CHEMOTHERAPY

Chemotherapy Adverse Events Reported to the FDA Over Time

How are Chemotherapy adverse event reports trending over time?

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

Most Common Chemotherapy Adverse Events Reported to the FDA

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

Nausea	37 (1.77%)
Diarrhoea	36 (1.72%)
Fatigue	36 (1.72%)
Malaise	31 (1.48%)
Neoplasm Malignant	26 (1.24%)
Vomiting	26 (1.24%)
Pain	25 (1.19%)
Drug Ineffective	24 (1.15%)
White Blood Cell Count Decreased	23 (1.1%)
Asthenia	22 (1.05%)
Breast Cancer	19 (.91%)
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Dyspnoea	19 (.91%)
Neutropenia	19 (.91%)
Leukopenia	18 (.86%)
Pyrexia	18 (.86%)
Weight Decreased	18 (.86%)
Anaemia	16 (.76%)
Infection	16 (.76%)
Off Label Use	15 (.72%)
Pneumonia	15 (.72%)
Dehydration	14 (.67%)
Dizziness	14 (.67%)
Headache	14 (.67%)
Condition Aggravated	13 (.62%)
Fall	13 (.62%)
Death	12 (.57%)
Oedema Peripheral	12 (.57%)
Rash	12 (.57%)
Insomnia	11 (.53%)
Lung Neoplasm Malignant	11 (.53%)
Platelet Count Decreased	11 (.53%)
Thrombocytopenia	11 (.53%)
Alopecia	10 (.48%)
Confusional State	10 (.48%)
Febrile Neutropenia	10 (.48%)
Feeling Abnormal	10 (.48%)
Gastrooesophageal Reflux Disease	10 (.48%)
Hypotension	10 (.48%)
Sepsis	10 (.48%)
Weight Increased	10 (.48%)
Agranulocytosis	9 (.43%)
Convulsion	9 (.43%)
Drug Dose Omission	9 (.43%)
Lymphoma	9 (.43%)
Osteoporosis	9 (.43%)
Pleural Effusion	9 (.43%)
Renal Failure	9 (.43%)
Agitation	8 (.38%)
Cerebral Haemorrhage	8 (.38%)
Colon Cancer	8 (.38%)
Constipation	8 (.38%)
Cough	8 (.38%)
Disease Progression	8 (.38%)
Drug Toxicity	8 (.38%)
Immunosuppression	8 (.38%)
Memory Impairment	8 (.38%)
Muscle Spasms	8 (.38%)
Myocardial Infarction	8 (.38%)
Pancytopenia	8 (.38%)
Swelling	8 (.38%)
Thrombosis	8 (.38%)
Adverse Event	7 (.33%)
Atrial Fibrillation	7 (.33%)
Blood Pressure Increased	7 (.33%)
Cardiac Disorder	7 (.33%)
Cataract	7 (.33%)
Dysgeusia	7 (.33%)
Gastric Disorder	7 (.33%)
Gastrointestinal Haemorrhage	7 (.33%)
Malignant Neoplasm Progression	7 (.33%)
Mucosal Inflammation	7 (.33%)
Nocardiosis	7 (.33%)
Visual Impairment	7 (.33%)
Abdominal Discomfort	6 (.29%)
Abdominal Pain	6 (.29%)
Abdominal Pain Upper	6 (.29%)
Amnesia	6 (.29%)
Aphasia	6 (.29%)
Breast Cancer Female	6 (.29%)
Cystitis	6 (.29%)
Depression	6 (.29%)
Gastrointestinal Carcinoma	6 (.29%)
Haematemesis	6 (.29%)
Haemoglobin Decreased	6 (.29%)
Hypersensitivity	6 (.29%)
Incorrect Dose Administered	6 (.29%)
Lung Infection	6 (.29%)
Mobility Decreased	6 (.29%)
Multi-organ Failure	6 (.29%)
Muscular Weakness	6 (.29%)
Nasopharyngitis	6 (.29%)
Osteopenia	6 (.29%)
Respiratory Failure	6 (.29%)
Staphylococcal Infection	6 (.29%)
Throat Irritation	6 (.29%)
Tremor	6 (.29%)
Wrong Technique In Drug Usage Proce...	6 (.29%)
Abnormal Behaviour	5 (.24%)
Ageusia	5 (.24%)
Balance Disorder	5 (.24%)
Body Height Decreased	5 (.24%)

