Warfarin

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.

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

Title	Posted	Study ID	Phase	Status	Sponsor
COMPARISON OF WARFARIN AND RIVAROXABAN IN THE TREATMENT OF LOWER LIMB DEEP VENOUS THROMBOSIS	2025/07/22	NCT07077954	Not Applicable	Completed	Children Hospital and Institute of Child Health, Lahore
DOAC or VKA in Patients With AF and Stroke While on DOAC - a Pilot Trial	2025/06/08	NCT07011095	Early Phase 1	Not yet recruiting	Population Health Research Institute
A Study of BGM0504 in Overweight or Obese Participants	2025/04/09	NCT06920056	Phase 1	Recruiting	BrightGene Bio-Medical Technology Co., Ltd.
A Study of Enlicitide Decanoate (MK-0616), Warfarin, and Lisinopril in Healthy Adult Participants (MK-0616-026)	2025/01/14	NCT06772779	Phase 1	Completed	Merck Sharp & Dohme LLC
Safety and Effectiveness of Early Aspirin Administration After Mitral Valve Repair	2024/12/18	NCT06738992	Phase 4	Recruiting	Guangdong Provincial People's Hospital
Influence of HRS9531 on Gastric Emptying and Pharmacokinetics of Metformin, Atorvastatin, Warfarin, and Digoxin in Healthy Subjects	2024/12/09	NCT06723691	Phase 1	Completed	Fujian Shengdi Pharmaceutical Co., Ltd.
An Open-label, DDI Study to Investigate the Effects of Amlitelimab on the PK of Selected Cytochrome P450 Substrates	2024/11/13	NCT06686628	Phase 1	Active, not recruiting	Sanofi
Aspirin and Hemocompatibility Events in Chronic Advanced Heart Failure Patients with Assist Device	2024/10/23	NCT06655376	Phase 4	Recruiting	Columbia University
The Safety and Effectiveness of Warfarin Vs Apixaban in Patients with NVAF/ VTE and ESKD on Dialysis	2024/09/20	NCT06606275	N/A	Completed	Abu Dhabi Health Services Company
RandomizEd compariSOn of apixaban versus warfarin in patients with Left VEntricular thrombus after Acute Myocardial Infarction (RESOLVE-AMI).	2024/07/23	2024-514416-28-00	Phase 4	Recruiting	Karolinska Institutet

FDA Drug Approvals

Approved Product	Manufacturer	NDC Code	Route	Strength	Effective Date
Warfarin Sodium	Aphena Pharma Solutions - Tennessee, LLC	43353-054	ORAL	10 mg in 1 1	4/25/2015
Warfarin Sodium	Cardinal Health 107, LLC	55154-4697	ORAL	5 mg in 1 1	6/29/2019
Warfarin Sodium	American Health Packaging	68084-027	ORAL	2.5 mg in 1 1	12/14/2023
Warfarin Sodium	Northwind Pharmaceuticals, LLC.	51655-629	ORAL	5 mg in 1 1	4/3/2023
Warfarin Sodium	Golden State Medical Supply, Inc.	51407-345	ORAL	4 mg in 1 1	6/7/2022
Warfarin Sodium	Proficient Rx LP	63187-750	ORAL	10 mg in 1 1	5/1/2020
Warfarin Sodium	Med-Health Pharma, LLC	51138-061	ORAL	7.5 mg in 1 1	2/9/2011
Warfarin Sodium	Zydus Lifesciences Limited	65841-053	ORAL	2 mg in 1 1	10/3/2023
Warfarin Sodium	Amneal Pharmaceuticals LLC	65162-767	ORAL	6 mg in 1 1	11/20/2022
Warfarin Sodium	Zydus Lifesciences Limited	65841-064	ORAL	2.5 mg in 1 1	10/3/2023

EMA Drug Approvals

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

HSA Drug Approvals

Approved Product	Manufacturer	Approval Number	Dosage Form	Strength	Approval Date
Apo-Warfarin 2mg Tablet	Apotex Inc.	SIN13516P	TABLET	2 mg	8/12/2008
Apo-Warfarin 1mg Tablet	Apotex Inc.	SIN13515P	TABLET	1 mg	8/12/2008
Apo-Warfarin 5mg Tablet	Apotex Inc.	SIN13517P	TABLET	5 mg	8/12/2008
MAREVAN TABLET 3 mg (NEW ZEALAND)	DOUGLAS MANUFACTURING LTD	SIN08019P	TABLET	3 mg	2/2/1995
MAREVAN TABLET 5 mg (NEW ZEALAND)	DOUGLAS MANUFACTURING LTD	SIN08147P	TABLET	5 mg	5/5/1995
MAREVAN TABLET 1 mg (NEW ZEALAND)	DOUGLAS MANUFACTURING LTD	SIN08146P	TABLET	1 mg	5/5/1995

NMPA Drug Approvals

Approved Product	Company	Approval Number	Drug Type	Dosage Form	Approval Date
No NMPA approvals found for this drug.

