Adverse Drug Reaction Classification System

Pharmaceutical Information
Drug Name Warfarin sodium
Drug ID BADD_D02374
Description Warfarin is an anticoagulant drug normally used to prevent blood clot formation as well as migration. Although originally marketed as a pesticide (d-Con, Rodex, among others), Warfarin has since become the most frequently prescribed oral anticoagulant in North America. Warfarin has several properties that should be noted when used medicinally, including its ability to cross the placental barrier during pregnancy which can result in fetal bleeding, spontaneous abortion, preterm birth, stillbirth, and neonatal death. Additional adverse effects such as necrosis, purple toe syndrome, osteoporosis, valve and artery calcification, and drug interactions have also been documented with warfarin use. Warfarin does not actually affect blood viscosity, rather, it inhibits vitamin-k dependent synthesis of biologically active forms of various clotting factors in addition to several regulatory factors.
Indications and Usage **Indicated** for:[label,L6616] 1) Prophylaxis and treatment of venous thromboembolism and related pulmonary embolism. 2) Prophylaxis and treatment of thromboembolism associated with atrial fibrillation. 3) Prophylaxis and treatment of thromboembolism associated with cardiac valve replacement. 4) Use as adjunct therapy to reduce mortality, recurrent myocardial infarction, and thromboembolic events post myocardial infarction. **Off-label** uses include: 1) Secondary prevention of stroke and transient ischemic attacks in patients with rheumatic mitral valve disease but without atrial fibrillation.[A179182]
Marketing Status approved
ATC Code B01AA03
DrugBank ID DB00682
KEGG ID D00564
MeSH ID D014859
PubChem ID 16204922
TTD Drug ID D0E3OF
NDC Product Code 50090-2141; 50090-5004; 51655-993; 63187-745; 65841-059; 70518-0253; 70518-0261; 71205-952; 71610-593; 51407-788; 57237-121; 62584-984; 62584-994; 63629-8843; 65841-057; 70518-1467; 71335-1059; 71335-9700; 72189-405; 0832-1219; 0093-1713; 51407-785; 51672-4031; 55154-4696; 57237-123; 68071-4385; 68084-027; 68382-057; 68788-7358; 71335-1718; 71335-2148; 71610-179; 70518-0255; 70518-0273; 70518-1006; 71335-0270; 71335-0637; 0093-1721; 51407-787; 57237-122; 65841-058; 68788-7357; 71205-953; 71335-0452; 71335-1615; 71610-589; 72189-210; 0832-1218; 63629-8146; 65841-056; 70518-0266; 71205-954; 71335-0243; 71610-574; 0093-1714; 0093-1720; 43063-176; 50090-5439; 51407-784; 51407-791; 51655-620; 51655-629; 57237-119; 57237-124; 63187-674; 63187-750; 65841-064; 68382-052; 68382-054; 68382-056; 70518-0280; 71205-950; 71205-951; 71205-955; 71610-173; 71610-575; 0832-1211; 0832-1214; 0832-1215; 51407-790; 51672-4028; 51672-4030; 51672-4032; 65841-054; 68382-053; 68382-058; 68382-059; 68788-7515; 71335-0348; 71335-9643; 0832-1216; 63278-1058; 0093-1712; 0093-1718; 0093-1723; 51407-792; 51672-4027; 51672-4029; 51672-4033; 57237-120; 58118-0041; 63629-8418; 65841-052; 65841-053; 65841-055; 67296-1284; 68382-055; 70518-1492; 71335-0840; 0832-1212; 0832-1217; 65841-102; 0093-1715; 0093-1716; 50090-2033; 50090-3110; 51407-789; 51672-4034; 51672-4035; 55154-4695; 57237-125; 57237-127; 68382-064; 70518-0727; 70518-2900; 0832-1213; 51407-786; 55154-4697; 57237-126
UNII 6153CWM0CL
Synonyms Warfarin | 4-Hydroxy-3-(3-oxo-1-phenylbutyl)-2H-1-benzopyran-2-one | Apo-Warfarin | Aldocumar | Gen-Warfarin | Warfant | Coumadin | Marevan | Warfarin Potassium | Potassium, Warfarin | Warfarin Sodium | Sodium, Warfarin | Coumadine | Tedicumar
Chemical Information
Molecular Formula C19H15NaO4
CAS Registry Number 129-06-6
SMILES CC(=O)CC(C1=CC=CC=C1)C2=C(C3=CC=CC=C3OC2=O)[O-].[Na+]
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)
Abdominal distension07.01.04.001--
Abdominal pain07.01.05.002--
Alopecia23.02.02.001--
Anaphylactic reaction24.06.03.006; 10.01.07.001--
Chills15.05.03.016; 08.01.09.001--
Death08.04.01.001--
Dermatitis bullous23.03.01.002--
Diarrhoea07.02.01.001--
Dysgeusia17.02.07.003; 07.14.03.001--
Flatulence07.01.04.002--
Gangrene24.04.05.003; 23.06.06.001; 11.02.01.003--Not Available
Hepatitis09.01.07.004--Not Available
Hepatitis cholestatic09.01.01.002--Not Available
Hypersensitivity10.01.03.003--
Nausea07.01.07.001--
Necrosis24.04.02.006; 08.03.03.001--Not Available
Pruritus23.03.12.001--
Rash23.03.13.001--Not Available
Tracheobronchitis11.01.09.020; 22.07.01.016--Not Available
Urticaria10.01.06.001; 23.04.02.001--
Vasculitis24.12.04.027; 10.02.02.006--
Vomiting07.01.07.003--
Tracheal disorder22.04.07.005--Not Available
Haemorrhage24.07.01.002--Not Available
Hepatic enzyme increased13.03.04.028--Not Available
Arteriosclerotic retinopathy24.03.07.008; 06.10.02.004--Not Available
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