This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Warfarin and submitted to the FDA during the sample period of about a year. The information is not vetted and should not be considered as verified clinical evidence.
Reports by Event Outcome
All Cases (29)
Death (5)
Life Threatening Events (4)
Reports by Reaction Type
International Normalised Ratio Increased (9),
Drug Interaction (6),
Drug Ineffective (2),
Skin Exfoliation (2),
Pyrexia (2),
Completed Suicide (2),
Hallucination (2),
Toxicity To Various Agents (2),
Renal Impairment (2),
Diarrhoea (2),
Rhabdomyolysis (1),
Infection (1)
Possible Warfarin side effects in 51 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-23
Patient: 51 year old female
Reactions: International Normalised Ratio Abnormal, Lower Gastrointestinal Haemorrhage, Gastritis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Ibuprofen
Dosage: unk
Indication: Back Pain
Warfarin
Indication: Product Used FOR Unknown Indication
Possible Warfarin side effects in 62 year old male
Reported by a physician from Portugal on 2012-08-15
Patient: 62 year old male, weighing 70.0 kg (154.0 pounds)
Reactions: Product Quality Issue, Product Substitution Issue, Ischaemic Stroke, Drug Interaction, Hemiparesis, Hemianopia, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Simvastatin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Carvedilol
Dosage: 25 mg/day
Administration route: Oral
Indication: Hypertension
Captopril
Dosage: unk
Indication: Product Used FOR Unknown Indication
Potassium Chloride
Dosage: unk
Indication: Product Used FOR Unknown Indication
Spironolactone
Dosage: unk
Indication: Product Used FOR Unknown Indication
Acetylsalicylic Acid SRT
Dosage: 300 mg, unk
Administration route: Oral
Indication: Transient Ischaemic Attack
Diazepam
Dosage: unk
Indication: Product Used FOR Unknown Indication
Warfarin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Nifedipine
Dosage: 30 mg, 2x/day
Indication: Product Used FOR Unknown Indication
Enalapril
Dosage: unk
Indication: Product Used FOR Unknown Indication
Amlodipine
Dosage: unk
Indication: Product Used FOR Unknown Indication
Enoxaparin
Dosage: unk
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Lisinopril Dihydrate; Irbesartan and Hydrochlorothiazide; Rilmenidine
Possible Warfarin side effects in 75 year old male
Reported by a pharmacist from United Kingdom on 2012-08-01
Patient: 75 year old male
Reactions: Haemorrhage, International Normalised Ratio Increased, Drug Interaction
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Benylin Chesty Cough
Administration route: Oral
Indication: Cough
Warfarin
Indication: Product Used FOR Unknown Indication
Other drugs received by patient: Bisoprolol Fumarate; Spironolactone; Atorvastatin; Folic Acid; Colchicine
Possible Warfarin side effects in
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-01
Patient:
Reactions: Haemoglobin Decreased, Alanine Aminotransferase Increased, Aspartate Aminotransferase Increased, International Normalised Ratio Increased, Drug Interaction
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Cymbalta
Dosage: 50 mg, qd
Acetaminophen
Dosage: 650 mg, qid
Administration route: Oral
Warfarin
Dosage: 1-6 mg, qd
Administration route: Oral
Zocor
Dosage: 20 mg, qd
Administration route: Oral
Possible Warfarin side effects in female
Reported by a consumer/non-health professional from United States on 2012-07-31
Patient: female
Reactions: Thrombosis, Diarrhoea, Dehydration, International Normalised Ratio Increased, Muscular Weakness
Drug(s) suspected as cause:
Xalkori
Dosage: unk
Warfarin
Dosage: unk
Xalkori
Dosage: 250 mg, 2x/day
Administration route: Oral
Indication: Lung Neoplasm Malignant
