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Warfarin Side Effects

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.

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.

Warfarin Side Effects Reported to FDA

The following 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.


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.
Haemorrhage, Anaemia
on Mar 11, 2014 Male from US , 64 years of age, weighting 238.3 lb, was treated with Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: haemorrhage, anaemia. Warfarin dosage: N/A. Patient was hospitalized.

Haemorrhagic Diathesis
Patient was taking Warfarin. Patient felt the following Warfarin side effects: haemorrhagic diathesis on Mar 11, 2014 from US Additional patient health information: Female , 64 years of age, weighting 169.8 lb, was diagnosed with and. Warfarin dosage: 1 To 1.5 Tablets. Patient was hospitalized.

Haemorrhagic Diathesis
Adverse event was reported on Mar 11, 2014 by a Female taking Warfarin (Dosage: 2 Tablets Qd Oral) was diagnosed with and. Location: US , 53 years of age, weighting 177.0 lb, After Warfarin was administered, patient encountered several Warfarin side effects: haemorrhagic diathesis. Patient was hospitalized.

Compartment Syndrome, International Normalised Ratio Increased
on Mar 11, 2014 Male from GB , 57 years of age, was diagnosed with and was treated with Warfarin Sodium. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: compartment syndrome, international normalised ratio increased. Warfarin Sodium dosage: 1 St 2 Day=10 Mg?3 Rd Day=5 Mg.
Associated medications used:
  • Aspirin
  • Simvastatin
  • Co-amoxiclav
  • Heparin
  • Flucloxacillin
  • Benzylpenicillin
Patient was hospitalized.


Haematuria, Lower Gastrointestinal Haemorrhage, Epistaxis, International Normalised Ratio Increased
on Mar 11, 2014 Male from US , 61 years of age, was treated with Warfarin Sodium. Patient felt the following Warfarin side effects: haematuria, lower gastrointestinal haemorrhage, epistaxis, international normalised ratio increased. Warfarin Sodium dosage: Tabs. Patient was hospitalized.

International Normalised Ratio Increased, Pallor, Blood Pressure Decreased, Gastric Haemorrhage, Syncope, Unresponsive To Stimuli
Patient was taking Warfarin. After Warfarin was administered, patient encountered several Warfarin side effects: international normalised ratio increased, pallor, blood pressure decreased, gastric haemorrhage, syncope, unresponsive to stimuli on Mar 10, 2014 from US Additional patient health information: Male , 79 years of age, weighting 218.5 lb, was diagnosed with and. Warfarin dosage: N/A. Patient was hospitalized.

International Normalised Ratio Increased, Haemoglobin Decreased, Gastrointestinal Haemorrhage
Adverse event was reported on Mar 06, 2014 by a Male taking Warfarin (Dosage: Mg) was diagnosed with and. Location: US , 83 years of age, weighting 164.5 lb, Directly after, patient experienced the unwanted or unexpected Warfarin side effects: international normalised ratio increased, haemoglobin decreased, gastrointestinal haemorrhage.
Associated medications used:
  • Aspirin
Patient was hospitalized.

Haemorrhage Urinary Tract, Haematuria, Nasopharyngitis, International Normalised Ratio Increased
on Mar 06, 2014 Male from US , weighting 171.1 lb, was diagnosed with and was treated with Warfarin. Patient felt the following Warfarin side effects: haemorrhage urinary tract, haematuria, nasopharyngitis, international normalised ratio increased. Warfarin dosage: N/A. Patient was hospitalized.

Asthenia, Melaena, Epistaxis, International Normalised Ratio Increased
on Mar 06, 2014 Male from US , 69 years of age, weighting 190.5 lb, was treated with Warfarin. After Warfarin was administered, patient encountered several Warfarin side effects: asthenia, melaena, epistaxis, international normalised ratio increased. Warfarin dosage: N/A. Patient was hospitalized.

