Coumadin (Warfarin Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

Potential adverse reactions to COUMADIN may include:

• Fatal or nonfatal hemorrhage from any tissue or organ. This is a consequence of the anticoagulant effect. The signs, symptoms, and severity will vary according to the location and degree or extent of the bleeding. Hemorrhagic complications may present as paralysis; paresthesia; headache, chest, abdomen, joint, muscle or other pain; dizziness; shortness of breath, difficult breathing or swallowing; unexplained swelling; weakness; hypotension; or unexplained shock. Therefore, the possibility of hemorrhage should be considered in evaluating the condition of any anticoagulated patient with complaints which do not indicate an obvious diagnosis. Bleeding during anticoagulant therapy does not always correlate with PT/INR. (See OVERDOSAGE: Treatment.)
• Bleeding which occurs when the PT/INR is within the therapeutic range warrants diagnostic investigation since it may unmask a previously unsuspected lesion, e.g., tumor, ulcer, etc.
• Necrosis of skin and other tissues. (See WARNINGS.)
• Adverse reactions reported infrequently include: hypersensitivity/allergic reactions, including anaphylactic reactions, systemic cholesterol microembolization, purple toes syndrome, hepatitis, cholestatic hepatic injury, jaundice, elevated liver enzymes, hypotension, vasculitis, edema, anemia, pallor, fever, rash, dermatitis, including bullous eruptions, urticaria, angina syndrome, chest pain, abdominal pain including cramping, flatulence/bloating, fatigue, lethargy, malaise, asthenia, nausea, vomiting, diarrhea, pain, headache, dizziness, loss of consciousness, syncope, coma, taste perversion, pruritus, alopecia, cold intolerance, and paresthesia including feeling cold and chills.

Rare events of tracheal or tracheobronchial calcification have been reported in association with long-term warfarin therapy. The clinical significance of this event is unknown.

Priapism has been associated with anticoagulant administration; however, a causal relationship has not been established.

REPORTS OF SIDE EFFECTS / ADVERSE REACTIONS RELATED TO COUMADIN

Possible Coumadin side effects / adverse reactions in 79 year old female

Reported by a pharmacist from United States on 2007-01-03

Patient: 79 year old female

Reactions: Atelectasis, International Normalised Ratio Increased, Pleural Effusion, Mental Status Changes, Muscular Weakness, Hypertension, Cerebrovascular Accident, Haematoma

Adverse event resulted in: death

Suspect drug(s):
Plavix
    Dosage: 75mg daily po
    Administration route: Oral
    Indication: Drug Therapy

Coumadin
    Dosage: 5mg daily po
    Administration route: Oral
    Indication: Drug Therapy

Possible Coumadin side effects / adverse reactions in 77 year old male

Reported by a pharmacist from United States on 2007-01-03

Patient: 77 year old male

Reactions: Abdominal Pain, Multi-Organ Failure, Retroperitoneal Haematoma, Haemorrhage, Procedural Complication, Asthenia, Blood Pressure Decreased

Adverse event resulted in: death

Suspect drug(s):
Plavix
    Dosage: 75mg daily po
    Administration route: Oral
    Start date: 2006-06-26
    End date: 2006-06-29

Coumadin
    Dosage: 6.5mg daily po
    Administration route: Oral

Possible Coumadin side effects / adverse reactions in 62 year old male

Reported by a individual with unspecified qualification from United States on 2007-01-05

Patient: 62 year old male weighing 98.6 kg (216.9 pounds)

Reactions: Retroperitoneal Haematoma, Arthralgia, Groin Pain

Adverse event resulted in: hospitalization

Suspect drug(s):
Coumadin

Other drugs received by patient: Amiodarone HCL; Carvedilol; Digoxin; Escitalopram Oxalate; Furosemide; Potassium Acetate; Spironolactone; Ramipril