IRINOTECAN

Irinotecan Adverse Events Reported to the FDA Over Time

How are Irinotecan adverse event reports trending over time?

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

Most Common Irinotecan Adverse Events Reported to the FDA

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

Diarrhoea	1760 (4.93%)
Vomiting	860 (2.41%)
Dehydration	802 (2.25%)
Neutropenia	777 (2.18%)
Nausea	721 (2.02%)
Pyrexia	563 (1.58%)
Febrile Neutropenia	489 (1.37%)
Leukopenia	422 (1.18%)
Death	419 (1.17%)
Asthenia	396 (1.11%)
Thrombocytopenia	385 (1.08%)
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Anaemia	366 (1.03%)
Abdominal Pain	357 (1%)
Disease Progression	330 (.92%)
Fatigue	330 (.92%)
Sepsis	327 (.92%)
Haemoglobin Decreased	324 (.91%)
Pulmonary Embolism	313 (.88%)
Hypotension	286 (.8%)
Pneumonia	286 (.8%)
Interstitial Lung Disease	281 (.79%)
Dyspnoea	276 (.77%)
Stomatitis	275 (.77%)
White Blood Cell Count Decreased	270 (.76%)
Decreased Appetite	268 (.75%)
General Physical Health Deteriorati...	265 (.74%)
Hypokalaemia	218 (.61%)
Renal Failure Acute	217 (.61%)
Malignant Neoplasm Progression	211 (.59%)
Anorexia	199 (.56%)
Malaise	187 (.52%)
Neutrophil Count Decreased	187 (.52%)
Platelet Count Decreased	176 (.49%)
Convulsion	171 (.48%)
Dermatitis Acneiform	166 (.47%)
Rash	166 (.47%)
Mucosal Inflammation	165 (.46%)
Deep Vein Thrombosis	163 (.46%)
Weight Decreased	159 (.45%)
Intestinal Obstruction	154 (.43%)
Gastrointestinal Haemorrhage	153 (.43%)
Ileus	149 (.42%)
Hypertension	148 (.41%)
Renal Failure	148 (.41%)
Respiratory Failure	147 (.41%)
Hyponatraemia	142 (.4%)
Neuropathy Peripheral	141 (.4%)
Pancytopenia	138 (.39%)
Hypomagnesaemia	136 (.38%)
Infection	133 (.37%)
Confusional State	128 (.36%)
Ascites	124 (.35%)
Atrial Fibrillation	124 (.35%)
Disseminated Intravascular Coagulat...	124 (.35%)
Chills	123 (.34%)
Small Intestinal Obstruction	112 (.31%)
Constipation	111 (.31%)
Pleural Effusion	110 (.31%)
Blood Creatinine Increased	108 (.3%)
Dizziness	107 (.3%)
Headache	103 (.29%)
Septic Shock	103 (.29%)
Multi-organ Failure	102 (.29%)
Pain	99 (.28%)
Hepatic Failure	98 (.27%)
Urinary Tract Infection	95 (.27%)
Fall	94 (.26%)
Drug Toxicity	91 (.25%)
Tachycardia	91 (.25%)
Oedema Peripheral	89 (.25%)
Back Pain	88 (.25%)
Colorectal Cancer	88 (.25%)
Thrombosis	86 (.24%)
Hypocalcaemia	85 (.24%)
Neoplasm Progression	85 (.24%)
Oesophagitis	85 (.24%)
Intestinal Perforation	84 (.24%)
Depressed Level Of Consciousness	83 (.23%)
Neoplasm Malignant	83 (.23%)
Chest Pain	82 (.23%)
Haemorrhage	82 (.23%)
Cerebrovascular Accident	81 (.23%)
Dysphagia	81 (.23%)
Cardiac Arrest	80 (.22%)
Large Intestine Perforation	79 (.22%)
Condition Aggravated	78 (.22%)
Abdominal Distension	77 (.22%)
Somnolence	77 (.22%)
Blood Potassium Decreased	75 (.21%)
Paronychia	75 (.21%)
Neutropenic Sepsis	74 (.21%)
Abdominal Pain Upper	73 (.2%)
Syncope	73 (.2%)
Epistaxis	72 (.2%)
Cardiac Failure	71 (.2%)
Cerebral Haemorrhage	71 (.2%)
Bone Marrow Failure	70 (.2%)
Hyperglycaemia	70 (.2%)
Blood Bilirubin Increased	68 (.19%)
Blood Pressure Decreased	68 (.19%)
Haematocrit Decreased	68 (.19%)