Lacunar Infarction, Central Nervous System Lesion, Haemoglobin Decreased, Haemorrhage, Cardiac Arrest
Patient was taking Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: lacunar infarction, central nervous system lesion, haemoglobin decreased, haemorrhage, cardiac arrest on Mar 05, 2014 from US Additional patient health information: Female , 57 years of age, was diagnosed with and. Warfarin dosage: N/A.
Associated medications used:
  • Aztreonam (azactam)
  • Moxifloxacin (avelox)
  • Dilatiazem Hcl (cardizem)
  • Bid Vancomycin (vancocin)
  • T/th/satinsulin Aspart (novolog)
  • Norepinephrine (levophed)
  • Micafungin (mycamine)
  • Metronidazole (flagyl) 500mg


Gastrointestinal Haemorrhage, Haematemesis, International Normalised Ratio Increased
Adverse event was reported on Mar 05, 2014 by a Female taking Warfarin (Dosage: N/A) was diagnosed with and. Location: US , 52 years of age, Patient felt the following Warfarin side effects: gastrointestinal haemorrhage, haematemesis, international normalised ratio increased.
Multiple prescriptions taken:
  • Aspirin-low (aspirin)
  • Cleocin (clindamycin Hcl)
  • Coumadin (warfarin)
  • Enalapril Maleate
  • Glipizide
  • Lantus (insulin Glargine)
  • Lexapro (escitalopram)
  • Lumigan (bimatoprost)
Patient was hospitalized.

Haemorrhage, Hypotension, Stoma Site Haemorrhage, International Normalised Ratio Increased, Blood Potassium Increased
on Mar 05, 2014 Female from US , 73 years of age, was treated with Warfarin. After Warfarin was administered, patient encountered several Warfarin side effects: haemorrhage, hypotension, stoma site haemorrhage, international normalised ratio increased, blood potassium increased. Warfarin dosage: N/A. Patient was hospitalized.

Splenic Rupture, Live Birth
on Mar 06, 2014 Female from HK , 29 years of age, was treated with Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: splenic rupture, live birth. Warfarin dosage: N/A.
Associated medications used:
  • Heparin
Patient was hospitalized.

Computerised Tomogram Head Abnormal, International Normalised Ratio Increased, Incorrect Dose Administered
Patient was taking Warfarin 4 Mg. Patient felt the following Warfarin side effects: computerised tomogram head abnormal, international normalised ratio increased, incorrect dose administered on Mar 04, 2014 from US Additional patient health information: Female , 81 years of age, weighting 170.0 lb, was diagnosed with and. Warfarin 4 Mg dosage: N/A. Patient was hospitalized.

Haemorrhage Intracranial, International Normalised Ratio Increased
Adverse event was reported on Mar 06, 2014 by a Male taking Warfarin (Dosage: N/A) was diagnosed with and. Location: GB , 82 years of age, After Warfarin was administered, patient encountered several Warfarin side effects: haemorrhage intracranial, international normalised ratio increased. Patient was hospitalized.

Haematochezia, Haematuria, International Normalised Ratio Increased
on Mar 04, 2014 Male from US , 66 years of age, weighting 226.2 lb, was diagnosed with and was treated with Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: haematochezia, haematuria, international normalised ratio increased. Warfarin dosage: N/A. Patient was hospitalized.

Anaemia, Investigation, Gastrointestinal Haemorrhage, Renal Failure Acute
on Mar 04, 2014 Male from US , 84 years of age, was diagnosed with and was treated with Warfarin. Patient felt the following Warfarin side effects: anaemia, investigation, gastrointestinal haemorrhage, renal failure acute. Warfarin dosage: N/A.
Multiple prescriptions taken:
  • Aspirin
Patient was hospitalized.

Gastric Haemorrhage, International Normalised Ratio Abnormal, Renal Failure Acute
Patient was taking Warfarin. After Warfarin was administered, patient encountered several Warfarin side effects: gastric haemorrhage, international normalised ratio abnormal, renal failure acute on Mar 04, 2014 from US Additional patient health information: Male , 81 years of age, weighting 212.5 lb, was diagnosed with and. Warfarin dosage: 1 Mg Ud Po.
Multiple concurrent drugs taken:
  • Sulfamethoxazole/trimethoprim (1 Tab Bid Po)
Patient was hospitalized.