PPB Drug Approvals

Approved Product	Registration No.	Company	Licence No.	Strength	Registration Date
No PPB approvals found for this drug.

TGA Drug Approvals

Approved Product	ARTG ID	Sponsor	Registration Type	Status	Registration Date
CHEMMART WARFARIN warfarin sodium (as clathrate) 2 mg tablet bottle pack	225715	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/5/2016
WARFARIN APOTEX warfarin sodium (as clathrate) 5 mg tablet bottle pack	225717	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/5/2016
MAREVAN warfarin sodium 1mg tablet bottle	12511	Viatris Pty Ltd	Medicine	A	8/13/1991
COUMADIN warfarin sodium 1mg tablet bottle	42269	Viatris Pty Ltd	Medicine	A	10/13/1992
COUMADIN warfarin sodium 2mg tablet bottle	14937	Viatris Pty Ltd	Medicine	A	9/9/1991
GenRx WARFARIN warfarin sodium (as clathrate) 5 mg tablet bottle pack	225727	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/5/2016
CHEMMART WARFARIN warfarin sodium (as clathrate) 1 mg tablet bottle pack	225716	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/5/2016
GenRx WARFARIN warfarin sodium (as clathrate) 1 mg tablet bottle pack	225724	Arrotex Pharmaceuticals Pty Ltd	Medicine	A	5/5/2016
MAREVAN warfarin sodium 5mg tablet bottle	12514	Viatris Pty Ltd	Medicine	A	8/13/1991
COUMADIN warfarin sodium 5mg tablet bottle	42279	Viatris Pty Ltd	Medicine	A	10/13/1992

Health Canada Drug Approvals

Approved Product	Company	DIN	Dosage Form	Strength	Market Date
NU-WARFARIN	nu-pharm inc	02335662	Tablet - Oral	4.0 MG	N/A
NU-WARFARIN	nu-pharm inc	02335654	Tablet - Oral	3.0 MG	N/A
MYLAN-WARFARIN	Mylan Pharmaceuticals ULC	02244467	Tablet - Oral	10 MG	12/18/2001
TARO-WARFARIN	Taro Pharmaceuticals Inc	02242685	Tablet - Oral	5 MG	8/9/2000
MYLAN-WARFARIN	Mylan Pharmaceuticals ULC	02287498	Tablet - Oral	3 MG	10/21/2006
NOVO-WARFARIN	novopharm limited	02265311	Tablet - Oral	3 MG	2/23/2005
COUMADIN TAB 6 MG	bristol-myers squibb canada	02240206	Tablet - Oral	6 MG	9/29/2000
MYLAN-WARFARIN	Mylan Pharmaceuticals ULC	02287501	Tablet - Oral	6 MG	10/21/2006
NOVO-WARFARIN	novopharm limited	02265281	Tablet - Oral	2 MG	2/23/2005
NU-WARFARIN	nu-pharm inc	02335638	Tablet - Oral	2 MG	N/A

CIMA AEMPS Drug Approvals

Approved Product	Company	Registration Number	Pharmaceutical Form	Prescription Type	Status
No CIMA AEMPS (Spain) approvals found for this drug.

Philippines FDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Philippines FDA approvals found for this drug.

Saudi SFDA Drug Approvals

Approved Product	Company	License Number	Dosage Form	Strength	Approval Date
No Saudi SFDA approvals found for this drug.

Malaysia NPRA Drug Approvals

Approved Product	Company	Registration Number	Dosage Form	Strength	Approval Date
No Malaysia NPRA approvals found for this drug.

UK EMC Drug Information

Medicine Name	MA Holder	MA Number	Pharmaceutical Form	Active Ingredient	Authorization Date
No UK EMC drug information found for this drug.

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