CRIZOTINIB

Crizotinib Adverse Events Reported to the FDA Over Time

How are Crizotinib adverse event reports trending over time?

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

Most Common Crizotinib Adverse Events Reported to the FDA

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

Death	60 (3.98%)
Constipation	37 (2.46%)
Interstitial Lung Disease	34 (2.26%)
Alanine Aminotransferase Increased	30 (1.99%)
Disease Progression	30 (1.99%)
Oedema Peripheral	29 (1.92%)
Cytolytic Hepatitis	25 (1.66%)
Nausea	23 (1.53%)
Pneumonia	23 (1.53%)
Diarrhoea	21 (1.39%)
Deep Vein Thrombosis	20 (1.33%)
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Neoplasm Malignant	20 (1.33%)
Dyspnoea	19 (1.26%)
Haemoptysis	19 (1.26%)
Renal Failure Acute	19 (1.26%)
Asthenia	18 (1.19%)
Dehydration	18 (1.19%)
Vomiting	18 (1.19%)
Aspartate Aminotransferase Increase...	17 (1.13%)
Decreased Appetite	17 (1.13%)
Hyponatraemia	17 (1.13%)
Hepatic Failure	16 (1.06%)
Hypoalbuminaemia	15 (1%)
Pulmonary Embolism	15 (1%)
Respiratory Failure	15 (1%)
Neutropenia	14 (.93%)
Atrial Fibrillation	13 (.86%)
Hepatotoxicity	13 (.86%)
Non-small Cell Lung Cancer	13 (.86%)
Pleural Effusion	13 (.86%)
Thrombocytopenia	13 (.86%)
Febrile Neutropenia	12 (.8%)
Generalised Oedema	11 (.73%)
Orthostatic Hypotension	11 (.73%)
Diarrhoea Haemorrhagic	10 (.66%)
Fatigue	10 (.66%)
Ileus	10 (.66%)
Renal Impairment	10 (.66%)
Convulsion	9 (.6%)
Gastrointestinal Haemorrhage	9 (.6%)
Leukopenia	9 (.6%)
Lymphopenia	9 (.6%)
Pericardial Effusion	9 (.6%)
Abdominal Pain	8 (.53%)
Basal Cell Carcinoma	8 (.53%)
Confusional State	8 (.53%)
Gastric Ulcer	8 (.53%)
Hypoproteinaemia	8 (.53%)
Liver Function Test Abnormal	8 (.53%)
Lung Infection	8 (.53%)
Malignant Melanoma	8 (.53%)
Oesophagitis	8 (.53%)
Blood Albumin Decreased	7 (.46%)
Hypokalaemia	7 (.46%)
Nephrolithiasis	7 (.46%)
Pneumocystis Jiroveci Pneumonia	7 (.46%)
Pulmonary Artery Thrombosis	7 (.46%)
Visual Acuity Reduced	7 (.46%)
Blood Lactate Dehydrogenase Increas...	6 (.4%)
Electrocardiogram Qt Prolonged	6 (.4%)
Epistaxis	6 (.4%)
Gait Disturbance	6 (.4%)
Hypopituitarism	6 (.4%)
Hypotension	6 (.4%)
Optic Atrophy	6 (.4%)
Photopsia	6 (.4%)
Urinary Tract Infection	6 (.4%)
Venous Thrombosis	6 (.4%)
Vitreous Detachment	6 (.4%)
Abdominal Distension	5 (.33%)
Ascites	5 (.33%)
Blood Creatinine Increased	5 (.33%)
Blood Glucose Increased	5 (.33%)
Bradycardia	5 (.33%)
Drug Interaction	5 (.33%)
Dysphagia	5 (.33%)
Gamma-glutamyltransferase Increased	5 (.33%)
Haemoglobin Decreased	5 (.33%)
Hypercreatininaemia	5 (.33%)
Hypoxia	5 (.33%)
Intestinal Obstruction	5 (.33%)
Loss Of Consciousness	5 (.33%)
Multi-organ Failure	5 (.33%)
Palpitations	5 (.33%)
Pneumonitis	5 (.33%)
Renal Failure	5 (.33%)
Sinus Bradycardia	5 (.33%)
Syncope	5 (.33%)
Tumour Necrosis	5 (.33%)
Visual Impairment	5 (.33%)
Anaemia	4 (.27%)
Bacterial Test Positive	4 (.27%)
Blood Uric Acid Increased	4 (.27%)
Cardiac Arrest	4 (.27%)
Depression	4 (.27%)
Dizziness	4 (.27%)
Gastrooesophageal Reflux Disease	4 (.27%)
Headache	4 (.27%)
Hepatitis	4 (.27%)
Hepatitis Fulminant	4 (.27%)
Musculoskeletal Pain	4 (.27%)

