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Warfarin Side Effects

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Common Warfarin Side Effects


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

International Normalised Ratio Increased (2815)
Haemorrhage (724)
Gastrointestinal Haemorrhage (550)
Haemoglobin Decreased (487)
Anaemia (472)
Fall (416)
International Normalised Ratio Abnormal (386)
Gastric Haemorrhage (382)
Haematuria (372)
Epistaxis (337)
International Normalised Ratio Decreased (329)
Haematoma (277)
Asthenia (275)
Dyspnoea (274)
Dizziness (253)
Cerebral Haemorrhage (236)
Haematocrit Decreased (225)
Melaena (218)
Contusion (212)
Hypotension (205)

➢ 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.

Warfarin Side Effects Reported to FDA



Warfarin Side Effect Report#9999408
Haemorrhage, Anaemia
This is a report of a 64-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin (dosage: NA, start time:
Jan 01, 2013), combined with: NA. and developed a serious reaction and side effect(s): Haemorrhage, Anaemia after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin treatment in male patients, resulting in Haemorrhage side effect. The patient was hospitalized.
Warfarin Side Effect Report#9999344
Haemorrhagic Diathesis
This report suggests a potential Warfarin Haemorrhagic Diathesis side effect(s) that can have serious consequences. A 64-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,deep vein thrombosis and used Warfarin (dosage: 1 To 1.5 Tablets) starting NS. After starting Warfarin the patient began experiencing various side effects, including: Haemorrhagic DiathesisAdditional drugs used concurrently: NA.The patient was hospitalized. Although Warfarin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Haemorrhagic Diathesis, may still occur.
Warfarin Side Effect Report#9999343
Haemorrhagic Diathesis
This Haemorrhagic Diathesis problem was reported by a consumer or non-health professional from US. A 53-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: deep vein thrombosis,pulmonary embolism. On NS this consumer started treatment with Warfarin (dosage: 2 Tablets Qd Oral). The following drugs were being taken at the same time: NA. When using Warfarin, the patient experienced the following unwanted symptoms/side effects: Haemorrhagic DiathesisThe 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 Haemorrhagic Diathesis, may become evident only after a product is in use by the general population.
Warfarin Side Effect Report#9998024
Compartment Syndrome, International Normalised Ratio Increased
This Compartment Syndrome side effect was reported by a health professional from GB. A 57-year-old male patient (weight:NA) experienced the following symptoms/conditions: deep vein thrombosis.The patient was prescribed Warfarin Sodium (drug dosage: 1 St 2 Day=10 Mg?3 Rd Day=5 Mg), which was initiated on NS. Concurrently used drugs:
  • Aspirin
  • Simvastatin
  • Co-amoxiclav
  • Heparin
  • Flucloxacillin
  • Benzylpenicillin
.After starting to take Warfarin Sodium the consumer reported adverse symptoms, such as: Compartment Syndrome, International Normalised Ratio IncreasedThese side effects may potentially be related to Warfarin Sodium. The patient was hospitalized.
Warfarin Side Effect Report#9997962
Haematuria, Lower Gastrointestinal Haemorrhage, Epistaxis, International Normalised Ratio Increased
This is a report of a 61-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin Sodium (dosage: Tabs, start time: NS), combined with: NA. and developed a serious reaction and side effect(s): Haematuria, Lower Gastrointestinal Haemorrhage, Epistaxis, 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 Haematuria side effect. The patient was hospitalized.
Warfarin Side Effect Report#9995957
International Normalised Ratio Increased, Pallor, Blood Pressure Decreased, Gastric Haemorrhage, Syncope, Unresponsive To Stimuli
This report suggests a potential Warfarin International Normalised Ratio Increased side effect(s) that can have serious consequences. A 79-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,cerebrovascular accident and used Warfarin (dosage: NA) starting
Mar 02, 1998. After starting Warfarin the patient began experiencing various side effects, including: International Normalised Ratio Increased, Pallor, Blood Pressure Decreased, Gastric Haemorrhage, Syncope, Unresponsive To StimuliAdditional drugs used concurrently: NA.The patient was hospitalized. Although Warfarin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as International Normalised Ratio Increased, may still occur.
Warfarin Side Effect Report#9982489
