TOPOTECAN

Topotecan Adverse Events Reported to the FDA Over Time

How are Topotecan adverse event reports trending over time?

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

Most Common Topotecan Adverse Events Reported to the FDA

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

Anaemia	315 (3.03%)
Nausea	247 (2.38%)
Vomiting	243 (2.34%)
Thrombocytopenia	240 (2.31%)
Neutropenia	237 (2.28%)
Pyrexia	177 (1.7%)
Dyspnoea	171 (1.65%)
White Blood Cell Count Decreased	170 (1.64%)
Dehydration	161 (1.55%)
Platelet Count Decreased	157 (1.51%)
Febrile Neutropenia	154 (1.48%)
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Diarrhoea	150 (1.44%)
Fatigue	136 (1.31%)
Neutrophil Count Decreased	131 (1.26%)
Asthenia	126 (1.21%)
Death	123 (1.18%)
Haemoglobin Decreased	118 (1.14%)
General Physical Health Deteriorati...	105 (1.01%)
Pancytopenia	100 (.96%)
Abdominal Pain	99 (.95%)
Pneumonia	93 (.89%)
Leukopenia	92 (.89%)
Sepsis	90 (.87%)
Disease Progression	81 (.78%)
Hypotension	73 (.7%)
Drug Toxicity	71 (.68%)
Constipation	68 (.65%)
Red Blood Cell Count Decreased	65 (.63%)
Confusional State	63 (.61%)
Interstitial Lung Disease	58 (.56%)
Headache	57 (.55%)
Hyponatraemia	56 (.54%)
Pain	56 (.54%)
Pulmonary Embolism	55 (.53%)
Blood Creatinine Increased	54 (.52%)
Decreased Appetite	54 (.52%)
Respiratory Failure	53 (.51%)
Pleural Effusion	52 (.5%)
Renal Failure	51 (.49%)
Ileus	50 (.48%)
Urinary Tract Infection	50 (.48%)
Anorexia	49 (.47%)
Dizziness	48 (.46%)
Febrile Bone Marrow Aplasia	48 (.46%)
Aspartate Aminotransferase Increase...	44 (.42%)
Malignant Neoplasm Progression	43 (.41%)
Alanine Aminotransferase Increased	42 (.4%)
Hypokalaemia	41 (.39%)
Weight Decreased	41 (.39%)
Infection	40 (.38%)
Rash	40 (.38%)
Mental Status Changes	39 (.38%)
Renal Failure Acute	39 (.38%)
Chest Pain	38 (.37%)
Oedema Peripheral	37 (.36%)
Ascites	36 (.35%)
Bone Marrow Failure	35 (.34%)
Drug Ineffective	35 (.34%)
Somnolence	34 (.33%)
Abdominal Distension	32 (.31%)
Condition Aggravated	32 (.31%)
Convulsion	32 (.31%)
Cough	32 (.31%)
Haematuria	31 (.3%)
Pain In Extremity	30 (.29%)
Syncope	30 (.29%)
Blood Lactate Dehydrogenase Increas...	29 (.28%)
Blood Sodium Decreased	29 (.28%)
Blood Urea Increased	29 (.28%)
C-reactive Protein Increased	29 (.28%)
Haematocrit Decreased	29 (.28%)
Septic Shock	29 (.28%)
Blood Bilirubin Increased	28 (.27%)
Chills	28 (.27%)
Depressed Level Of Consciousness	28 (.27%)
Deep Vein Thrombosis	27 (.26%)
Malaise	26 (.25%)
Subileus	26 (.25%)
Blood Alkaline Phosphatase Increase...	25 (.24%)
Hypoxia	25 (.24%)
Alopecia	24 (.23%)
Erythema	24 (.23%)
Fall	24 (.23%)
Mucosal Inflammation	24 (.23%)
Gastrointestinal Haemorrhage	23 (.22%)
Hydronephrosis	23 (.22%)
Lymphopenia	23 (.22%)
Protein Total Decreased	23 (.22%)
Back Pain	22 (.21%)
Blood Potassium Decreased	22 (.21%)
Epistaxis	22 (.21%)
Staphylococcal Infection	22 (.21%)
Atrial Fibrillation	21 (.2%)
Haematotoxicity	21 (.2%)
Heart Rate Increased	21 (.2%)
Hypomagnesaemia	21 (.2%)
Lethargy	21 (.2%)
Multi-organ Failure	21 (.2%)
Respiratory Distress	21 (.2%)
Tachycardia	21 (.2%)
Blood Culture Positive	20 (.19%)

