Warfarin (Coumadin)
What to know about Warfarin — also sold as Coumadin, Marevan: uses, side effects, interactions, and safety considerations for people taking it or caring for someone who is.
Warfarin (brand names: Coumadin, Marevan) is classified as Low risk (1 risk points) by AllMeds. It is a S4 medication under the TGA in Australia. FDA approved in the United States. Anticoagulant with bleeding risk but minimal direct CNS effects on workplace function.
Key Takeaways
- TGA Schedule: S4 in Australia
- Risk level: Low (1 points)
- PBS listed: Subsidised under the Australian Pharmaceutical Benefits Scheme
Scheduling and Classification
| Jurisdiction | Classification | Status |
|---|---|---|
| Australia (TGA) | S4 | PBS listed |
| United States (FDA) | Rx only | FDA approved |
Risk Profile
Anticoagulant with bleeding risk but minimal direct CNS effects on workplace function.
How Warfarin is regulated
Warfarin is overseen by medicines regulators in each country. The rules below explain how it's scheduled, what oversight applies, and what to discuss with your doctor or pharmacist before starting, changing, or stopping this medication.
Australia TGA / PBS / State Schemes
Classified as S4 under the Therapeutic Goods Administration (TGA).
Listed on the Pharmaceutical Benefits Scheme (PBS) for subsidised prescribing.
United States FDA / CDC / State WC
FDA approved for use in the United States.
FDA Boxed Warning: 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 )
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Important: This page is general health information, not personal medical advice. If you have questions about your medication — including starting it, stopping it, changing the dose, or combining it with something else — speak with your doctor or pharmacist. For an emergency or suspected overdose, call your local emergency number or poison information service immediately. Information is drawn from regulator and clinical guideline sources (TGA, FDA, MHRA, NICE, PBS, CDC); see our methodology for details.