International Normalised Ratio Increased, Haemoglobin Decreased, Gastrointestinal Haemorrhage
This International Normalised Ratio Increased problem was reported by a pharmacist from US. A 83-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation,stent placement. On
Dec 17, 2013 this consumer started treatment with Warfarin (dosage: Mg). The following drugs were being taken at the same time:
  • Aspirin
When using Warfarin, the patient experienced the following unwanted symptoms/side effects: International Normalised Ratio Increased, Haemoglobin Decreased, Gastrointestinal HaemorrhageThe 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.
Warfarin Side Effect Report#9982104
Haemorrhage Urinary Tract, Haematuria, Nasopharyngitis, International Normalised Ratio Increased
This Haemorrhage Urinary Tract side effect was reported by a consumer or non-health professional from US. A male patient (weight:NA) experienced the following symptoms/conditions: deep vein thrombosis.The patient was prescribed Warfarin (drug dosage: NA), which was initiated on
Sep 23, 2009. Concurrently used drugs: NA..After starting to take Warfarin the consumer reported adverse symptoms, such as: Haemorrhage Urinary Tract, Haematuria, Nasopharyngitis, International Normalised Ratio IncreasedThese side effects may potentially be related to Warfarin. The patient was hospitalized.
Warfarin Side Effect Report#9981834
Asthenia, Melaena, Epistaxis, International Normalised Ratio Increased
This is a report of a 69-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin (dosage: NA, start time:
Nov 25, 2003), combined with: NA. and developed a serious reaction and side effect(s): Asthenia, Melaena, Epistaxis, International Normalised Ratio Increased after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin treatment in male patients, resulting in Asthenia side effect. The patient was hospitalized.
Warfarin Side Effect Report#9980650
Lacunar Infarction, Central Nervous System Lesion, Haemoglobin Decreased, Haemorrhage, Cardiac Arrest
This report suggests a potential Warfarin Lacunar Infarction side effect(s) that can have serious consequences. A 57-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation and used Warfarin (dosage: NA) starting NS. After starting Warfarin the patient began experiencing various side effects, including: Lacunar Infarction, Central Nervous System Lesion, Haemoglobin Decreased, Haemorrhage, Cardiac ArrestAdditional drugs used concurrently:
  • Aztreonam (azactam)
  • Moxifloxacin (avelox)
  • Dilatiazem Hcl (cardizem)
  • Bid Vancomycin (vancocin)
  • T/th/satinsulin Aspart (novolog)
  • Norepinephrine (levophed)
  • Micafungin (mycamine)
  • Metronidazole (flagyl) 500mg
Although Warfarin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Lacunar Infarction, may still occur.
Warfarin Side Effect Report#9980343
Gastrointestinal Haemorrhage, Haematemesis, International Normalised Ratio Increased
This Gastrointestinal Haemorrhage problem was reported by a pharmacist from US. A 52-year-old female patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Warfarin (dosage: NA). The following drugs were being taken at the same time:
  • Aspirin-low (aspirin)
  • Cleocin (clindamycin Hcl)
  • Coumadin (warfarin)
  • Enalapril Maleate
  • Glipizide
  • Lantus (insulin Glargine)
  • Lexapro (escitalopram)
  • Lumigan (bimatoprost)
When using Warfarin, the patient experienced the following unwanted symptoms/side effects: Gastrointestinal Haemorrhage, Haematemesis, International Normalised Ratio IncreasedThe 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 Gastrointestinal Haemorrhage, may become evident only after a product is in use by the general population.
Warfarin Side Effect Report#9980156
Haemorrhage, Hypotension, Stoma Site Haemorrhage, International Normalised Ratio Increased, Blood Potassium Increased
This Haemorrhage side effect was reported by a pharmacist from US. A 73-year-old female patient (weight:NA) experienced the following symptoms/conditions: NA.The patient was prescribed Warfarin (drug dosage: NA), which was initiated on NS. Concurrently used drugs: NA..After starting to take Warfarin the consumer reported adverse symptoms, such as: Haemorrhage, Hypotension, Stoma Site Haemorrhage, International Normalised Ratio Increased, Blood Potassium IncreasedThese side effects may potentially be related to Warfarin. The patient was hospitalized.
Warfarin Side Effect Report#9972922
Splenic Rupture, Live Birth
This is a report of a 29-year-old female patient (weight: NA) from HK, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin (dosage: NA, start time: 2010), combined with:
  • Heparin
