0300.000043%-
Duodenal vascular ectasia07.15.04.008; 24.03.03.0460.000043%-
Eosinophilic pleural effusion01.02.04.023; 22.05.02.0090.000043%-
Eye haematoma06.07.02.009; 12.01.04.034; 24.07.05.0170.000065%-
Gait inability08.01.02.011; 17.02.05.069---
Gastrointestinal angiectasia07.15.04.009; 24.03.03.0480.000065%-
Gastrointestinal polyp07.20.01.022; 16.05.01.0070.000174%-
Gastrointestinal vascular malformation haemorrhagic07.15.04.010; 24.07.02.0640.000065%-
Giant cell arteritis06.07.02.010; 10.02.02.032; 17.08.02.033; 24.12.02.0030.000108%-
Haematoma muscle12.01.07.015; 15.05.03.036; 24.07.01.0910.000594%-
Haemoperitoneum07.07.02.007; 12.01.17.007; 24.07.02.0650.000586%-
Haemorrhagic cholecystitis09.03.01.008; 24.07.01.0940.000152%-
Haemorrhagic vasculitis01.01.04.012; 10.02.02.033; 23.06.01.015; 24.12.04.0120.000043%-
Heavy menstrual bleeding21.01.03.0050.002863%-
Hepatic cytolysis09.01.07.0360.000369%-
Hepatic haemangioma rupture09.04.01.005; 16.06.01.005; 24.07.01.0960.000108%-
Hyperleukocytosis01.02.01.0180.000043%-
Hypersensitivity pneumonitis10.01.03.056; 22.01.01.0270.000087%-
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