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

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

Hematology Investigations	841 (8.09%)
Gastrointestinal Signs	702 (6.75%)
White Blood Cell	524 (5.04%)
Anemias Nonhemolytic And Marrow Dep...	501 (4.82%)
Infections - Pathogen Unspecified	461 (4.44%)
Respiratory	416 (4%)
Electrolyte And Fluid Balance Condi...	310 (2.98%)
Neurological	299 (2.88%)
Platelet	249 (2.4%)
Gastrointestinal Motility And Defec...	242 (2.33%)
Body Temperature Conditions	182 (1.75%)
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Epidermal And Dermal Conditions	158 (1.52%)
Hepatobiliary	156 (1.5%)
Renal And Urinary Tract Investigati...	143 (1.38%)
Lower Respiratory Tract Disorders	140 (1.35%)
Appetite And General Nutritional	139 (1.34%)
Water, Electrolyte And Mineral	139 (1.34%)
Renal Disorders	134 (1.29%)
Fatal Outcomes	132 (1.27%)
Bacterial Infectious	125 (1.2%)
Cardiac Arrhythmias	124 (1.19%)
Gastrointestinal Stenosis And Obstr...	118 (1.14%)
Decreased And Nonspecific Blood Pre...	112 (1.08%)
Hepatic And Hepatobiliary	91 (.88%)
Miscellaneous And Site Unspecified ...	91 (.88%)
Deliria	89 (.86%)
Musculoskeletal And Connective Tiss...	88 (.85%)
Protein And Chemistry Analyses	75 (.72%)
Chemical Injury And Poisoning	74 (.71%)
Gastrointestinal Hemorrhages	74 (.71%)
Urinary Tract Signs	74 (.71%)
Cardiac And Vascular Investigations	69 (.66%)
Therapeutic And Nontherapeutic Effe...	68 (.65%)
Gastrointestinal Inflammatory Condi...	67 (.64%)
Physical Examination Topics	65 (.63%)
Embolism And Thrombosis	62 (.6%)
Enzyme	60 (.58%)
Headaches	60 (.58%)
Pleural	58 (.56%)
Pulmonary Vascular	58 (.56%)
Seizures	55 (.53%)
Peritoneal And Retroperitoneal Cond...	50 (.48%)
Bone, Calcium, Magnesium And Phosph...	49 (.47%)
Fungal Infectious	48 (.46%)
Metastases	48 (.46%)
Medication Errors	46 (.44%)
Microbiology And Serology	44 (.42%)
Injuries	43 (.41%)
Psychiatric	43 (.41%)
Skin Appendage Conditions	43 (.41%)
Coronary Artery	41 (.39%)
Respiratory And Mediastinal Neoplas...	36 (.35%)
Vision	36 (.35%)
Central Nervous System Vascular	35 (.34%)
Administration Site Reactions	32 (.31%)
Metabolic, Nutritional And Blood Ga...	32 (.31%)
Reproductive Neoplasms Female Malig...	32 (.31%)
Gastrointestinal Neoplasms Malignan...	31 (.3%)
Heart Failures	31 (.3%)
Allergic Conditions	30 (.29%)
Muscle	30 (.29%)
Vascular	30 (.29%)
Viral Infectious	30 (.29%)
Oral Soft Tissue Conditions	29 (.28%)
Upper Respiratory Tract Disorders	29 (.28%)
Hematological And Lymphoid Tissue T...	27 (.26%)
Procedural And Device Related Injur...	27 (.26%)
Gastrointestinal Ulceration And Per...	25 (.24%)
Movement Disorders	25 (.24%)
Cardiac Disorder Signs	24 (.23%)
Hematological	24 (.23%)
Leukemias	24 (.23%)
Glucose Metabolism Disorders	23 (.22%)
Peripheral Neuropathies	23 (.22%)
Protein And Amino Acid Metabolism	23 (.22%)
Encephalopathies	22 (.21%)
Exocrine Pancreas Conditions	22 (.21%)
Gastrointestinal	22 (.21%)
Gastrointestinal Conditions	21 (.2%)
Neoplasm Related Morbidities	21 (.2%)
Mental Impairment	20 (.19%)
Skin And Subcutaneous Tissue	20 (.19%)
Vascular Hemorrhagic	20 (.19%)
Vascular Hypertensive	20 (.19%)
Vulvovaginal Disorders	20 (.19%)
Immunology And Allergy	19 (.18%)
Lifestyle Issues	17 (.16%)
Skin Vascular Abnormalities	17 (.16%)
Anxiety Disorders	16 (.15%)
Inner Ear And Viiith Cranial Nerve	16 (.15%)
Arteriosclerosis, Stenosis, Vascula...	15 (.14%)
Bronchial Disorders	15 (.14%)
Pericardial	15 (.14%)
Therapeutic Procedures And Supporti...	15 (.14%)
Coagulopathies And Bleeding Diathes...	14 (.13%)
Spleen, Lymphatic And Reticulendoth...	14 (.13%)
Ocular Infections, Irritations And ...	13 (.13%)
Congenital And Hereditary	12 (.12%)
Eating Disorders	12 (.12%)
Joint	12 (.12%)
Nervous System Neoplasms Malignant ...	12 (.12%)

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