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Warfarin Side Effects and Adverse Effects reported to US Food and Drug Administration (FDA)

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Showing 1-25 of 6408 

Anaemia, Hyperglycaemia, Sinus Tachycardia, Electrocardiogram St Segment Elevation, Blood Pressure Increased (8477152-X)
on Jun 25, 2012 Male from UNITED STATES , 81 years of age, weighting 137.3 lb, was diagnosed with
  • atrial fibrillation
and was treated with Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: anaemia, hyperglycaemia, sinus tachycardia, electrocardiogram st segment elevation, blood pressure increased. Warfarin Sodium dosage: 1 Tab Every Day Po. Patient was hospitalized.

Femoral Nerve Palsy, Muscle Haemorrhage (8475968-7)
Patient was taking Warfarin Sodium. Patient felt the following Warfarin side effects: femoral nerve palsy, muscle haemorrhage on Jun 18, 2012 from TURKEY Additional patient health information: Female , 70 years of age, was diagnosed with
  • mitral valve replacement
and. Warfarin Sodium dosage: N/A. Patient was hospitalized.

International Normalised Ratio Increased, Malaise, Clostridium Test Positive, Diarrhoea (8472664-7)
Adverse event was reported on Jun 22, 2012 by a Male taking Warfarin Sodium (Dosage: Mg Po) was diagnosed with
  • atrial fibrillation
and. Location: UNITED STATES , 67 years of age, weighting 237.2 lb, After Warfarin was administered, patient encountered several Warfarin side effects: international normalised ratio increased, malaise, clostridium test positive, diarrhoea. Patient was hospitalized.

International Normalised Ratio Increased, Gastric Haemorrhage, Haemoglobin Decreased (8472585-X)
on Jun 22, 2012 Male from UNITED STATES , 67 years of age, weighting 124.3 lb, was diagnosed with
  • deep vein thrombosis
and was treated with Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: international normalised ratio increased, gastric haemorrhage, haemoglobin decreased. Warfarin Sodium dosage: 1 Tab Every Day Po. Patient was hospitalized.


Dyspnoea, Muscle Spasms, Blood Creatine Phosphokinase Increased (8471740-2)
on Jun 18, 2012 Male from JAPAN , 56 years of age, weighting 227.1 lb, was diagnosed with
  • atrial fibrillation
and was treated with Warfarin Sodium. Patient felt the following Warfarin side effects: dyspnoea, muscle spasms, blood creatine phosphokinase increased. Warfarin Sodium dosage: N/A.
Multiple prescriptions taken:
  • Clonazepam
  • Lansoprazole
  • Olmetec
  • Lyrica
  • Crestor
  • Carvedilol
Patient was hospitalized.

Dysgeusia, Prostatic Specific Antigen Increased, Heart Rate Decreased (8470908-9)
Patient was taking Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: dysgeusia, prostatic specific antigen increased, heart rate decreased on Jun 19, 2012 from UNITED STATES Additional patient health information: Male , 73 years of age, . Warfarin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Prevacid
  • Humulin N
  • Antiglaucoma Preparations And Miotics
  • Multaq
  • Lipitor


Haemorrhage, Anaemia (8470447-5)
Adverse event was reported on Oct 10, 2011 by a Male taking Warfarin Sodium (Dosage: Unk) . Location: UNITED STATES , 75 years of age, Directly after, patient experienced the unwanted or unexpected Warfarin side effects: haemorrhage, anaemia.
Associated medications used:
  • Revlimid (5 Mg, 1 In 1 D, Po)


International Normalised Ratio Decreased, Hypotension, Atrial Fibrillation, Product Substitution Issue, Product Quality Issue, Cerebrovascular Accident, Fatigue, Decreased Appetite, Malaise (8465667-X)
on Jun 04, 2012 Male from UNITED STATES , 80 years of age, was diagnosed with
  • atrial fibrillation
and was treated with Warfarin Sodium. Patient felt the following Warfarin side effects: international normalised ratio decreased, hypotension, atrial fibrillation, product substitution issue, product quality issue, cerebrovascular accident, fatigue, decreased appetite, malaise. Warfarin Sodium dosage: 7.5 Mg;qd;po.
Multiple prescriptions taken:
  • Metoprolol
Patient was hospitalized.

Coagulopathy, Anaemia, Fall, Renal Failure Chronic, International Normalised Ratio Increased, Iron Deficiency, Haemorrhage (8465627-9)
on Jun 21, 2012 Male from UNITED STATES , 93 years of age, weighting 190.5 lb, was diagnosed with
  • atrial fibrillation
and was treated with Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: coagulopathy, anaemia, fall, renal failure chronic, international normalised ratio increased, iron deficiency, haemorrhage. Warfarin Sodium dosage: Mg Po. Patient was hospitalized.