Start date: 2012-04-03
Possible Warfarin side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-12
Patient: female
Reactions: Drug Ineffective, Drug Interaction, Pulmonary Oedema, Shock
Drug(s) suspected as cause:
Warfarin
Cephalexin
Indication: Pulmonary Oedema
Other drugs received by patient possibly interacting with the suspect drug:
Dofetilide
Azithromycin
Indication: Pulmonary Oedema
Possible Warfarin side effects in 79 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-11
Patient: 79 year old female
Reactions: Skin Exfoliation
Drug(s) suspected as cause:
Amiodarone Hydrochloride
Dosage: unk
Nicorandil
Dosage: unk
Administration route: Oral
Warfarin
Dosage: unk
Administration route: Oral
Diltiazem HCL
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2012-04-01
End date: 2012-05-01
Possible Warfarin side effects in female
Reported by a consumer/non-health professional from United States on 2012-06-08
Patient: female, weighing 113.0 kg (248.6 pounds)
Reactions: Gingival Recession, Stomatitis, Tongue Disorder
Drug(s) suspected as cause:
Nicotrol
Dosage: 4 cartridges of 4 mg
Start date: 2012-05-06
End date: 2012-05-07
Nicotrol
Dosage: 3 cartridges of 4 mg
Indication: Smoking Cessation Therapy
Start date: 2012-05-05
End date: 2012-05-05
Nicotrol
Dosage: 3 cartridges of 4 mg
Start date: 2012-05-08
End date: 2012-05-08
Warfarin
Dosage: unk
Indication: Anticoagulant Therapy
Possible Warfarin side effects in 79 year old female
Reported by a health professional (non-physician/pharmacist) from Japan on 2012-06-04
Patient: 79 year old female
Reactions: Skin Exfoliation
Drug(s) suspected as cause:
Diltiazem HCL
Dosage: 100 mg, unk
Administration route: Oral
Start date: 2012-04-01
End date: 2012-05-01
Nicorandil
Dosage: unk
Administration route: Oral
Warfarin
Dosage: unk
Administration route: Oral
Amiodarone Hydrochloride
Dosage: unk
Possible Warfarin side effects in 40 year old male
Reported by a physician from Japan on 2012-05-31
Patient: 40 year old male, weighing 69.0 kg (151.8 pounds)
Reactions: International Normalised Ratio Increased
Drug(s) suspected as cause:
Zyvox
Dosage: 600 mg, 2x/day
Indication: Graft Infection
Start date: 2011-09-16
End date: 2011-10-04
Warfarin
Dosage: 4 mg/day
Administration route: Oral
Start date: 2011-09-13
End date: 2011-09-15
Warfarin
Dosage: unk
Start date: 2011-09-08
Warfarin
Dosage: 4.5 mg/day
Administration route: Oral
Start date: 2011-09-16
End date: 2011-09-17
Warfarin
Dosage: 5 mg/day
Administration route: Oral
Start date: 2011-09-18
End date: 2011-09-20
Other drugs received by patient: Verapamil HCL; Lansoprazole; Lopressor; Heparin
Possible Warfarin side effects in 65 year old male
Reported by a physician from United States on 2012-05-30
Patient: 65 year old male
Reactions: Cardio-Respiratory Arrest, Completed Suicide, Toxicity To Various Agents
Adverse event resulted in: death
Drug(s) suspected as cause:
Venlafaxine
Dosage: unk
Administration route: Oral
Lamotrigine
Dosage: unk
Administration route: Oral
Acetaminophen
Dosage: unk
Administration route: Oral
Alprazolam
Dosage: unk
Administration route: Oral
Propranolol HCL
Dosage: unk
Administration route: Oral
Modafinil
Dosage: unk
Administration route: Oral
Doxepin
Dosage: unk
Administration route: Oral
Warfarin
Dosage: unk
Administration route: Oral
Possible Warfarin side effects in 63 year old male
Reported by a physician from Japan on 2012-05-29
Patient: 63 year old male, weighing 68.8 kg (151.4 pounds)
Reactions: Renal Impairment, International Normalised Ratio Increased
Drug(s) suspected as cause:
Zyvox
Dosage: 600 mg, 2x/day
Indication: Endocarditis
Start date: 2011-10-11
End date: 2011-11-29
Rifadin
