Drug
Palonosetron
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 | Hair Colour Changes | 58 | 27.8 | 28.2 | signal |
| 2 | Hair Texture Abnormal | 58 | 25.9 | 26.3 | signal |
| 3 | Madarosis | 49 | 25.2 | 25.5 | signal |
| 4 | Febrile Neutropenia | 256 | 23.3 | 25.0 | signal |
| 5 | Inappropriate Antidiuretic Hormone Secretion | 27 | 15.9 | 16.1 | signal |
| 6 | Hypomagnesaemia | 36 | 15.6 | 15.8 | signal |
| 7 | Cytokine Release Syndrome | 48 | 15.1 | 15.3 | signal |
| 8 | Polyneuropathy | 28 | 14.1 | 14.3 | signal |
| 9 | Neutrophil Count Decreased | 88 | 13.1 | 13.4 | signal |
| 10 | Respiratory Depression | 24 | 11.8 | 11.8 | signal |
| 11 | Hypokalaemia | 87 | 11.4 | 11.7 | signal |
| 12 | Neutropenia | 253 | 11.2 | 12.0 | signal |
| 13 | Infusion Related Reaction | 120 | 10.9 | 11.3 | signal |
| 14 | Mucosal Inflammation | 45 | 10.4 | 10.5 | signal |
| 15 | Oral Candidiasis | 22 | 10.2 | 10.2 | signal |
| 16 | Leukopenia | 82 | 9.9 | 10.1 | signal |
| 17 | Myelosuppression | 55 | 9.7 | 9.8 | signal |
| 18 | Pneumonitis | 43 | 9.6 | 9.7 | signal |
| 19 | Thrombotic Microangiopathy | 15 | 9.3 | 9.3 | signal |
| 20 | Bacteraemia | 18 | 9.2 | 9.2 | signal |
| 21 | Thrombocytopenia | 148 | 8.0 | 8.3 | signal |
| 22 | Sinus Tachycardia | 18 | 7.6 | 7.7 | signal |
| 23 | Hyperbilirubinaemia | 13 | 7.6 | 7.6 | signal |
| 24 | Neuropathy Peripheral | 119 | 7.6 | 7.8 | signal |
| 25 | Lymphocyte Count Decreased | 22 | 7.5 | 7.5 | signal |
| 26 | Ileus | 15 | 7.3 | 7.3 | signal |
| 27 | Stomatitis | 73 | 7.2 | 7.4 | signal |
| 28 | Impaired Quality Of Life | 17 | 7.1 | 7.1 | signal |
| 29 | Palmar-plantar Erythrodysaesthesia Syndrome | 27 | 6.9 | 7.0 | signal |
| 30 | Alopecia | 225 | 6.9 | 7.3 | signal |
| 31 | Upper Gastrointestinal Haemorrhage | 19 | 6.8 | 6.8 | signal |
| 32 | Hypoxia | 38 | 6.5 | 6.6 | signal |
| 33 | Ventricular Fibrillation | 12 | 6.5 | 6.5 | signal |
| 34 | Anaemia | 199 | 6.3 | 6.6 | signal |
| 35 | Small Intestinal Obstruction | 12 | 5.9 | 5.9 | signal |
| 36 | Altered State Of Consciousness | 21 | 5.8 | 5.9 | signal |
| 37 | Pancytopenia | 51 | 5.5 | 5.6 | signal |
| 38 | Device Related Infection | 14 | 5.4 | 5.5 | signal |
| 39 | Brain Fog | 13 | 5.3 | 5.4 | signal |
| 40 | Leukocytosis | 16 | 5.3 | 5.3 | signal |
| 41 | Hypophagia | 22 | 5.2 | 5.2 | signal |
| 42 | Aspartate Aminotransferase Increased | 46 | 5.2 | 5.3 | signal |
| 43 | Oxygen Saturation Decreased | 48 | 5.2 | 5.2 | signal |
| 44 | Metastases To Liver | 15 | 5.1 | 5.2 | signal |
| 45 | Hyponatraemia | 48 | 5.1 | 5.2 | signal |
| 46 | Adrenal Insufficiency | 10 | 5.0 | 5.0 | signal |
| 47 | Colitis | 31 | 4.9 | 5.0 | signal |
| 48 | Throat Tightness | 22 | 4.9 | 4.9 | signal |
| 49 | Platelet Count Decreased | 86 | 4.8 | 4.9 | signal |
| 50 | Decreased Appetite | 178 | 4.6 | 4.8 | signal |
| 51 | Pancreatitis Acute | 17 | 4.6 | 4.6 | signal |
