VINORELBINE

Vinorelbine Adverse Events Reported to the FDA Over Time

How are Vinorelbine adverse event reports trending over time?

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

Most Common Vinorelbine Adverse Events Reported to the FDA

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

Neutropenia	426 (3.38%)
Febrile Neutropenia	285 (2.26%)
Pyrexia	254 (2.01%)
Vomiting	228 (1.81%)
Diarrhoea	219 (1.74%)
Dyspnoea	185 (1.47%)
Nausea	178 (1.41%)
Pneumonia	142 (1.13%)
Dehydration	141 (1.12%)
Leukopenia	140 (1.11%)
Anaemia	132 (1.05%)
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Abdominal Pain	129 (1.02%)
Asthenia	128 (1.01%)
Neutropenic Sepsis	121 (.96%)
Fatigue	119 (.94%)
Interstitial Lung Disease	109 (.86%)
Sepsis	108 (.86%)
Renal Failure Acute	99 (.79%)
General Physical Health Deteriorati...	96 (.76%)
White Blood Cell Count Decreased	95 (.75%)
Mucosal Inflammation	94 (.75%)
Haemoglobin Decreased	92 (.73%)
Pulmonary Embolism	91 (.72%)
Thrombocytopenia	91 (.72%)
Hypotension	90 (.71%)
Constipation	88 (.7%)
Septic Shock	83 (.66%)
Death	81 (.64%)
Disease Progression	78 (.62%)
Chest Pain	77 (.61%)
Malignant Neoplasm Progression	76 (.6%)
Platelet Count Decreased	75 (.59%)
Respiratory Failure	75 (.59%)
Decreased Appetite	69 (.55%)
Pancytopenia	64 (.51%)
Anorexia	63 (.5%)
Pain	63 (.5%)
Neutrophil Count Decreased	59 (.47%)
Pleural Effusion	58 (.46%)
Drug Toxicity	57 (.45%)
Pneumonitis	57 (.45%)
Hypokalaemia	56 (.44%)
Bone Marrow Failure	55 (.44%)
Confusional State	55 (.44%)
Cough	54 (.43%)
Chills	48 (.38%)
Infection	47 (.37%)
Dizziness	45 (.36%)
Pain In Extremity	45 (.36%)
Malaise	44 (.35%)
Stomatitis	44 (.35%)
Aspartate Aminotransferase Increase...	43 (.34%)
Blood Creatinine Increased	43 (.34%)
Oedema Peripheral	43 (.34%)
Alanine Aminotransferase Increased	42 (.33%)
Convulsion	42 (.33%)
Cardiac Failure	41 (.33%)
Tachycardia	41 (.33%)
Condition Aggravated	40 (.32%)
Febrile Bone Marrow Aplasia	39 (.31%)
Renal Failure	39 (.31%)
Palmar-plantar Erythrodysaesthesia ...	38 (.3%)
Atrial Fibrillation	37 (.29%)
Hepatic Failure	35 (.28%)
Headache	34 (.27%)
Hyponatraemia	34 (.27%)
Multi-organ Failure	34 (.27%)
Neoplasm Progression	34 (.27%)
Neuropathy Peripheral	34 (.27%)
Deep Vein Thrombosis	32 (.25%)
Fall	32 (.25%)
Haematocrit Decreased	32 (.25%)
Paraesthesia	32 (.25%)
Back Pain	31 (.25%)
Dysphagia	31 (.25%)
Hypoxia	31 (.25%)
Oesophagitis	31 (.25%)
Weight Decreased	31 (.25%)
Blood Alkaline Phosphatase Increase...	30 (.24%)
Cellulitis	30 (.24%)
Lethargy	30 (.24%)
Rash	30 (.24%)
Erythema	29 (.23%)
Blood Lactate Dehydrogenase Increas...	28 (.22%)
Depressed Level Of Consciousness	28 (.22%)
Ileus Paralytic	28 (.22%)
Intestinal Obstruction	28 (.22%)
Lung Disorder	28 (.22%)
Somnolence	28 (.22%)
Syncope	28 (.22%)
Acute Myeloid Leukaemia	27 (.21%)
Myocardial Infarction	27 (.21%)
Respiratory Distress	27 (.21%)
Metastases To Bone	26 (.21%)
Myalgia	26 (.21%)
Neutropenic Infection	26 (.21%)
Performance Status Decreased	26 (.21%)
Cardiac Arrest	25 (.2%)
Extravasation	25 (.2%)
Ileus	25 (.2%)
Inappropriate Antidiuretic Hormone ...	25 (.2%)