Dosage: 600 mg, 1x/day
Administration route: Oral
Indication: Endocarditis
Start date: 2011-10-14
End date: 2011-12-10
Warfarin
Dosage: unk
Administration route: Oral
Indication: Endocarditis
Start date: 2011-09-29
End date: 2011-12-10
Habekacin
Dosage: 200 mg, 1x/day
Indication: Endocarditis
Start date: 2011-10-14
End date: 2011-11-11
Other drugs received by patient: Gentamicin Sulfate; Celoop; Aspirin; Lasix; Cefazolin Sodium; Vancomycin; Magnesium Oxide Heavy; Aldactone; Miya BM; Rabeprazole Sodium; Gaslon; Avapro; Sigmart; Miya BM; Isosorbide Dinitrate; Lendormin
Possible Warfarin side effects in 64 year old female
Reported by a physician from Japan on 2012-05-29
Patient: 64 year old female, weighing 59.0 kg (129.8 pounds)
Reactions: International Normalised Ratio Increased, Pancytopenia
Drug(s) suspected as cause:
Warfarin
Dosage: 3.5 mg, daily
Start date: 2011-11-04
End date: 2011-11-17
Zyvox
Dosage: 600 mg, 2x/day
Indication: Endocarditis
Start date: 2011-09-23
End date: 2011-10-20
Warfarin
Dosage: 2.5 mg, daily
Start date: 2011-09-28
End date: 2011-10-24
Warfarin
Dosage: 3 mg, daily
Start date: 2011-10-25
End date: 2011-11-03
Other drugs received by patient: Meropenem; Lasix; Lasix; DAI-Kenchu-TO; Enalapril Maleate; Aldactone; Bisoprolol Fumarate; Magnesium Sulfate; Lansoprazole; Adona; Seroquel; Aspirin; Phenytoin Sodium CAP; Slow-K; Aldactone; Lanirapid; Lasix; Gasmotin; Carvedilol; Miya BM; Aldactone
Possible Warfarin side effects in 75 year old male
Reported by a consumer/non-health professional from United Kingdom on 2012-04-18
Patient: 75 year old male
Reactions: Hallucination
Drug(s) suspected as cause:
Prednisolone
Indication: Chronic Obstructive Pulmonary Disease
Albuterol
Ramipril
Warfarin
Indication: Atrial Fibrillation
Formoterol Fumarate
Cysteine
Formoterol Fumarate
Metformin HCL
Verapamil
Indication: Atrial Fibrillation
Furosemide
Atorvastatin
Other drugs received by patient: Spiriva; Symbicort
Possible Warfarin side effects in 95 year old male
Reported by a physician from Japan on 2012-04-16
Patient: 95 year old male
Reactions: Jaundice
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Warfarin
Dosage: unk
Lipitor
Dosage: unk
Administration route: Oral
Lansoprazole
Dosage: unk
Plavix
Dosage: unk
Possible Warfarin side effects in male
Reported by a physician from United Kingdom on 2012-03-26
Patient: male
Reactions: Renal Impairment, Diarrhoea, Flatulence, Abdominal Distension
Drug(s) suspected as cause:
Warfarin
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2011-12-13
End date: 2012-01-01
Warfarin
Administration route: Oral
Other drugs received by patient: Lansoprazole; Lansoprazole; Warfarin
Possible Warfarin side effects in 75 year old male
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-03-22
Patient: 75 year old male
Reactions: Hallucination
Drug(s) suspected as cause:
Formoterol Fumarate
Dosage: unk
Metformin HCL
Dosage: unk
Atorvastatin
Dosage: unk
Verapamil
Dosage: unk
Cysteine
Dosage: unk
Warfarin
Dosage: unk
Albuterol
Dosage: unk
Furosemide
Dosage: unk
Prednisolone
Dosage: unk
Ramipril
Dosage: unk
Possible Warfarin side effects in 73 year old female
Reported by a health professional (non-physician/pharmacist) from United Kingdom on 2012-02-28
Patient: 73 year old female, weighing 98.0 kg (215.6 pounds)
Reactions: International Normalised Ratio Increased
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Warfarin
Dosage: 10 mg, unk
Administration route: Oral
Indication: Pulmonary Embolism
Start date: 2012-02-03
End date: 2012-02-05
Piperacillin and Tazobactam
Dosage: 4.5 g, unk
Indication: Pneumonia
Start date: 2012-02-02
End date: 2012-02-06
