Drug
Palonosetron Hydrochloride
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 | Neutrophil Count Decreased | 235 | 23.3 | 24.4 | signal |
| 2 | Febrile Neutropenia | 338 | 20.5 | 21.9 | signal |
| 3 | Hair Colour Changes | 64 | 20.5 | 20.7 | signal |
| 4 | Hair Texture Abnormal | 64 | 19.1 | 19.3 | signal |
| 5 | Madarosis | 53 | 18.2 | 18.4 | signal |
| 6 | Myelosuppression | 148 | 17.5 | 18.0 | signal |
| 7 | Lymphocyte Count Decreased | 60 | 13.6 | 13.8 | signal |
| 8 | Hypomagnesaemia | 46 | 13.3 | 13.4 | signal |
| 9 | Cytokine Release Syndrome | 59 | 12.4 | 12.6 | signal |
| 10 | Inappropriate Antidiuretic Hormone Secretion | 31 | 12.2 | 12.3 | signal |
| 11 | Hypokalaemia | 133 | 11.6 | 11.9 | signal |
| 12 | Bacteraemia | 34 | 11.6 | 11.7 | signal |
| 13 | Mucosal Inflammation | 67 | 10.3 | 10.4 | signal |
| 14 | Neutropenia | 323 | 9.6 | 10.1 | signal |
| 15 | Respiratory Depression | 29 | 9.5 | 9.5 | signal |
| 16 | Polyneuropathy | 28 | 9.4 | 9.5 | signal |
| 17 | Leukopenia | 115 | 9.2 | 9.4 | signal |
| 18 | Oral Candidiasis | 27 | 8.3 | 8.4 | signal |
| 19 | Pneumonitis | 56 | 8.3 | 8.4 | signal |
| 20 | Infusion Related Reaction | 136 | 8.3 | 8.4 | signal |
| 21 | Ileus | 24 | 7.8 | 7.8 | signal |
| 22 | Aspartate Aminotransferase Increased | 96 | 7.2 | 7.4 | signal |
| 23 | Platelet Count Decreased | 190 | 7.1 | 7.4 | signal |
| 24 | Upper Gastrointestinal Haemorrhage | 28 | 6.6 | 6.7 | signal |
| 25 | Thrombotic Microangiopathy | 16 | 6.6 | 6.6 | signal |
| 26 | Thrombocytopenia | 184 | 6.6 | 6.8 | signal |
| 27 | Anaemia | 312 | 6.5 | 6.9 | signal |
| 28 | Stomatitis | 99 | 6.5 | 6.6 | signal |
| 29 | Neuropathy Peripheral | 151 | 6.4 | 6.6 | signal |
| 30 | Interstitial Lung Disease | 77 | 6.4 | 6.5 | signal |
| 31 | Palmar-plantar Erythrodysaesthesia Syndrome | 37 | 6.3 | 6.4 | signal |
| 32 | Altered State Of Consciousness | 32 | 5.9 | 6.0 | signal |
| 33 | Alanine Aminotransferase Increased | 91 | 5.9 | 6.0 | signal |
| 34 | White Blood Cell Count Decreased | 157 | 5.8 | 5.9 | signal |
| 35 | Hypocalcaemia | 27 | 5.7 | 5.8 | signal |
| 36 | Device Related Infection | 22 | 5.7 | 5.7 | signal |
| 37 | Alopecia | 278 | 5.7 | 5.9 | signal |
| 38 | Sinus Tachycardia | 20 | 5.7 | 5.7 | signal |
| 39 | Impaired Quality Of Life | 20 | 5.6 | 5.6 | signal |
| 40 | Blood Lactate Dehydrogenase Increased | 22 | 5.5 | 5.5 | signal |
| 41 | Bone Marrow Failure | 28 | 5.5 | 5.5 | signal |
| 42 | Hyperbilirubinaemia | 14 | 5.4 | 5.5 | signal |
| 43 | Ventricular Fibrillation | 15 | 5.4 | 5.4 | signal |
| 44 | Ascites | 38 | 5.2 | 5.2 | signal |
| 45 | Malignant Neoplasm Progression | 130 | 5.1 | 5.2 | signal |
| 46 | Hypoxia | 44 | 5.0 | 5.1 | signal |
| 47 | Metastases To Liver | 22 | 5.0 | 5.0 | signal |
| 48 | Hyponatraemia | 69 | 4.9 | 5.0 | signal |
| 49 | Small Intestinal Obstruction | 15 | 4.9 | 4.9 | signal |
| 50 | Pancytopenia | 68 | 4.9 | 4.9 | signal |
