Warfarin
Athrombin, Athrombin-k, Coumadin, Panwarfin (warfarin) is a small molecule pharmaceutical. Warfarin was first approved as Athrombin-k on 1982-01-01. It is used to treat atrial fibrillation, postoperative complications, pulmonary embolism, stroke, and thromboembolism amongst others in the USA. The pharmaceutical is active against vitamin K epoxide reductase complex subunit 1.
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Trade Name
FDA
EMA
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Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Warfarin potassium
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ATHROMBIN-K | Pharmaceutical Research Associates Inc | N-011771 DISCN | 1982-01-01 | 4 products |
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FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| coumadin | New Drug Application | 2012-11-15 |
| jantoven | ANDA | 2017-08-24 |
| warfarin sodium | ANDA | 2023-05-31 |
Indications
FDA
EMA
Indication | Ontology | MeSH | ICD-10 |
|---|---|---|---|
| atrial fibrillation | EFO_0000275 | D001281 | I48.0 |
| postoperative complications | — | D011183 | — |
| pulmonary embolism | EFO_0003827 | D011655 | I26 |
| stroke | EFO_0000712 | D020521 | I63.9 |
| thromboembolism | HP_0001907 | D013923 | — |
| thrombophlebitis | HP_0004418 | D013924 | — |
Agency Specific
FDA
EMA
No data
Patent Expiration
No data
HCPCS
Code | Description |
|---|---|
| G9143 | Warfarin responsiveness testing by genetic technique using any method, any number of specimen(s) |
| Level 2: G9143-G9143 | Warfarin Responsiveness Testing |
Clinical
Clinical Trials
399 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Atrial fibrillation | D001281 | EFO_0000275 | I48.0 | — | 22 | 23 | 25 | 47 | 114 |
| Healthy volunteers/patients | — | 43 | — | — | 1 | 4 | 48 | ||
| Venous thrombosis | D020246 | HP_0004936 | I82.40 | 1 | 5 | 11 | 13 | 15 | 43 |
| Pulmonary embolism | D011655 | EFO_0003827 | I26 | — | 2 | 6 | 6 | 14 | 27 |
| Stroke | D020521 | EFO_0000712 | I63.9 | 1 | 6 | 17 | 3 | 3 | 26 |
| Venous thromboembolism | D054556 | EFO_0004286 | I74 | — | 2 | 5 | 1 | 12 | 20 |
| Thromboembolism | D013923 | HP_0001907 | — | 4 | 11 | 3 | 2 | 19 | |
| Heart valve diseases | D006349 | EFO_0009551 | I08 | — | 4 | 1 | 2 | 8 | 14 |
| Thrombosis | D013927 | — | — | 3 | 3 | 5 | 11 | ||
| Hemorrhage | D006470 | MP_0001914 | R58 | — | — | 4 | 3 | 3 | 10 |
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Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cardiovascular diseases | D002318 | EFO_0000319 | I98 | 1 | — | 5 | — | 4 | 10 |
| Myocardial infarction | D009203 | EFO_0000612 | I21 | — | 3 | 2 | — | 3 | 7 |
| Atrial flutter | D001282 | EFO_0003911 | — | 1 | 5 | — | — | 5 | |
| Heart diseases | D006331 | EFO_0003777 | I51.9 | — | — | 5 | — | — | 5 |
| Intracranial thrombosis | D020767 | 1 | 1 | 2 | — | 1 | 4 | ||
| Transient ischemic attack | D002546 | EFO_0003764 | G45.9 | — | 1 | 2 | — | — | 3 |
| Peripheral vascular diseases | D016491 | EFO_0003875 | I73.9 | — | — | 2 | — | 1 | 3 |
| Prostatic neoplasms | D011471 | C61 | 1 | 1 | 1 | — | — | 3 | |
| Vascular diseases | D014652 | EFO_0004264 | I77 | — | — | 2 | — | 1 | 3 |
| Myocardial ischemia | D017202 | EFO_1001375 | I20-I25 | — | — | 2 | — | — | 2 |
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Indications Phases 2
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Embolism and thrombosis | D016769 | — | 1 | — | — | 1 | 2 | ||
| Pulmonary hypertension | D006976 | EFO_0001361 | I27.20 | — | 2 | — | — | — | 2 |
| Heart valve prosthesis | D006350 | EFO_0003906 | — | 1 | — | — | — | 1 | |
| Replacement arthroplasty knee | D019645 | — | 1 | — | — | — | 1 | ||
| Hypoprothrombinemias | D007020 | 1 | 1 | — | — | — | 1 |
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Neoplasms | D009369 | C80 | 8 | — | — | — | 1 | 9 | |
