This is an index of side effect / adverse reaction reports (a.k.a. adverse event reports) related to Coumadin (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 (1905)
Death (142)
Life Threatening Events (93)
Disability (40)
Reports by Reaction Type
International Normalised Ratio Increased (352),
Anaemia (219),
Fall (123),
Gastrointestinal Haemorrhage (107),
Haemorrhage (102),
International Normalised Ratio Decreased (90),
Epistaxis (87),
Pulmonary Embolism (79),
Deep Vein Thrombosis (78),
Rectal Haemorrhage (73),
Dyspnoea (71),
International Normalised Ratio Fluctuation (69)
Below are a few examples of reports where side effects / adverse reactions may be related to Coumadin (Warfarin). For a complete list or a specific selection of reports, please use the links above.
Possible Coumadin side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: female
Reactions: Rectal Haemorrhage, Deep Vein Thrombosis
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Coumadin
Indication: Thrombosis
Rebif
Indication: Multiple Sclerosis
Start date: 2009-11-19
End date: 2010-01-01
Rebif
Start date: 2010-01-01
Possible Coumadin side effects in 59 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-27
Patient: 59 year old female, weighing 54.0 kg (118.8 pounds)
Reactions: Off Label Use, Procedural Complication, Pulmonary Artery Thrombosis, Treatment Noncompliance
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Coumadin
Indication: Product Used FOR Unknown Indication
Flolan
Dosage: 32ngkm unknown
Indication: Heart Disease Congenital
Start date: 2011-05-10
End date: 2012-08-07
Other drugs received by patient: Dobutamine
Possible Coumadin side effects in 84 year old female
Reported by a physician from France on 2012-08-27
Patient: 84 year old female
Reactions: Haemarthrosis, Wound Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Other drugs received by patient: Cordarone; Metformin HCL; Calcium D3 Sandoz; Cozaar; Adalat; Acetaminophen; Athymil; Glyburide; Imovane; Celectol; Toco
Possible Coumadin side effects in 84 year old female
Reported by a consumer/non-health professional from France on 2012-08-27
Patient: 84 year old female
Reactions: Haemarthrosis, Wound Infection
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Other drugs received by patient: Toco; Metformin HCL; Celectol; Athymil; Imovane; Glyburide; Adalat; Cordarone; Cozaar; Calcium D3 Sandoz; Acetaminophen
Possible Coumadin side effects in 74 year old male
Reported by a consumer/non-health professional from United States on 2012-08-27
Patient: 74 year old male, weighing 108.4 kg (238.5 pounds)
Reactions: International Normalised Ratio Increased, Expired Drug Administered, Intentional Drug Misuse
Drug(s) suspected as cause:
Coumadin
Indication: Product Used FOR Unknown Indication
Coumadin
Tylenol-500
Administration route: Oral
Tylenol-500
Dosage: 2 caplets 2 times a day
Administration route: Oral
Indication: Arthralgia
Start date: 2012-06-01
End date: 2012-07-03
Other drugs received by patient: Aricept; Vasotec; Vytorin
Possible Coumadin side effects in male
Reported by a physician from United States on 2012-08-27
Patient: male
Reactions: Surgery, Procedural Haemorrhage
Drug(s) suspected as cause:
Celebrex
Dosage: unk
Coumadin
Dosage: unk
Possible Coumadin side effects in
Reported by a physician from United States on 2012-08-24
Patient:
Reactions: Contusion, Palpitations, Extrasystoles, Tricuspid Valve Incompetence, Hypercoagulation, Deep Vein Thrombosis, Ligament Sprain
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dosage: unk
Indication: Deep Vein Thrombosis
Nuvaring
Indication: Contraception
Start date: 2005-04-13
End date: 2005-05-29
Other drugs received by patient: Vitamins (Unspecified)
Possible Coumadin side effects in 47 year old female
Reported by a pharmacist from United States on 2012-08-24
Patient: 47 year old female
Reactions: Catheterisation Cardiac, Procedural Complication, Heart Injury
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Tracleer
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Other drugs received by patient: Adcirca
Possible Coumadin side effects in 87 year old male
Reported by a consumer/non-health professional from France on 2012-08-24
Patient: 87 year old male