| 51 | Disseminated Intravascular Coagulation | 17 | 4.8 | 4.8 | signal |
| 52 | Drug-induced Liver Injury | 37 | 4.8 | 4.8 | signal |
| 53 | Decreased Appetite | 272 | 4.7 | 4.9 | signal |
| 54 | Adrenal Insufficiency | 14 | 4.7 | 4.7 | signal |
| 55 | Blood Alkaline Phosphatase Increased | 29 | 4.7 | 4.7 | signal |
| 56 | Leukocytosis | 21 | 4.6 | 4.7 | signal |
| 57 | Lymphopenia | 16 | 4.6 | 4.6 | signal |
| 58 | Oxygen Saturation Decreased | 63 | 4.5 | 4.6 | signal |
| 59 | Mouth Ulceration | 23 | 4.4 | 4.4 | signal |
| 60 | Hepatic Failure | 33 | 4.4 | 4.4 | signal |
| 61 | Ear Discomfort | 11 | 4.3 | 4.3 | signal |
| 62 | Blood Bilirubin Increased | 29 | 4.3 | 4.3 | signal |
| 63 | Electrolyte Imbalance | 12 | 4.2 | 4.2 | signal |
| 64 | Hepatic Function Abnormal | 38 | 4.1 | 4.1 | signal |
| 65 | Cholecystitis | 12 | 4.0 | 4.0 | signal |
| 66 | Haematuria | 34 | 4.0 | 4.0 | signal |
| 67 | Colitis | 37 | 3.9 | 4.0 | signal |
| 68 | Constipation | 212 | 3.9 | 4.0 | signal |
| 69 | Oral Pain | 22 | 3.9 | 3.9 | signal |
| 70 | Multiple Organ Dysfunction Syndrome | 27 | 3.9 | 3.9 | signal |
| 71 | Gastroenteritis | 14 | 3.8 | 3.9 | signal |
| 72 | Hypophagia | 24 | 3.8 | 3.8 | signal |
| 73 | Vasculitis | 11 | 3.8 | 3.8 | signal |
| 74 | Metastases To Central Nervous System | 12 | 3.7 | 3.8 | signal |
| 75 | Throat Tightness | 25 | 3.7 | 3.7 | signal |
| 76 | C-reactive Protein Increased | 33 | 3.6 | 3.6 | signal |
| 77 | Prescribed Underdose | 18 | 3.6 | 3.6 | signal |
| 78 | Pneumocystis Jirovecii Pneumonia | 9 | 3.6 | 3.6 | signal |
| 79 | Brain Fog | 13 | 3.6 | 3.6 | signal |
| 80 | Disease Progression | 105 | 3.6 | 3.6 | signal |
| 81 | Serotonin Syndrome | 17 | 3.6 | 3.6 | signal |
| 82 | Acute Respiratory Failure | 17 | 3.6 | 3.6 | signal |
| 83 | Temperature Intolerance | 9 | 3.5 | 3.5 | signal |
| 84 | Flushing | 89 | 3.5 | 3.5 | signal |
| 85 | Peritonitis | 18 | 3.5 | 3.5 | signal |
| 86 | Urosepsis | 8 | 3.5 | 3.5 | signal |
| 87 | Toxic Epidermal Necrolysis | 13 | 3.5 | 3.5 | signal |
| 88 | Erythema Multiforme | 8 | 3.4 | 3.4 | signal |
| 89 | Skin Reaction | 12 | 3.4 | 3.4 | signal |
| 90 | Pancreatitis Acute | 19 | 3.4 | 3.4 | signal |
| 91 | Clostridium Difficile Colitis | 9 | 3.4 | 3.4 | signal |
| 92 | Dehydration | 113 | 3.4 | 3.4 | signal |
| 93 | Gastric Ulcer | 16 | 3.4 | 3.4 | signal |
| 94 | Delirium | 29 | 3.4 | 3.4 | signal |
| 95 | Cytopenia | 10 | 3.3 | 3.4 | signal |
| 96 | Sepsis | 93 | 3.3 | 3.4 | signal |
| 97 | Dysarthria | 31 | 3.3 | 3.3 | signal |
| 98 | Pyrexia | 283 | 3.3 | 3.4 | signal |
| 99 | Haematocrit Decreased | 16 | 3.2 | 3.2 | signal |
| 100 | Acute Kidney Injury | 121 | 3.2 | 3.2 | signal |
| 101 | Tachycardia | 70 | 3.2 | 3.2 | signal |
| 102 | Ventricular Tachycardia | 13 | 3.1 | 3.1 | signal |
| 103 | Metastases To Lung | 9 | 3.1 | 3.1 | signal |
| 104 | Candida Infection | 13 | 3.1 | 3.1 | signal |
| 105 | Musculoskeletal Chest Pain | 12 | 3.1 | 3.1 | signal |
