ADVERSE REACTIONS
Potential adverse reactions to warfarin sodium tablets 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.
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REPORTS OF SUSPECTED WARFARIN SIDE EFFECTS / ADVERSE REACTIONS
Below is a sample of reports where side effects / adverse reactions may be related to Warfarin. The information is not vetted and should not be considered as verified clinical evidence.
Possible Warfarin side effects / adverse reactions in 81 year old male
Reported by a pharmacist from United States on 2011-12-21
Patient: 81 year old male weighing 58.0 kg (127.6 pounds)
Reactions: Rhabdomyolysis, International Normalised Ratio Increased, Drug Interaction, Blue TOE Syndrome, Transaminases Increased, Renal Failure Acute
Adverse event resulted in: hospitalization
Suspect drug(s):
Warfarin
Administration route: Oral
Zocor
Administration route: Oral
Start date: 2007-01-01
Gemfibrozil
Administration route: Oral
Start date: 2005-01-01
Other drugs received by patient: Acetaminophen and Codeine; Lisinopril; Nortriptyline; Aspirin
Possible Warfarin side effects / adverse reactions in 82 year old male
Reported by a physician from United States on 2011-12-22
Patient: 82 year old male
Reactions: Completed Suicide, Toxicity TO Various Agents
Adverse event resulted in: death
Suspect drug(s):
Pregabalin
Dosage: unk
Administration route: Oral
Cyclobenzaprine
Dosage: unk
Administration route: Oral
Acetaminophen and Hydrocodone Bitartrate
Dosage: unk
Administration route: Oral
Warfarin
Dosage: unk
Administration route: Oral
Amlodipine Besylate
Dosage: unk
Administration route: Oral
Methadone
Dosage: unk
Administration route: Oral
Hydroxychloroquine
Dosage: unk
Administration route: Oral
Possible Warfarin side effects / adverse reactions in 36 year old male
Reported by a physician from Japan on 2011-12-23
Patient: 36 year old male weighing 96.0 kg (211.2 pounds)
Reactions: Colorectal Cancer, Cerebral Haemorrhage
Adverse event resulted in: death, hospitalization
Suspect drug(s):
Panitumumab
Dosage: 6 mg/kg, q2wk
Indication: Colorectal Cancer
Start date: 2010-10-26
End date: 2010-10-26
Warfarin
Dosage: unk
Administration route: Oral
Other drugs received by patient: Lobu; Ketoprofen; Lansoprazole; Depas
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