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Warfarin Sodium Side Effects

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Common Warfarin Sodium Side Effects


The most commonly reported Warfarin Sodium side effects are:
Severe Wrist Pain (1)
Nose Bleeds (1)

If you have experienced a side effect listed above, you can check a box to report it.


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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.

Warfarin Sodium Side Effects Reported to FDA



Warfarin Sodium Side Effect Report#9998024
Compartment Syndrome, International Normalised Ratio Increased
This is a report of a 57-year-old male patient (weight: NA) from GB, suffering from the following health symptoms/conditions: deep vein thrombosis, who was treated with Warfarin Sodium (dosage: 1 St 2 Day=10 Mg?3 Rd Day=5 Mg, start time: NS), combined with:
  • Aspirin
  • Simvastatin
  • Co-amoxiclav
  • Heparin
  • Flucloxacillin
  • Benzylpenicillin
and developed a serious reaction and side effect(s): Compartment Syndrome, International Normalised Ratio Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in male patients, resulting in Compartment Syndrome side effect. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9997962
Haematuria, Lower Gastrointestinal Haemorrhage, Epistaxis, International Normalised Ratio Increased
This report suggests a potential Warfarin Sodium Haematuria side effect(s) that can have serious consequences. A 61-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Warfarin Sodium (dosage: Tabs) starting NS. After starting Warfarin Sodium the patient began experiencing various side effects, including: Haematuria, Lower Gastrointestinal Haemorrhage, Epistaxis, International Normalised Ratio IncreasedAdditional drugs used concurrently: NA.The patient was hospitalized. Although Warfarin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haematuria, may still occur.
Warfarin Sodium Side Effect Report#9955777
Splenic Rupture
This Splenic Rupture problem was reported by a health professional from HK. A 29-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On 2010 this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Heparin (Iuh Infusion)
When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Splenic RuptureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Splenic Rupture, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9929396
Intestinal Haematoma, Upper Gastrointestinal Haemorrhage, Overdose, Blood Urea Increased, Blood Creatinine Increased, Hypotension
This Intestinal Haematoma side effect was reported by a consumer or non-health professional from TR. A 67-year-old male patient (weight:NA) experienced the following symptoms/conditions: mitral valve replacement,atrial fibrillation.The patient was prescribed Warfarin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Intestinal Haematoma, Upper Gastrointestinal Haemorrhage, Overdose, Blood Urea Increased, Blood Creatinine Increased, HypotensionThese side effects may potentially be related to Warfarin Sodium. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9921910
Intestinal Haematoma, Intestinal Obstruction
This is a report of a 48-year-old male patient (weight: NA) from TR, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin Sodium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Intestinal Haematoma, Intestinal Obstruction after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in male patients, resulting in Intestinal Haematoma side effect. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9915518
Haemorrhage Intracranial, Renal Failure Acute, Acidosis, Cardio-respiratory Arrest
This report suggests a potential Warfarin Sodium Haemorrhage Intracranial side effect(s) that can have serious consequences. A 71-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: pulmonary embolism and used Warfarin Sodium (dosage: NA) starting
Jun 29, 2013. After starting Warfarin Sodium the patient began experiencing various side effects, including: Haemorrhage Intracranial, Renal Failure Acute, Acidosis, Cardio-respiratory ArrestAdditional drugs used concurrently:
  • Lovenox
  • Morphine Sulfate
  • Morphine Sulfate
  • Vitamin B Complex
  • Colace
  • Lorazepam
  • Ondansetron
  • Oxycodone
The patient was hospitalized. Although Warfarin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemorrhage Intracranial, may still occur.
Warfarin Sodium Side Effect Report#9893096
Haematuria, Rash
This Haematuria problem was reported by a consumer or non-health professional from TR. A 63-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: pulmonary embolism,arthralgia. On NS this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Herbal Mixture Containing Hypericum Perforatum + Passiflora Incarnata
When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Haematuria, RashAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Haematuria, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9881458
Small Intestinal Haemorrhage, Haemoglobin Decreased, Syncope, Chest Pain, Haemorrhagic Anaemia, Peptic Ulcer, Coagulopathy, Oesophagitis
This Small Intestinal Haemorrhage side effect was reported by a health professional from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: deep vein thrombosis.The patient was prescribed Warfarin Sodium Tablets Usp 5mg (drug dosage: NA), which was initiated on 2000. Concurrently used drugs: NA..After starting to take Warfarin Sodium Tablets Usp 5mg the consumer reported adverse symptoms, such as: Small Intestinal Haemorrhage, Haemoglobin Decreased, Syncope, Chest Pain, Haemorrhagic Anaemia, Peptic Ulcer, Coagulopathy, OesophagitisThese side effects may potentially be related to Warfarin Sodium Tablets Usp 5mg. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9866749
