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The following serious adverse reactions to COUMADIN are discussed in greater detail in other sections of the labeling:

  • Hemorrhage [see BOXED WARNING, WARNINGS AND PRECAUTIONS, and OVERDOSAGE]
  • Necrosis of skin and other tissues [see WARNINGS AND PRECAUTIONS]
  • Systemic atheroemboli and cholesterol microemboli [see WARNINGS AND PRECAUTIONS]

Other adverse reactions to COUMADIN 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 COUMADIN 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