WARFARIN

Warfarin Adverse Events Reported to the FDA Over Time

How are Warfarin adverse event reports trending over time?

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

Most Common Warfarin Adverse Events Reported to the FDA

What are the most common Warfarin 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, 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 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

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

Hematology Investigations	13071 (14.9%)
Gastrointestinal Hemorrhages	4167 (4.75%)
Injuries	3231 (3.68%)
Therapeutic And Nontherapeutic Effe...	3196 (3.64%)
Neurological	2768 (3.16%)
Gastrointestinal Signs	2605 (2.97%)
Central Nervous System Vascular	2511 (2.86%)
Vascular Hemorrhagic	2357 (2.69%)
Respiratory	2316 (2.64%)
Infections - Pathogen Unspecified	2059 (2.35%)
Epidermal And Dermal Conditions	1962 (2.24%)
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Anemias Nonhemolytic And Marrow Dep...	1487 (1.69%)
Cardiac Arrhythmias	1474 (1.68%)
Embolism And Thrombosis	1351 (1.54%)
Renal Disorders	1222 (1.39%)
Medication Errors	1160 (1.32%)
Urinary Tract Signs	1081 (1.23%)
Upper Respiratory Tract Disorders	1079 (1.23%)
Musculoskeletal And Connective Tiss...	987 (1.13%)
Decreased And Nonspecific Blood Pre...	945 (1.08%)
Coagulopathies And Bleeding Diathes...	894 (1.02%)
Gastrointestinal Motility And Defec...	836 (.95%)
Cardiac And Vascular Investigations	792 (.9%)
Muscle	775 (.88%)
Gastrointestinal Ulceration And Per...	761 (.87%)
Electrolyte And Fluid Balance Condi...	663 (.76%)
Pulmonary Vascular	654 (.75%)
Joint	610 (.7%)
Heart Failures	609 (.69%)
Hepatic And Hepatobiliary	606 (.69%)
Renal And Urinary Tract Investigati...	581 (.66%)
Bacterial Infectious	567 (.65%)
Headaches	555 (.63%)
Skin Appendage Conditions	555 (.63%)
Fatal Outcomes	545 (.62%)
Procedural And Device Related Injur...	539 (.61%)
Skin Vascular Abnormalities	525 (.6%)
Hepatobiliary	512 (.58%)
Lower Respiratory Tract Disorders	484 (.55%)
Appetite And General Nutritional	479 (.55%)
Chemical Injury And Poisoning	455 (.52%)
Coronary Artery	443 (.5%)
Physical Examination Topics	432 (.49%)
Peritoneal And Retroperitoneal Cond...	427 (.49%)
Gastrointestinal Inflammatory Condi...	404 (.46%)
Deliria	378 (.43%)
Toxicology And Therapeutic Drug Mon...	372 (.42%)
Movement Disorders	366 (.42%)
Lifestyle Issues	365 (.42%)
Administration Site Reactions	363 (.41%)
Bone And Joint Injuries	362 (.41%)
Anxiety Disorders	323 (.37%)
Body Temperature Conditions	322 (.37%)
Metabolic, Nutritional And Blood Ga...	322 (.37%)
Platelet	299 (.34%)
Cardiac Disorder Signs	297 (.34%)
Gastrointestinal Vascular Condition...	277 (.32%)
Pleural	259 (.3%)
Psychiatric	257 (.29%)
Vascular Hypertensive	254 (.29%)
Sleep Disorders	247 (.28%)
Tissue	246 (.28%)
Water, Electrolyte And Mineral	245 (.28%)
Dental And Gingival Conditions	243 (.28%)
Arteriosclerosis, Stenosis, Vascula...	242 (.28%)
Vision	242 (.28%)
Seizures	239 (.27%)
Gastrointestinal Conditions	235 (.27%)
Allergic Conditions	228 (.26%)
Mental Impairment	228 (.26%)
Oral Soft Tissue Conditions	223 (.25%)
Vascular	218 (.25%)
Suicidal And Self-injurious Behavio...	215 (.25%)
Pericardial	214 (.24%)
Bronchial Disorders	194 (.22%)
Ocular Hemorrhages And Vascular	194 (.22%)
Product Quality Issues	184 (.21%)
White Blood Cell	181 (.21%)
Diverticular	170 (.19%)
Peripheral Neuropathies	167 (.19%)
Myocardial	165 (.19%)
Enzyme	158 (.18%)
Glucose Metabolism Disorders	149 (.17%)
Abdominal Hernias And Other Abdomin...	146 (.17%)
Therapeutic Procedures And Supporti...	146 (.17%)
Cardiac Valve	143 (.16%)
Disturbances In Thinking	142 (.16%)
Miscellaneous And Site Unspecified ...	141 (.16%)
Depressed Mood Disorders	136 (.16%)
Gastrointestinal	136 (.16%)
Viral Infectious	128 (.15%)
Skin And Subcutaneous Tissue	122 (.14%)
Bone Disorders	116 (.13%)
Bone, Calcium, Magnesium And Phosph...	111 (.13%)
Gastrointestinal Neoplasms Malignan...	111 (.13%)
Gastrointestinal Stenosis And Obstr...	111 (.13%)
Increased Intracranial Pressure And...	111 (.13%)
Menstrual Cycle And Uterine Bleedin...	110 (.13%)
Aneurysms And Artery Dissections	107 (.12%)
Gallbladder	105 (.12%)
Eye	104 (.12%)

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This graph shows the top categories of adverse events submitted to the FDA for Warfarin, 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 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.