| 106 | Hyperglycaemia | 28 | 3.1 | 3.1 | signal |
| 107 | Bronchospasm | 11 | 3.1 | 3.1 | signal |
| 108 | Gamma-glutamyltransferase Increased | 17 | 3.1 | 3.1 | signal |
| 109 | Septic Shock | 33 | 3.1 | 3.1 | signal |
| 110 | Hyperthyroidism | 11 | 3.0 | 3.0 | signal |
| 111 | Vomiting | 356 | 3.0 | 3.2 | signal |
| 112 | Nausea | 597 | 3.0 | 3.3 | signal |
| 113 | Taste Disorder | 15 | 3.0 | 3.0 | signal |
| 114 | Proteinuria | 14 | 3.0 | 3.0 | signal |
| 115 | Drug Eruption | 13 | 3.0 | 3.0 | signal |
| 116 | Pleural Effusion | 44 | 2.9 | 2.9 | signal |
| 117 | Blood Test Abnormal | 10 | 2.9 | 2.9 | signal |
| 118 | Intestinal Perforation | 8 | 2.8 | 2.9 | signal |
| 119 | Hospice Care | 7 | 2.8 | 2.8 | signal |
| 120 | Circulatory Collapse | 12 | 2.8 | 2.8 | signal |
| 121 | Lung Infection | 11 | 2.8 | 2.8 | signal |
| 122 | Productive Cough | 33 | 2.8 | 2.8 | signal |
| 123 | Pneumothorax | 11 | 2.8 | 2.8 | signal |
| 124 | Epistaxis | 52 | 2.8 | 2.8 | signal |
| 125 | Cardio-respiratory Arrest | 29 | 2.8 | 2.8 | signal |
| 126 | Respiratory Failure | 50 | 2.7 | 2.8 | signal |
| 127 | Neutrophil Count Increased | 7 | 2.7 | 2.7 | signal |
| 128 | Cold Sweat | 12 | 2.7 | 2.7 | signal |
| 129 | Rash Maculo-papular | 15 | 2.7 | 2.7 | signal |
| 130 | Chest Discomfort | 69 | 2.7 | 2.7 | signal |
| 131 | Anaphylactic Reaction | 37 | 2.7 | 2.7 | signal |
| 132 | Upper Respiratory Tract Infection | 31 | 2.7 | 2.7 | signal |
| 133 | Colon Cancer | 10 | 2.7 | 2.7 | signal |
| 134 | Anaphylactic Shock | 17 | 2.7 | 2.7 | signal |
| 135 | Oedema Peripheral | 81 | 2.6 | 2.7 | signal |
| 136 | Incontinence | 7 | 2.6 | 2.6 | signal |
| 137 | Hyperkalaemia | 23 | 2.6 | 2.6 | signal |
| 138 | Blood Urea Increased | 11 | 2.6 | 2.6 | signal |
| 139 | Pericardial Effusion | 15 | 2.6 | 2.6 | signal |
| 140 | Face Oedema | 11 | 2.6 | 2.6 | signal |
| 141 | Appendicitis | 6 | 2.6 | 2.6 | signal |
| 142 | Haemoptysis | 18 | 2.6 | 2.6 | signal |
| 143 | Deep Vein Thrombosis | 42 | 2.6 | 2.6 | signal |
| 144 | Acute Myeloid Leukaemia | 10 | 2.6 | 2.6 | signal |
| 145 | Flank Pain | 6 | 2.6 | 2.6 | signal |
| 146 | Hypotension | 128 | 2.6 | 2.6 | signal |
| 147 | Abdominal Pain | 147 | 2.5 | 2.6 | signal |
| 148 | Nephropathy Toxic | 7 | 2.5 | 2.5 | signal |
| 149 | Stevens-johnson Syndrome | 14 | 2.5 | 2.5 | signal |
| 150 | Hepatitis | 16 | 2.5 | 2.5 | signal |
| 151 | Haematochezia | 34 | 2.5 | 2.5 | signal |
| 152 | Pneumonia | 199 | 2.5 | 2.5 | signal |
| 153 | Haemorrhoids | 12 | 2.5 | 2.5 | signal |
| 154 | Sedation | 16 | 2.5 | 2.5 | signal |
| 155 | Hepatomegaly | 6 | 2.4 | 2.4 | no signal |
| 156 | Neoplasm Progression | 21 | 2.4 | 2.4 | signal |
| 157 | Agranulocytosis | 11 | 2.4 | 2.4 | signal |
| 158 | Cardiac Arrest | 49 | 2.4 | 2.4 | signal |
| 159 | Syncope | 59 | 2.4 | 2.4 | signal |
| 160 | Akathisia | 8 | 2.3 | 2.3 | signal |
| 161 | Unresponsive To Stimuli | 15 | 2.3 | 2.3 | signal |
| 162 | Ejection Fraction Decreased | 9 | 2.3 | 2.3 | signal |