| Type 2 diabetes mellitus | D003924 | EFO_0001360 | E11 | 6 | — | — | — | — | 6 |
| Rheumatoid arthritis | D001172 | EFO_0000685 | M06.9 | 4 | — | — | — | — | 4 |
| Pharmacokinetics | D010599 | 3 | — | — | — | 1 | 4 | ||
| Alzheimer disease | D000544 | EFO_0000249 | F03 | 3 | — | — | — | — | 3 |
| Psoriasis | D011565 | EFO_0000676 | L40 | 2 | — | — | — | — | 2 |
| Atopic dermatitis | D003876 | EFO_0000274 | L20 | 2 | — | — | — | — | 2 |
| Overactive urinary bladder | D053201 | EFO_1000781 | N32.81 | 2 | — | — | — | — | 2 |
| Parkinson disease | D010300 | EFO_0002508 | G20 | 2 | — | — | — | — | 2 |
| Ulcerative colitis | D003093 | EFO_0000729 | K51 | 1 | — | — | — | — | 1 |
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Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Oral surgery | D013515 | — | — | — | — | 1 | 1 | ||
| Postoperative complications | D011183 | — | — | — | — | 1 | 1 | ||
| Oral surgical procedures | D019647 | — | — | — | — | 1 | 1 | ||
| Uterine hemorrhage | D014592 | — | — | — | — | 1 | 1 | ||
| Periodontal diseases | D010510 | K05.6 | — | — | — | — | 1 | 1 | |
| Embolic stroke | D000083262 | — | — | — | — | 1 | 1 | ||
| Gastrointestinal hemorrhage | D006471 | K92.2 | — | — | — | — | 1 | 1 | |
| Pregnancy | D011247 | EFO_0002950 | Z33.1 | — | — | — | — | 1 | 1 |
| Mesenteric ischemia | D065666 | K55.1 | — | — | — | — | 1 | 1 | |
| Bradycardia | D001919 | HP_0001662 | R00.1 | — | — | — | — | 1 | 1 |
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Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | WARFARIN |
| INN | warfarin |
| Description | 4-hydroxy-3-(3-oxo-1-phenylbutyl)-1-benzopyran-2-one is a member of the class of coumarins that is 4-hydroxycoumarin which is substituted at position 3 by a 1-phenyl-3-oxo-1-butyl group. It is a methyl ketone and a hydroxycoumarin. |
| Classification | Small molecule |
| Drug class | warfarin analogs |
| Image (chem structure or protein) | |
| Structure (InChI/SMILES or Protein Sequence) | CC(=O)CC(c1ccccc1)c1c(O)c2ccccc2oc1=O |
Identifiers
| PDB | — |
| CAS-ID | 129-06-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1464 |
| ChEBI ID | 87732 |
| PubChem CID | 54678486 |
| DrugBank | DB00682 |
| UNII ID | 5Q7ZVV76EI (ChemIDplus, GSRS) |
Target
Agency Approved
VKORC1
VKORC1
Organism
Homo sapiens
Gene name
VKORC1
Gene synonyms
VKOR
NCBI Gene ID
Protein name
vitamin K epoxide reductase complex subunit 1
Protein synonyms
phylloquinone epoxide reductase, vitamin K dependent clotting factors deficiency 2, Vitamin K1 2,3-epoxide reductase subunit 1, vitamin K1 epoxide reductase (warfarin-sensitive)
Uniprot ID
Mouse ortholog
Vkorc1 (27973)
vitamin K epoxide reductase complex subunit 1 (Q9CRC0)
Alternate
No data
Variants
Clinical Variant
Identifier | Target mutation | Effect | Evaluation | Status |
|---|---|---|---|---|
| VCV000225969 | CYP4F2, 1297G>A, Val433Met | drug response | 2021-03-24 | 1A |
| VCV000225947 | NC_000010.11:g.94645745G>A | drug response | 2021-04-12 | 1A |
| VCV000002211 | VKORC1, -1639G>A | drug response | 2021-03-24 | 1A |
| VCV000226016 | VKORC1, *134G>A | drug response | 2021-03-24 | 1B |
| VCV000225975 | VKORC1, 283+837T>C | drug response | 2021-03-24 | 1B |
| VCV000037344 | VKORC1, 174-136C>T | drug response | 2021-03-29 | 1B |
| VCV000226030 | VKORC1, -1639G>T | drug response | 2018-04-06 | 2A |
| VCV000226026 | VKORC1, 283+124G>C | drug response | 2021-03-24 | 2A |
| VCV000225983 | VKORC1, 173+324T>G | drug response | 2021-03-24 | 2A |
| VCV000017848 | APOE, 526C>T, Arg176Cys | drug response | 2021-03-24 | 2B |
Financial
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Safety
Black-box Warning
Black-box warning for: Coumadin, Jantoven, Warfarin sodium
Adverse Events
Top Adverse Reactions
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43 adverse events reported
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