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WARFARIN SODIUM

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Warfarin Sodium Adverse Events Reported to the FDA Over Time

How are Warfarin Sodium adverse event reports trending over time?

This graph shows volume of adverse events submitted to the FDA by quarter for Warfarin Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients. Adverse events are counted if Warfarin Sodium is flagged as the suspect drug causing the adverse event.

Most Common Warfarin Sodium Adverse Events Reported to the FDA

What are the most common Warfarin Sodium adverse events reported to the FDA?

International Normalised Ratio Incr...
6403 (7.3%)
Drug Interaction
1971 (2.25%)
Haemorrhage
1535 (1.75%)
International Normalised Ratio Decr...
1404 (1.6%)
Gastrointestinal Haemorrhage
1353 (1.54%)
Anaemia
1225 (1.4%)
Fall
1067 (1.22%)
Epistaxis
960 (1.09%)
Haemoglobin Decreased
938 (1.07%)
International Normalised Ratio Abno...
866 (.99%)
Dyspnoea
801 (.91%)
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Asthenia
797 (.91%)
International Normalised Ratio Fluc...
775 (.88%)
Haematoma
769 (.88%)
Contusion
766 (.87%)
Dizziness
755 (.86%)
Haematuria
718 (.82%)
Cerebral Haemorrhage
660 (.75%)
Nausea
660 (.75%)
Rectal Haemorrhage
653 (.74%)
Coagulopathy
576 (.66%)
Prothrombin Time Prolonged
574 (.65%)
Hypotension
572 (.65%)
Drug Ineffective
563 (.64%)
Deep Vein Thrombosis
549 (.63%)
Diarrhoea
527 (.6%)
Melaena
521 (.59%)
Atrial Fibrillation
503 (.57%)
Fatigue
502 (.57%)
Thrombosis
501 (.57%)
Headache
485 (.55%)
Pulmonary Embolism
483 (.55%)
Renal Failure Acute
468 (.53%)
Oedema Peripheral
466 (.53%)
Death
458 (.52%)
Cerebrovascular Accident
449 (.51%)
Subdural Haematoma
444 (.51%)
Haematocrit Decreased
440 (.5%)
Abdominal Pain
429 (.49%)
Vomiting
421 (.48%)
Pneumonia
409 (.47%)
Gastric Haemorrhage
391 (.45%)
Haemorrhage Intracranial
375 (.43%)
Chest Pain
368 (.42%)
Pain In Extremity
365 (.42%)
Rash
362 (.41%)
Pain
344 (.39%)
Malaise
319 (.36%)
Haemoptysis
314 (.36%)
Pyrexia
314 (.36%)
Renal Failure
309 (.35%)
Cardiac Failure Congestive
301 (.34%)
Confusional State
300 (.34%)
Overdose
298 (.34%)
Haematochezia
294 (.34%)
Alopecia
291 (.33%)
Urinary Tract Infection
291 (.33%)
Haematemesis
284 (.32%)
Drug Toxicity
281 (.32%)
Condition Aggravated
250 (.28%)
Muscle Haemorrhage
247 (.28%)
Syncope
246 (.28%)
Decreased Appetite
245 (.28%)
Back Pain
240 (.27%)
Pruritus
239 (.27%)
Weight Decreased
239 (.27%)
Arthralgia
238 (.27%)
Upper Gastrointestinal Haemorrhage
237 (.27%)
Loss Of Consciousness
230 (.26%)
Hypertension
229 (.26%)
Faeces Discoloured
225 (.26%)
Myocardial Infarction
222 (.25%)
Cough
221 (.25%)
Dehydration
220 (.25%)
Medication Error
220 (.25%)
Ecchymosis
209 (.24%)
Platelet Count Decreased
199 (.23%)
Abdominal Pain Upper
195 (.22%)
Thrombocytopenia
192 (.22%)
Respiratory Failure
190 (.22%)
Blood Creatinine Increased
189 (.22%)
Head Injury
182 (.21%)
Insomnia
182 (.21%)
Activated Partial Thromboplastin Ti...
181 (.21%)
Constipation
179 (.2%)
Transient Ischaemic Attack
179 (.2%)
Skin Necrosis
174 (.2%)
Skin Discolouration
173 (.2%)
Lower Gastrointestinal Haemorrhage
171 (.19%)
Retroperitoneal Haematoma
171 (.19%)
Sepsis
169 (.19%)
Blood Urine Present
164 (.19%)
Cardiac Arrest
164 (.19%)
Cardiac Failure
163 (.19%)
Gingival Bleeding
163 (.19%)
Blood Pressure Decreased
159 (.18%)
Tachycardia
154 (.18%)
Gastric Ulcer
152 (.17%)
Feeling Abnormal
150 (.17%)
Incorrect Dose Administered
150 (.17%)
Pleural Effusion
150 (.17%)

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This graph shows the top adverse events submitted to the FDA for Warfarin Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Warfarin Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Adverse Event Categories for Warfarin Sodium

What are the most common Warfarin Sodium adverse events reported to the FDA?

