LEUCOVORIN

Leucovorin Adverse Events Reported to the FDA Over Time

How are Leucovorin adverse event reports trending over time?

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

Most Common Leucovorin Adverse Events Reported to the FDA

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

Diarrhoea	840 (3.16%)
Vomiting	604 (2.27%)
Dehydration	538 (2.02%)
Nausea	500 (1.88%)
Neutropenia	445 (1.67%)
Pyrexia	441 (1.66%)
Febrile Neutropenia	330 (1.24%)
Abdominal Pain	328 (1.23%)
Sepsis	262 (.99%)
Fatigue	243 (.91%)
Dyspnoea	240 (.9%)
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Asthenia	239 (.9%)
Anaemia	237 (.89%)
Pulmonary Embolism	232 (.87%)
Stomatitis	218 (.82%)
Haemoglobin Decreased	217 (.82%)
Hypotension	212 (.8%)
Thrombocytopenia	184 (.69%)
Pneumonia	176 (.66%)
Disease Progression	170 (.64%)
Death	163 (.61%)
Mucosal Inflammation	162 (.61%)
Leukopenia	161 (.61%)
Hypokalaemia	160 (.6%)
Interstitial Lung Disease	156 (.59%)
Decreased Appetite	151 (.57%)
Infection	149 (.56%)
White Blood Cell Count Decreased	148 (.56%)
Renal Failure Acute	144 (.54%)
Respiratory Failure	143 (.54%)
Deep Vein Thrombosis	141 (.53%)
General Physical Health Deteriorati...	139 (.52%)
Drug Toxicity	136 (.51%)
Platelet Count Decreased	127 (.48%)
Hypertension	123 (.46%)
Renal Failure	123 (.46%)
Chest Pain	122 (.46%)
Pleural Effusion	121 (.46%)
Anorexia	119 (.45%)
Blood Creatinine Increased	118 (.44%)
Neuropathy Peripheral	114 (.43%)
Chills	111 (.42%)
Blood Potassium Decreased	108 (.41%)
Weight Decreased	106 (.4%)
Atrial Fibrillation	105 (.39%)
Gastrointestinal Haemorrhage	105 (.39%)
Malignant Neoplasm Progression	101 (.38%)
Myocardial Infarction	100 (.38%)
Neutrophil Count Decreased	95 (.36%)
Ascites	93 (.35%)
Fall	93 (.35%)
Back Pain	92 (.35%)
Confusional State	92 (.35%)
Dizziness	90 (.34%)
Intestinal Perforation	90 (.34%)
Aspartate Aminotransferase Increase...	88 (.33%)
Malaise	86 (.32%)
Loss Of Consciousness	83 (.31%)
Syncope	82 (.31%)
Constipation	81 (.3%)
Small Intestinal Obstruction	81 (.3%)
Alanine Aminotransferase Increased	78 (.29%)
Hypersensitivity	77 (.29%)
Septic Shock	77 (.29%)
Intestinal Obstruction	76 (.29%)
Pancytopenia	76 (.29%)
Cardiac Arrest	75 (.28%)
Pain	75 (.28%)
Tachycardia	73 (.27%)
Paraesthesia	70 (.26%)
Abdominal Pain Upper	69 (.26%)
Dysphagia	69 (.26%)
Haematocrit Decreased	69 (.26%)
Rash	69 (.26%)
Convulsion	68 (.26%)
Oesophagitis	68 (.26%)
Dermatitis Acneiform	67 (.25%)
Multi-organ Failure	67 (.25%)
Blood Sodium Decreased	66 (.25%)
Headache	65 (.24%)
Hypoaesthesia	65 (.24%)
Cough	64 (.24%)
Ileus	64 (.24%)
Staphylococcal Infection	63 (.24%)
Hyponatraemia	62 (.23%)
Epistaxis	60 (.23%)
Peritonitis	60 (.23%)
Urinary Tract Infection	59 (.22%)
Heart Rate Increased	58 (.22%)
Hypomagnesaemia	58 (.22%)
Metastases To Liver	58 (.22%)
White Blood Cell Count Increased	58 (.22%)
Blood Bilirubin Increased	57 (.21%)
Hyperhidrosis	57 (.21%)
Hypoxia	57 (.21%)
Acute Myocardial Infarction	56 (.21%)
Thrombosis	56 (.21%)
Blood Alkaline Phosphatase Increase...	55 (.21%)
International Normalised Ratio Incr...	55 (.21%)
Oedema Peripheral	55 (.21%)
Blood Glucose Increased	54 (.2%)

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This graph shows the top adverse events submitted to the FDA for Leucovorin, 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 Leucovorin 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 Leucovorin