| 52 | Hyperthyroidism | 11 | 4.6 | 4.6 | signal |
| 53 | Clostridium Difficile Colitis | 8 | 4.5 | 4.5 | signal |
| 54 | Blood Lactate Dehydrogenase Increased | 12 | 4.5 | 4.5 | signal |
| 55 | Ascites | 22 | 4.5 | 4.5 | signal |
| 56 | Dysarthria | 28 | 4.5 | 4.5 | signal |
| 57 | Blood Bilirubin Increased | 20 | 4.4 | 4.5 | signal |
| 58 | Gastric Ulcer | 14 | 4.4 | 4.4 | signal |
| 59 | Toxic Epidermal Necrolysis | 11 | 4.4 | 4.4 | signal |
| 60 | Blood Alkaline Phosphatase Increased | 18 | 4.3 | 4.4 | signal |
| 61 | Blood Test Abnormal | 10 | 4.3 | 4.3 | signal |
| 62 | Intestinal Perforation | 8 | 4.3 | 4.3 | signal |
| 63 | Hospice Care | 7 | 4.3 | 4.3 | signal |
| 64 | Flushing | 71 | 4.2 | 4.2 | signal |
| 65 | Serotonin Syndrome | 13 | 4.1 | 4.1 | signal |
| 66 | Constipation | 144 | 4.0 | 4.1 | signal |
| 67 | Incontinence | 7 | 4.0 | 4.0 | signal |
| 68 | Haematocrit Decreased | 13 | 3.9 | 3.9 | signal |
| 69 | Musculoskeletal Chest Pain | 10 | 3.9 | 3.9 | signal |
| 70 | Dehydration | 86 | 3.9 | 3.9 | signal |
| 71 | Lymphopenia | 9 | 3.8 | 3.8 | signal |
| 72 | Skin Reaction | 9 | 3.8 | 3.8 | signal |
| 73 | Pneumothorax | 10 | 3.8 | 3.8 | signal |
| 74 | Tachycardia | 56 | 3.8 | 3.8 | signal |
| 75 | Bronchospasm | 9 | 3.8 | 3.8 | signal |
| 76 | Nephropathy Toxic | 7 | 3.8 | 3.8 | signal |
| 77 | Metastases To Central Nervous System | 8 | 3.7 | 3.8 | signal |
| 78 | Cold Sweat | 11 | 3.7 | 3.7 | signal |
| 79 | Oral Pain | 14 | 3.7 | 3.8 | signal |
| 80 | Gastroenteritis | 9 | 3.7 | 3.7 | signal |
| 81 | Haematuria | 21 | 3.7 | 3.7 | signal |
| 82 | Multiple Organ Dysfunction Syndrome | 17 | 3.7 | 3.7 | signal |
| 83 | Metastases To Lung | 7 | 3.6 | 3.6 | signal |
| 84 | Disease Progression | 71 | 3.6 | 3.7 | signal |
| 85 | Vasculitis | 7 | 3.6 | 3.6 | signal |
| 86 | Pneumocystis Jirovecii Pneumonia | 6 | 3.6 | 3.6 | signal |
| 87 | Candida Infection | 10 | 3.6 | 3.6 | signal |
| 88 | Cholecystitis | 7 | 3.5 | 3.5 | signal |
| 89 | Alanine Aminotransferase Increased | 36 | 3.5 | 3.5 | signal |
| 90 | Hypocalcaemia | 11 | 3.5 | 3.5 | signal |
| 91 | Septic Shock | 25 | 3.5 | 3.5 | signal |
| 92 | Hypercalcaemia | 7 | 3.4 | 3.4 | signal |
| 93 | Disseminated Intravascular Coagulation | 8 | 3.4 | 3.4 | signal |
| 94 | Anaphylactic Reaction | 31 | 3.4 | 3.4 | signal |
| 95 | Hepatic Failure | 17 | 3.4 | 3.4 | signal |
| 96 | Pleural Effusion | 34 | 3.3 | 3.4 | signal |
| 97 | Acute Kidney Injury | 85 | 3.3 | 3.4 | signal |
| 98 | Vomiting | 259 | 3.3 | 3.5 | signal |
| 99 | Taste Disorder | 11 | 3.3 | 3.3 | signal |
| 100 | Nausea | 432 | 3.3 | 3.6 | signal |
| 101 | Unresponsive To Stimuli | 14 | 3.3 | 3.3 | signal |
| 102 | Rash Maculo-papular | 12 | 3.2 | 3.3 | signal |
| 103 | Interstitial Lung Disease | 26 | 3.2 | 3.2 | signal |
| 104 | Sedation | 14 | 3.2 | 3.2 | signal |