Prostate Cancer, Epistaxis
This is a report of a 80-year-old patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin Sodium (dosage: NA, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Prostate Cancer, Epistaxis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in patients, resulting in Prostate Cancer side effect.
Warfarin Sodium Side Effect Report#9853627
Pulmonary Congestion, Oropharyngeal Pain, Dyspnoea, Arterial Occlusive Disease, Scar, Mobility Decreased, Night Sweats, Diarrhoea, Feeling Abnormal
This report suggests a potential Warfarin Sodium Tablets Usp 5mg Pulmonary Congestion side effect(s) that can have serious consequences. A 70-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: arrhythmia,heart rate decreased and used Warfarin Sodium Tablets Usp 5mg (dosage: NA) starting 201310. After starting Warfarin Sodium Tablets Usp 5mg the patient began experiencing various side effects, including: Pulmonary Congestion, Oropharyngeal Pain, Dyspnoea, Arterial Occlusive Disease, Scar, Mobility Decreased, Night Sweats, Diarrhoea, Feeling AbnormalAdditional drugs used concurrently: NA.The patient was hospitalized. Although Warfarin Sodium Tablets Usp 5mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Pulmonary Congestion, may still occur.
Warfarin Sodium Side Effect Report#9844319
Atrial Fibrillation
This Atrial Fibrillation problem was reported by a pharmacist from US. A 69-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time: NA. When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Atrial FibrillationThe 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 Atrial Fibrillation, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9824916
Leukaemia, International Normalised Ratio Abnormal
This Leukaemia side effect was reported by a consumer or non-health professional from US. A 69-year-old male patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Warfarin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Symbicort
  • Glyburide
  • Terazosin
  • Metformin
  • Lantus
  • Byetta
  • Benicar
  • Potassium
.After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Leukaemia, International Normalised Ratio AbnormalThese side effects may potentially be related to Warfarin Sodium.
Warfarin Sodium Side Effect Report#9808214
International Normalised Ratio Increased, Pericardial Haemorrhage, Pleurisy, Haemothorax, Nasopharyngitis
This is a report of a 65-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin Sodium Tablets Usp 1mg (dosage: NA, start time: 201211), combined with:
  • Warfarin Sodium Tablets Usp 2mg
  • Z-pak
  • Z-pak
  • Metformin
and developed a serious reaction and side effect(s): International Normalised Ratio Increased, Pericardial Haemorrhage, Pleurisy, Haemothorax, Nasopharyngitis after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium Tablets Usp 1mg treatment in female patients, resulting in International Normalised Ratio Increased side effect. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9784968
Coagulation Time Prolonged, Post Procedural Haemorrhage
This report suggests a potential Warfarin Sodium Coagulation Time Prolonged side effect(s) that can have serious consequences. A 56-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Warfarin Sodium (dosage: Intragastric Administration;?5mg Daily For 3 Days, Followed By 2.5mg Daily) starting NS. After starting Warfarin Sodium the patient began experiencing various side effects, including: Coagulation Time Prolonged, Post Procedural HaemorrhageAdditional drugs used concurrently:
  • Bismuth Salicylate+metronidazole+tetracycline Hcl
  • Enoxaparin Sodium
  • Loperamide
  • Diphenoxylate Hcl + Atropine Sulfate (1 Df= 5 Mg/0.05)
  • Multivitamin
  • Vitamin D (1 Df= 50,000 Units)
  • Prednisone
  • Ipratropium + Albuterol (Nebulized)
The patient was hospitalized. Although Warfarin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Coagulation Time Prolonged, may still occur.
Warfarin Sodium Side Effect Report#9775724
Splenectomy, Vaginal Haemorrhage
This Splenectomy problem was reported by a consumer or non-health professional from US. A 60-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On
Dec 07, 2013 this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Levothyroxine
  • Simvastatin
  • Sertraline
  • Metoprolol
When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Splenectomy, Vaginal HaemorrhageAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Splenectomy, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9772793
Gastrointestinal Haemorrhage, International Normalised Ratio Increased
This Gastrointestinal Haemorrhage side effect was reported by a consumer or non-health professional from TR. A 82-year-old female patient (weight:NA) experienced the following symptoms/conditions: atrial fibrillation.The patient was prescribed Warfarin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Gastrointestinal Haemorrhage, International Normalised Ratio IncreasedThese side effects may potentially be related to Warfarin Sodium. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9772783
Cerebrovascular Accident, Penis Disorder
This is a report of a 77-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Warfarin Sodium (dosage: NA, start time: 2006), combined with:
  • Spiriva
  • Lasix
  • Potassium
  • Zocor
  • Amlodipine
  • Toprol
and developed a serious reaction and side effect(s): Cerebrovascular Accident, Penis Disorder after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in male patients, resulting in Cerebrovascular Accident side effect. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9770363
Chest Pain, Blue Toe Syndrome, Onychomadesis, International Normalised Ratio Decreased
