NILOTINIB

Nilotinib Adverse Events Reported to the FDA Over Time

How are Nilotinib adverse event reports trending over time?

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

Most Common Nilotinib Adverse Events Reported to the FDA

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

Pyrexia	29 (2.29%)
Pleural Effusion	28 (2.21%)
Electrocardiogram Qt Prolonged	25 (1.97%)
Abdominal Pain	19 (1.5%)
Chest Pain	19 (1.5%)
Drug Ineffective	19 (1.5%)
Malignant Neoplasm Progression	19 (1.5%)
Death	18 (1.42%)
Diarrhoea	18 (1.42%)
Nausea	18 (1.42%)
Pneumonia	18 (1.42%)
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Syncope	16 (1.26%)
Arthralgia	15 (1.18%)
Thrombocytopenia	15 (1.18%)
Blast Crisis In Myelogenous Leukaem...	14 (1.11%)
Dyspnoea	14 (1.11%)
Anaemia	13 (1.03%)
Headache	13 (1.03%)
Pancytopenia	13 (1.03%)
Platelet Count Decreased	13 (1.03%)
Cardiac Failure	11 (.87%)
Neutrophil Count Decreased	11 (.87%)
Vomiting	11 (.87%)
Neutropenia	10 (.79%)
Asthenia	9 (.71%)
Myocardial Infarction	9 (.71%)
Neoplasm Malignant	9 (.71%)
Rash	9 (.71%)
White Blood Cell Count Decreased	9 (.71%)
Candidiasis	8 (.63%)
Chronic Myeloid Leukaemia	8 (.63%)
Drug Interaction	8 (.63%)
Febrile Neutropenia	8 (.63%)
Oedema Peripheral	8 (.63%)
White Blood Cell Count Increased	8 (.63%)
Blast Cell Count Increased	7 (.55%)
Chest Discomfort	7 (.55%)
Constipation	7 (.55%)
Disease Progression	7 (.55%)
Dyspnoea Exertional	7 (.55%)
Intestinal Obstruction	7 (.55%)
Pain	7 (.55%)
Pericardial Effusion	7 (.55%)
Septic Shock	7 (.55%)
Blindness Transient	6 (.47%)
Bronchitis	6 (.47%)
Cardiac Arrest	6 (.47%)
Cardio-respiratory Arrest	6 (.47%)
Dehydration	6 (.47%)
Gastritis	6 (.47%)
Generalised Oedema	6 (.47%)
Ileus	6 (.47%)
Leukocytosis	6 (.47%)
Pseudomonas Infection	6 (.47%)
Sepsis	6 (.47%)
Abdominal Distension	5 (.39%)
Bronchopneumonia	5 (.39%)
Decreased Appetite	5 (.39%)
Duodenal Stenosis	5 (.39%)
Duodenal Ulcer	5 (.39%)
Encephalopathy	5 (.39%)
Endoscopy Upper Gastrointestinal Tr...	5 (.39%)
Fluid Retention	5 (.39%)
Gastrointestinal Haemorrhage	5 (.39%)
Hypotension	5 (.39%)
Infection	5 (.39%)
Multi-organ Failure	5 (.39%)
Peripheral Arterial Occlusive Disea...	5 (.39%)
Subcutaneous Abscess	5 (.39%)
Ventricular Fibrillation	5 (.39%)
Acinetobacter Bacteraemia	4 (.32%)
Anxiety	4 (.32%)
Blood Creatinine Increased	4 (.32%)
Bronchopulmonary Aspergillosis	4 (.32%)
Chromosome Analysis Abnormal	4 (.32%)
Completed Suicide	4 (.32%)
Drug Administration Error	4 (.32%)
Duodenal Operation	4 (.32%)
Dyspepsia	4 (.32%)
Faecal Volume Decreased	4 (.32%)
Fall	4 (.32%)
Gastric Cancer	4 (.32%)
Gastrointestinal Stromal Tumour	4 (.32%)
Hyperbilirubinaemia	4 (.32%)
Left Ventricular Hypertrophy	4 (.32%)
Loss Of Consciousness	4 (.32%)
Migraine	4 (.32%)
Nasal Polypectomy	4 (.32%)
Non-small Cell Lung Cancer	4 (.32%)
Pain In Extremity	4 (.32%)
Papilloma	4 (.32%)
Respiratory Failure	4 (.32%)
Staphylococcal Infection	4 (.32%)
Tachycardia	4 (.32%)
Urinary Tract Infection	4 (.32%)
Vith Nerve Paralysis	4 (.32%)
Weight Decreased	4 (.32%)
Weight Increased	4 (.32%)
Abortion Spontaneous	3 (.24%)
Acute Myeloid Leukaemia	3 (.24%)
Acute Myocardial Infarction	3 (.24%)