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

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

White Blood Cell	894 (7.09%)
Infections - Pathogen Unspecified	751 (5.96%)
Gastrointestinal Signs	670 (5.31%)
Respiratory	546 (4.33%)
Hematology Investigations	474 (3.76%)
Gastrointestinal Motility And Defec...	350 (2.78%)
Neurological	343 (2.72%)
Lower Respiratory Tract Disorders	298 (2.36%)
Anemias Nonhemolytic And Marrow Dep...	294 (2.33%)
Electrolyte And Fluid Balance Condi...	292 (2.32%)
Body Temperature Conditions	277 (2.2%)
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Epidermal And Dermal Conditions	233 (1.85%)
Cardiac Arrhythmias	216 (1.71%)
Renal Disorders	201 (1.59%)
Hepatic And Hepatobiliary	196 (1.55%)
Bacterial Infectious	175 (1.39%)
Hepatobiliary	172 (1.36%)
Decreased And Nonspecific Blood Pre...	156 (1.24%)
Appetite And General Nutritional	151 (1.2%)
Metastases	151 (1.2%)
Miscellaneous And Site Unspecified ...	148 (1.17%)
Administration Site Reactions	132 (1.05%)
Musculoskeletal And Connective Tiss...	119 (.94%)
Gastrointestinal Inflammatory Condi...	113 (.9%)
Cardiac And Vascular Investigations	103 (.82%)
Fatal Outcomes	99 (.79%)
Pulmonary Vascular	96 (.76%)
Heart Failures	95 (.75%)
Platelet	95 (.75%)
Therapeutic And Nontherapeutic Effe...	90 (.71%)
Central Nervous System Vascular	86 (.68%)
Chemical Injury And Poisoning	86 (.68%)
Medication Errors	81 (.64%)
Muscle	80 (.63%)
Embolism And Thrombosis	78 (.62%)
Pleural	75 (.59%)
Injuries	74 (.59%)
Deliria	73 (.58%)
Renal And Urinary Tract Investigati...	73 (.58%)
Coronary Artery	71 (.56%)
Gastrointestinal Stenosis And Obstr...	70 (.56%)
Enzyme	68 (.54%)
Oral Soft Tissue Conditions	66 (.52%)
Physical Examination Topics	63 (.5%)
Urinary Tract Signs	62 (.49%)
Bone, Calcium, Magnesium And Phosph...	60 (.48%)
Metabolic, Nutritional And Blood Ga...	56 (.44%)
Bone Disorders	55 (.44%)
Fungal Infectious	55 (.44%)
Skin And Subcutaneous Tissue	55 (.44%)
Seizures	54 (.43%)
Movement Disorders	53 (.42%)
Peripheral Neuropathies	53 (.42%)
Allergic Conditions	52 (.41%)
Cardiac Disorder Signs	51 (.4%)
Gastrointestinal Ulceration And Per...	51 (.4%)
Water, Electrolyte And Mineral	51 (.4%)
Respiratory And Mediastinal Neoplas...	48 (.38%)
Vision	45 (.36%)
Leukemias	42 (.33%)
Peritoneal And Retroperitoneal Cond...	42 (.33%)
Cranial Nerve Disorders	41 (.33%)
Joint	40 (.32%)
Bronchial Disorders	39 (.31%)
Skin Vascular Abnormalities	39 (.31%)
Vascular Inflammations	39 (.31%)
Myocardial	38 (.3%)
Protein And Chemistry Analyses	38 (.3%)
Headaches	37 (.29%)
Exocrine Pancreas Conditions	36 (.29%)
Glucose Metabolism Disorders	35 (.28%)
Viral Infectious	35 (.28%)
Upper Respiratory Tract Disorders	34 (.27%)
Skin Appendage Conditions	32 (.25%)
Vascular	32 (.25%)
Breast Neoplasms Malignant And Unsp...	31 (.25%)
Gastrointestinal Hemorrhages	31 (.25%)
Procedural And Device Related Injur...	31 (.25%)
Arteriosclerosis, Stenosis, Vascula...	30 (.24%)
Lifestyle Issues	29 (.23%)
Microbiology And Serology	29 (.23%)
Vascular Hypertensive	27 (.21%)
Hypothalamus And Pituitary Gland	26 (.21%)
Psychiatric	26 (.21%)
Injuries By Physical Agents	25 (.2%)
Nephropathies	25 (.2%)
Tissue	25 (.2%)
Hematological	24 (.19%)
Sleep Disorders	24 (.19%)
Acid-base	23 (.18%)
Gastrointestinal Conditions	23 (.18%)
Protein And Amino Acid Metabolism	23 (.18%)
Anxiety Disorders	20 (.16%)
Depressed Mood Disorders	20 (.16%)
Dental And Gingival Conditions	18 (.14%)
Hematological And Lymphoid Tissue T...	18 (.14%)
Neoplasm Related Morbidities	18 (.14%)
Spleen, Lymphatic And Reticulendoth...	18 (.14%)
Coagulopathies And Bleeding Diathes...	17 (.13%)
Investigations, Imaging And Histopa...	17 (.13%)
Pericardial	17 (.13%)

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