and developed a serious reaction and side effect(s): Splenic Rupture, Live Birth after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin treatment in female patients, resulting in Splenic Rupture side effect. The patient was hospitalized.
Warfarin Side Effect Report#9969544
Computerised Tomogram Head Abnormal, International Normalised Ratio Increased, Incorrect Dose Administered
This report suggests a potential Warfarin 4 Mg Computerised Tomogram Head Abnormal side effect(s) that can have serious consequences. A 81-year-old female patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,aortic valve replacement and used Warfarin 4 Mg (dosage: NA) starting NS. After starting Warfarin 4 Mg the patient began experiencing various side effects, including: Computerised Tomogram Head Abnormal, International Normalised Ratio Increased, Incorrect Dose AdministeredAdditional drugs used concurrently: NA.The patient was hospitalized. Although Warfarin 4 Mg demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Computerised Tomogram Head Abnormal, may still occur.
Warfarin Side Effect Report#9967699
Haemorrhage Intracranial, International Normalised Ratio Increased
This Haemorrhage Intracranial problem was reported by a physician from GB. A 82-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: atrial fibrillation. On NS this consumer started treatment with Warfarin (dosage: NA). The following drugs were being taken at the same time: NA. When using Warfarin, the patient experienced the following unwanted symptoms/side effects: Haemorrhage Intracranial, International Normalised Ratio IncreasedThe 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 Haemorrhage Intracranial, may become evident only after a product is in use by the general population.
Warfarin Side Effect Report#9962004
Haematochezia, Haematuria, International Normalised Ratio Increased
This Haematochezia side effect was reported by a pharmacist from US. A 66-year-old male patient (weight:NA) experienced the following symptoms/conditions: pulmonary embolism.The patient was prescribed Warfarin (drug dosage: NA), which was initiated on
Jul 24, 2012. Concurrently used drugs: NA..After starting to take Warfarin the consumer reported adverse symptoms, such as: Haematochezia, Haematuria, International Normalised Ratio IncreasedThese side effects may potentially be related to Warfarin. The patient was hospitalized.
Warfarin Side Effect Report#9961981
Anaemia, Investigation, Gastrointestinal Haemorrhage, Renal Failure Acute
This is a report of a 84-year-old male patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation,thrombosis prophylaxis, who was treated with Warfarin (dosage: NA, start time:
Sep 25, 2013), combined with:
  • Aspirin
and developed a serious reaction and side effect(s): Anaemia, Investigation, Gastrointestinal Haemorrhage, Renal Failure Acute after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin treatment in male patients, resulting in Anaemia side effect. The patient was hospitalized.
Warfarin Side Effect Report#9961451
Gastric Haemorrhage, International Normalised Ratio Abnormal, Renal Failure Acute
This report suggests a potential Warfarin Gastric Haemorrhage side effect(s) that can have serious consequences. A 81-year-old male patient (weight: NA) from US was diagnosed with the following symptoms/conditions: atrial fibrillation,infection and used Warfarin (dosage: 1 Mg Ud Po) starting
Feb 19, 2014. After starting Warfarin the patient began experiencing various side effects, including: Gastric Haemorrhage, International Normalised Ratio Abnormal, Renal Failure AcuteAdditional drugs used concurrently:
  • Sulfamethoxazole/trimethoprim (1 Tab Bid Po)
The patient was hospitalized. Although Warfarin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Gastric Haemorrhage, may still occur.
Warfarin Side Effect Report#9961167
Haemorrhage
This Haemorrhage problem was reported by a pharmacist from US. A 59-year-old male patient (weight: NA) was diagnosed with the following symptoms/conditions: heart valve replacement. On
Aug 09, 2011 this consumer started treatment with Warfarin (dosage: Mg). The following drugs were being taken at the same time: NA. When using Warfarin, the patient experienced the following unwanted symptoms/side effects: HaemorrhageThe 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 Haemorrhage, may become evident only after a product is in use by the general population.
Warfarin Side Effect Report#9959954
International Normalised Ratio Increased, Haematoma, Compartment Syndrome
This International Normalised Ratio Increased side effect was reported by a physician from US. A 75-year-old female patient (weight:NA) experienced the following symptoms/conditions: deep vein thrombosis.The patient was prescribed Warfarin (drug dosage: 8 Pills Daily, Qd, Oral), which was initiated on
