EPIRUBICIN

Epirubicin Adverse Events Reported to the FDA Over Time

How are Epirubicin adverse event reports trending over time?

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

Most Common Epirubicin Adverse Events Reported to the FDA

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

Neutropenia	455 (3.02%)
Pyrexia	368 (2.44%)
Febrile Neutropenia	357 (2.37%)
Vomiting	274 (1.82%)
Nausea	258 (1.71%)
Diarrhoea	244 (1.62%)
Dyspnoea	200 (1.33%)
General Physical Health Deteriorati...	191 (1.27%)
Leukopenia	187 (1.24%)
Thrombocytopenia	149 (.99%)
Anaemia	148 (.98%)
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Pulmonary Embolism	138 (.92%)
Mucosal Inflammation	124 (.82%)
White Blood Cell Count Decreased	122 (.81%)
Sepsis	121 (.8%)
Pneumonia	119 (.79%)
Cardiac Failure	111 (.74%)
Asthenia	109 (.72%)
Fatigue	108 (.72%)
Interstitial Lung Disease	107 (.71%)
Neutropenic Sepsis	102 (.68%)
Dehydration	91 (.6%)
Cardiomyopathy	90 (.6%)
Infection	89 (.59%)
Acute Myeloid Leukaemia	88 (.58%)
Death	85 (.56%)
Pain	85 (.56%)
Abdominal Pain	84 (.56%)
Septic Shock	81 (.54%)
Malaise	77 (.51%)
Pancytopenia	75 (.5%)
Stomatitis	74 (.49%)
Chest Pain	73 (.48%)
Cough	71 (.47%)
Haemoglobin Decreased	71 (.47%)
Platelet Count Decreased	70 (.46%)
Alopecia	69 (.46%)
Drug Exposure During Pregnancy	67 (.44%)
Deep Vein Thrombosis	66 (.44%)
Ejection Fraction Decreased	64 (.42%)
Disease Progression	63 (.42%)
Dizziness	60 (.4%)
Headache	59 (.39%)
Palmar-plantar Erythrodysaesthesia ...	57 (.38%)
Pleural Effusion	56 (.37%)
Drug Toxicity	53 (.35%)
Neutrophil Count Decreased	53 (.35%)
Pain In Extremity	53 (.35%)
Hypotension	52 (.34%)
Arthralgia	51 (.34%)
Myocarditis	51 (.34%)
Constipation	50 (.33%)
Decreased Appetite	50 (.33%)
Malignant Neoplasm Progression	50 (.33%)
Weight Decreased	49 (.32%)
Back Pain	47 (.31%)
Renal Failure Acute	47 (.31%)
Chills	46 (.31%)
Respiratory Failure	46 (.31%)
Syncope	46 (.31%)
Thrombosis	46 (.31%)
Myalgia	45 (.3%)
Atrial Fibrillation	44 (.29%)
Erythema	44 (.29%)
Hypokalaemia	44 (.29%)
Myocardial Infarction	44 (.29%)
Tachycardia	42 (.28%)
Paraesthesia	41 (.27%)
Aspartate Aminotransferase Increase...	40 (.27%)
Dysphagia	40 (.27%)
Pneumonitis	39 (.26%)
Urinary Tract Infection	39 (.26%)
Alanine Aminotransferase Increased	38 (.25%)
Gastritis	37 (.25%)
Renal Failure	37 (.25%)
Ischaemic Stroke	36 (.24%)
Multi-organ Failure	36 (.24%)
Hepatic Failure	35 (.23%)
Hyponatraemia	35 (.23%)
Cardiac Arrest	34 (.23%)
Rash	34 (.23%)
Hypersensitivity	33 (.22%)
Neuropathy Peripheral	33 (.22%)
Peripheral Ischaemia	33 (.22%)
Drug Ineffective	32 (.21%)
Febrile Bone Marrow Aplasia	32 (.21%)
Left Ventricular Dysfunction	32 (.21%)
Myelodysplastic Syndrome	32 (.21%)
Neoplasm Malignant	31 (.21%)
Palpitations	31 (.21%)
Condition Aggravated	30 (.2%)
Confusional State	30 (.2%)
Extravasation	30 (.2%)
Oedema Peripheral	30 (.2%)
Off Label Use	30 (.2%)
Cardiac Failure Congestive	29 (.19%)
Cardiotoxicity	29 (.19%)
Convulsion	29 (.19%)
Disseminated Intravascular Coagulat...	29 (.19%)
Hepatic Function Abnormal	29 (.19%)
Progressive Multifocal Leukoencepha...	29 (.19%)

