Adverse Drug Reaction Classification System

         

Pharmaceutical Information
Drug Name Fondaparinux
Drug ID BADD_D02423
Description Fondaparinux (Arixtra) is a synthetic anticoagulant agent consisting of five monomeric sugar units and a O-methyl group at the reducing end of the molecule. It is structurally similar to polymeric glycosaminoglycan heparin and heparan sulfate (HS) when they are cleaved into monomeric units. The monomeric sequence in heparin and HS is thought to form the high affinity binding site for the natural anti-coagulant factor, antithrombin III (ATIII). Once bound to heparin or HS, the anticoagulant activity of ATIII is potentiated by 1000-fold. Fondaparinux potentiates the neutralizing action of ATIII on activated Factor X 300-fold. Fondaparinux may be used: to prevent venous thromboembolism in patients who have undergone orthopedic surgery of the lower limbs (e.g. hip fracture, hip replacement and knee surgery); to prevent VTE in patients undergoing abdominal surgery who are are at high risk of thromboembolic complications; in the treatment of deep vein thrombosis (DVT) and pumonary embolism (PE); in the management of unstable angina (UA) and non-ST segment elevation myocardial infarction (NSTEMI); and in the management of ST segment elevation myocardial infarction (STEMI).
Indications and Usage Approved for: (1) prophylaxis of VTE for up to one month post surgery in patients undergoing orthopedic surgery of the lower limbs such as hip fracture, hip replacement and knee surgery; (2) prophylaxis of VTE patients undergoing abdominal surgery who are at high risk of thromboembolic complications (e.g. patients undergoing abdominal cancer surgery); (3) treatment of acute DVT and PE; (4) management of UA and NSTEMI for the prevention of death and subsequent myocardial infarction (MI); and (5) management of STEMI for the prevention of death and myocardial reinfarction in patients who are managed with thrombolytics or who are initially to receive no form of reperfusion therapy. Fondaparinux should not be used as the sole anticoagulant during percutaneous coronary intervention (PCI) due to an increased risk of guiding catheter thrombosis.
Marketing Status approved; investigational
ATC Code B01AX05
DrugBank ID DB00569
KEGG ID D01844
MeSH ID D000077425
PubChem ID 5282448
TTD Drug ID D0NE9T
NDC Product Code Not Available
UNII J177FOW5JL
Synonyms Fondaparinux | Fondaparinux Sodium | Quixidar | Arixtra
Chemical Information
Molecular Formula C31H53N3O49S8
CAS Registry Number 104993-28-4
SMILES COC1C(C(C(C(O1)COS(=O)(=O)O)OC2C(C(C(C(O2)C(=O)O)OC3C(C(C(C(O3)COS(=O)(=O)O)OC4C (C(C(C(O4)C(=O)O)OC5C(C(C(C(O5)COS(=O)(=O)O)O)O)NS(=O)(=O)O)O)O)OS(=O)(=O)O)NS(= O)(=O)O)O)OS(=O)(=O)O)O)NS(=O)(=O)O
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)
Dyspnoea02.11.05.003; 22.02.01.0040.034538%
Ecchymosis24.07.06.002; 23.06.01.001; 01.01.03.0010.009868%Not Available
Eczema23.03.04.0060.007401%
Eosinophilia01.02.04.0010.007401%
Epistaxis24.07.01.005; 22.04.03.0010.014802%
Gastric haemorrhage24.07.02.007; 07.12.01.0010.007401%
Gastric ulcer07.04.03.0020.004934%
Gastrointestinal haemorrhage07.12.02.001; 24.07.02.0090.037005%Not Available
Haemarthrosis24.07.01.046; 15.01.01.004; 12.04.03.0010.009868%Not Available
Haematemesis24.07.02.011; 07.12.02.0020.027137%Not Available
Haematochezia07.12.02.003; 24.07.02.0120.007401%Not Available
Haematoma24.07.01.0010.180091%
Haematuria24.07.01.047; 21.10.01.018; 20.02.01.0060.022203%
Haemorrhage intracranial24.07.04.003; 17.08.01.0080.022203%
Haemorrhage subcutaneous24.07.06.010; 23.06.07.0020.007401%Not Available
Haemorrhagic stroke17.08.01.011; 24.07.04.0140.019736%Not Available
Headache17.14.01.0010.041939%
Hemiparesis17.01.04.0010.007401%
Hemiplegia17.01.04.0020.007401%Not Available
Hepatic function abnormal09.01.02.0010.019736%Not Available
Hepatocellular injury09.01.07.0080.004934%Not Available
Hyperthermia12.05.01.002; 08.05.01.0010.004934%Not Available
Hypocalcaemia14.04.01.0040.004934%
Hypokalaemia14.05.03.0020.004934%
Hypotension24.06.03.0020.019736%
Hypovolaemic shock24.06.02.0170.012335%Not Available
Injection site haematoma24.07.01.009; 12.07.03.004; 08.02.03.0040.007401%Not Available
Injection site haemorrhage24.07.01.010; 12.07.03.005; 08.02.03.0050.013322%Not Available
Injection site pain12.07.03.011; 08.02.03.0100.030097%Not Available
Intestinal obstruction07.13.01.0020.007401%Not Available
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