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This graph shows the top categories of adverse events submitted to the FDA for Warfarin Sodium, as well as related generic and/or brandname drugs containing the same primary active ingredients, from Q1 2004 to Q3 2012. Adverse events are counted if Warfarin Sodium is flagged as a suspect drug causing the adverse event. For each adverse event listed, percent (%) represents percentage of the adverse event to all adverse events reported for the drug. Percent does not represent a rate related to drug utilization.

Common Uses of Warfarin Sodium According to Those Reporting Adverse Events

Why are people taking Warfarin Sodium, according to those reporting adverse events to the FDA?

Atrial Fibrillation
8041
Drug Use For Unknown Indication
3504
Product Used For Unknown Indication
2838
Deep Vein Thrombosis
2551
Anticoagulant Therapy
2548
Pulmonary Embolism
1736
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Thrombosis Prophylaxis
1585
Thrombosis
1424
Prophylaxis
913
Cerebrovascular Accident
602
Heart Valve Replacement
485
Aortic Valve Replacement
468
Cardiac Disorder
437
Mitral Valve Replacement
349
Coagulopathy
289
Cerebrovascular Accident Prophylaxi...
236
Ill-defined Disorder
218
Embolism
201
Arrhythmia
189
Myocardial Infarction
184
Transient Ischaemic Attack
183
Atrial Flutter
171
Heart Rate Irregular
160
Coronary Artery Disease
157
Cerebral Infarction
138
Pulmonary Hypertension
124
Cardiac Valve Disease
119
Cardiac Pacemaker Insertion
102
Pulmonary Thrombosis
97
Cardiac Failure Congestive
96
Antiphospholipid Syndrome
95
Cardiac Valve Prosthesis User
91
Venous Thrombosis
84
Blood Disorder
80
Cardiovascular Disorder
78
Factor V Leiden Mutation
75
Pulmonary Arterial Hypertension
73
Hypercoagulation
71
Cardiomyopathy
69
Stent Placement
67
Intracardiac Thrombus
64
Thrombophlebitis
63
Hypertension
62
Cardiac Failure
60
Peripheral Vascular Disorder
60
Cardiac Operation
54
Phlebitis
49
Surgery
47
Coronary Artery Bypass
47
Embolism Venous
46
Protein S Deficiency
42