Reactions: Gastrointestinal Haemorrhage, Anaemia, Erosive Oesophagitis, Melaena
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aspirin
Dosage: 1 df:kardegic 75 mg powder for oral solution in sachet
Administration route: Oral
Start date: 2012-02-01
Coumadin
Dosage: 1 df:coumadine 2 mg scored tablet (warfarin sodium) 1 unk-2mar12(1 month) resumed unk date
Administration route: Oral
Start date: 2012-02-01
Other drugs received by patient: Furosemide; Fluticasone Propionate / Salmeterol; Procoralan; Spasfon; Atorvastatin; Levothyroxine Sodium
Possible Coumadin side effects in 87 year old female
Reported by a health professional (non-physician/pharmacist) from United States on 2012-08-24
Patient: 87 year old female
Reactions: International Normalised Ratio Increased, Transfusion, Toxicity To Various Agents
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Tracleer
Dosage: unk
Administration route: Oral
Indication: Pulmonary Arterial Hypertension
Start date: 2009-08-27
Ventavis
Dosage: 5 mcg, 6 x daily
Indication: Pulmonary Arterial Hypertension
Start date: 2011-02-24
Possible Coumadin side effects in 82 year old female
Reported by a consumer/non-health professional from Italy on 2012-08-24
Patient: 82 year old female
Reactions: Hypocoagulable State, Anaemia, Injury, Haematoma
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Other drugs received by patient: Nitroglycerin; Altiazem
Possible Coumadin side effects in 84 year old male
Reported by a consumer/non-health professional from Italy on 2012-08-23
Patient: 84 year old male
Reactions: Hypocoagulable State, Anaemia
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Other drugs received by patient: Pantoprazole; Polase; Lorazepam; Bisoprolol Fumarate; Furosemide
Possible Coumadin side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: female
Reactions: International Normalised Ratio Increased
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dianeal
Indication: Peritoneal Dialysis
Dianeal LOW Calcium W / Dextrose 1.5%
Indication: Peritoneal Dialysis
Possible Coumadin side effects in 65 year old male
Reported by a consumer/non-health professional from Italy on 2012-08-23
Patient: 65 year old male
Reactions: Haematuria, Anaemia, Rectal Haemorrhage, Duodenal Ulcer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dosage: 1df= 1dose
Administration route: Oral
Indication: Factor V Leiden Mutation
Start date: 2008-01-01
End date: 2012-07-28
Ibuprofen
Dosage: 1df= 1dose
Administration route: Oral
Indication: Back Pain
Start date: 2012-07-21
End date: 2012-07-28
Scopolamine
Dosage: buscopan 20 mg/ml. 1df=1 dose
Indication: Abdominal Pain
Start date: 2012-07-21
End date: 2012-07-28
Other drugs received by patient: Allopurinol; Pentacol
Possible Coumadin side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Paresis, Drug Resistance, Antiphospholipid Antibodies Positive, Drug Hypersensitivity, Pulmonary Embolism, Vena Cava Filter Insertion, Joint Injury, Cholelithiasis, Anticoagulation Drug Level Below Therapeutic, Antiphospholipid Syndrome, Arthralgia, Alopecia, Cholecystectomy, Pulmonary Thrombosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Coumadin
Dosage: 12 mg, qd
Start date: 2011-09-01
Coumadin
Dosage: unk
End date: 2010-12-01
Coumadin
Dosage: unk
Indication: Anticoagulant Therapy
Start date: 2009-08-01
End date: 2009-12-01
Nuvaring
Dosage: unk
Indication: Contraception
Start date: 2009-07-01
End date: 2009-08-01
Possible Coumadin side effects in
Reported by a physician from United States on 2012-08-23
Patient:
Reactions: Migraine, Pneumonia Primary Atypical, Lung Neoplasm, Haemorrhagic Disorder, Pulmonary Embolism, Hypercoagulation, Streptococcal Infection, Off Label Use, Lung Disorder, Menorrhagia, Muscle Spasms, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Indication: Anticoagulant Therapy
Start date: 2009-12-01
Hormonal Contraceptives (Unspecified)
Indication: Product Used FOR Unknown Indication
Nuvaring
Indication: Menstrual Cycle Management
Start date: 2007-01-01
End date: 2009-12-31
Nuvaring
Start date: 2009-06-01
Possible Coumadin side effects in 81 year old female
Reported by a consumer/non-health professional from France on 2012-08-23
Patient: 81 year old female
Reactions: Shock Haemorrhagic, Cardiac Arrest