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

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

Gastrointestinal Signs	2387 (6.69%)
Gastrointestinal Motility And Defec...	1990 (5.58%)
Infections - Pathogen Unspecified	1784 (5%)
White Blood Cell	1766 (4.95%)
Hematology Investigations	1413 (3.96%)
Electrolyte And Fluid Balance Condi...	1355 (3.8%)
Neurological	1011 (2.83%)
Respiratory	935 (2.62%)
Epidermal And Dermal Conditions	704 (1.97%)
Lower Respiratory Tract Disorders	628 (1.76%)
Anemias Nonhemolytic And Marrow Dep...	625 (1.75%)
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Body Temperature Conditions	590 (1.65%)
Appetite And General Nutritional	570 (1.6%)
Cardiac Arrhythmias	551 (1.54%)
Renal Disorders	527 (1.48%)
Gastrointestinal Stenosis And Obstr...	514 (1.44%)
Hepatic And Hepatobiliary	484 (1.36%)
Fatal Outcomes	466 (1.31%)
Decreased And Nonspecific Blood Pre...	454 (1.27%)
Gastrointestinal Ulceration And Per...	447 (1.25%)
Platelet	423 (1.19%)
Miscellaneous And Site Unspecified ...	417 (1.17%)
Gastrointestinal Hemorrhages	413 (1.16%)
Gastrointestinal Inflammatory Condi...	393 (1.1%)
Oral Soft Tissue Conditions	383 (1.07%)
Bacterial Infectious	381 (1.07%)
Embolism And Thrombosis	375 (1.05%)
Skin Appendage Conditions	351 (.98%)
Pulmonary Vascular	327 (.92%)
Central Nervous System Vascular	324 (.91%)
Physical Examination Topics	305 (.85%)
Cardiac And Vascular Investigations	291 (.82%)
Gastrointestinal Neoplasms Malignan...	285 (.8%)
Water, Electrolyte And Mineral	271 (.76%)
Hepatobiliary	270 (.76%)
Metastases	262 (.73%)
Bone, Calcium, Magnesium And Phosph...	261 (.73%)
Seizures	245 (.69%)
Coronary Artery	239 (.67%)
Renal And Urinary Tract Investigati...	229 (.64%)
Musculoskeletal And Connective Tiss...	216 (.61%)
Peripheral Neuropathies	212 (.59%)
Peritoneal And Retroperitoneal Cond...	209 (.59%)
Therapeutic And Nontherapeutic Effe...	198 (.55%)
Procedural And Device Related Injur...	192 (.54%)
Urinary Tract Signs	186 (.52%)
Injuries	183 (.51%)
Coagulopathies And Bleeding Diathes...	170 (.48%)
Deliria	166 (.47%)
Fungal Infectious	165 (.46%)
Pleural	156 (.44%)
Movement Disorders	155 (.43%)
Muscle	152 (.43%)
Vascular Hypertensive	152 (.43%)
Upper Respiratory Tract Disorders	124 (.35%)
Protein And Chemistry Analyses	121 (.34%)
Allergic Conditions	119 (.33%)
Gastrointestinal Conditions	114 (.32%)
Heart Failures	113 (.32%)
Chemical Injury And Poisoning	110 (.31%)
Metabolic, Nutritional And Blood Ga...	110 (.31%)
Glucose Metabolism Disorders	107 (.3%)
Headaches	105 (.29%)
Enzyme	104 (.29%)
Viral Infectious	99 (.28%)
Skin And Subcutaneous Tissue	97 (.27%)
Microbiology And Serology	94 (.26%)
Vascular Hemorrhagic	94 (.26%)
Encephalopathies	92 (.26%)
Tissue	89 (.25%)
Neoplasm Related Morbidities	88 (.25%)
Lifestyle Issues	86 (.24%)
Bile Duct	85 (.24%)
Vision	81 (.23%)
Administration Site Reactions	77 (.22%)
Nervous System Neoplasms Malignant ...	77 (.22%)
Acid-base	76 (.21%)
Gastrointestinal Vascular Condition...	75 (.21%)
Leukemias	74 (.21%)
Bone And Joint Injuries	70 (.2%)
Hemolyses And Related Conditions	70 (.2%)
Increased Intracranial Pressure And...	64 (.18%)
Cardiac Disorder Signs	63 (.18%)
Vascular	63 (.18%)
Protein And Amino Acid Metabolism	61 (.17%)
Bone Disorders	59 (.17%)
Bronchial Disorders	59 (.17%)
Myocardial	58 (.16%)
Arteriosclerosis, Stenosis, Vascula...	55 (.15%)
Psychiatric	55 (.15%)
Joint	54 (.15%)
Hematological	53 (.15%)
Exocrine Pancreas Conditions	52 (.15%)
Medication Errors	49 (.14%)
Ocular Infections, Irritations And ...	49 (.14%)
Skin Vascular Abnormalities	48 (.13%)
Neuromuscular	46 (.13%)
Anxiety Disorders	44 (.12%)
Investigations, Imaging And Histopa...	41 (.11%)
Mental Impairment	41 (.11%)
Cranial Nerve Disorders	39 (.11%)

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