Atrial Fibrillation (8464994-X)
Patient was taking Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: atrial fibrillation on May 22, 2012 from JAPAN Additional patient health information: Female , weighting 85.54 lb, was diagnosed with
  • cerebral infarction
and. Warfarin Sodium dosage: N/A.
Associated medications used:
  • Famotidine (10 Mg, Uid/qd)
Patient was hospitalized.

Thrombosis (8464530-8)
Adverse event was reported on Oct 17, 2011 by a Male taking Warfarin Sodium (Dosage: N/A) . Location: UNITED STATES , 62 years of age, Patient felt the following Warfarin side effects: thrombosis.
Multiple prescriptions taken:
  • Lovaza
  • Revlimid (10 Mg, 1 In 1 D, Po)
  • Altace (ramiipril)
  • Zocor
  • Nexium


Gastrointestinal Haemorrhage (8463844-5)
on Nov 08, 2011 Female from UNITED STATES , 77 years of age, was treated with Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: gastrointestinal haemorrhage. Warfarin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Insulin
  • Omeprazole
  • Furosemide
  • Revlimid (10 Mg, Daily X 21 Days, Po; 10 Mg, Daily X 21 Days, Po)
  • Revlimid (10 Mg, Daily X 21 Days, Po; 10 Mg, Daily X 21 Days, Po)
  • Glipizide
  • Atenolol
Patient was hospitalized.

Cardiac Failure Congestive, Interstitial Lung Disease, Coagulation Time Prolonged (8463326-0)
on Jun 13, 2012 Male from JAPAN , 81 years of age, was treated with Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: cardiac failure congestive, interstitial lung disease, coagulation time prolonged. Warfarin dosage: Unk.
Associated medications used:
  • Estracyt (313.4 Mg, 1x/day)
  • Estracyt (156.7 Mg, 1x/day)
  • Pravastatin (Unk)
  • Nitroderm (Unk)
  • Aspirin (Unk)
  • Estracyt (Unk)
  • Losartan Potassium (Unk)
  • Isosorbide Mononitrate (Unk)
Patient was hospitalized.

International Normalised Ratio Increased, Contusion (8462656-6)
Patient was taking Warfarin Sodium. Patient felt the following Warfarin side effects: international normalised ratio increased, contusion on Jun 19, 2012 from UNITED STATES Additional patient health information: Female , 65 years of age, was diagnosed with
  • deep vein thrombosis
and. Warfarin Sodium dosage: 8 Mg, Daily, Po.

Delirium, Poisoning (8462426-9)
Adverse event was reported on Jun 11, 2012 by a Female taking Warfarin Sodium (Dosage: N/A) . Location: TURKEY , 66 years of age, After Warfarin was administered, patient encountered several Warfarin side effects: delirium, poisoning. Patient was hospitalized.

Testicular Oedema, Oedema Peripheral (8462331-8)
on Jun 20, 2012 Male from UNITED STATES , weighting 165.0 lb, was diagnosed with
  • cardiac disorder
and was treated with Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: testicular oedema, oedema peripheral. Warfarin dosage: Unk.
Associated medications used:
  • Potassium (Unk)
  • Ambien (Unk)
  • Lyrica (50 Mg, 3x/day)


International Normalised Ratio Abnormal, Weight Increased, Pain (8462320-3)
on Jun 19, 2012 Female from UNITED STATES , weighting 286.6 lb, was diagnosed with
  • coagulopathy
  • complex regional pain syndrome
and was treated with Warfarin. Patient felt the following Warfarin side effects: international normalised ratio abnormal, weight increased, pain. Warfarin dosage: Unk.
Multiple prescriptions taken:
  • Lyrica (50 Mg, 3x/day)
  • Lyrica (100 Mg, 3x/day)


Haemorrhagic Diathesis, International Normalised Ratio Increased (8462063-6)
Patient was taking Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: haemorrhagic diathesis, international normalised ratio increased on Jun 14, 2012 from JAPAN Additional patient health information: Female , 64 years of age, weighting 147.7 lb, . Warfarin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Lendormin
  • Fosrenol
  • Cinacalcet Hydrochloride
  • Meropenem
  • Nexium
  • Cefazolin
  • Lipitor
  • Amlodipine
Patient was hospitalized and became disabled.