Adverse event resulted in: life threatening event, hospitalization
Drug(s) suspected as cause:
Coumadin
Possible Coumadin side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-23
Patient: male, weighing 103.8 kg (228.5 pounds)
Reactions: Diabetes Mellitus, Oral Cavity Fistula, Tricuspid Valve Incompetence, Chronic Obstructive Pulmonary Disease, Cardiomegaly, Oedema Peripheral, Pulmonary Oedema, Pneumonitis, Hyperparathyroidism Secondary, Hyperphosphataemia, Left Ventricular Hypertrophy, Coronary Artery Disease, Cardiomyopathy, Nephrosclerosis, Alpha Haemolytic Streptococcal Infection, Staphylococcal Infection, Ventricular Tachycardia, Compression Fracture, Nicotine Dependence, Somnolence, Fall, Hypoacusis, Plasma Protein Metabolism Disorder, Chest Pain, Bone Disorder, Depression, Umbilical Hernia, Emphysema, Cataract, Dyspnoea, Paraesthesia Oral, Gout, Muscular Weakness, Bundle Branch Block Left, Arrhythmia, Arthralgia, Sepsis, Mitral Valve Incompetence, Hypoalbuminaemia, Loose Tooth, Mononeuritis, Hypertensive Nephropathy, Coagulopathy, Extrasystoles, Osteomyelitis, Phosphorus Metabolism Disorder, Pericardial Effusion, Hypoaesthesia Oral, Cardiac Failure Congestive, Pneumonia, Anaemia, Gingival Disorder, Hypoaesthesia, Bacteraemia, Mastication Disorder, Haemorrhagic Diathesis, Venous Thrombosis, Sleep Apnoea Syndrome, Aortic Valve Incompetence, Excessive Granulation Tissue, Venous Occlusion, Atelectasis, Aortic Bruit, Constipation, Neuropathy Peripheral, Left Ventricular Dysfunction, Pleural Effusion, Scoliosis, Peripheral Vascular Disorder, Nephrogenic Anaemia, Hyponatraemia, Renal Failure Chronic, Osteoarthritis, Osteonecrosis of JAW, Bradycardia, Hypertension, Leukocytosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Aredia
Dosage: 90 mg
Start date: 1997-12-04
Coumadin
Zometa
Other drugs received by patient: Alprazolam; Calcium Carbonate; Vincristine; Labetalol HCL; Paroxetine; Aspirin; Tagamet; Lodine; Doxorubicin Hydrochloride; Thalidomide; Allopurinol; Furosemide; Adriamycin PFS; Vancomycin; Hydralazine HCL; Metolazone; Neurontin; Dexamethasone; Pyridoxine HCL; Promethazine
Possible Coumadin side effects in
Reported by a lawyer from United States on 2012-08-23
Patient:
Reactions: Abdominal Pain, Migraine, Pain in Extremity, Nausea, Coagulopathy, Pulmonary Embolism, Treatment Noncompliance, Muscle Strain, Chest Pain, Hypertension, Cough, Deep Vein Thrombosis
Adverse event resulted in: hospitalization, disablity
Drug(s) suspected as cause:
Coumadin
Dosage: unk
Indication: Prophylaxis
Start date: 2009-12-19
Nuvaring
Dosage: unk
Indication: Contraception
Start date: 2009-02-01
End date: 2009-12-01
Possible Coumadin side effects in
Reported by a individual with unspecified qualification from United States on 2012-08-22
Patient:
Reactions: Drug Resistance, Angina Pectoris, International Normalised Ratio Increased, Otitis Media Acute, Pulmonary Embolism, Hypercoagulation, Cardiomegaly, Acute Sinusitis, Depression, Bronchitis, Pharyngitis, Metabolic Syndrome, Cough
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Indication: Anticoagulant Therapy
Start date: 2009-12-01
End date: 2010-03-01
Nuvaring
Indication: Contraception
Start date: 2009-06-01
End date: 2009-12-11
Nuvaring
Indication: Menstrual Cycle Management
Start date: 2009-06-01
End date: 2009-12-11
Other drugs received by patient: Hydrochlorothiazide; Vitamin B Complex CAP; Hoodia Gordonii; Vitamins (Unspecified)
Possible Coumadin side effects in 84 year old female
Reported by a physician from France on 2012-08-22
Patient: 84 year old female
Reactions: Haemoglobin Decreased, RED Blood Cell Count Decreased, Rectal Haemorrhage, International Normalised Ratio Abnormal
Adverse event resulted in: life threatening event
Drug(s) suspected as cause:
Coumadin
Dosage: 1 df = two scored tablets daily
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-04-16
End date: 2012-04-30
Pradaxa
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-05-01
End date: 2012-05-02
Other drugs received by patient: Digoxin; Hyperium; Micardis; Amlodipine Besylate; Pravastatin; Lexomil; Polyethylene Glycol; Lansoprazole
Possible Coumadin side effects in 90 year old male
Reported by a pharmacist from United States on 2012-08-22
Patient: 90 year old male, weighing 90.0 kg (198.0 pounds)
