ONDANSETRON

Ondansetron Adverse Events Reported to the FDA Over Time

How are Ondansetron adverse event reports trending over time?

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

Most Common Ondansetron Adverse Events Reported to the FDA

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

Nausea	411 (2.58%)
Vomiting	388 (2.44%)
Drug Exposure During Pregnancy	347 (2.18%)
Drug Ineffective	291 (1.83%)
Death	165 (1.04%)
Abdominal Pain	164 (1.03%)
Hypotension	148 (.93%)
Malaise	146 (.92%)
Drug Interaction	143 (.9%)
Dyspnoea	143 (.9%)
Headache	142 (.89%)
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Constipation	141 (.89%)
Dehydration	128 (.8%)
Pyrexia	122 (.77%)
Loss Of Consciousness	117 (.74%)
Diarrhoea	116 (.73%)
Pruritus	116 (.73%)
Ventricular Tachycardia	113 (.71%)
Dystonia	105 (.66%)
Cardiac Arrest	97 (.61%)
Dizziness	95 (.6%)
Erythema	95 (.6%)
Convulsion	88 (.55%)
Bradycardia	86 (.54%)
Febrile Neutropenia	80 (.5%)
Tachycardia	78 (.49%)
Somnolence	77 (.48%)
Chest Pain	76 (.48%)
Alanine Aminotransferase Increased	75 (.47%)
Rash	75 (.47%)
Serotonin Syndrome	75 (.47%)
Asthenia	74 (.46%)
Dyskinesia	73 (.46%)
Hepatotoxicity	73 (.46%)
Torsade De Pointes	72 (.45%)
Syncope	68 (.43%)
Oxygen Saturation Decreased	63 (.4%)
Anxiety	62 (.39%)
Dilatation Intrahepatic Duct Acquir...	62 (.39%)
Hypersensitivity	62 (.39%)
Liver Function Test Abnormal	61 (.38%)
Tremor	60 (.38%)
Migraine	56 (.35%)
Venoocclusive Liver Disease	56 (.35%)
Electrocardiogram Qt Prolonged	55 (.35%)
Extrapyramidal Disorder	55 (.35%)
Premature Baby	55 (.35%)
Pneumonia	54 (.34%)
Chills	53 (.33%)
Hyperhidrosis	53 (.33%)
Unresponsive To Stimuli	53 (.33%)
Arrhythmia	52 (.33%)
Neutropenia	52 (.33%)
Long Qt Syndrome	51 (.32%)
Chest Discomfort	50 (.31%)
Pain	50 (.31%)
Weight Decreased	50 (.31%)
Blood Bilirubin Increased	49 (.31%)
Anaphylactic Reaction	48 (.3%)
Agitation	47 (.3%)
Aspartate Aminotransferase Increase...	47 (.3%)
Grand Mal Convulsion	47 (.3%)
Fatigue	46 (.29%)
Maternal Drugs Affecting Foetus	46 (.29%)
Anaemia	45 (.28%)
Cardio-respiratory Arrest	45 (.28%)
Urticaria	45 (.28%)
Atrial Fibrillation	44 (.28%)
Confusional State	44 (.28%)
Large Intestine Perforation	44 (.28%)
Off Label Use	43 (.27%)
Sinus Tachycardia	43 (.27%)
Thrombocytopenia	43 (.27%)
Sinus Bradycardia	42 (.26%)
Blood Pressure Decreased	41 (.26%)
Depressed Level Of Consciousness	41 (.26%)
Medication Error	41 (.26%)
Rash Erythematous	41 (.26%)
Ventricular Fibrillation	41 (.26%)
Drug Toxicity	39 (.25%)
Peritonitis	39 (.25%)
Abdominal Distension	38 (.24%)
Haemoglobin Decreased	38 (.24%)
Muscle Spasms	38 (.24%)
Renal Failure Acute	38 (.24%)
Abdominal Pain Upper	37 (.23%)
Flushing	37 (.23%)
Respiratory Arrest	37 (.23%)
Blood Alkaline Phosphatase Increase...	36 (.23%)
Lung Cancer Metastatic	36 (.23%)
Cytolytic Hepatitis	35 (.22%)
Sepsis	35 (.22%)
Vision Blurred	35 (.22%)
Completed Suicide	34 (.21%)
Leukopenia	34 (.21%)
Heart Rate Increased	33 (.21%)
Hypertension	33 (.21%)
Disease Progression	32 (.2%)
Hypokalaemia	32 (.2%)
Hypoxia	32 (.2%)
Drug Hypersensitivity	31 (.19%)

