ISOVORIN

Isovorin Adverse Events Reported to the FDA Over Time

How are Isovorin adverse event reports trending over time?

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

Most Common Isovorin Adverse Events Reported to the FDA

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

Interstitial Lung Disease	40 (3.56%)
Disseminated Intravascular Coagulat...	35 (3.11%)
Neutrophil Count Decreased	24 (2.14%)
Diarrhoea	23 (2.05%)
Pyrexia	23 (2.05%)
White Blood Cell Count Decreased	22 (1.96%)
Hypertension	21 (1.87%)
Neutropenia	20 (1.78%)
Shock	20 (1.78%)
Acute Respiratory Distress Syndrome	18 (1.6%)
Disease Progression	18 (1.6%)
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Renal Failure Acute	18 (1.6%)
Altered State Of Consciousness	17 (1.51%)
Platelet Count Decreased	17 (1.51%)
Haemoglobin Decreased	16 (1.42%)
Leukopenia	16 (1.42%)
Stomatitis	14 (1.25%)
Vomiting	14 (1.25%)
Anaemia	13 (1.16%)
Aspartate Aminotransferase Increase...	12 (1.07%)
Hepatic Function Abnormal	12 (1.07%)
Pneumonia	12 (1.07%)
Death	11 (.98%)
Febrile Neutropenia	11 (.98%)
Gastrointestinal Perforation	11 (.98%)
Multi-organ Failure	11 (.98%)
Intestinal Obstruction	10 (.89%)
Nausea	10 (.89%)
Thrombocytopenia	10 (.89%)
Abdominal Pain	9 (.8%)
Alanine Aminotransferase Increased	9 (.8%)
Anaphylactic Shock	9 (.8%)
Renal Failure	9 (.8%)
Small Intestinal Perforation	9 (.8%)
Anaphylactoid Reaction	8 (.71%)
Anorexia	8 (.71%)
Cholecystitis Acute	8 (.71%)
Epistaxis	8 (.71%)
Flushing	8 (.71%)
Granulocyte Count Decreased	8 (.71%)
Hypoaesthesia	8 (.71%)
Respiratory Failure	8 (.71%)
Sepsis	8 (.71%)
Blood Bilirubin Increased	7 (.62%)
Cerebral Infarction	7 (.62%)
Anaphylactoid Shock	6 (.53%)
Blood Alkaline Phosphatase Increase...	6 (.53%)
Bone Marrow Failure	6 (.53%)
Cardiac Failure	6 (.53%)
Convulsion	6 (.53%)
Dehydration	6 (.53%)
Dysarthria	6 (.53%)
Enterocolitis	6 (.53%)
Fall	6 (.53%)
Hyperammonaemia	6 (.53%)
Hypersensitivity	6 (.53%)
Ileus	6 (.53%)
Liver Disorder	6 (.53%)
Pancytopenia	6 (.53%)
Peritonitis	6 (.53%)
Rash	6 (.53%)
Tumour Lysis Syndrome	6 (.53%)
Blood Creatine Phosphokinase Increa...	5 (.44%)
Large Intestine Perforation	5 (.44%)
Angina Pectoris	4 (.36%)
Cardiac Arrest	4 (.36%)
Cerebral Haemorrhage	4 (.36%)
Colorectal Cancer	4 (.36%)
Decreased Appetite	4 (.36%)
Gastric Ulcer	4 (.36%)
Gastrointestinal Haemorrhage	4 (.36%)
Haematuria	4 (.36%)
Ileal Perforation	4 (.36%)
Malaise	4 (.36%)
Neuropathy Peripheral	4 (.36%)
Pancreatitis Acute	4 (.36%)
Pharyngitis	4 (.36%)
Pneumothorax	4 (.36%)
Pulmonary Embolism	4 (.36%)
Renal Impairment	4 (.36%)
Respiratory Arrest	4 (.36%)
Retinal Detachment	4 (.36%)
Urine Output Decreased	4 (.36%)
Alanine Aminotransferase Abnormal	3 (.27%)
Anal Fistula	3 (.27%)
Aortic Dissection	3 (.27%)
Ascites	3 (.27%)
Aspartate Aminotransferase Abnormal	3 (.27%)
Bile Duct Stone	3 (.27%)
Blood Bilirubin Abnormal	3 (.27%)
Blood Creatinine Increased	3 (.27%)
Blood Pressure Increased	3 (.27%)
C-reactive Protein Increased	3 (.27%)
Constipation	3 (.27%)
Dermatitis Acneiform	3 (.27%)
Disease Recurrence	3 (.27%)
Disorientation	3 (.27%)
Duodenal Ulcer	3 (.27%)
Dyspnoea	3 (.27%)
Fatigue	3 (.27%)
Gastric Ulcer Haemorrhage	3 (.27%)