Other drugs received by patient: Isosorbide Mononitrate; Rosuvastatin; Acetylsalicylic Acid; Enoxaparin; Furosemide; Novorapid; Fluticasone Propionate / Salmeterol; Insulin Detemir; Ramipril; Salbutamol; Tramadol; Alendronate Sodium; Levothyroxine; Diltiazem; Paracetamol
Possible Warfarin side effects in 51 year old male
Reported by a physician from Japan on 2012-02-21
Patient: 51 year old male
Reactions: Hepatic Function Abnormal, Pyrexia, Eosinophil Count Increased
Drug(s) suspected as cause:
Argatroban
Dosage: unk
Start date: 2011-07-24
End date: 2011-07-25
Argatroban
Dosage: unk
Indication: Heparin-Induced Thrombocytopenia
Start date: 2011-07-23
End date: 2011-07-24
Vancomycin
Indication: Endocarditis
Warfarin
Indication: Anticoagulant Therapy
Argatroban
Dosage: unk
Start date: 2011-07-26
End date: 2011-07-27
Argatroban
Dosage: unk
Start date: 2011-07-28
End date: 2011-07-29
Zyvox
Rifampicin
Indication: Endocarditis
Argatroban
Dosage: unk
Start date: 2011-07-29
End date: 2011-07-30
Argatroban
Dosage: unk
Start date: 2011-07-25
End date: 2011-07-26
Heparin
Dosage: unk
Indication: Anticoagulant Therapy
Start date: 2011-07-16
Arbekacin Sulfate
Indication: Endocarditis
Argatroban
Dosage: unk
Start date: 2011-07-27
End date: 2011-07-28
Possible Warfarin side effects in male
Reported by a physician from Italy on 2012-02-17
Patient: male, weighing 77.7 kg (170.9 pounds)
Reactions: Pneumonia, Anaemia, Condition Aggravated, Concomitant Disease Progression
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Ilaris
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2012-01-17
Blinded NO Treatment Received
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2012-01-17
Placebo
Dosage: double blinded
Indication: Cardiovascular Event Prophylaxis
Start date: 2012-01-17
Warfarin
Dosage: unk
Start date: 2011-04-29
Other drugs received by patient: Aspirin; Furosemide; Nitroglycerin; Ramipril
Possible Warfarin side effects in 52 year old female
Reported by a physician from United Kingdom on 2012-02-15
Patient: 52 year old female, weighing 68.5 kg (150.7 pounds)
Reactions: Sinus Headache, Nasal Congestion, Erythema, Sinusitis, Eye Pain, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Warfarin
Indication: Pulmonary Hypertension
Warfarin
Indication: Atrial Septal Defect
Sildenafil Citrate
Dosage: 20 mg, 3x/day
Administration route: Oral
Indication: Pulmonary Hypertension
Start date: 2009-07-01
Bosentan
Dosage: 125 mg, 2x/day
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-07-01
Warfarin
Dosage: unk
Indication: Coagulopathy
Start date: 2004-01-01
Other drugs received by patient: Digoxin; Ferrous Sulfate TAB; Omeprazole
Possible Warfarin side effects in 71 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-02-08
Patient: 71 year old female
Reactions: Activated Partial Thromboplastin Time Prolonged, Drug Ineffective, International Normalised Ratio Increased, Drug Interaction
Drug(s) suspected as cause:
Levetiracetam
Dosage: 2.5 g, bid, iv
Indication: Complex Partial Seizures
Warfarin
Dosage: 0.75 mg, ngt
Indication: Deep Vein Thrombosis
Valproic Acid
Dosage: 250 mg, q6h, hgt
Midazolam
Dosage: 3 mg, x1; iv
Indication: Complex Partial Seizures
Other drugs received by patient: Dexamethasone; Temozolomide; Pravastatin; Fish OIL
Possible Warfarin side effects in 91 year old female
Reported by a physician from Japan on 2012-01-06
Patient: 91 year old female
Reactions: Gastrointestinal Haemorrhage, Shock Haemorrhagic
Adverse event resulted in: death, hospitalization
Drug(s) suspected as cause:
Celecoxib
Dosage: unk
Administration route: Oral
Warfarin
Dosage: unk
Other drugs received by patient: Aspirin
Possible Warfarin side effects in 52 year old male