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

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

Infections - Pathogen Unspecified	94 (4.49%)
Gastrointestinal Signs	92 (4.39%)
Hematology Investigations	74 (3.53%)
Neurological	74 (3.53%)
Respiratory	65 (3.1%)
Gastrointestinal Motility And Defec...	61 (2.91%)
White Blood Cell	58 (2.77%)
Therapeutic And Nontherapeutic Effe...	50 (2.39%)
Miscellaneous And Site Unspecified ...	44 (2.1%)
Epidermal And Dermal Conditions	42 (2.01%)
Breast Neoplasms Malignant And Unsp...	33 (1.58%)
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Physical Examination Topics	33 (1.58%)
Medication Errors	31 (1.48%)
Anemias Nonhemolytic And Marrow Dep...	25 (1.19%)
Gastrointestinal Neoplasms Malignan...	25 (1.19%)
Injuries	25 (1.19%)
Electrolyte And Fluid Balance Condi...	24 (1.15%)
Fungal Infectious	24 (1.15%)
Skin Appendage Conditions	24 (1.15%)
Bone Disorders	23 (1.1%)
Respiratory And Mediastinal Neoplas...	23 (1.1%)
Gastrointestinal Hemorrhages	22 (1.05%)
Bacterial Infectious	21 (1%)
Cardiac And Vascular Investigations	21 (1%)
Cardiac Arrhythmias	21 (1%)
Metastases	20 (.96%)
Therapeutic Procedures And Supporti...	20 (.96%)
Mental Impairment	19 (.91%)
Body Temperature Conditions	18 (.86%)
Central Nervous System Vascular	18 (.86%)
Leukemias	18 (.86%)
Musculoskeletal And Connective Tiss...	18 (.86%)
Renal Disorders	18 (.86%)
Vision	18 (.86%)
Muscle	17 (.81%)
Anxiety Disorders	16 (.76%)
Headaches	14 (.67%)
Immunodeficiency Syndromes	14 (.67%)
Appetite And General Nutritional	13 (.62%)
Hepatic And Hepatobiliary	13 (.62%)
Decreased And Nonspecific Blood Pre...	12 (.57%)
Fatal Outcomes	12 (.57%)
Hearing	12 (.57%)
Oral Soft Tissue Conditions	12 (.57%)
Reproductive Neoplasms Female Malig...	12 (.57%)
Sleep Disorders	12 (.57%)
Movement Disorders	11 (.53%)
Platelet	11 (.53%)
Seizures	11 (.53%)
Water, Electrolyte And Mineral	11 (.53%)
Bone And Joint Injuries	10 (.48%)
Cardiac Disorder Signs	10 (.48%)
Deliria	10 (.48%)
Embolism And Thrombosis	10 (.48%)
Immune	10 (.48%)
Pleural	10 (.48%)
Urinary Tract Signs	10 (.48%)
Coronary Artery	9 (.43%)
Glucose Metabolism Disorders	9 (.43%)
Lifestyle Issues	9 (.43%)
Lymphomas	9 (.43%)
Metabolic, Nutritional And Blood Ga...	9 (.43%)
Renal And Urinary Tract Neoplasms M...	9 (.43%)
Viral Infectious	9 (.43%)
Chemical Injury And Poisoning	8 (.38%)
Disturbances In Thinking	8 (.38%)
Gastrointestinal Conditions	8 (.38%)
Joint	8 (.38%)
Plasma Cell Neoplasms	8 (.38%)
Upper Respiratory Tract Disorders	8 (.38%)
Administration Site Reactions	7 (.33%)
Anterior Eye Structural Change, Dep...	7 (.33%)
Depressed Mood Disorders	7 (.33%)
Eye	7 (.33%)
Gastrointestinal Inflammatory Condi...	7 (.33%)
Lower Respiratory Tract Disorders	7 (.33%)
Peripheral Neuropathies	7 (.33%)
Toxicology And Therapeutic Drug Mon...	7 (.33%)
Allergic Conditions	6 (.29%)
Cranial Nerve Disorders	6 (.29%)
Hematological And Lymphoid Tissue T...	6 (.29%)
Hepatobiliary	6 (.29%)
Injuries By Physical Agents	6 (.29%)
Procedural And Device Related Injur...	6 (.29%)
Protein And Chemistry Analyses	6 (.29%)
Pulmonary Vascular	6 (.29%)
Renal And Urinary Tract Investigati...	6 (.29%)
Gastrointestinal Stenosis And Obstr...	5 (.24%)
Heart Failures	5 (.24%)
Immunology And Allergy	5 (.24%)
Psychiatric	5 (.24%)
Psychiatric And Behavioural Symptom...	5 (.24%)
Bladder And Bladder Neck Disorders	4 (.19%)
Breast	4 (.19%)
Coagulopathies And Bleeding Diathes...	4 (.19%)
Demyelinating	4 (.19%)
Endocrine Investigations	4 (.19%)
Gastrointestinal Ulceration And Per...	4 (.19%)
Increased Intracranial Pressure And...	4 (.19%)
Investigations, Imaging And Histopa...	4 (.19%)
Myocardial	4 (.19%)

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