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

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

Hematology Investigations	91 (8.1%)
Lower Respiratory Tract Disorders	61 (5.43%)
Infections - Pathogen Unspecified	50 (4.45%)
White Blood Cell	47 (4.18%)
Gastrointestinal Ulceration And Per...	45 (4%)
Neurological	43 (3.83%)
Hepatobiliary	38 (3.38%)
Coagulopathies And Bleeding Diathes...	35 (3.11%)
Gastrointestinal Signs	33 (2.94%)
Renal Disorders	33 (2.94%)
Hepatic And Hepatobiliary	32 (2.85%)
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Allergic Conditions	29 (2.58%)
Respiratory	27 (2.4%)
Gastrointestinal Motility And Defec...	26 (2.31%)
Anemias Nonhemolytic And Marrow Dep...	25 (2.22%)
Body Temperature Conditions	23 (2.05%)
Decreased And Nonspecific Blood Pre...	23 (2.05%)
Vascular Hypertensive	21 (1.87%)
Gastrointestinal Stenosis And Obstr...	20 (1.78%)
Central Nervous System Vascular	14 (1.25%)
Oral Soft Tissue Conditions	14 (1.25%)
Appetite And General Nutritional	12 (1.07%)
Electrolyte And Fluid Balance Condi...	12 (1.07%)
Epidermal And Dermal Conditions	12 (1.07%)
Enzyme	11 (.98%)
Fatal Outcomes	11 (.98%)
Gastrointestinal Hemorrhages	11 (.98%)
Gallbladder	10 (.89%)
Platelet	10 (.89%)
Renal And Urinary Tract Investigati...	10 (.89%)
Peritoneal And Retroperitoneal Cond...	9 (.8%)
Cardiac Arrhythmias	8 (.71%)
Coronary Artery	8 (.71%)
Gastrointestinal Conditions	8 (.71%)
Upper Respiratory Tract Disorders	8 (.71%)
Vascular	8 (.71%)
Gastrointestinal Inflammatory Condi...	7 (.62%)
Gastrointestinal Neoplasms Malignan...	7 (.62%)
Injuries	7 (.62%)
Peripheral Neuropathies	7 (.62%)
Pulmonary Vascular	7 (.62%)
Seizures	7 (.62%)
Skin Appendage Conditions	7 (.62%)
Urinary Tract Signs	7 (.62%)
Bile Duct	6 (.53%)
Encephalopathies	6 (.53%)
Heart Failures	6 (.53%)
Protein And Amino Acid Metabolism	6 (.53%)
Cardiac And Vascular Investigations	5 (.44%)
Exocrine Pancreas Conditions	5 (.44%)
Nephropathies	5 (.44%)
Deliria	4 (.36%)
Embolism And Thrombosis	4 (.36%)
Fungal Infectious	4 (.36%)
Musculoskeletal And Connective Tiss...	4 (.36%)
Ocular Structural Change, Deposit A...	4 (.36%)
Pleural	4 (.36%)
Viral Infectious	4 (.36%)
Aneurysms And Artery Dissections	3 (.27%)
Bone And Joint Injuries	3 (.27%)
Gastrointestinal Vascular Condition...	3 (.27%)
Glucose Metabolism Disorders	3 (.27%)
Hematological	3 (.27%)
Hemolyses And Related Conditions	3 (.27%)
Muscle	3 (.27%)
Physical Examination Topics	3 (.27%)
Protein And Chemistry Analyses	3 (.27%)
Abortions And Stillbirth	2 (.18%)
Administration Site Reactions	2 (.18%)
Bronchial Disorders	2 (.18%)
Cardiac Disorder Signs	2 (.18%)
Chemical Injury And Poisoning	2 (.18%)
Eye	2 (.18%)
Fractures	2 (.18%)
Manic And Bipolar Mood Disorders	2 (.18%)
Metastases	2 (.18%)
Movement Disorders	2 (.18%)
Neoplasm Related Morbidities	2 (.18%)
Ocular Hemorrhages And Vascular	2 (.18%)
Retina, Choroid And Vitreous Hemorr...	2 (.18%)
Thyroid Gland	2 (.18%)
Vascular Hemorrhagic	2 (.18%)
Vision	2 (.18%)
Arteriosclerosis, Stenosis, Vascula...	1 (.09%)
Bacterial Infectious	1 (.09%)
Dental And Gingival Conditions	1 (.09%)
Disturbances In Thinking	1 (.09%)
Headaches	1 (.09%)
Hematological And Lymphoid Tissue T...	1 (.09%)
Increased Intracranial Pressure And...	1 (.09%)
Medication Errors	1 (.09%)
Miscellaneous And Site Unspecified ...	1 (.09%)
Mycobacterial Infectious	1 (.09%)
Myocardial	1 (.09%)
Neurological Disorders Of The Eye	1 (.09%)
Ocular Neuromuscular	1 (.09%)
Procedural And Device Related Injur...	1 (.09%)
Psychiatric	1 (.09%)
Reproductive Tract	1 (.09%)
Schizophrenia And Other Psychotic	1 (.09%)
Therapeutic And Nontherapeutic Effe...	1 (.09%)

Share/Embed Graph Export Data

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