LEVOLEUCOVORIN CALCIUM

Levoleucovorin Calcium Adverse Events Reported to the FDA Over Time

How are Levoleucovorin Calcium adverse event reports trending over time?

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

Most Common Levoleucovorin Calcium Adverse Events Reported to the FDA

What are the most common Levoleucovorin Calcium adverse events reported to the FDA?

Dermatitis Acneiform	24 (2.42%)
Interstitial Lung Disease	23 (2.32%)
Diarrhoea	21 (2.12%)
Stomatitis	20 (2.02%)
Neutropenia	19 (1.92%)
Decreased Appetite	16 (1.62%)
Anaemia	15 (1.52%)
White Blood Cell Count Decreased	15 (1.52%)
Colorectal Cancer	14 (1.41%)
Nausea	14 (1.41%)
Vomiting	14 (1.41%)
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Febrile Neutropenia	13 (1.31%)
Neutrophil Count Decreased	13 (1.31%)
Dehydration	12 (1.21%)
Thrombocytopenia	12 (1.21%)
Renal Failure Acute	11 (1.11%)
Dry Skin	10 (1.01%)
Platelet Count Decreased	10 (1.01%)
Pyrexia	10 (1.01%)
Shock	10 (1.01%)
Abdominal Pain	9 (.91%)
Sepsis	9 (.91%)
Hypomagnesaemia	8 (.81%)
Leukopenia	8 (.81%)
Neuropathy Peripheral	8 (.81%)
Paronychia	8 (.81%)
Blood Pressure Decreased	7 (.71%)
Duodenal Ulcer Haemorrhage	7 (.71%)
Hepatic Function Abnormal	7 (.71%)
Multi-organ Failure	7 (.71%)
Pneumonia	7 (.71%)
Pruritus	7 (.71%)
Renal Impairment	7 (.71%)
Anorexia	6 (.61%)
Coma	6 (.61%)
Coombs Positive Haemolytic Anaemia	6 (.61%)
Disease Progression	6 (.61%)
Disseminated Intravascular Coagulat...	6 (.61%)
Drug Eruption	6 (.61%)
Dry Mouth	6 (.61%)
Dyspnoea	6 (.61%)
Fatigue	6 (.61%)
General Physical Health Deteriorati...	6 (.61%)
Hypocalcaemia	6 (.61%)
Large Intestine Perforation	6 (.61%)
Urticaria	6 (.61%)
Aplasia Pure Red Cell	5 (.51%)
Candidiasis	5 (.51%)
Death	5 (.51%)
Delirium	5 (.51%)
Enterocolitis	5 (.51%)
Gait Disturbance	5 (.51%)
Haemolysis	5 (.51%)
Hepatic Atrophy	5 (.51%)
Hydronephrosis	5 (.51%)
Hypokalaemia	5 (.51%)
Infection	5 (.51%)
Infusion Related Reaction	5 (.51%)
International Normalised Ratio Incr...	5 (.51%)
Localised Intraabdominal Fluid Coll...	5 (.51%)
Pleural Effusion	5 (.51%)
Splenomegaly	5 (.51%)
Subileus	5 (.51%)
Thrombosis	5 (.51%)
Abdominal Abscess	4 (.4%)
Anaemia Macrocytic	4 (.4%)
Anaphylactic Shock	4 (.4%)
Asthenia	4 (.4%)
Back Pain	4 (.4%)
Cholangitis	4 (.4%)
Dysphagia	4 (.4%)
Eye Discharge	4 (.4%)
Faecaloma	4 (.4%)
Granulocytopenia	4 (.4%)
Hyperammonaemia	4 (.4%)
Hypoalbuminaemia	4 (.4%)
Intestinal Fistula	4 (.4%)
Keratitis	4 (.4%)
Microcytic Anaemia	4 (.4%)
Oesophageal Varices Haemorrhage	4 (.4%)
Alopecia	3 (.3%)
Ascites	3 (.3%)
Blood Creatinine Increased	3 (.3%)
Blood Lactate Dehydrogenase Increas...	3 (.3%)
Blood Sodium Increased	3 (.3%)
Bone Pain	3 (.3%)
Cardiac Arrest	3 (.3%)
Cardio-respiratory Arrest	3 (.3%)
Chromaturia	3 (.3%)
Colon Cancer Recurrent	3 (.3%)
Constipation	3 (.3%)
Convulsion	3 (.3%)
Deep Vein Thrombosis	3 (.3%)
Dermatitis	3 (.3%)
Dysgeusia	3 (.3%)
Erythema	3 (.3%)
Gastroenteritis	3 (.3%)
Haematuria	3 (.3%)
Hepatic Enzyme Increased	3 (.3%)
Hyponatraemia	3 (.3%)
Inflammation	3 (.3%)

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

What are the most common Levoleucovorin Calcium adverse events reported to the FDA?