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

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

Gastrointestinal Signs	1153 (7.24%)
Cardiac Arrhythmias	966 (6.07%)
Neurological	887 (5.57%)
Epidermal And Dermal Conditions	698 (4.39%)
Therapeutic And Nontherapeutic Effe...	550 (3.46%)
Respiratory	508 (3.19%)
Chemical Injury And Poisoning	447 (2.81%)
Hepatic And Hepatobiliary	390 (2.45%)
Movement Disorders	369 (2.32%)
Hepatobiliary	302 (1.9%)
Gastrointestinal Motility And Defec...	299 (1.88%)
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Cardiac And Vascular Investigations	291 (1.83%)
Infections - Pathogen Unspecified	252 (1.58%)
Medication Errors	223 (1.4%)
Electrolyte And Fluid Balance Condi...	219 (1.38%)
Decreased And Nonspecific Blood Pre...	205 (1.29%)
Headaches	198 (1.24%)
White Blood Cell	198 (1.24%)
Fatal Outcomes	195 (1.23%)
Hematology Investigations	182 (1.14%)
Allergic Conditions	181 (1.14%)
Muscle	163 (1.02%)
Body Temperature Conditions	162 (1.02%)
Seizures	154 (.97%)
Administration Site Reactions	150 (.94%)
Anxiety Disorders	138 (.87%)
Coronary Artery	131 (.82%)
Metabolic, Nutritional And Blood Ga...	131 (.82%)
Neuromuscular	129 (.81%)
Vision	123 (.77%)
Renal Disorders	114 (.72%)
Musculoskeletal And Connective Tiss...	105 (.66%)
Physical Examination Topics	105 (.66%)
Ocular Neuromuscular	90 (.57%)
Procedural And Device Related Injur...	89 (.56%)
Skin Appendage Conditions	88 (.55%)
Enzyme	84 (.53%)
Lower Respiratory Tract Disorders	84 (.53%)
Neonatal And Perinatal Conditions	84 (.53%)
Vascular	83 (.52%)
Urinary Tract Signs	82 (.52%)
Myocardial	74 (.46%)
Water, Electrolyte And Mineral	73 (.46%)
Anemias Nonhemolytic And Marrow Dep...	70 (.44%)
Bile Duct	69 (.43%)
Deliria	69 (.43%)
Therapeutic Procedures And Supporti...	67 (.42%)
Upper Respiratory Tract Disorders	67 (.42%)
Appetite And General Nutritional	65 (.41%)
Injuries	63 (.4%)
Bacterial Infectious	61 (.38%)
Disturbances In Thinking	61 (.38%)
Miscellaneous And Site Unspecified ...	61 (.38%)
Angiedema And Urticaria	60 (.38%)
Gastrointestinal Ulceration And Per...	59 (.37%)
Gastrointestinal Inflammatory Condi...	58 (.36%)
Respiratory And Mediastinal Neoplas...	58 (.36%)
Mental Impairment	57 (.36%)
Peritoneal And Retroperitoneal Cond...	57 (.36%)
Oral Soft Tissue Conditions	56 (.35%)
Musculoskeletal And Connective Tiss...	55 (.35%)
Bronchial Disorders	54 (.34%)
Product Quality Issues	54 (.34%)
Vascular Hypertensive	54 (.34%)
Glucose Metabolism Disorders	53 (.33%)
Suicidal And Self-injurious Behavio...	51 (.32%)
Cardiac Disorder Signs	50 (.31%)
Encephalopathies	50 (.31%)
Joint	49 (.31%)
Renal And Urinary Tract Investigati...	48 (.3%)
Congenital And Hereditary	46 (.29%)
Platelet	46 (.29%)
Cardiac And Vascular Disorders Cong...	45 (.28%)
Central Nervous System Vascular	44 (.28%)
Bone, Calcium, Magnesium And Phosph...	43 (.27%)
Ocular Sensory Symptoms	43 (.27%)
Eye	41 (.26%)
Pregnancy, Labour, Delivery And Pos...	40 (.25%)
Viral Infectious	40 (.25%)
Embolism And Thrombosis	39 (.25%)
Gastrointestinal Hemorrhages	39 (.25%)
Gastrointestinal Stenosis And Obstr...	39 (.25%)
Gastrointestinal Tract Disorders Co...	39 (.25%)
Mood Disorders	39 (.25%)
Psychiatric	39 (.25%)
Inner Ear And Viiith Cranial Nerve	37 (.23%)
Acid-base	36 (.23%)
Changes In Physical Activity	36 (.23%)
Exocrine Pancreas Conditions	36 (.23%)
Neonatal Respiratory	36 (.23%)
Abortions And Stillbirth	35 (.22%)
Pleural	35 (.22%)
Skin Vascular Abnormalities	35 (.22%)
Sleep Disorders	35 (.22%)
Fetal Complications	32 (.2%)
Obstetric And Gynecological Therape...	32 (.2%)
Protein And Chemistry Analyses	32 (.2%)
Pulmonary Vascular	32 (.2%)
Gastrointestinal Conditions	30 (.19%)
Psychiatric And Behavioural Symptom...	30 (.19%)
Vascular Hemorrhagic	30 (.19%)

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