Haemorrhage
Adverse event was reported on Mar 04, 2014 by a Male taking Warfarin (Dosage: Mg) was diagnosed with and. Location: US , 59 years of age, weighting 243.6 lb, Directly after, patient experienced the unwanted or unexpected Warfarin side effects: haemorrhage. Patient was hospitalized.

International Normalised Ratio Increased, Haematoma, Compartment Syndrome
on Feb 28, 2014 Female from US , 75 years of age, weighting 316.0 lb, was diagnosed with and was treated with Warfarin. Patient felt the following Warfarin side effects: international normalised ratio increased, haematoma, compartment syndrome. Warfarin dosage: 8 Pills Daily, Qd, Oral.
Multiple prescriptions taken:
  • Advair Diskus
  • Albuterol Sulfate
  • Neb Solution
  • Benefiber
  • Mitrazol
  • Mirapex
  • Tussin
  • Insulin
Patient was hospitalized.

Splenic Rupture
on Mar 04, 2014 Female from HK , 29 years of age, was treated with Warfarin Sodium. After Warfarin was administered, patient encountered several Warfarin side effects: splenic rupture. Warfarin Sodium dosage: N/A.
Multiple concurrent drugs taken:
  • Heparin (Iuh Infusion)


Splenic Rupture
Patient was taking Warfarin. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: splenic rupture on Mar 04, 2014 from HK Additional patient health information: Female , 29 years of age, . Warfarin dosage: N/A.
Associated medications used:
  • Heparin


Splenic Rupture, Splenic Haemorrhage, Peritoneal Haemorrhage, Abdominal Pain Upper, Back Pain, Abdominal Distension, Acute Abdomen, Abdominal Tenderness, Maternal Exposure During Pregnancy
Adverse event was reported on Mar 01, 2014 by a Female taking Warfarin (Dosage: N/A) . Location: HK , 29 years of age, Patient felt the following Warfarin side effects: splenic rupture, splenic haemorrhage, peritoneal haemorrhage, abdominal pain upper, back pain, abdominal distension, acute abdomen, abdominal tenderness, maternal exposure during pregnancy.
Multiple prescriptions taken:
  • Heparin


Haematuria, Rash, International Normalised Ratio Increased, Toxicity To Various Agents
on Feb 26, 2014 Female from TR , 63 years of age, was diagnosed with and was treated with Warfarin (warfarin) (warfarin). After Warfarin was administered, patient encountered several Warfarin side effects: haematuria, rash, international normalised ratio increased, toxicity to various agents. Warfarin (warfarin) (warfarin) dosage: 5mg Per Day.

Feeding Tube Complication, Catheter Site Haemorrhage, Decubitus Ulcer, Wound Secretion
on Feb 27, 2014 Female from US , 62 years of age, weighting 183.9 lb, was diagnosed with and was treated with Warfarin 2 Mg. Directly after, patient experienced the unwanted or unexpected Warfarin side effects: feeding tube complication, catheter site haemorrhage, decubitus ulcer, wound secretion. Warfarin 2 Mg dosage: 2 Mg ( 1 Pill) Qd Oral.
Associated medications used:
  • Albuterol
  • Amiodarone
  • Aspirin
  • Buproprion
  • Carvedilol
  • Cefepime
  • Vancomycin
  • Simvastatin
Patient was hospitalized.

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PillPack: Pharmacy Simplified

Keep Track of Side Effects

Note Your Observations

It is really important to keep of your 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


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  • 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.

    Discuss Warfarin Side Effects



    Did You Have a Warfarin Side Effect?

    Yes, Severe
    Yes, Moderate
    Yes, Minor
    No

    How Effective is Warfarin for You?

    Exceeded Expectations
    Effective
    Somewhat Effective
    Not Effective

    Safety Alerts, Active Ingredients, Usage Information

    Alternative WARFARIN Names:COUMADIN JANTOVEN

    Active Ingredient: WARFARIN

    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]

    Latest Warfarin clinical trials