Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS The following serious adverse reactions to warfarin sodium are discussed in greater detail in other sections of the labeling: Hemorrhage [see Boxed Warning, Warnings and Precautions (5.1), and Overdosage ( 10 )] Tissue Necrosis [see Warnings and Precautions ( 5.2 )] Calciphylaxis [see Warnings and Precautions ( 5.3 )] Acute Kidney Injury [see Warnings and Precautions ( 5.4 )] Systemic Atheroemboli and Cholesterol Microemboli [see Warnings and Precautions ( 5.5 )] Limb Ischemia, Necrosis, and Gangrene in Patients with HIT and HITTS [see Warnings and Precautions ( 5.6 )] Other Clinical Settings with Increased Risks [see Warnings and Precautions ( 5.8 )] Other adverse reactions to warfarin sodium include: Immune system disorders: hypersensitivity/allergic reactions (including urticaria and anaphylactic reactions) Vascular disorders: vasculitis Hepatobiliary disorders: hepatitis, elevated liver enzymes.
Cholestatic hepatitis has been associated with concomitant administration of warfarin sodium and ticlopidine.
Gastrointestinal disorders: nausea, vomiting, diarrhea, taste perversion, abdominal pain, flatulence, bloating Skin disorders: rash, dermatitis (including bullous eruptions), pruritus, alopecia Respiratory disorders: tracheal or tracheobronchial calcification General disorders: chills Most common adverse reactions to warfarin sodium are fatal and nonfatal hemorrhage from any tissue or organ.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Teva at 1-888-838-2872 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
5 WARNINGS AND PRECAUTIONS Tissue necrosis: Necrosis or gangrene of skin or other tissues can occur, with severe cases requiring debridement or amputation.
Discontinue warfarin sodium and consider alternative anticoagulants if necessary.
( 5.2 ) Calciphylaxis: Fatal and serious cases have occurred.
Discontinue warfarin sodium and consider alternative anticoagulation therapy.
( 5.3 ) Acute kidney injury may occur during episodes of excessive anticoagulation and hematuria.
Like all medications, Warfarin Sodium can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: