ARSENIC TRIOXIDE

Arsenic Trioxide Adverse Events Reported to the FDA Over Time

How are Arsenic Trioxide adverse event reports trending over time?

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

Most Common Arsenic Trioxide Adverse Events Reported to the FDA

What are the most common Arsenic Trioxide adverse events reported to the FDA?

Pyrexia	28 (2.33%)
White Blood Cell Count Decreased	22 (1.83%)
Haemoglobin Decreased	21 (1.75%)
Electrocardiogram Qt Prolonged	20 (1.66%)
Hypotension	20 (1.66%)
Platelet Count Decreased	19 (1.58%)
Pneumonia	19 (1.58%)
Dyspnoea	18 (1.5%)
Pleural Effusion	16 (1.33%)
Nausea	14 (1.16%)
Fatigue	13 (1.08%)
	Show More
Vomiting	13 (1.08%)
Abdominal Pain	12 (1%)
Asthenia	11 (.91%)
Febrile Neutropenia	11 (.91%)
Renal Failure Acute	11 (.91%)
Alanine Aminotransferase Increased	10 (.83%)
Chills	10 (.83%)
Convulsion	10 (.83%)
Disease Progression	10 (.83%)
Disseminated Intravascular Coagulat...	10 (.83%)
Bronchopneumonia	9 (.75%)
Confusional State	9 (.75%)
Dehydration	9 (.75%)
Cardiac Failure	8 (.67%)
Condition Aggravated	8 (.67%)
Cough	8 (.67%)
Fluid Overload	8 (.67%)
Blood Alkaline Phosphatase Increase...	7 (.58%)
Cerebral Haemorrhage	7 (.58%)
Extrasystoles	7 (.58%)
Leukocytosis	7 (.58%)
Lung Infiltration	7 (.58%)
Muscular Weakness	7 (.58%)
Pericardial Effusion	7 (.58%)
Respiratory Depression	7 (.58%)
Sepsis	7 (.58%)
Tachycardia	7 (.58%)
Ventricular Extrasystoles	7 (.58%)
Ventricular Tachycardia	7 (.58%)
White Blood Cell Count Increased	7 (.58%)
Abdominal Distension	6 (.5%)
Acute Promyelocytic Leukaemia	6 (.5%)
Anaemia	6 (.5%)
Aspartate Aminotransferase Increase...	6 (.5%)
Blood Lactate Dehydrogenase Increas...	6 (.5%)
Bundle Branch Block Right	6 (.5%)
Dyspnoea Exertional	6 (.5%)
Hyperhidrosis	6 (.5%)
Hypoxia	6 (.5%)
Malignant Neoplasm Progression	6 (.5%)
Palpitations	6 (.5%)
Renal Impairment	6 (.5%)
Respiratory Distress	6 (.5%)
Thrombocytopenia	6 (.5%)
Torsade De Pointes	6 (.5%)
Anxiety	5 (.42%)
Atrial Fibrillation	5 (.42%)
Blood Culture Positive	5 (.42%)
Diarrhoea	5 (.42%)
Epistaxis	5 (.42%)
Fungal Infection	5 (.42%)
Gastrointestinal Haemorrhage	5 (.42%)
Haematemesis	5 (.42%)
Haemodialysis	5 (.42%)
Loss Of Consciousness	5 (.42%)
Myelodysplastic Syndrome	5 (.42%)
Renal Failure	5 (.42%)
Respiratory Failure	5 (.42%)
Acute Promyelocytic Leukaemia Diffe...	4 (.33%)
Blood Bilirubin Increased	4 (.33%)
Brain Herniation	4 (.33%)
Chest Pain	4 (.33%)
Decreased Appetite	4 (.33%)
Drug Dose Omission	4 (.33%)
Drug Interaction	4 (.33%)
Drug Withdrawal Syndrome	4 (.33%)
Eosinophil Count Increased	4 (.33%)
Fall	4 (.33%)
Gamma-glutamyltransferase Increased	4 (.33%)
Headache	4 (.33%)
Herpes Zoster	4 (.33%)
Leukaemia Recurrent	4 (.33%)
Melaena	4 (.33%)
Neutropenia	4 (.33%)
Neutrophil Percentage Decreased	4 (.33%)
Off Label Use	4 (.33%)
Pulmonary Haemorrhage	4 (.33%)
Pulmonary Oedema	4 (.33%)
Splenomegaly	4 (.33%)
Tremor	4 (.33%)
Abdominal Pain Upper	3 (.25%)
Acute Abdomen	3 (.25%)
Anaphylactic Reaction	3 (.25%)
Atrioventricular Block First Degree	3 (.25%)
Back Pain	3 (.25%)
Bacteraemia	3 (.25%)
Blood Bicarbonate Decreased	3 (.25%)
Blood Sodium Decreased	3 (.25%)
Brain Oedema	3 (.25%)
Cardiac Failure Congestive	3 (.25%)

Share/Embed Graph Export Data

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

What are the most common Arsenic Trioxide adverse events reported to the FDA?