Reactions: Cerebral Haemorrhage
Adverse event resulted in: life threatening event, hospitalization, disablity
Drug(s) suspected as cause:
Coumadin
Possible Coumadin side effects in 47 year old female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 47 year old female, weighing 79.0 kg (173.8 pounds)
Reactions: Muscle Haemorrhage, Overdose, International Normalised Ratio Increased, Compartment Syndrome
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Letairis
Dosage: tabs
Administration route: Oral
Start date: 2009-01-19
Treprostinil
Dosage: 10mg/ml inj for inf,93.6mcg/kg;20dec11-unk,106.56mcg/kg;0.074mcg/kg;01aug12-unk
Indication: Pulmonary Arterial Hypertension
Start date: 2011-12-20
Other drugs received by patient: Digoxin; Revatio; Spironolactone
Possible Coumadin side effects in 62 year old male
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: 62 year old male
Reactions: Haemoptysis, International Normalised Ratio Increased, Hypertension
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Possible Coumadin side effects in male
Reported by a pharmacist from United States on 2012-08-22
Patient: male, weighing 133.0 kg (292.6 pounds)
Reactions: Haemoglobin Decreased, Retroperitoneal Haematoma, Hypotension, Hypoxia, Epistaxis
Adverse event resulted in: death
Drug(s) suspected as cause:
Coumadin
Dosage: 5mg, daily, po
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2012-04-12
End date: 2012-04-16
Lovenox
Dosage: 130mg, q12h, sq
Indication: Atrial Fibrillation
Start date: 2012-04-05
End date: 2012-04-16
Other drugs received by patient: Gabapentin; Pravastatin; Aspirin; Fluconazole; Fuosemide; Meropenem; Digoxin; Insulin Lispro; Metoprolol Tartrate; Miralax; Prednisone; Pantoprazole
Possible Coumadin side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Drug Ineffective, Coagulopathy, Haemorrhagic Anaemia, Toxicity To Various Agents, Kidney Transplant Rejection, Catheter Site Haemorrhage, Haematochezia, Aortic Valve Replacement, Hypertension, Deep Vein Thrombosis
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Dosage: unk
Indication: Aortic Valve Replacement
Prograf
Dosage: 4 mg, bid
Administration route: Oral
Indication: Renal Transplant
Start date: 2007-12-25
Possible Coumadin side effects in 79 year old male
Reported by a pharmacist from Italy on 2012-08-22
Patient: 79 year old male
Reactions: International Normalised Ratio Increased
Drug(s) suspected as cause:
Azithromycin
Dosage: 500 mg, 1x/day
Administration route: Oral
Indication: Bronchitis
Start date: 2012-05-28
End date: 2012-05-30
Coumadin
Dosage: 13.75 mg, weekly
Administration route: Oral
Indication: Atrial Fibrillation
Start date: 2010-09-06
End date: 2012-05-31
Levofloxacin
Dosage: 500 mg, 1x/day
Administration route: Oral
Indication: Bronchitis
Start date: 2012-05-31
End date: 2012-06-05
Other drugs received by patient: Atorvastatin; Limpidex; Avodart; Enalapril Maleate; Rifaximin; Carvedilol
Possible Coumadin side effects in female
Reported by a consumer/non-health professional from United States on 2012-08-22
Patient: female
Reactions: Product Quality Issue, Nervous System Disorder
Adverse event resulted in: disablity
Drug(s) suspected as cause:
Coumadin
Possible Coumadin side effects in male
Reported by a health professional (non-physician/pharmacist) from Italy on 2012-08-21
Patient: male
Reactions: Haematuria, Anaemia, Rectal Haemorrhage, Duodenal Ulcer
Adverse event resulted in: hospitalization
Drug(s) suspected as cause:
Coumadin
Administration route: Oral
Indication: Factor V Leiden Mutation
Start date: 2008-01-01
End date: 2012-07-28
Ibuprofen
Administration route: Oral
Indication: Back Pain
Start date: 2012-07-21
End date: 2012-07-28
Scopolamine
Indication: Abdominal Pain
Start date: 2012-07-21
End date: 2012-07-28
Other drugs received by patient: TPN
Possible Coumadin side effects in male
Reported by a consumer/non-health professional from United States on 2012-08-21
Patient: male
Reactions: COR Pulmonale, Drug Interaction, Chronic Obstructive Pulmonary Disease
Adverse event resulted in: death
Drug(s) suspected as cause:
Coumadin
Digoxin
Revatio
Dosage: 60 mg
Indication: Lung Disorder
Start date: 2011-11-01
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