This report suggests a potential Warfarin Sodium Chest Pain side effect(s) that can have serious consequences. A 53-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: NA and used Warfarin Sodium (dosage: NA) starting NS. After starting Warfarin Sodium the patient began experiencing various side effects, including: Chest Pain, Blue Toe Syndrome, Onychomadesis, International Normalised Ratio DecreasedAdditional drugs used concurrently:
  • Lantus
  • Digoxin
  • Lisinopril
  • Metoprolol
  • Simvastatin
  • Furosemide
  • Baby Aspirin
The patient was hospitalized. Although Warfarin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Chest Pain, may still occur.
Warfarin Sodium Side Effect Report#9744395
Skin Necrosis, Multi-organ Failure
This Skin Necrosis problem was reported by a health professional from PT. A 81-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: NA. On NS this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time: NA. When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Skin Necrosis, Multi-organ FailureAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Skin Necrosis, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9737169
Periorbital Haematoma
This Periorbital Haematoma side effect was reported by a health professional from AU. A 56-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary embolism.The patient was prescribed Warfarin Sodium (drug dosage: NA), which was initiated on NS. Concurrently used drugs:
  • Reteplase
  • Heparin
.After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Periorbital HaematomaThese side effects may potentially be related to Warfarin Sodium. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9736724
Vein Discolouration, Cellulitis, Impaired Work Ability, Sciatica
This is a report of a 74-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Warfarin Sodium Tablets Usp 2mg (dosage: NA, start time: 2009), combined with: NA. and developed a serious reaction and side effect(s): Vein Discolouration, Cellulitis, Impaired Work Ability, Sciatica after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium Tablets Usp 2mg treatment in male patients, resulting in Vein Discolouration side effect. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9721981
Erythema
This report suggests a potential Warfarin Sodium Erythema side effect(s) that can have serious consequences. A 79-year-old female patient (weight: NA) from IT was diagnosed with the following symptoms/conditions: atrial fibrillation and used Warfarin Sodium (dosage: NA) starting
Oct 01, 2013. After starting Warfarin Sodium the patient began experiencing various side effects, including: ErythemaAdditional drugs used concurrently:
  • Diltiazem Hcl
  • Lansoprazole
  • Furosemide
  • Bisoprolol Hemifumarate
  • Hydrochlorothiazide
  • Canrenone
  • Ticlopidine Hcl
  • Ramipril
The patient was hospitalized. Although Warfarin Sodium demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Erythema, may still occur.
Warfarin Sodium Side Effect Report#9721535
Vascular Calcification
This Vascular Calcification problem was reported by a health professional from TW. A 71-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Warfarin Sodium (dosage: NA). The following drugs were being taken at the same time:
  • Clopidogrel Bisulfate (Initial For 6months)
  • Aspirin (Initial For 6 Months)
  • Verapamil
When using Warfarin Sodium, the patient experienced the following unwanted symptoms/side effects: Vascular CalcificationAlthough all drugs are carefully tested before they are licensed for use, they carry side effect risks. Some side effects, such as Vascular Calcification, may become evident only after a product is in use by the general population.
Warfarin Sodium Side Effect Report#9720938
Cerebral Haemorrhage, Fall
This Cerebral Haemorrhage side effect was reported by a consumer or non-health professional from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Warfarin Sodium (drug dosage: NA), which was initiated on
Jun 22, 2012. Concurrently used drugs:
  • Plavix
  • Matulane
  • Aspirin
  • Cozaar
  • Soma
  • Lipitor
  • Vicodin
  • Imdur
.After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Cerebral Haemorrhage, FallThese side effects may potentially be related to Warfarin Sodium. The patient was hospitalized.
Warfarin Sodium Side Effect Report#9720132
Renal Failure Acute, Overdose
This is a report of a 82-year-old female patient (weight: NA) from JP, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Warfarin Sodium (dosage: NA, start time: 2003), combined with: NA. and developed a serious reaction and side effect(s): Renal Failure Acute, Overdose after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in female patients, resulting in Renal Failure Acute side effect. The patient was hospitalized.


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The appearance of Warfarin Sodium 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.

    Warfarin Sodium 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 Warfarin Sodium Side Effects

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    Warfarin Sodium Safety Alerts, Active Ingredients, Usage Information

    NDC0555-0831
    TypeHUMAN PRESCRIPTION DRUG
    Proprietary NameWarfarin Sodium
    NameWarfarin Sodium
    Dosage FormTABLET
    RouteORAL
    On market since19970725
    LabelerBarr Laboratories Inc.
    Active Ingredient(s)WARFARIN SODIUM
    Strength(s)1
    Unit(s)mg/1
    Pharma ClassVitamin K Antagonist [EPC],Vitamin K Inhibitors [MoA]

    More About Warfarin sodium

    Side Effects reported to FDA: 5680

    Warfarin Sodium safety alerts: 2013 2011 2006

    Reported deaths: 600

    Reported hospitalizations: 3723

    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]

    Latest Warfarin Sodium clinical trials