Renal Failure Acute (8461114-2)
Adverse event was reported on Jun 12, 2012 by a Male taking Warfarin (Dosage: 5 Mg, 1x/day) was diagnosed with
  • cerebrovascular accident
  • cardiac disorder
  • myocardial infarction
and. Location: UNITED STATES , 84 years of age, Directly after, patient experienced the unwanted or unexpected Warfarin side effects: renal failure acute.
Associated medications used:
  • Aspirin (81 Mg, 1x/day)
  • Lasix (20 Mg, 1x/day)
  • Coreg (5 Mg, 1x/day)


Skin Necrosis, Multi-organ Failure, Sepsis (8460793-3)
on Jun 11, 2012 Female from UNITED KINGDOM , 82 years of age, was diagnosed with
  • post procedural pulmonary embolism
and was treated with Warfarin Sodium. Patient felt the following Warfarin side effects: skin necrosis, multi-organ failure, sepsis. Warfarin Sodium dosage: N/A.

Groin Pain, Catheter Site Pain (8458949-9)
on Jun 12, 2012 Female from UNITED STATES , weighting 161.0 lb, was treated with Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: groin pain, catheter site pain. Warfarin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Sodium Chloride (2 Sprays Fours Daily As Needed)
  • Vismodegib
  • Lovenox (80mg/0.8 Ml)


Hypotensive Transfusion Reaction, Dizziness (8458339-9)
Patient was taking Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: hypotensive transfusion reaction, dizziness on Jun 11, 2012 from UNITED STATES Additional patient health information: Male , 81 years of age, . Warfarin Sodium dosage: N/A.
Associated medications used:
  • Allopurinol
  • Lisinopril
  • Celecoxib
  • Insulin


Renal Impairment (8457876-0)
Adverse event was reported on Jun 13, 2012 by a Female taking Warfarin Sodium (Dosage: N/A) . Location: JAPAN , 90 years of age, Patient felt the following Warfarin side effects: renal impairment.
Multiple prescriptions taken:
  • Enalapril Maleate
  • Tramadol Hcl
  • Tramadol Hcl (2 Df Four Per Day)
  • Tramadol Hcl
  • Tramadol Hcl (2 Df Four Per Day)
  • Mexirate
  • Norvasc


Skin Necrosis (8457624-4)
on Jun 11, 2012 Female from UNITED KINGDOM , 82 years of age, was diagnosed with
  • pulmonary embolism
and was treated with Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: skin necrosis. Warfarin Sodium dosage: Started A Year Ago.

International Normalised Ratio Increased (8457428-2)
on Jun 18, 2012 Female from NORWAY , 80 years of age, was treated with Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: international normalised ratio increased. Warfarin Sodium dosage: N/A.
Associated medications used:
  • Aspirin
  • Zocor


Showing 1-25 of 6408 

Warfarin Health Episodes

How Can Warfarin Affect You?

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It is very important to keep track of all side effects and discuss them with your doctor. If you think you may have a medical emergency, call your doctor or 911 immediately.

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Most drugs have a large list of nonsevere or mild adverse effects which do not rule out continued usage. These effects depend on individual sensitivity, and can include nausea, dizziness, diarrhea, malaise, vomiting, headache, dermatitis, dry mouth, etc. Check commonly reported side effects . These can be considered a form of pseudo-allergic reaction, as not all users experience these effects; many users experience none at all.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

Warfarin Information

Alternative WARFARIN Names:COUMADIN JANTOVEN

Active Ingredient: WARFARIN

More About Warfarin

Side Effects reported to FDA: 6408. View Warfarin Adverse Reports

Warfarin safety alerts: 2013 2011 2007 2006

Reported deaths: 565

Reported hospitalizations: 3549

Coumadin (warfarin sodium) Crystalline 5 mg Tablets: Recall - Tablets May Have Higher than Expected Potency

[Posted 05/03/2011]

AUDIENCE: Cardiology, Pharmacy, Patients

ISSUE: Bristol-Myers Squibb initiated a voluntary recall of one lot of 1,000-count bottles of Coumadin (warfarin sodium) Crystalline 5 mg tablets. Company testing of tablets from a returned bottle found a tablet to be higher in potency than expected. The lot number affected in the U.S. is 9H49374A with an expiry date of September 30, 2012. A decrease of active ingredient may increase the risk of clots which could lead to heart attack or stroke, and if there is too much active ingredient, there is an increased risk of bleeding.

BACKGROUND: Coumadin is prescribed to treat or prevent blood clots.

RECOMMENDATION: Patients who may have 5 mg tablets should not interrupt their therapy but should seek advice from their pharmacist to see if they have tablets originating from the affected lot and if so, should consult their physician for appropriate medical advice.


Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

  • Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
  • Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178


[05/02/2011 - Press Release - Bristol-Myers Squibb]

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