| 105 | Haemoptysis | 15 | 3.2 | 3.2 | signal |
| 106 | Erythema Multiforme | 5 | 3.2 | 3.2 | signal |
| 107 | Circulatory Collapse | 9 | 3.2 | 3.2 | signal |
| 108 | Mouth Ulceration | 11 | 3.1 | 3.1 | signal |
| 109 | Pericardial Effusion | 12 | 3.1 | 3.1 | signal |
| 110 | Acute Myeloid Leukaemia | 8 | 3.1 | 3.1 | signal |
| 111 | Malignant Neoplasm Progression | 52 | 3.1 | 3.1 | signal |
| 112 | Cardiac Arrest | 42 | 3.0 | 3.1 | signal |
| 113 | Feeling Hot | 30 | 2.9 | 2.9 | signal |
| 114 | Hyperkalaemia | 17 | 2.9 | 2.9 | signal |
| 115 | Paraesthesia Oral | 7 | 2.9 | 2.9 | signal |
| 116 | Peritonitis | 10 | 2.9 | 2.9 | signal |
| 117 | Chest Discomfort | 49 | 2.9 | 2.9 | signal |
| 118 | Proteinuria | 9 | 2.9 | 2.9 | signal |
| 119 | Cardio-respiratory Arrest | 20 | 2.9 | 2.9 | signal |
| 120 | White Blood Cell Count Decreased | 51 | 2.8 | 2.8 | signal |
| 121 | Hypoaesthesia Oral | 7 | 2.8 | 2.8 | signal |
| 122 | Syncope | 46 | 2.8 | 2.8 | signal |
| 123 | Stevens-johnson Syndrome | 10 | 2.7 | 2.7 | signal |
| 124 | Epistaxis | 33 | 2.6 | 2.7 | signal |
| 125 | Pallor | 12 | 2.6 | 2.6 | signal |
| 126 | Akathisia | 6 | 2.6 | 2.6 | signal |
| 127 | Myocardial Ischaemia | 5 | 2.6 | 2.6 | no signal |
| 128 | Neoplasm | 5 | 2.6 | 2.6 | no signal |
| 129 | Oropharyngeal Pain | 40 | 2.6 | 2.6 | signal |
| 130 | Diarrhoea Haemorrhagic | 4 | 2.6 | 2.6 | no signal |
| 131 | Cytopenia | 5 | 2.5 | 2.5 | no signal |
| 132 | Haematochezia | 23 | 2.5 | 2.5 | signal |
| 133 | Therapy Change | 4 | 2.5 | 2.5 | no signal |
| 134 | Face Oedema | 7 | 2.5 | 2.5 | signal |
| 135 | Neoplasm Progression | 14 | 2.4 | 2.4 | signal |
| 136 | Bone Marrow Failure | 8 | 2.3 | 2.3 | signal |
| 137 | Lymphoma | 6 | 2.3 | 2.3 | no signal |
| 138 | Lung Infection | 6 | 2.3 | 2.3 | no signal |
| 139 | Oral Discomfort | 5 | 2.2 | 2.2 | no signal |
| 140 | Anaphylactic Shock | 9 | 2.1 | 2.1 | signal |
| 141 | Prescribed Underdose | 7 | 2.1 | 2.1 | no signal |
| 142 | Ovarian Cancer | 3 | 1.9 | 1.9 | no signal |
| 143 | Eructation | 6 | 1.9 | 1.9 | no signal |
| 144 | Metastases To Bone | 5 | 1.8 | 1.8 | no signal |
| 145 | Diabetic Ketoacidosis | 7 | 1.8 | 1.8 | no signal |
| 146 | Emotional Distress | 35 | 1.7 | 1.7 | no signal |
| 147 | Hepatocellular Injury | 4 | 1.7 | 1.7 | no signal |
| 148 | Breast Cancer Metastatic | 3 | 1.7 | 1.7 | no signal |
| 149 | Extrapyramidal Disorder | 7 | 1.7 | 1.7 | no signal |
| 150 | Pulmonary Arterial Hypertension | 4 | 1.6 | 1.6 | no signal |
| 151 | Cytomegalovirus Infection | 4 | 1.4 | 1.4 | no signal |
| 152 | Pancreatic Carcinoma | 6 | 1.2 | 1.2 | no signal |
| 153 | Osteonecrosis Of Jaw | 5 | 1.2 | 1.2 | no signal |
| 154 | Premature Delivery | 3 | 1.1 | 1.1 | no signal |
| 155 | Oesophageal Carcinoma | 5 | 1.0 | 1.0 | no signal |
| 156 | Application Site Erythema | 3 | 0.7 | 0.7 | no signal |