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

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

Infections - Pathogen Unspecified	69 (5.45%)
Gastrointestinal Signs	67 (5.29%)
Hematology Investigations	56 (4.42%)
Cardiac And Vascular Investigations	43 (3.4%)
Respiratory	39 (3.08%)
Therapeutic And Nontherapeutic Effe...	37 (2.92%)
Cardiac Arrhythmias	36 (2.84%)
Leukemias	36 (2.84%)
Pleural	32 (2.53%)
Anemias Nonhemolytic And Marrow Dep...	30 (2.37%)
Body Temperature Conditions	29 (2.29%)
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Miscellaneous And Site Unspecified ...	29 (2.29%)
White Blood Cell	28 (2.21%)
Neurological	27 (2.13%)
Coronary Artery	26 (2.05%)
Gastrointestinal Motility And Defec...	25 (1.97%)
Gastrointestinal Stenosis And Obstr...	24 (1.9%)
Epidermal And Dermal Conditions	23 (1.82%)
Fatal Outcomes	20 (1.58%)
Joint	20 (1.58%)
Headaches	17 (1.34%)
Hepatic And Hepatobiliary	15 (1.18%)
Platelet	15 (1.18%)
Fungal Infectious	14 (1.11%)
Physical Examination Topics	14 (1.11%)
Arteriosclerosis, Stenosis, Vascula...	13 (1.03%)
Myocardial	13 (1.03%)
Bacterial Infectious	12 (.95%)
Electrolyte And Fluid Balance Condi...	12 (.95%)
Decreased And Nonspecific Blood Pre...	11 (.87%)
Heart Failures	11 (.87%)
Pericardial	11 (.87%)
Vision	10 (.79%)
Gastrointestinal	9 (.71%)
Gastrointestinal Neoplasms Malignan...	9 (.71%)
Gastrointestinal Ulceration And Per...	9 (.71%)
Musculoskeletal And Connective Tiss...	9 (.71%)
Renal Disorders	9 (.71%)
Appetite And General Nutritional	8 (.63%)
Enzyme	8 (.63%)
Gastrointestinal Hemorrhages	8 (.63%)
Gastrointestinal Inflammatory Condi...	8 (.63%)
Cytogenetic	7 (.55%)
Gastrointestinal Therapeutic Proced...	7 (.55%)
Injuries	7 (.55%)
Bile Duct	6 (.47%)
Cardiac Disorder Signs	6 (.47%)
Lower Respiratory Tract Disorders	6 (.47%)
Medication Errors	6 (.47%)
Skin Vascular Abnormalities	6 (.47%)
Encephalopathies	5 (.39%)
Glucose Metabolism Disorders	5 (.39%)
Metabolic, Nutritional And Blood Ga...	5 (.39%)
Muscle	5 (.39%)
Peritoneal And Retroperitoneal Cond...	5 (.39%)
Renal And Urinary Tract Investigati...	5 (.39%)
Therapeutic Procedures And Supporti...	5 (.39%)
Anxiety Disorders	4 (.32%)
Central Nervous System Vascular	4 (.32%)
Cornification And Dystrophic Skin	4 (.32%)
Cranial Nerve Disorders	4 (.32%)
Head And Neck Therapeutic Procedure...	4 (.32%)
Hepatobiliary	4 (.32%)
Immune	4 (.32%)
Miscellaneous And Site Unspecified ...	4 (.32%)
Pulmonary Vascular	4 (.32%)
Respiratory And Mediastinal Neoplas...	4 (.32%)
Suicidal And Self-injurious Behavio...	4 (.32%)
Thyroid Gland	4 (.32%)
Abortions And Stillbirth	3 (.24%)
Bone, Calcium, Magnesium And Phosph...	3 (.24%)
Cardiac Therapeutic Procedures	3 (.24%)
Chromosomal Abnormalities And Abnor...	3 (.24%)
Embolism And Thrombosis	3 (.24%)
Gastrointestinal Vascular Condition...	3 (.24%)
Neoplasm Related Morbidities	3 (.24%)
Procedural And Device Related Injur...	3 (.24%)
Protein And Chemistry Analyses	3 (.24%)
Reproductive Tract	3 (.24%)
Spleen, Lymphatic And Reticulendoth...	3 (.24%)
Upper Respiratory Tract Disorders	3 (.24%)
Vascular Hemorrhagic	3 (.24%)
Bronchial Disorders	2 (.16%)
Cardiac Valve	2 (.16%)
Chemical Injury And Poisoning	2 (.16%)
Depressed Mood Disorders	2 (.16%)
Exocrine Pancreas Conditions	2 (.16%)
Hematological	2 (.16%)
Investigations, Imaging And Histopa...	2 (.16%)
Menstrual Cycle And Uterine Bleedin...	2 (.16%)
Metastases	2 (.16%)
Movement Disorders	2 (.16%)
Ocular Injuries	2 (.16%)
Ocular Neuromuscular	2 (.16%)
Peripheral Neuropathies	2 (.16%)
Pregnancy, Labour, Delivery And Pos...	2 (.16%)
Reproductive Neoplasms Male Maligna...	2 (.16%)
Testicular And Epididymal	2 (.16%)
Vulvovaginal Disorders	2 (.16%)
Adrenal Gland	1 (.08%)
Allergic Conditions	1 (.08%)

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