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Warfarin

Generic Name
Warfarin
Brand Names
Coumadin, Jantoven
Drug Type
Small Molecule
Chemical Formula
C19H16O4
CAS Number
81-81-2
Unique Ingredient Identifier
5Q7ZVV76EI

Overview

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.

Background

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.

Indication

Indicated for: 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.

Associated Conditions

  • Myocardial Infarction
  • Pulmonary Embolism
  • Stroke
  • Systemic Embolism
  • Thromboembolism
  • Transient Ischemic Attack
  • Venous Thrombosis (Disorder)

Clinical Trials

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Title
Posted
Study ID
Phase
Status
Sponsor
2015/12/01
Phase 1
Completed
2015/10/14
Phase 1
Completed
2015/09/28
Phase 4
Terminated
Electrophysiology Research Foundation
2015/09/09
Phase 3
UNKNOWN
2015/09/04
Phase 1
Completed
2015/08/24
Phase 1
Completed
2015/08/13
Phase 3
UNKNOWN
Espero Biopharma
2015/07/23
Phase 4
Terminated
Susan Smyth
2015/07/08
Phase 2
UNKNOWN
Meshalkin Research Institute of Pathology of Circulation
2015/06/23
N/A
Completed

FDA Drug Approvals

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Approved Product
Manufacturer
NDC Code
Route
Strength
Effective Date
A-S Medication Solutions
50090-2646
ORAL
1 mg in 1 1
4/8/2025
A-S Medication Solutions
50090-2039
ORAL
5 mg in 1 1
7/26/2018
Northwind Pharmaceuticals, LLC
51655-282
ORAL
4 mg in 1 1
3/23/2015
Aphena Pharma Solutions - Tennessee, LLC
43353-053
ORAL
7.5 mg in 1 1
4/25/2015
Aphena Pharma Solutions - Tennessee, LLC
43353-021
ORAL
2 mg in 1 1
4/25/2015
NuCare Pharmaceuticals,Inc.
68071-5003
ORAL
3 mg in 1 1
2/19/2021
Sun Pharmaceutical Industries, Inc.
51672-4029
ORAL
2.5 mg in 1 1
12/21/2023
Taro Pharmaceuticals U.S.A., Inc.
51672-4029
ORAL
2.5 mg in 1 1
12/21/2023
Physicians Total Care, Inc.
54868-4402
ORAL
4 mg in 1 1
2/9/2012
A-S Medication Solutions
50090-5058
ORAL
5 mg in 1 1
11/30/2022

EMA Drug Approvals

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Authorization Holder
Status
Issued Date
No EMA approvals found for this drug.

HSA Drug Approvals

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No HSA approvals found for this drug.

NMPA Drug Approvals

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Approval Number
Drug Type
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Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

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TGA Drug Approvals

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