Apr 01, 2013. Concurrently used drugs:
  • Advair Diskus
  • Albuterol Sulfate
  • Neb Solution
  • Benefiber
  • Mitrazol
  • Mirapex
  • Tussin
  • Insulin
.After starting to take Warfarin the consumer reported adverse symptoms, such as: International Normalised Ratio Increased, Haematoma, Compartment SyndromeThese side effects may potentially be related to Warfarin. The patient was hospitalized.
Warfarin Side Effect Report#9955777
Splenic Rupture
This is a report of a 29-year-old female patient (weight: NA) from HK, suffering from the following health symptoms/conditions: NA, who was treated with Warfarin Sodium (dosage: NA, start time: 2010), combined with:
  • Heparin (Iuh Infusion)
and developed a serious reaction and side effect(s): Splenic Rupture after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin Sodium treatment in female patients, resulting in Splenic Rupture side effect.
Warfarin Side Effect Report#9954782
Splenic Rupture
This report suggests a potential Warfarin Splenic Rupture side effect(s) that can have serious consequences. A 29-year-old female patient (weight: NA) from HK was diagnosed with the following symptoms/conditions: NA and used Warfarin (dosage: NA) starting 2010. After starting Warfarin the patient began experiencing various side effects, including: Splenic RuptureAdditional drugs used concurrently:
  • Heparin
Although Warfarin demonstrated significant improvements in a number of clinically relevant cases, troublesome symptoms, such as Splenic Rupture, may still occur.
Warfarin Side Effect Report#9937144
Splenic Rupture, Splenic Haemorrhage, Peritoneal Haemorrhage, Abdominal Pain Upper, Back Pain, Abdominal Distension, Acute Abdomen, Abdominal Tenderness, Maternal Exposure During Pregnancy
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 NS this consumer started treatment with Warfarin (dosage: NA). The following drugs were being taken at the same time:
  • Heparin
When using Warfarin, the patient experienced the following unwanted symptoms/side effects: Splenic Rupture, Splenic Haemorrhage, Peritoneal Haemorrhage, Abdominal Pain Upper, Back Pain, Abdominal Distension, Acute Abdomen, Abdominal Tenderness, Maternal Exposure During PregnancyAlthough 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 Side Effect Report#9934469
Haematuria, Rash, International Normalised Ratio Increased, Toxicity To Various Agents
This Haematuria side effect was reported by a health professional from TR. A 63-year-old female patient (weight:NA) experienced the following symptoms/conditions: pulmonary embolism,arthralgia.The patient was prescribed Warfarin (warfarin) (warfarin) (drug dosage: 5mg Per Day), which was initiated on NS. Concurrently used drugs: NA..After starting to take Warfarin (warfarin) (warfarin) the consumer reported adverse symptoms, such as: Haematuria, Rash, International Normalised Ratio Increased, Toxicity To Various AgentsThese side effects may potentially be related to Warfarin (warfarin) (warfarin).
Warfarin Side Effect Report#9932791
Feeding Tube Complication, Catheter Site Haemorrhage, Decubitus Ulcer, Wound Secretion
This is a report of a 62-year-old female patient (weight: NA) from US, suffering from the following health symptoms/conditions: atrial fibrillation, who was treated with Warfarin 2 Mg (dosage: 2 Mg ( 1 Pill) Qd Oral, start time: NS), combined with:
  • Albuterol
  • Amiodarone
  • Aspirin
  • Buproprion
  • Carvedilol
  • Cefepime
  • Vancomycin
  • Simvastatin
and developed a serious reaction and side effect(s): Feeding Tube Complication, Catheter Site Haemorrhage, Decubitus Ulcer, Wound Secretion after the beginning of treatment. This case can indicate the possible existence of increased vulnerability to Warfarin 2 Mg treatment in female patients, resulting in Feeding Tube Complication side effect. The patient was hospitalized.

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The appearance of Warfarin 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 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 Side Effects

    Did You Have a Warfarin Side Effect?

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    Yes, Moderate
    Yes, Minor
    No

    How Effective is Warfarin for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Warfarin 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

    Side Effects reported to FDA: 7783

    Warfarin safety alerts: 2014 2013 2011 2007 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]

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