Hematology Investigations	87 (7.23%)
Respiratory	79 (6.57%)
Cardiac Arrhythmias	60 (4.99%)
Infections - Pathogen Unspecified	57 (4.74%)
Gastrointestinal Signs	51 (4.24%)
Cardiac And Vascular Investigations	36 (2.99%)
Body Temperature Conditions	29 (2.41%)
Neurological	29 (2.41%)
Renal Disorders	26 (2.16%)
Hepatobiliary	25 (2.08%)
White Blood Cell	25 (2.08%)
	Show More
Electrolyte And Fluid Balance Condi...	23 (1.91%)
Decreased And Nonspecific Blood Pre...	22 (1.83%)
Gastrointestinal Hemorrhages	19 (1.58%)
Leukemias	17 (1.41%)
Pleural	17 (1.41%)
Bacterial Infectious	16 (1.33%)
Enzyme	15 (1.25%)
Injuries	14 (1.16%)
Lower Respiratory Tract Disorders	14 (1.16%)
Central Nervous System Vascular	13 (1.08%)
Miscellaneous And Site Unspecified ...	13 (1.08%)
Seizures	13 (1.08%)
Hepatic And Hepatobiliary	12 (1%)
Metabolic, Nutritional And Blood Ga...	12 (1%)
Deliria	11 (.91%)
Fungal Infectious	11 (.91%)
Heart Failures	11 (.91%)
Microbiology And Serology	11 (.91%)
Therapeutic And Nontherapeutic Effe...	11 (.91%)
Coagulopathies And Bleeding Diathes...	10 (.83%)
Gastrointestinal Motility And Defec...	10 (.83%)
Pericardial	10 (.83%)
Anemias Nonhemolytic And Marrow Dep...	9 (.75%)
Anxiety Disorders	9 (.75%)
Muscle	9 (.75%)
Cardiac Disorder Signs	8 (.67%)
Increased Intracranial Pressure And...	8 (.67%)
Myocardial	8 (.67%)
Platelet	8 (.67%)
Water, Electrolyte And Mineral	8 (.67%)
Epidermal And Dermal Conditions	7 (.58%)
Metastases	7 (.58%)
Musculoskeletal And Connective Tiss...	7 (.58%)
Skin Appendage Conditions	7 (.58%)
Upper Respiratory Tract Disorders	7 (.58%)
Appetite And General Nutritional	6 (.5%)
Chemical Injury And Poisoning	6 (.5%)
Hematological And Lymphoid Tissue T...	6 (.5%)
Joint	6 (.5%)
Movement Disorders	6 (.5%)
Viral Infectious	6 (.5%)
Medication Errors	5 (.42%)
Penile And Scrotal Disorders	5 (.42%)
Protein And Chemistry Analyses	5 (.42%)
Spleen, Lymphatic And Reticulendoth...	5 (.42%)
Therapeutic Procedures And Supporti...	5 (.42%)
Urinary Tract Signs	5 (.42%)
Vascular Hemorrhagic	5 (.42%)
Vision	5 (.42%)
Administration Site Reactions	4 (.33%)
Bone, Calcium, Magnesium And Phosph...	4 (.33%)
Cardiac Valve	4 (.33%)
Depressed Mood Disorders	4 (.33%)
Headaches	4 (.33%)
Investigations, Imaging And Histopa...	4 (.33%)
Mental Impairment	4 (.33%)
Peripheral Neuropathies	4 (.33%)
Allergic Conditions	3 (.25%)
Arteriosclerosis, Stenosis, Vascula...	3 (.25%)
Bronchial Disorders	3 (.25%)
Changes In Physical Activity	3 (.25%)
Fatal Outcomes	3 (.25%)
Gastrointestinal Neoplasms Malignan...	3 (.25%)
Hematological	3 (.25%)
Neurological, Special Senses And Ps...	3 (.25%)
Oral Soft Tissue Conditions	3 (.25%)
Physical Examination Topics	3 (.25%)
Respiratory And Mediastinal Neoplas...	3 (.25%)
Skin Neoplasms Malignant And Unspec...	3 (.25%)
Vascular	3 (.25%)
Bile Duct	2 (.17%)
Cranial Nerve Disorders	2 (.17%)
Cytoplasmic Disorders Congenital	2 (.17%)
Dental And Gingival Conditions	2 (.17%)
Embolism And Thrombosis	2 (.17%)
Neoplasm Related Morbidities	2 (.17%)
Ocular Neuromuscular	2 (.17%)
Plasma Cell Neoplasms	2 (.17%)
Red Blood Cell	2 (.17%)
Respiratory And Pulmonary Investiga...	2 (.17%)
Skin And Subcutaneous Tissue	2 (.17%)
Toxicology And Therapeutic Drug Mon...	2 (.17%)
Abdominal Hernias And Other Abdomin...	1 (.08%)
Adrenal Gland	1 (.08%)
Autoimmune	1 (.08%)
Bladder And Bladder Neck Disorders	1 (.08%)
Bone And Joint Injuries	1 (.08%)
Central Nervous System Infections A...	1 (.08%)
Congenital And Hereditary	1 (.08%)
Cornification And Dystrophic Skin	1 (.08%)

Share/Embed Graph Export Data

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