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WARFARIN
WARFARIN is a drug. It is currently FDA-approved (first approved 1954).
At a glance
| Generic name | WARFARIN |
|---|---|
| Modality | Small molecule |
| Phase | FDA-approved |
| First approval | 1954 |
Approved indications
Boxed warnings
- WARNING: BLEEDING RISK Warfarin sodium can cause major or fatal bleeding [see Warnings and Precautions ( 5.1 )] . Perform regular monitoring of INR in all treated patients [see Dosage and Administration ( 2.1 )] . Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy [see Drug Interactions ( 7 )] . Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding [see Patient Counseling Information ( 17 )] . WARNING: BLEEDING RISK See full prescribing information for complete boxed warning. Warfarin sodium can cause major or fatal bleeding. ( 5.1 ) Perform regular monitoring of INR in all treated patients. ( 2.1 ) Drugs, dietary changes, and other factors affect INR levels achieved with warfarin sodium therapy. ( 7 ) Instruct patients about prevention measures to minimize risk of bleeding and to report signs and symptoms of bleeding. ( 17 )
Common side effects
- Nausea
- Vomiting
- Diarrhea
- Abdominal pain
- Rash
- Pruritus
- Taste perversion
- Flatulence
- Bloating
- Dermatitis
- Alopecia
- Chills
Serious adverse events
- Hemorrhage (fatal and nonfatal)
- Tissue Necrosis
- Calciphylaxis
- Acute Kidney Injury
- Systemic Atheroemboli and Cholesterol Microemboli
- Limb Ischemia, Necrosis, and Gangrene
- Hypersensitivity/Allergic reactions (including anaphylactic reactions)
- Vasculitis
- Hepatitis
- Tracheal or tracheobronchial calcification
Key clinical trials
- A Trial of Pharmacist Management of Oral Anticoagulation THerapy in the communitY for AF (PHASE4)
- Rivaroxaban vs Warfarin in Patients With Mechanical Heart Valves (PHASE3)
- SWITCH: Apixaban vs Vitamin K in HM3 (PHASE3)
- A Study to Evaluate the Effect of Multiple Doses of JNJ-56021927 on the Pharmacokinetics of Multiple Cytochrome P450 and Transporter Substrates in Participants With Castration-Resistant Prostate Cancer (PHASE1)
- Personalized Medicine Decision-Making in a Virtual Clinical Setting
- The PEERLESS II Study (NA)
- Catheter Ablation Plus LAAO Versus Anticoagulation in Frail Elderly Patients With Atrial Fibrillation (NA)
- LVT DURATION: Pilot Study of Anticoagulation Duration for Left Ventricular Thrombus (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| FDA label | Mechanism, indications, dosing, boxed warnings, drug interactions |
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- WARFARIN CI brief — competitive landscape report
- WARFARIN updates RSS · CI watch RSS
Frequently asked questions about WARFARIN
What is WARFARIN?
WARFARIN is a Small molecule drug.
When was WARFARIN approved?
WARFARIN was first approved on 1954.
What development phase is WARFARIN in?
WARFARIN is FDA-approved (marketed).
What are the side effects of WARFARIN?
Common side effects of WARFARIN include Nausea, Vomiting, Diarrhea, Abdominal pain, Rash, Pruritus. Serious adverse events: Hemorrhage (fatal and nonfatal), Tissue Necrosis, Calciphylaxis, Acute Kidney Injury.
Related
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing