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Coumadin Side Effects

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Common Coumadin Side Effects


The most commonly reported Coumadin side effects (click to view or check a box to report):

International Normalised Ratio Increased (1107)
Anaemia (417)
International Normalised Ratio Decreased (383)
Fall (368)
International Normalised Ratio Fluctuation (333)
Epistaxis (253)
Gastrointestinal Haemorrhage (250)
Haemorrhage (247)
Asthenia (220)
Haematoma (215)
Dyspnoea (206)
Contusion (195)
Dizziness (192)
Rectal Haemorrhage (166)
Death (166)
Nausea (159)
Diarrhoea (156)
Subdural Haematoma (155)
Thrombosis (139)
Melaena (137)

➢ More



If you or someone in your family has experienced a serious side effect to a health product, you are encouraged to report the experience to your health care professional (e.g. physician, pharmacist). You could also complete a copy of the side effect reporting form or report your side effect to FDA.

Coumadin Side Effects Reported to FDA



Coumadin Side Effect Report#9996552
Confusional State, Hypotension, Malaise, Presyncope, Vision Blurred, Chest Discomfort
This is a report of a 80-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: NA, who was treated with Coumadin Tabs 5 Mg (dosage: 1df: 1 Unit, start time:
Dec 12, 2013), combined with:
  • Ramipril (1dt: 1 Unit)
  • Tildiem Retard (Tablet)
and developed a serious reaction and side effect(s): Confusional State, Hypotension, Malaise, Presyncope, Vision Blurred, Chest Discomfort after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin Tabs 5 Mg treatment in male patients, resulting in Confusional State side effect. The patient was hospitalized.
Coumadin Side Effect Report#9996503
Disorientation, Fall, Haemorrhage Intracranial, Balance Disorder
This report suggests a potential Coumadin Disorientation side effect(s) that can have serious consequences. A 87-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Coumadin (dosage: NA) starting NS. After starting Coumadin the patient began experiencing various side effects, including: Disorientation, Fall, Haemorrhage Intracranial, Balance DisorderAdditional drugs used concurrently: NA. Although Coumadin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Disorientation, may still occur.
Coumadin Side Effect Report#9992846
Arrhythmia
This Arrhythmia problem was reported by a consumer or non-health professional from TR. A 68-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Coumadin (dosage: Ongoing). The following drugs were being taken at the same time: NA. When using Coumadin, the patient experienced the following unwanted symptoms/side effects: ArrhythmiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arrhythmia, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9992579
Pancreatitis Acute
This Pancreatitis Acute side effect was reported by a consumer or non-health professional from FR. A 19-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary embolism.The patient was prescribed Coumadine (drug dosage: NA), which was initiated on
Feb 06, 2014. Concurrently used drugs: NA..After starting to take Coumadine the consumer reported adverse symptoms, such as: Pancreatitis AcuteThese side effects may potentially be related to Coumadine. The patient was hospitalized.
Coumadin Side Effect Report#9992570
Cardiac Disorder
This is a report of a 74-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Coumadin (dosage: Tablet?two And Half, start time: NS), combined with:
  • Procardia Xl
  • Protonix
  • Glucotrol
  • Lipitor
  • Accupril
and developed a serious reaction and side effect(s): Cardiac Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin treatment in female patients, resulting in Cardiac Disorder side effect.
Coumadin Side Effect Report#9981441
Road Traffic Accident, Aortic Valve Replacement, Contusion, Urticaria
This report suggests a potential Coumadin Tabs Road Traffic Accident side effect(s) that can have serious consequences. A 46-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Coumadin Tabs (dosage: NA) starting 1996. After starting Coumadin Tabs the patient began experiencing various side effects, including: Road Traffic Accident, Aortic Valve Replacement, Contusion, UrticariaAdditional drugs used concurrently:
  • Metoprolol
The patient was hospitalized. Although Coumadin Tabs demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Road Traffic Accident, may still occur.
Coumadin Side Effect Report#9960362
Polyp, Cardiac Pacemaker Insertion, International Normalised Ratio Decreased
This Polyp problem was reported by a consumer or non-health professional from US. A 80-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Coumadin (dosage: Increased To 3mg For 3 Day Per Week). The following drugs were being taken at the same time: NA. When using Coumadin, the patient experienced the following unwanted symptoms/side effects: Polyp, Cardiac Pacemaker Insertion, International Normalised Ratio DecreasedThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Polyp, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9940989
Chronic Leukaemia
This Chronic Leukaemia side effect was reported by a consumer or non-health professional from US. A 93-year-old female patient (weight:NA) experienced the following symptoms/conditions: cardiac fibrillation.The patient was prescribed Coumadin (drug dosage: 1df=2.2 Units Nos), which was initiated on NS. Concurrently used drugs:
  • Atenolol
  • Losartan
  • Norvasc
  • Furosemide
  • Allopurinol
  • Rituxan
.After starting to take Coumadin the consumer reported adverse symptoms, such as: Chronic LeukaemiaThese side effects may potentially be related to Coumadin.
Coumadin Side Effect Report#9934858
Abdominal Pain, Peripheral Artery Aneurysm
This is a report of a 82-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Coumadin Tabs 5 Mg (dosage: 1 Df = 1 Unit, start time:
Jan 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Abdominal Pain, Peripheral Artery Aneurysm after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin Tabs 5 Mg treatment in male patients, resulting in Abdominal Pain side effect. The patient was hospitalized.
Coumadin Side Effect Report#9925559
Haematoma, Renal Failure Acute, Hyperkalaemia, Anaemia, International Normalised Ratio Increased, Activated Partial Thromboplastin Time Prolonged, Overdose
This report suggests a potential Coumadine Haematoma side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Coumadine (dosage: 1 Df= 1 To 5 Mg) starting
Jan 19, 2014. After starting Coumadine the patient began experiencing various side effects, including: Haematoma, Renal Failure Acute, Hyperkalaemia, Anaemia, International Normalised Ratio Increased, Activated Partial Thromboplastin Time Prolonged, OverdoseAdditional drugs used concurrently:
  • Heparin Sodium
  • Sintrom
  • Calciparine
The patient was hospitalized. Although Coumadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematoma, may still occur.
Coumadin Side Effect Report#9921872
Renal Impairment, Blood Urea Increased, Diarrhoea, Hyperglycaemia
This Renal Impairment problem was reported by a consumer or non-health professional from TR. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,coronary artery disease. On NS this consumer started treatment with Coumadin (dosage: 1df= 5mg For 5days, 7.5mg For The Following 2 Days.). The following drugs were being taken at the same time:
  • Aspirin
  • Coraspin
  • Insulin
  • Beloc-zok
  • Monoket
When using Coumadin, the patient experienced the following unwanted symptoms/side effects: Renal Impairment, Blood Urea Increased, Diarrhoea, HyperglycaemiaThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Renal Impairment, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9917871
Joint Effusion
This Joint Effusion side effect was reported by a consumer or non-health professional from IT. A 85-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Coumadin Tabs 5 Mg (drug dosage: 1 Df = 1unit?interrupted On 14dec13), which was initiated on
Dec 01, 2013. Concurrently used drugs:
  • Cordarone (Tablet)
  • Rytmonorm (Tablet)
.After starting to take Coumadin Tabs 5 Mg the consumer reported adverse symptoms, such as: Joint EffusionThese side effects may potentially be related to Coumadin Tabs 5 Mg. The patient was hospitalized.
Coumadin Side Effect Report#9915185
Duodenal Ulcer, Haemorrhage, Faeces Discoloured
This is a report of a 79-year-old male patient (weight: NA) from IT, suffering from the following health symptoms/conditions: atrial fibrillation,cardiac disorder, who was treated with Coumadin Tabs 5 Mg (dosage: 1df:1 Unit, start time:
Jan 01, 2013), combined with:
  • Lanoxin (1df:1 Unit?0.125 Mg Tabs)
  • Citalopram
  • Ranitidine
  • Spiriva
  • Aliflus Diskus
  • Kanrenol
  • Lasix (Tabs)
  • Quark (Tabs)
and developed a serious reaction and side effect(s): Duodenal Ulcer, Haemorrhage, Faeces Discoloured after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin Tabs 5 Mg treatment in male patients, resulting in Duodenal Ulcer side effect. The patient was hospitalized.
Coumadin Side Effect Report#9913705
Haematoma, International Normalised Ratio Increased, Haemoglobin Decreased, Renal Failure Acute
This report suggests a potential Coumadin Tabs Haematoma side effect(s) that can have serious consequences. A 86-year-old female patient (weight: NA) from FR was diagnosed with the following symptoms/conditions: NA and used Coumadin Tabs (dosage: Rechallenged At 1 Mg Per Day?dose Rapidly Increased At 2 Mg.) starting NS. After starting Coumadin Tabs the patient began experiencing various side effects, including: Haematoma, International Normalised Ratio Increased, Haemoglobin Decreased, Renal Failure AcuteAdditional drugs used concurrently:
  • Paracetamol
  • Kardegic
  • Crestor
  • Allopurinol
  • Aprovel
  • Pantoprazole
  • Furosemide
  • Amlodipine
The patient was hospitalized. Although Coumadin Tabs demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematoma, may still occur.
Coumadin Side Effect Report#9912500
Abdominal Wall Haematoma, Abdominal Pain, Swelling
This Abdominal Wall Haematoma problem was reported by a consumer or non-health professional from IT. A 78-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: thrombosis prophylaxis. On
Jan 01, 2013 this consumer started treatment with Coumadin Tabs 5 Mg (dosage: Interrupted On 20-jan-2014 And Restarted). The following drugs were being taken at the same time:
  • Calcitriol
  • Calcium Mefolinate
  • Mirtazapine
  • Cardicor (Tabs)
  • Deltacortene (Tabs)
  • Depalgos (1df:5+325 Mg Tabs)
  • Eutirox (Tabs)
  • Lanoxin
When using Coumadin Tabs 5 Mg, the patient experienced the following unwanted symptoms/side effects: Abdominal Wall Haematoma, Abdominal Pain, SwellingAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Abdominal Wall Haematoma, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9912492
Myocardial Infarction
This Myocardial Infarction side effect was reported by a consumer or non-health professional from TR. A 64-year-old male patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Coumadin (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Carvedilol
  • Lasix
  • Dilatrend (1 Df=25 Units Nos)
  • Digoxin (1df-0.25 Units Nos)
.After starting to take Coumadin the consumer reported adverse symptoms, such as: Myocardial InfarctionThese side effects may potentially be related to Coumadin. The patient was hospitalized.
Coumadin Side Effect Report#9912448
Embolic Stroke, Epistaxis, Overdose
This is a report of a 77-year-old female patient (weight: NA) from IT, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Coumadin Tabs 5 Mg (dosage: 1df- 1 Unit?01jan2013 To 23nov2013?unk To 01dec2013, start time:
Jan 01, 2013), combined with:
  • Clexane (Axa Injection Solution)
and developed a serious reaction and side effect(s): Embolic Stroke, Epistaxis, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin Tabs 5 Mg treatment in female patients, resulting in Embolic Stroke side effect. The patient was hospitalized.
Coumadin Side Effect Report#9912166
Coma
This report suggests a potential Coumadine Coma side effect(s) that can have serious consequences. A 36-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Coumadine (dosage: NA) starting 200401. After starting Coumadine the patient began experiencing various side effects, including: ComaAdditional drugs used concurrently:
  • Dilantin (1 Df = 300mg In Morning, 200mg In Noon And 200mg In Night) Three Times A Day)
  • Amlodipine
The patient was hospitalized. Although Coumadine demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coma, may still occur.
Coumadin Side Effect Report#9912144
Arthralgia
This Arthralgia problem was reported by a consumer or non-health professional from CA. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Coumadin (dosage: Lot 5mg# 2f69855a Exp:aug2014?lot 2mg #2h63512b Exp:nov2014?lot 1mg# 2d71819c Exp:jun 2014). The following drugs were being taken at the same time: NA. When using Coumadin, the patient experienced the following unwanted symptoms/side effects: ArthralgiaAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Arthralgia, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9911286
Melaena, Anaemia, Renal Failure
This Melaena side effect was reported by a consumer or non-health professional from FR. A 81-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Coumadine (drug dosage: NA), which was initiated on
Aug 16, 2013. Concurrently used drugs:
  • Xarelto (Film-coated Tablet)
  • Deroxat
  • Arixtra
  • Stilnox (Film-coated Scored Tablet)
  • Perindopril
  • Alprazolam
.After starting to take Coumadine the consumer reported adverse symptoms, such as: Melaena, Anaemia, Renal FailureThese side effects may potentially be related to Coumadine. The patient was hospitalized.
Coumadin Side Effect Report#9909034
Cerebral Haemorrhage, Coma
This is a report of a 63-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Coumadin (dosage: Chronic, start time: NS), combined with:
  • Enalapril
  • Bentyl
  • Coreg
  • Soma
  • Vicodin
and developed a serious reaction and side effect(s): Cerebral Haemorrhage, Coma after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin treatment in male patients, resulting in Cerebral Haemorrhage side effect. The patient was hospitalized.
Coumadin Side Effect Report#9908631
International Normalised Ratio Increased, Cardiac Failure Congestive, Hypophagia
This report suggests a potential Coumadin International Normalised Ratio Increased side effect(s) that can have serious consequences. A 84-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,urinary tract infection and used Coumadin (dosage: Chronic) starting NS. After starting Coumadin the patient began experiencing various side effects, including: International Normalised Ratio Increased, Cardiac Failure Congestive, HypophagiaAdditional drugs used concurrently:
  • Cipro (Recent)
  • Digoxin
  • Mvi
  • Verapamil
  • Metoprolol
  • Lasix
The patient was hospitalized. Although Coumadin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as International Normalised Ratio Increased, may still occur.
Coumadin Side Effect Report#9908596
International Normalised Ratio Increased, Haematuria, Urinary Tract Infection
This International Normalised Ratio Increased problem was reported by a pharmacist from US. A 94-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,clostridium difficile infection. On NS this consumer started treatment with Coumadin (dosage: Chronic?4mg Alt 2mg Daily Po). The following drugs were being taken at the same time:
  • Flagyl (Recent)
  • Omeprazole
  • Culturelle
  • Finasteride
  • Kcl
  • Lasix
  • Rosuvastatin
  • Docusate
When using Coumadin, the patient experienced the following unwanted symptoms/side effects: International Normalised Ratio Increased, Haematuria, Urinary Tract InfectionThe patient was hospitalized.Although all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as International Normalised Ratio Increased, may become evident only after a product is in use by the general population.
Coumadin Side Effect Report#9908542
Fall, Haemorrhage Intracranial
This Fall side effect was reported by a pharmacist from US. A 86-year-old female patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Coumadin (drug dosage: Chronic??4mg Tths Po), which was initiated on NS. Concurrently used drugs: NA..After starting to take Coumadin the consumer reported adverse symptoms, such as: Fall, Haemorrhage IntracranialThese side effects may potentially be related to Coumadin. The patient was hospitalized.
Coumadin Side Effect Report#9908525
Hypovolaemic Shock, Shock Haemorrhagic, Anaemia, Renal Failure Acute, Upper Gastrointestinal Haemorrhage
This is a report of a 88-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation,urinary tract infection, who was treated with Coumadin (dosage: Chronic?15mg Qpm Po, start time: NS), combined with:
  • Septra Ds (Recent)
  • Vit C
  • Atenolol
  • Finasteride
  • Vitamin E
  • Protonix
  • Lasix
  • Magnesium Oxide
and developed a serious reaction and side effect(s): Hypovolaemic Shock, Shock Haemorrhagic, Anaemia, Renal Failure Acute, Upper Gastrointestinal Haemorrhage after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Coumadin treatment in male patients, resulting in Hypovolaemic Shock side effect. The patient was hospitalized.


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The appearance of Coumadin on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but it does not mean that FDA has found a causal relationship between the drug and the listed risk.

Track Your Side Effects

Note Your Observations

It is really important to keep track of your health symptoms, right from the time you start a new medicine. You can do it any way you prefer: in a notebook, in a computer file or using our online tool. You should also note down any other medicines you are taking at the same time, because there could be an interaction between these medicines.

Why Your Notes are Important

Your notes could be helpful in several ways:

  • You can use them to remind you of details that may alert your health care professional(s) to a problem
  • You will have a record to refer to in the future, in case you are ever prescribed the same medicine again

  • Log Form

    You can use the following log form to write down important information, like the date and time you experienced a side effect and your symptoms, how strong the symptoms were, and any other medicines you were using.

    Medicine Name and Dosage:
    Side Effects Scale Date & Time Other Medicine(s) or Treatment(s)
    Scale: 1 = very mild to 10 = very bad

    Side effects reports are analyzed to discover potential health product safety signals. Some important reactions may take an extremely long time to develop or occur infrequently. Continued monitoring of adverse reactions is thus essential to maintain a comprehensive safety and effectiveness profile of health products.

    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.

    Coumadin reports list potential signals of serious risks and new safety information that were identified using the FDA Adverse Event Reporting System (FAERS).
    FAERS is a database that contains information on adverse event and medication errors reports submitted to FDA by healthcare professionals (such as physicians, pharmacists, nurses and others), consumers (such as patients, family members, layers and others) and manufacturers.

    Discuss Coumadin Side Effects

    Did You Have a Coumadin Side Effect?

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    Yes, Moderate
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    No

    How Effective is Coumadin for You?

    Exceeded Expectations
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    Coumadin Safety Alerts, Active Ingredients, Usage Information

    NDC0056-0168
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameCOUMADIN
    Namewarfarin sodium
    Dosage FormTABLET
    RouteORAL
    On market since20090101
    LabelerBristol-Myers Squibb Pharma Company
    Active Ingredient(s)WARFARIN SODIUM
    Strength(s)4
    Unit(s)mg/1
    Pharma ClassVitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]

    Coumadin Dosage, Warnings, Usage.

    Side Effects reported to FDA: 6495

    Coumadin safety alerts: 2013 2011 2010 2007 2006

    Reported deaths: 750

    Reported hospitalizations: 2829

    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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