Reported by a health professional (non-physician/pharmacist) from United States on 2012-01-04
Patient: 52 year old male
Reactions: Intentional Overdose
Adverse event resulted in: death
Drug(s) suspected as cause:
Warfarin
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Acetaminophen
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Propafenone
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Carvedilol
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Oxazepam
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Ibuprofen
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Temazepam
Dosage: unk
Administration route: Oral
Start date: 2006-01-01
End date: 2006-01-01
Possible Warfarin side effects in 59 year old male
Reported by a physician from Japan on 2011-12-23
Patient: 59 year old male, weighing 46.0 kg (101.2 pounds)
Reactions: Arthropod Sting, Anaphylactic Shock, Tonsillitis, Pyrexia, Oral Candidiasis, Granulocytopenia, Pharyngeal Ulceration, Infection
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Enalapril Maleate
Administration route: Oral
Start date: 2011-11-17
End date: 2011-11-24
Lasix
Dosage: (75); therapy start date: 4 oct (year not specified)
Administration route: Oral
Start date: 2011-10-17
End date: 2011-11-10
Magnesium Oxide
Dosage: dose: 0.67
Administration route: Oral
Indication: Constipation
Start date: 2011-10-14
End date: 2011-11-10
Plavix
Dosage: therapy started: 8 oct (year not specified), therapy end date: 10 nov (year not specified)
Administration route: Oral
Start date: 2011-10-03
End date: 2011-11-10
Enalapril Maleate
Administration route: Oral
Start date: 2011-10-11
End date: 2011-11-10
Sennoside A+B
Dosage: dose: 2
Administration route: Oral
Indication: Constipation
Start date: 2011-10-14
End date: 2011-11-10
Aspirin
Administration route: Oral
Start date: 2011-11-17
End date: 2011-11-24
Teprenone
Administration route: Oral
Indication: Prophylaxis
Start date: 2011-10-13
End date: 2011-11-10
Warfarin
Administration route: Oral
Indication: Cardiac Disorder
Start date: 2011-10-15
End date: 2011-11-10
Lasix
Dosage: (75); therapy start date: 4 oct (year not specified)
Administration route: Oral
Start date: 2011-11-17
End date: 2011-11-24
Carvedilol
Dosage: (2.5); therapy start date: 06 oct (year not specified)
Administration route: Oral
Start date: 2011-10-09
End date: 2011-11-10
Lansoprazole
Dosage: (15); therapy start date: 5 oct (year not specified)
Administration route: Oral
Start date: 2011-10-05
End date: 2011-11-10
Livalo
Administration route: Oral
Indication: Dyslipidaemia
Start date: 2011-10-26
End date: 2011-11-10
Aspirin
Administration route: Oral
Indication: Myocardial Infarction
Start date: 2011-10-03
End date: 2011-11-10
Other drugs received by patient: Aldactone
Possible Warfarin side effects 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
Drug(s) suspected as cause:
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
Possible Warfarin side effects 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
Drug(s) suspected as cause:
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 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
Drug(s) suspected as cause:
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 in male
Reported by a consumer/non-health professional from United States on 2011-10-31
Patient: male, weighing 104.3 kg (229.5 pounds)
Reactions: Fatigue, Balance Disorder, Head Injury, Total Lung Capacity Decreased, Fall
Drug(s) suspected as cause:
Warfarin
Dosage: unk
Cordarone
Dosage: 200 mg, 2x/day
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2010-10-01
End date: 2011-04-01
Cordarone
Indication: Heart Rate Irregular
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