Drug
Arsenic Trioxide
Important: Reactions below are the flagged terms from this drug’s
FAERS report history (min. 3 co-reports per term) — PRR/ROR indicate
disproportionality in spontaneous reporting, not causation.
Data from FDA FAERS via openFDA. Last recalculated: 2026-09-14.
| Reaction | Co-reports (a) | PRR | ROR | Signal | |
|---|---|---|---|---|---|
| 1 | Electrocardiogram Qt Prolonged | 261 | 67.4 | 76.0 | signal |
| 2 | Disseminated Intravascular Coagulation | 50 | 32.8 | 33.5 | signal |
| 3 | Leukocytosis | 47 | 24.0 | 24.5 | signal |
| 4 | Pericardial Effusion | 58 | 23.3 | 23.9 | signal |
| 5 | Pericarditis | 38 | 21.1 | 21.4 | signal |
| 6 | Acute Myeloid Leukaemia | 33 | 19.6 | 19.9 | signal |
| 7 | Hypomagnesaemia | 25 | 16.7 | 16.8 | signal |
| 8 | Ventricular Extrasystoles | 18 | 16.0 | 16.1 | signal |
| 9 | Blood Lactate Dehydrogenase Increased | 24 | 13.9 | 14.0 | signal |
| 10 | Gamma-glutamyltransferase Increased | 33 | 13.7 | 13.9 | signal |
| 11 | Mitral Valve Incompetence | 16 | 13.1 | 13.1 | signal |
| 12 | Myocarditis | 16 | 13.1 | 13.1 | signal |
| 13 | Hypokalaemia | 60 | 12.1 | 12.4 | signal |
| 14 | Hypercalcaemia | 16 | 12.0 | 12.1 | signal |
| 15 | Alanine Aminotransferase Increased | 79 | 11.9 | 12.3 | signal |
| 16 | Lymphopenia | 18 | 11.8 | 11.9 | signal |
| 17 | Myoclonus | 15 | 11.6 | 11.7 | signal |
| 18 | White Blood Cell Count Increased | 48 | 11.5 | 11.7 | signal |
| 19 | Hepatic Function Abnormal | 46 | 11.5 | 11.7 | signal |
| 20 | Aspartate Aminotransferase Increased | 65 | 11.3 | 11.6 | signal |
| 21 | Hepatotoxicity | 27 | 11.3 | 11.4 | signal |
| 22 | Pleural Effusion | 74 | 11.2 | 11.6 | signal |
| 23 | Neurotoxicity | 21 | 11.2 | 11.3 | signal |
| 24 | Ventricular Tachycardia | 20 | 11.1 | 11.2 | signal |
| 25 | Vasculitis | 14 | 11.1 | 11.2 | signal |
| 26 | Febrile Neutropenia | 79 | 11.0 | 11.4 | signal |
| 27 | Blood Alkaline Phosphatase Increased | 29 | 10.8 | 10.9 | signal |
| 28 | Mucosal Inflammation | 30 | 10.6 | 10.8 | signal |
| 29 | Pancytopenia | 59 | 9.8 | 10.0 | signal |
| 30 | Acute Respiratory Distress Syndrome | 18 | 9.4 | 9.5 | signal |
| 31 | Subarachnoid Haemorrhage | 10 | 9.0 | 9.1 | signal |
| 32 | Sinus Bradycardia | 9 | 8.6 | 8.6 | signal |
| 33 | Cardiomegaly | 11 | 8.2 | 8.2 | signal |
| 34 | Cardiomyopathy | 13 | 8.1 | 8.2 | signal |
| 35 | Hypoxia | 30 | 7.9 | 8.0 | signal |
| 36 | Bacteraemia | 10 | 7.8 | 7.9 | signal |
| 37 | Drug Reaction With Eosinophilia And Systemic Symptoms | 21 | 7.6 | 7.7 | signal |
| 38 | Hepatic Cytolysis | 10 | 7.6 | 7.6 | signal |
| 39 | Fluid Overload | 12 | 7.5 | 7.5 | signal |
| 40 | Haemorrhage Intracranial | 12 | 7.4 | 7.4 | signal |
| 41 | Staphylococcal Infection | 24 | 6.7 | 6.8 | signal |
| 42 | Respiratory Distress | 20 | 6.7 | 6.7 | signal |
| 43 | Drug Toxicity | 10 | 6.7 | 6.7 | signal |
| 44 | Transaminases Increased | 16 | 6.7 | 6.7 | signal |