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

Gastrointestinal Signs	1791 (6.74%)
Infections - Pathogen Unspecified	1419 (5.34%)
Hematology Investigations	1055 (3.97%)
Gastrointestinal Motility And Defec...	994 (3.74%)
White Blood Cell	982 (3.69%)
Electrolyte And Fluid Balance Condi...	891 (3.35%)
Neurological	823 (3.1%)
Respiratory	807 (3.04%)
Cardiac Arrhythmias	525 (1.97%)
Lower Respiratory Tract Disorders	484 (1.82%)
Body Temperature Conditions	450 (1.69%)
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Bacterial Infectious	413 (1.55%)
Renal Disorders	392 (1.47%)
Gastrointestinal Ulceration And Per...	361 (1.36%)
Anemias Nonhemolytic And Marrow Dep...	355 (1.34%)
Cardiac And Vascular Investigations	355 (1.34%)
Epidermal And Dermal Conditions	354 (1.33%)
Appetite And General Nutritional	345 (1.3%)
Decreased And Nonspecific Blood Pre...	337 (1.27%)
Hepatobiliary	337 (1.27%)
Embolism And Thrombosis	333 (1.25%)
Water, Electrolyte And Mineral	320 (1.2%)
Coronary Artery	314 (1.18%)
Hepatic And Hepatobiliary	314 (1.18%)
Oral Soft Tissue Conditions	308 (1.16%)
Gastrointestinal Inflammatory Condi...	300 (1.13%)
Gastrointestinal Stenosis And Obstr...	297 (1.12%)
Gastrointestinal Hemorrhages	263 (.99%)
Pulmonary Vascular	256 (.96%)
Renal And Urinary Tract Investigati...	241 (.91%)
Musculoskeletal And Connective Tiss...	239 (.9%)
Fatal Outcomes	227 (.85%)
Physical Examination Topics	219 (.82%)
Platelet	217 (.82%)
Central Nervous System Vascular	206 (.77%)
Miscellaneous And Site Unspecified ...	194 (.73%)
Procedural And Device Related Injur...	193 (.73%)
Injuries	191 (.72%)
Peripheral Neuropathies	188 (.71%)
Peritoneal And Retroperitoneal Cond...	182 (.68%)
Skin Appendage Conditions	170 (.64%)
Metastases	169 (.64%)
Gastrointestinal Neoplasms Malignan...	163 (.61%)
Allergic Conditions	159 (.6%)
Metabolic, Nutritional And Blood Ga...	154 (.58%)
Chemical Injury And Poisoning	149 (.56%)
Pleural	146 (.55%)
Enzyme	144 (.54%)
Therapeutic And Nontherapeutic Effe...	142 (.53%)
Urinary Tract Signs	142 (.53%)
Bone, Calcium, Magnesium And Phosph...	132 (.5%)
Vascular Hypertensive	131 (.49%)
Upper Respiratory Tract Disorders	129 (.49%)
Microbiology And Serology	124 (.47%)
Deliria	121 (.46%)
Protein And Chemistry Analyses	111 (.42%)
Myocardial	110 (.41%)
Fungal Infectious	109 (.41%)
Cardiac Disorder Signs	101 (.38%)
Movement Disorders	99 (.37%)
Encephalopathies	98 (.37%)
Seizures	97 (.36%)
Administration Site Reactions	94 (.35%)
Vascular	94 (.35%)
Glucose Metabolism Disorders	91 (.34%)
Muscle	87 (.33%)
Gastrointestinal Conditions	83 (.31%)
Tissue	80 (.3%)
Acid-base	79 (.3%)
Heart Failures	78 (.29%)
Vascular Hemorrhagic	76 (.29%)
Gallbladder	75 (.28%)
Skin And Subcutaneous Tissue	75 (.28%)
Arteriosclerosis, Stenosis, Vascula...	69 (.26%)
Headaches	67 (.25%)
Spleen, Lymphatic And Reticulendoth...	67 (.25%)
Vision	67 (.25%)
Joint	63 (.24%)
Coagulopathies And Bleeding Diathes...	62 (.23%)
Mental Impairment	60 (.23%)
Viral Infectious	58 (.22%)
Lifestyle Issues	56 (.21%)
Gastrointestinal Vascular Condition...	54 (.2%)
Bile Duct	53 (.2%)
Exocrine Pancreas Conditions	53 (.2%)
Cardiac Valve	51 (.19%)
Neoplasm Related Morbidities	50 (.19%)
Psychiatric	48 (.18%)
Disturbances In Thinking	47 (.18%)
Hemolyses And Related Conditions	46 (.17%)
Anxiety Disorders	43 (.16%)
Medication Errors	43 (.16%)
Angiedema And Urticaria	42 (.16%)
Protein And Amino Acid Metabolism	42 (.16%)
Bone And Joint Injuries	40 (.15%)
Bronchial Disorders	38 (.14%)
Investigations, Imaging And Histopa...	38 (.14%)
Bone Disorders	35 (.13%)
Skin Vascular Abnormalities	35 (.13%)
Anal And Rectal Conditions	33 (.12%)
Urolithiases	33 (.12%)

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