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

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

White Blood Cell	1038 (6.88%)
Infections - Pathogen Unspecified	922 (6.11%)
Gastrointestinal Signs	753 (4.99%)
Respiratory	502 (3.33%)
Neurological	439 (2.91%)
Hematology Investigations	422 (2.8%)
Body Temperature Conditions	378 (2.51%)
Gastrointestinal Motility And Defec...	311 (2.06%)
Anemias Nonhemolytic And Marrow Dep...	291 (1.93%)
Cardiac Arrhythmias	260 (1.72%)
Epidermal And Dermal Conditions	257 (1.7%)
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Hepatic And Hepatobiliary	252 (1.67%)
Lower Respiratory Tract Disorders	251 (1.66%)
Myocardial	231 (1.53%)
Electrolyte And Fluid Balance Condi...	222 (1.47%)
Leukemias	204 (1.35%)
Bacterial Infectious	203 (1.35%)
Gastrointestinal Inflammatory Condi...	179 (1.19%)
Embolism And Thrombosis	178 (1.18%)
Pulmonary Vascular	175 (1.16%)
Heart Failures	169 (1.12%)
Hepatobiliary	159 (1.05%)
Platelet	159 (1.05%)
Cardiac And Vascular Investigations	155 (1.03%)
Musculoskeletal And Connective Tiss...	154 (1.02%)
Renal Disorders	145 (.96%)
Chemical Injury And Poisoning	143 (.95%)
Central Nervous System Vascular	129 (.86%)
Decreased And Nonspecific Blood Pre...	128 (.85%)
Procedural And Device Related Injur...	125 (.83%)
Skin Appendage Conditions	125 (.83%)
Physical Examination Topics	118 (.78%)
Administration Site Reactions	117 (.78%)
Oral Soft Tissue Conditions	113 (.75%)
Fatal Outcomes	112 (.74%)
Miscellaneous And Site Unspecified ...	106 (.7%)
Coronary Artery	105 (.7%)
Metastases	103 (.68%)
Muscle	103 (.68%)
Appetite And General Nutritional	100 (.66%)
Cardiac Disorder Signs	100 (.66%)
Therapeutic And Nontherapeutic Effe...	96 (.64%)
Viral Infectious	93 (.62%)
Peripheral Neuropathies	87 (.58%)
Gastrointestinal Ulceration And Per...	84 (.56%)
Pleural	79 (.52%)
Skin And Subcutaneous Tissue	79 (.52%)
Injuries	76 (.5%)
Joint	67 (.44%)
Musculoskeletal And Connective Tiss...	65 (.43%)
Glucose Metabolism Disorders	64 (.42%)
Peritoneal And Retroperitoneal Cond...	64 (.42%)
Gastrointestinal Neoplasms Malignan...	63 (.42%)
Urinary Tract Signs	63 (.42%)
Headaches	62 (.41%)
Fungal Infectious	59 (.39%)
Gastrointestinal Hemorrhages	58 (.38%)
Vision	56 (.37%)
Allergic Conditions	55 (.36%)
Movement Disorders	54 (.36%)
Arteriosclerosis, Stenosis, Vascula...	53 (.35%)
Deliria	53 (.35%)
Bone Disorders	52 (.34%)
Vascular	52 (.34%)
Renal And Urinary Tract Investigati...	51 (.34%)
Microbiology And Serology	50 (.33%)
Breast Neoplasms Malignant And Unsp...	49 (.32%)
Enzyme	49 (.32%)
Metabolic, Nutritional And Blood Ga...	45 (.3%)
Mental Impairment	44 (.29%)
Therapeutic Procedures And Supporti...	43 (.29%)
Coagulopathies And Bleeding Diathes...	41 (.27%)
Seizures	40 (.27%)
Tissue	39 (.26%)
Anxiety Disorders	38 (.25%)
Menstrual Cycle And Uterine Bleedin...	37 (.25%)
Water, Electrolyte And Mineral	37 (.25%)
Bone, Calcium, Magnesium And Phosph...	36 (.24%)
Medication Errors	36 (.24%)
Cardiac Valve	35 (.23%)
Protein And Chemistry Analyses	35 (.23%)
Bladder And Bladder Neck Disorders	33 (.22%)
Lifestyle Issues	33 (.22%)
Vascular Inflammations	33 (.22%)
Neoplasm Related Morbidities	32 (.21%)
Depressed Mood Disorders	31 (.21%)
Upper Respiratory Tract Disorders	31 (.21%)
Gastrointestinal Stenosis And Obstr...	30 (.2%)
Hematological	30 (.2%)
Obstetric And Gynecological Therape...	30 (.2%)
Encephalopathies	28 (.19%)
Mood Disorders	28 (.19%)
Vascular Hypertensive	28 (.19%)
Spleen, Lymphatic And Reticulendoth...	27 (.18%)
Ocular Infections, Irritations And ...	24 (.16%)
Endocrine Neoplasms Malignant And U...	23 (.15%)
Gallbladder	23 (.15%)
Sleep Disorders	23 (.15%)
Bronchial Disorders	22 (.15%)
Gastrointestinal Conditions	22 (.15%)
Hematological And Lymphoid Tissue T...	22 (.15%)

Share/Embed Graph Export Data

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