| 45 | Sinus Tachycardia | 10 | 6.5 | 6.5 | signal |
| 46 | Tuberculosis | 9 | 6.5 | 6.5 | signal |
| 47 | Myelodysplastic Syndrome | 10 | 6.4 | 6.4 | signal |
| 48 | Polyneuropathy | 8 | 6.2 | 6.2 | signal |
| 49 | White Blood Cell Count Decreased | 72 | 6.1 | 6.3 | signal |
| 50 | Respiratory Failure | 48 | 6.1 | 6.2 | signal |
| 51 | Blood Urea Increased | 11 | 6.0 | 6.1 | signal |
| 52 | Renal Failure Acute | 28 | 6.0 | 6.1 | signal |
| 53 | Ejection Fraction Decreased | 10 | 5.9 | 6.0 | signal |
| 54 | Tubulointerstitial Nephritis | 12 | 5.9 | 5.9 | signal |
| 55 | Blood Calcium Decreased | 7 | 5.7 | 5.7 | signal |
| 56 | Anorexia | 8 | 5.7 | 5.7 | signal |
| 57 | Hyperglycaemia | 22 | 5.6 | 5.6 | signal |
| 58 | Splenomegaly | 7 | 5.5 | 5.5 | signal |
| 59 | Drug Resistance | 14 | 5.0 | 5.1 | signal |
| 60 | Haematotoxicity | 5 | 5.0 | 5.0 | signal |
| 61 | Grand Mal Convulsion | 5 | 4.9 | 4.9 | signal |
| 62 | Neutropenia | 72 | 4.9 | 5.0 | signal |
| 63 | Cerebral Haemorrhage | 19 | 4.9 | 4.9 | signal |
| 64 | Leukopenia | 26 | 4.8 | 4.9 | signal |
| 65 | Neutrophil Count Decreased | 21 | 4.8 | 4.8 | signal |
| 66 | Pulmonary Oedema | 23 | 4.7 | 4.8 | signal |
| 67 | Thrombocytopenia | 56 | 4.6 | 4.7 | signal |
| 68 | Neuropathy Peripheral | 46 | 4.5 | 4.6 | signal |
| 69 | Hallucination, Visual | 10 | 4.4 | 4.4 | signal |
| 70 | Brain Oedema | 6 | 4.4 | 4.4 | signal |
| 71 | Myelosuppression | 16 | 4.3 | 4.4 | signal |
| 72 | Platelet Count Decreased | 50 | 4.3 | 4.4 | signal |
| 73 | Sudden Death | 5 | 4.3 | 4.3 | signal |
| 74 | Lung Infection | 7 | 4.1 | 4.1 | signal |
| 75 | Myocardial Ischaemia | 5 | 4.0 | 4.0 | signal |
| 76 | Dialysis | 6 | 3.9 | 3.9 | signal |
| 77 | Posterior Reversible Encephalopathy Syndrome | 4 | 3.9 | 3.9 | signal |
| 78 | Subdural Haematoma | 6 | 3.9 | 3.9 | signal |
| 79 | No Therapeutic Response | 5 | 3.7 | 3.7 | signal |
| 80 | Osteonecrosis Of Jaw | 10 | 3.7 | 3.7 | signal |
| 81 | Herpes Zoster | 23 | 3.7 | 3.7 | signal |
| 82 | Metastases To Central Nervous System | 5 | 3.6 | 3.6 | signal |
| 83 | Disease Progression | 45 | 3.5 | 3.6 | signal |
| 84 | Agranulocytosis | 7 | 3.5 | 3.5 | signal |
| 85 | Cholestasis | 7 | 3.4 | 3.4 | signal |
| 86 | Status Epilepticus | 4 | 3.3 | 3.3 | signal |
| 87 | Multi-organ Failure | 6 | 3.2 | 3.2 | signal |
| 88 | Cytopenia | 4 | 3.1 | 3.1 | no signal |
| 89 | Therapy Partial Responder | 5 | 3.1 | 3.1 | signal |
| 90 | Leukaemia | 3 | 2.9 | 2.9 | no signal |
| 91 | Osteonecrosis | 10 | 2.8 | 2.8 | signal |
| 92 | Malignant Neoplasm Progression | 30 | 2.7 | 2.7 | signal |
| 93 | Acute Hepatic Failure | 4 | 2.7 | 2.7 | no signal |
| 94 | Convulsion | 15 | 2.4 | 2.4 | signal |
| 95 | Neoplasm Progression | 9 | 2.4 | 2.4 | signal |
| 96 | Bone Marrow Failure | 5 | 2.3 | 2.3 | no signal |
| 97 | Extrapyramidal Disorder | 4 | 1.5 | 1.5 | no signal |