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

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

Gastrointestinal Motility And Defec...	76 (5.04%)
Gastrointestinal Signs	73 (4.84%)
Respiratory	71 (4.71%)
Hepatic And Hepatobiliary	68 (4.51%)
Hepatobiliary	64 (4.25%)
Fatal Outcomes	61 (4.05%)
Infections - Pathogen Unspecified	61 (4.05%)
Lower Respiratory Tract Disorders	52 (3.45%)
Electrolyte And Fluid Balance Condi...	46 (3.05%)
White Blood Cell	46 (3.05%)
Renal Disorders	40 (2.65%)
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Cardiac Arrhythmias	34 (2.26%)
Neurological	27 (1.79%)
Embolism And Thrombosis	26 (1.73%)
Vision	25 (1.66%)
Protein And Amino Acid Metabolism	23 (1.53%)
Pulmonary Vascular	23 (1.53%)
Appetite And General Nutritional	22 (1.46%)
Respiratory And Mediastinal Neoplas...	22 (1.46%)
Miscellaneous And Site Unspecified ...	21 (1.39%)
Pleural	19 (1.26%)
Skin Neoplasms Malignant And Unspec...	19 (1.26%)
Gastrointestinal Stenosis And Obstr...	18 (1.19%)
Decreased And Nonspecific Blood Pre...	17 (1.13%)
Fungal Infectious	15 (1%)
Gastrointestinal Inflammatory Condi...	14 (.93%)
Renal And Urinary Tract Investigati...	14 (.93%)
Central Nervous System Vascular	13 (.86%)
Gastrointestinal Hemorrhages	13 (.86%)
Platelet	13 (.86%)
Hematology Investigations	12 (.8%)
Ocular Structural Change, Deposit A...	12 (.8%)
Deliria	11 (.73%)
Enzyme	11 (.73%)
Epidermal And Dermal Conditions	11 (.73%)
Gastrointestinal Ulceration And Per...	11 (.73%)
Seizures	11 (.73%)
Cardiac And Vascular Investigations	10 (.66%)
Metabolic, Nutritional And Blood Ga...	9 (.6%)
Neoplasm Related Morbidities	9 (.6%)
Pericardial	9 (.6%)
Cardiac Disorder Signs	8 (.53%)
Musculoskeletal And Connective Tiss...	8 (.53%)
Physical Examination Topics	8 (.53%)
Bone And Joint Injuries	7 (.46%)
Bone, Calcium, Magnesium And Phosph...	7 (.46%)
Myocardial	7 (.46%)
Peritoneal And Retroperitoneal Cond...	7 (.46%)
Protein And Chemistry Analyses	7 (.46%)
Upper Respiratory Tract Disorders	7 (.46%)
Urolithiases	7 (.46%)
Exocrine Pancreas Conditions	6 (.4%)
Hypothalamus And Pituitary Gland	6 (.4%)
Metastases	6 (.4%)
Therapeutic And Nontherapeutic Effe...	6 (.4%)
Bacterial Infectious	5 (.33%)
Coronary Artery	5 (.33%)
Injuries	5 (.33%)
Metabolism	5 (.33%)
Microbiology And Serology	5 (.33%)
Allergic Conditions	4 (.27%)
Anemias Nonhemolytic And Marrow Dep...	4 (.27%)
Anxiety Disorders	4 (.27%)
Depressed Mood Disorders	4 (.27%)
Headaches	4 (.27%)
Medication Errors	4 (.27%)
Urinary Tract Signs	4 (.27%)
Vascular Inflammations	4 (.27%)
Anterior Eye Structural Change, Dep...	3 (.2%)
Body Temperature Conditions	3 (.2%)
Hematological	3 (.2%)
Neurological Disorders Of The Eye	3 (.2%)
Oral Soft Tissue Conditions	3 (.2%)
Procedural And Device Related Injur...	3 (.2%)
Purine And Pyrimidine Metabolism	3 (.2%)
Skin Appendage Conditions	3 (.2%)
Thyroid Gland	3 (.2%)
Cardiac Valve	2 (.13%)
Connective Tissue Disorders	2 (.13%)
Cranial Nerve Disorders	2 (.13%)
Glucose Metabolism Disorders	2 (.13%)
Hepatobiliary Neoplasms Malignant A...	2 (.13%)
Neuromuscular	2 (.13%)
Retina, Choroid And Vitreous Hemorr...	2 (.13%)
Sleep Disorders	2 (.13%)
Spinal Cord And Nerve Root	2 (.13%)
Spleen, Lymphatic And Reticulendoth...	2 (.13%)
Vascular Hemorrhagic	2 (.13%)
Viral Infectious	2 (.13%)
Water, Electrolyte And Mineral	2 (.13%)
Administration Site Reactions	1 (.07%)
Angiedema And Urticaria	1 (.07%)
Aural	1 (.07%)
Bladder And Bladder Neck Disorders	1 (.07%)
Changes In Physical Activity	1 (.07%)
Eating Disorders	1 (.07%)
Encephalopathies	1 (.07%)
Fractures	1 (.07%)
Heart Failures	1 (.07%)
Increased Intracranial Pressure And...	1 (.07%)
Injuries By Physical Agents	1 (.07%)

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