Drug Labels

LabelLabelerEffective
Warfarin SodiumBryant Ranch Prepack19-JUN-06
Warfarin Sodium PD-Rx Pharmaceuticals, Inc.29-MAR-10
Warfarin SodiumPD-Rx Pharmaceuticals, Inc.29-MAR-10
Warfarin SodiumBryant Ranch Prepack10-MAY-10
Warfarin SodiumState of Florida DOH Central Pharmacy03-JUN-10
Warfarin Sodium REMEDYREPACK INC. 20-OCT-10
Warfarin SodiumRebel Distributors Corp01-DEC-10
Warfarin SodiumREMEDYREPACK INC. 09-MAR-11
Warfarin Sodium REMEDYREPACK INC. 07-APR-11
Warfarin SodiumGolden State Medical Supply, Inc.11-MAY-11
Warfarin Sodium REMEDYREPACK INC. 23-MAY-11
Warfarin SodiumREMEDYREPACK INC. 30-JUN-11
Warfarin SodiumREMEDYREPACK INC. 30-AUG-11
Warfarin SodiumREMEDYREPACK INC. 30-AUG-11
Warfarin SodiumCardinal Health21-SEP-11
Warfarin SodiumREMEDYREPACK INC. 28-SEP-11
Warfarin SodiumREMEDYREPACK INC. 28-SEP-11
Warfarin SodiumREMEDYREPACK INC. 03-OCT-11
CoumadinBristol-Myers Squibb Holdings Pharma, Ltd. Liability Company04-OCT-11
CoumadinBristol-Myers Squibb Pharma Company04-OCT-11
Warfarin SodiumREMEDYREPACK INC. 19-OCT-11
Warfarin SodiumREMEDYREPACK INC. 03-NOV-11
Warfarin SodiumREMEDYREPACK INC. 15-NOV-11
Warfarin SodiumPD-Rx Pharmaceuticals, Inc.17-NOV-11
Warfarin SodiumTaro Pharmaceuticals U.S.A., Inc.17-NOV-11
Warfarin SodiumREMEDYREPACK INC. 30-NOV-11
Warfarin Sodium REMEDYREPACK INC. 02-DEC-11
Warfarin SodiumREMEDYREPACK INC. 06-DEC-11
JantovenUpsher-Smith Laboratories, Inc.07-DEC-11
Warfarin SodiumREMEDYREPACK INC. 19-DEC-11
Warfarin SodiumMylan Pharmaceuticals Inc.21-DEC-11
JantovenPhysicians Total Care, Inc.28-DEC-11
Warfarin Sodium Med-Health Pharma, LLC20-JAN-12
Warfarin SodiumPhysicians Total Care, Inc.06-MAR-12
Warfarin SodiumPhysicians Total Care, Inc.06-MAR-12
Warfarin SodiumSTAT Rx USA LLC07-MAR-12
CoumadinLake Erie Medical & Surgical Supply DBA Quality Care Products LLC26-MAR-12
JantovenCardinal Health01-JUN-12
Warfarin SodiumZydus Pharmaceuticals (USA) Inc.25-JUN-12
Warfarin SodiumAmerican Health Packaging12-JUL-12
Warfarin SodiumAmerican Health Packaging12-JUL-12
CoumadinAphena Pharma Solutions - Tennessee, Inc.14-AUG-12
CoumadinAphena Pharma Solutions - Tennessee, Inc.14-AUG-12
Warfarin SodiumAphena Pharma Solutions - Tennessee, Inc.16-AUG-12
Warfarin SodiumAphena Pharma Solutions - Tennessee, Inc.16-AUG-12
Warfarin SodiumBarr Laboratories Inc.04-SEP-12
Warfarin SodiumCamber Pharmaceuticals19-SEP-12
Warfarin Sodium STAT Rx USA LLC25-SEP-12
Warfarin SodiumBryant Ranch Prepack12-OCT-12
Warfarin SodiumBryant Ranch Prepack12-OCT-12
Warfarin SodiumBryant Ranch Prepack12-OCT-12
Warfarin SodiumBryant Ranch Prepack12-OCT-12
Warfarin SodiumBryant Ranch Prepack23-OCT-12
Warfarin SodiumCadila Healthcare Limited02-NOV-12
CoumadinPhysicians Total Care, Inc.15-NOV-12
CoumadinREMEDYREPACK INC. 26-FEB-13
CoumadinREMEDYREPACK INC. 28-FEB-13
CoumadinREMEDYREPACK INC. 01-MAR-13
CoumadinREMEDYREPACK INC. 04-MAR-13
CoumadinREMEDYREPACK INC. 04-MAR-13
CoumadinCardinal Health25-MAR-13
JantovenREMEDYREPACK INC. 27-MAR-13
Warfarin SodiumREMEDYREPACK INC. 27-MAR-13
CoumadinREMEDYREPACK INC. 27-MAR-13
CoumadinREMEDYREPACK INC. 01-APR-13
CoumadinREMEDYREPACK INC. 01-APR-13
CoumadinREMEDYREPACK INC. 03-APR-13

Warfarin Sodium Case Reports

What Warfarin Sodium safety concerns are being reported by doctors and researchers in the medical literature?

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About Results

This report contains aggregated drug side effects and adverse events for Warfarin Sodium. The data has been pulled from the United States Food and Drug Administration's (US FDA) Adverse Event Reporting System (AERS), a database containing more than 4,000,000 adverse event reports.

DrugCite expands your query using the Unified Medical Language System (UMLS) to include generic drugs and primary active ingredients. While the core of DrugCite's advanced drug filtering algorithm is based on the industry standard UMLS, DrugCite's proprietary filtering system also includes dozens of additional steps to reconcile malformed drug names in the FDA's data.

DrugCite only counts a drug if the submitter of the adverse event indicates that the drug is suspected to have caused the adverse event.

Depending on how the data is aggregated, different counts may occur. When someone submits an adverse event to the FDA, the submitter can attribute multiple adverse events to one or more drugs. For example, an individual taking Paxil could submit the adverse events "anxiety" and "suicidal ideation" for the same individual safety report (ISR). This means when DrugCite aggregates by adverse event, two distinct adverse events are counted in the adverse event graph; once for "anxiety" and again for "suicidal ideation". However, when DrugCite aggregates by individual safety reports irrespective of the details of the adverse events contained within the safety report, the report is only counted once.

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