Gastrointestinal Signs	46 (4.65%)
Hematology Investigations	46 (4.65%)
White Blood Cell	46 (4.65%)
Epidermal And Dermal Conditions	45 (4.55%)
Infections - Pathogen Unspecified	45 (4.55%)
Renal Disorders	35 (3.54%)
Anemias Nonhemolytic And Marrow Dep...	32 (3.23%)
Skin Appendage Conditions	32 (3.23%)
Lower Respiratory Tract Disorders	29 (2.93%)
Neurological	28 (2.83%)
Oral Soft Tissue Conditions	28 (2.83%)
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Gastrointestinal Ulceration And Per...	26 (2.63%)
Electrolyte And Fluid Balance Condi...	24 (2.42%)
Gastrointestinal Motility And Defec...	24 (2.42%)
Appetite And General Nutritional	22 (2.22%)
Gastrointestinal Neoplasms Malignan...	19 (1.92%)
Respiratory	19 (1.92%)
Hepatic And Hepatobiliary	18 (1.82%)
Bone, Calcium, Magnesium And Phosph...	16 (1.62%)
Hemolyses And Related Conditions	15 (1.52%)
Embolism And Thrombosis	14 (1.41%)
Platelet	12 (1.21%)
Body Temperature Conditions	11 (1.11%)
Cardiac And Vascular Investigations	11 (1.11%)
Decreased And Nonspecific Blood Pre...	10 (1.01%)
Metastases	10 (1.01%)
Ocular Infections, Irritations And ...	10 (1.01%)
Cardiac Arrhythmias	9 (.91%)
Gastrointestinal Stenosis And Obstr...	9 (.91%)
Peripheral Neuropathies	9 (.91%)
Spleen, Lymphatic And Reticulendoth...	9 (.91%)
Coagulopathies And Bleeding Diathes...	8 (.81%)
Deliria	8 (.81%)
Fungal Infectious	8 (.81%)
Peritoneal And Retroperitoneal Cond...	8 (.81%)
Protein And Amino Acid Metabolism	8 (.81%)
Renal And Urinary Tract Investigati...	8 (.81%)
Viral Infectious	8 (.81%)
Administration Site Reactions	7 (.71%)
Allergic Conditions	7 (.71%)
Fatal Outcomes	7 (.71%)
Gastrointestinal Hemorrhages	7 (.71%)
Musculoskeletal And Connective Tiss...	7 (.71%)
Urinary Tract Signs	7 (.71%)
Water, Electrolyte And Mineral	7 (.71%)
Angiedema And Urticaria	6 (.61%)
Gastrointestinal Inflammatory Condi...	6 (.61%)
Heart Failures	6 (.61%)
Salivary Gland Conditions	6 (.61%)
Encephalopathies	5 (.51%)
Gastrointestinal Conditions	5 (.51%)
Pleural	5 (.51%)
Bile Duct	4 (.4%)
Hepatobiliary	4 (.4%)
Metabolic, Nutritional And Blood Ga...	4 (.4%)
Seizures	4 (.4%)
Therapeutic And Nontherapeutic Effe...	4 (.4%)
Bacterial Infectious	3 (.3%)
Bone Disorders	3 (.3%)
Cardiac Disorder Signs	3 (.3%)
Central Nervous System Vascular	3 (.3%)
Enzyme	3 (.3%)
Upper Respiratory Tract Disorders	3 (.3%)
Acid-base	2 (.2%)
Anal And Rectal Conditions	2 (.2%)
Changes In Physical Activity	2 (.2%)
Headaches	2 (.2%)
Lifestyle Issues	2 (.2%)
Medication Errors	2 (.2%)
Miscellaneous And Site Unspecified ...	2 (.2%)
Physical Examination Topics	2 (.2%)
Procedural And Device Related Injur...	2 (.2%)
Protein And Chemistry Analyses	2 (.2%)
Pulmonary Vascular	2 (.2%)
Skin And Subcutaneous Tissue	2 (.2%)
Tissue	2 (.2%)
Ureteric	2 (.2%)
Vascular	2 (.2%)
Vascular Hypertensive	2 (.2%)
Anxiety Disorders	1 (.1%)
Arteriosclerosis, Stenosis, Vascula...	1 (.1%)
Bronchial Disorders	1 (.1%)
Cardiac Valve	1 (.1%)
Eating Disorders	1 (.1%)
Hematological And Lymphoid Tissue T...	1 (.1%)
Increased Intracranial Pressure And...	1 (.1%)
Injuries	1 (.1%)
Lymphatic Vessel	1 (.1%)
Microbiology And Serology	1 (.1%)
Movement Disorders	1 (.1%)
Myocardial	1 (.1%)
Neoplasm Related Morbidities	1 (.1%)
Neuromuscular	1 (.1%)
Reproductive Tract	1 (.1%)
Therapeutic Procedures And Supporti...	1 (.1%)
Tongue Conditions	1 (.1%)
Urethral Disorders	1 (.1%)
Vascular Hemorrhagic	1 (.1%)

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