BLINDED SUNITINIB MALATE

Blinded Sunitinib Malate Adverse Events Reported to the FDA Over Time

How are Blinded Sunitinib Malate adverse event reports trending over time?

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

Most Common Blinded Sunitinib Malate Adverse Events Reported to the FDA

What are the most common Blinded Sunitinib Malate adverse events reported to the FDA?

Diarrhoea	37 (2.86%)
Death	36 (2.78%)
Dehydration	33 (2.55%)
Vomiting	32 (2.47%)
Nausea	28 (2.16%)
Anaemia	21 (1.62%)
Hyponatraemia	21 (1.62%)
Sepsis	21 (1.62%)
Urinary Tract Infection	21 (1.62%)
Renal Failure Acute	19 (1.47%)
Disease Progression	18 (1.39%)
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Hypertension	17 (1.31%)
Hypomagnesaemia	16 (1.24%)
Pneumonia	16 (1.24%)
Confusional State	15 (1.16%)
Hypotension	15 (1.16%)
Thrombocytopenia	15 (1.16%)
Myocardial Infarction	14 (1.08%)
Anal Abscess	13 (1%)
Chest Pain	13 (1%)
Fatigue	13 (1%)
General Physical Health Deteriorati...	13 (1%)
Dyspnoea	12 (.93%)
Ileus	12 (.93%)
Neutropenia	12 (.93%)
Pyrexia	12 (.93%)
Renal Failure	12 (.93%)
Intestinal Obstruction	11 (.85%)
Acute Myocardial Infarction	10 (.77%)
Bone Pain	10 (.77%)
Non-small Cell Lung Cancer	10 (.77%)
Asthenia	9 (.7%)
Dizziness	9 (.7%)
Gastric Ulcer	9 (.7%)
Gastrointestinal Haemorrhage	9 (.7%)
Haematuria	9 (.7%)
Peripheral Sensory Neuropathy	9 (.7%)
Pleural Effusion	9 (.7%)
Subcutaneous Abscess	9 (.7%)
Cerebral Ischaemia	8 (.62%)
Cerebrovascular Accident	8 (.62%)
Headache	8 (.62%)
Hypocalcaemia	8 (.62%)
Anorexia	7 (.54%)
Decreased Appetite	7 (.54%)
Leukopenia	7 (.54%)
Mucosal Inflammation	7 (.54%)
Palmar-plantar Erythrodysaesthesia ...	7 (.54%)
Agitated Depression	6 (.46%)
Ataxia	6 (.46%)
Cardiac Failure Congestive	6 (.46%)
Cerebral Infarction	6 (.46%)
Diverticular Perforation	6 (.46%)
Febrile Neutropenia	6 (.46%)
Haemorrhage	6 (.46%)
Ischaemic Stroke	6 (.46%)
Mental Status Changes	6 (.46%)
Neutropenic Sepsis	6 (.46%)
Rectal Haemorrhage	6 (.46%)
Respiratory Failure	6 (.46%)
Abdominal Pain	5 (.39%)
Drug Toxicity	5 (.39%)
Failure To Thrive	5 (.39%)
Haemoptysis	5 (.39%)
Hydronephrosis	5 (.39%)
Intestinal Ischaemia	5 (.39%)
Loss Of Consciousness	5 (.39%)
Oedema Peripheral	5 (.39%)
Prostate Cancer	5 (.39%)
Pulmonary Embolism	5 (.39%)
Rectal Ulcer	5 (.39%)
Sudden Cardiac Death	5 (.39%)
Syncope	5 (.39%)
Acute Hepatic Failure	4 (.31%)
Aspartate Aminotransferase Increase...	4 (.31%)
Axonal Neuropathy	4 (.31%)
Blood Creatinine Increased	4 (.31%)
Cholecystitis Acute	4 (.31%)
Diabetic Ketoacidosis	4 (.31%)
Diplopia	4 (.31%)
Dysuria	4 (.31%)
Epistaxis	4 (.31%)
Fall	4 (.31%)
Hypokalaemia	4 (.31%)
Labyrinthitis	4 (.31%)
Lethargy	4 (.31%)
Lung Abscess	4 (.31%)
Lung Infection	4 (.31%)
Malaise	4 (.31%)
Mouth Haemorrhage	4 (.31%)
Muscular Weakness	4 (.31%)
Musculoskeletal Pain	4 (.31%)
Performance Status Decreased	4 (.31%)
Pneumonia Aspiration	4 (.31%)
Pruritus	4 (.31%)
Rash	4 (.31%)
Renal Impairment	4 (.31%)
Septic Shock	4 (.31%)
Small Intestinal Obstruction	4 (.31%)
Transient Ischaemic Attack	4 (.31%)
Vertigo	4 (.31%)

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This graph shows the top adverse events submitted to the FDA for Blinded Sunitinib Malate, 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 Blinded Sunitinib Malate 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 Blinded Sunitinib Malate

What are the most common Blinded Sunitinib Malate adverse events reported to the FDA?

