Coumadin (Warfarin Sodium) - Side Effects and Adverse Reactions

ADVERSE REACTIONS

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 (5.1) , and Overdosage (10) ]
• Necrosis of skin and other tissues [see Warnings and Precautions (5.2) ]
• Systemic atheroemboli and cholesterol microemboli [see Warnings and Precautions (5.3) ]

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

REPORTS OF SUSPECTED COUMADIN SIDE EFFECTS / ADVERSE REACTIONS

Possible Coumadin side effects / adverse reactions in 75 year old female

Reported by a consumer/non-health professional from United States on 2011-10-03

Patient: 75 year old female weighing 45.4 kg (99.8 pounds)

Reactions: Nasopharyngitis, Haemorrhage, Pain, Anaemia, Myelodysplastic Syndrome, Fatigue, Skin Discolouration, Alopecia, Depression, Cardiac Failure Congestive

Adverse event resulted in: life threatening event

Suspect drug(s):
Coumadin

Possible Coumadin side effects / adverse reactions in 84 year old male

Reported by a physician from United States on 2011-10-03

Patient: 84 year old male

Reactions: Soft Tissue Disorder, Atelectasis, Seborrhoeic Keratosis, Dyslipidaemia, Throat Cancer, Flatulence, Coagulopathy, Pulmonary Embolism, Oesophagitis Ulcerative, Fall, Hypokalaemia, Oesophageal Stenosis, Skin Cancer, Head and Neck Cancer, Injury, Cough, Hiatus Hernia, Prostate Cancer, Peptic Ulcer, Haemorrhoids, Anaemia, Atrial Fibrillation, Barrett's Oesophagus, Diarrhoea, Dehydration, Peptic Ulcer Haemorrhage, Hypothyroidism, Feeding Tube Complication, Hypertension, Deep Vein Thrombosis

Adverse event resulted in: hospitalization

Suspect drug(s):
Nexium
    Administration route: Oral
    Start date: 2000-01-01

Ibuprofen

Coumadin

Other drugs received by patient: Warfarin Sodium; Carafate; Thiamine HCL; Multivitamin with Iron and Fluoride; Levothyroxine; Xanax; Vitamin D with Calcium; Synthroid; Folic Acid; Percocet

Possible Coumadin side effects / adverse reactions in 86 year old male

Reported by a physician from Italy on 2011-10-04

Patient: 86 year old male

Reactions: Muscle Haemorrhage

Adverse event resulted in: life threatening event

Suspect drug(s):
Coumadin
    Indication: Pulmonary Embolism

Coumadin
    Indication: Deep Vein Thrombosis

Carnitor
    Dosage: 1 gm;qd;im
    Indication: Product Used FOR Unknown Indication
    Start date: 2011-04-23
    End date: 2011-05-01