Infections - Pathogen Unspecified	136 (10.51%)
Gastrointestinal Signs	70 (5.41%)
Electrolyte And Fluid Balance Condi...	63 (4.87%)
Fatal Outcomes	44 (3.4%)
Renal Disorders	43 (3.32%)
Gastrointestinal Motility And Defec...	40 (3.09%)
Neurological	38 (2.94%)
Central Nervous System Vascular	37 (2.86%)
Coronary Artery	30 (2.32%)
Respiratory	30 (2.32%)
Gastrointestinal Stenosis And Obstr...	29 (2.24%)
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Bone, Calcium, Magnesium And Phosph...	28 (2.16%)
White Blood Cell	25 (1.93%)
Gastrointestinal Ulceration And Per...	23 (1.78%)
Anemias Nonhemolytic And Marrow Dep...	22 (1.7%)
Appetite And General Nutritional	20 (1.55%)
Gastrointestinal Hemorrhages	19 (1.47%)
Peripheral Neuropathies	19 (1.47%)
Decreased And Nonspecific Blood Pre...	18 (1.39%)
Hepatic And Hepatobiliary	18 (1.39%)
Platelet	17 (1.31%)
Vascular Hypertensive	17 (1.31%)
Urinary Tract Signs	16 (1.24%)
Cardiac Arrhythmias	15 (1.16%)
Deliria	15 (1.16%)
Epidermal And Dermal Conditions	14 (1.08%)
Body Temperature Conditions	12 (.93%)
Hepatobiliary	12 (.93%)
Respiratory And Mediastinal Neoplas...	12 (.93%)
Heart Failures	11 (.85%)
Bacterial Infectious	10 (.77%)
Bone Disorders	10 (.77%)
Oral Soft Tissue Conditions	10 (.77%)
Gallbladder	9 (.7%)
Gastrointestinal Inflammatory Condi...	9 (.7%)
Headaches	9 (.7%)
Hematology Investigations	9 (.7%)
Lower Respiratory Tract Disorders	9 (.7%)
Musculoskeletal And Connective Tiss...	9 (.7%)
Pleural	9 (.7%)
Chemical Injury And Poisoning	8 (.62%)
Renal And Urinary Tract Investigati...	8 (.62%)
Depressed Mood Disorders	7 (.54%)
Embolism And Thrombosis	7 (.54%)
Skin And Subcutaneous Tissue	7 (.54%)
Skin Appendage Conditions	7 (.54%)
Anal And Rectal Conditions	6 (.46%)
Gastrointestinal Vascular Condition...	6 (.46%)
Injuries	6 (.46%)
Mental Impairment	6 (.46%)
Psychiatric	6 (.46%)
Vascular Hemorrhagic	6 (.46%)
Vision	6 (.46%)
Inner Ear And Viiith Cranial Nerve	5 (.39%)
Miscellaneous And Site Unspecified ...	5 (.39%)
Muscle	5 (.39%)
Peritoneal And Retroperitoneal Cond...	5 (.39%)
Pulmonary Vascular	5 (.39%)
Reproductive Neoplasms Male Maligna...	5 (.39%)
Diabetic Complications	4 (.31%)
Fungal Infectious	4 (.31%)
Physical Examination Topics	4 (.31%)
Upper Respiratory Tract Disorders	4 (.31%)
Vascular	4 (.31%)
Abdominal Hernias And Other Abdomin...	3 (.23%)
Bladder And Bladder Neck Disorders	3 (.23%)
Dental And Gingival Conditions	3 (.23%)
Gastrointestinal Neoplasms Malignan...	3 (.23%)
Glucose Metabolism Disorders	3 (.23%)
Metastases	3 (.23%)
Myocardial	3 (.23%)
Ocular Neuromuscular	3 (.23%)
Pericardial	3 (.23%)
Water, Electrolyte And Mineral	3 (.23%)
Anxiety Disorders	2 (.15%)
Cardiac And Vascular Disorders Cong...	2 (.15%)
Cardiac And Vascular Investigations	2 (.15%)
Enzyme	2 (.15%)
Gastrointestinal Conditions	2 (.15%)
Hearing	2 (.15%)
Ocular Infections, Irritations And ...	2 (.15%)
Procedural And Device Related Injur...	2 (.15%)
Salivary Gland Conditions	2 (.15%)
Seizures	2 (.15%)
Thyroid Gland	2 (.15%)
Vascular Inflammations	2 (.15%)
Administration Site Reactions	1 (.08%)
Allergic Conditions	1 (.08%)
Angiedema And Urticaria	1 (.08%)
Bone And Joint Injuries	1 (.08%)
Bronchial Disorders	1 (.08%)
Cranial Nerve Disorders	1 (.08%)
Disturbances In Thinking	1 (.08%)
Medication Errors	1 (.08%)
Metabolic, Nutritional And Blood Ga...	1 (.08%)
Microbiology And Serology	1 (.08%)
Movement Disorders	1 (.08%)
Ocular Hemorrhages And Vascular	1 (.08%)
Ocular Sensory Symptoms	1 (.08%)
Protein And Chemistry Analyses	1 (.08%)
Renal And Urinary Tract Neoplasms M...	1 (.08%)

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This graph shows the top categories of adverse events submitted to the FDA for Blinded Sunitinib Malate, 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 Blinded Sunitinib Malate 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.