| 163 | Drug Interaction | 91 | 2.3 | 2.3 | signal |
| 164 | Cerebral Infarction | 14 | 2.3 | 2.3 | signal |
| 165 | Chills | 67 | 2.3 | 2.3 | signal |
| 166 | Gastritis | 15 | 2.3 | 2.3 | signal |
| 167 | Diarrhoea | 366 | 2.3 | 2.4 | signal |
| 168 | Lacrimation Increased | 17 | 2.3 | 2.3 | signal |
| 169 | Hypercalcaemia | 7 | 2.3 | 2.3 | no signal |
| 170 | Hypothyroidism | 18 | 2.3 | 2.3 | signal |
| 171 | Acute Respiratory Distress Syndrome | 10 | 2.3 | 2.3 | signal |
| 172 | Eating Disorder | 12 | 2.2 | 2.2 | signal |
| 173 | Red Blood Cell Count Decreased | 16 | 2.2 | 2.2 | signal |
| 174 | Feeling Hot | 34 | 2.2 | 2.2 | signal |
| 175 | Urinary Retention | 18 | 2.2 | 2.2 | signal |
| 176 | Acute Myocardial Infarction | 16 | 2.2 | 2.2 | signal |
| 177 | Liver Injury | 13 | 2.2 | 2.2 | signal |
| 178 | Asthenia | 201 | 2.1 | 2.2 | signal |
| 179 | Diarrhoea Haemorrhagic | 5 | 2.1 | 2.1 | no signal |
| 180 | Hypoaesthesia Oral | 8 | 2.1 | 2.1 | no signal |
| 181 | Myocardial Ischaemia | 6 | 2.1 | 2.1 | no signal |
| 182 | Dysgeusia | 39 | 2.1 | 2.1 | signal |
| 183 | Oropharyngeal Pain | 48 | 2.1 | 2.1 | signal |
| 184 | Neurotoxicity | 9 | 2.1 | 2.1 | no signal |
| 185 | Retching | 11 | 2.1 | 2.1 | signal |
| 186 | Pallor | 14 | 2.1 | 2.1 | signal |
| 187 | Oral Discomfort | 7 | 2.0 | 2.0 | no signal |
| 188 | Paraesthesia Oral | 7 | 1.9 | 1.9 | no signal |
| 189 | Chromaturia | 11 | 1.9 | 2.0 | no signal |
| 190 | Limb Discomfort | 15 | 1.9 | 1.9 | no signal |
| 191 | Dermatitis | 10 | 1.9 | 1.9 | no signal |
| 192 | Jaundice | 13 | 1.9 | 1.9 | no signal |
| 193 | Dermatitis Allergic | 6 | 1.9 | 1.9 | no signal |
| 194 | Cytomegalovirus Infection | 8 | 1.9 | 1.9 | no signal |
| 195 | Tubulointerstitial Nephritis | 9 | 1.9 | 1.9 | no signal |
| 196 | Bone Pain | 28 | 1.9 | 1.9 | no signal |
| 197 | Muscle Twitching | 11 | 1.9 | 1.9 | no signal |
| 198 | Haematemesis | 12 | 1.9 | 1.9 | no signal |
| 199 | Lymphoma | 7 | 1.8 | 1.8 | no signal |
| 200 | Transaminases Increased | 10 | 1.8 | 1.8 | no signal |
| 201 | Paraesthesia | 70 | 1.8 | 1.8 | no signal |
| 202 | Erythema | 91 | 1.8 | 1.8 | no signal |
| 203 | Gastrointestinal Haemorrhage | 37 | 1.8 | 1.8 | no signal |
| 204 | Gingival Bleeding | 6 | 1.8 | 1.8 | no signal |
| 205 | Neoplasm | 5 | 1.7 | 1.7 | no signal |
| 206 | Metastases To Bone | 7 | 1.7 | 1.7 | no signal |
| 207 | Generalised Tonic-clonic Seizure | 7 | 1.7 | 1.7 | no signal |
| 208 | Hyperhidrosis | 54 | 1.7 | 1.7 | no signal |
| 209 | Diabetic Ketoacidosis | 10 | 1.7 | 1.7 | no signal |
| 210 | Therapy Change | 4 | 1.7 | 1.7 | no signal |
| 211 | Therapy Partial Responder | 6 | 1.6 | 1.6 | no signal |
| 212 | Initial Insomnia | 4 | 1.6 | 1.6 | no signal |
| 213 | Pain Of Skin | 10 | 1.5 | 1.5 | no signal |
| 214 | Eructation | 7 | 1.5 | 1.5 | no signal |
| 215 | Rhabdomyolysis | 15 | 1.4 | 1.4 | no signal |
| 216 | Throat Irritation | 16 | 1.4 | 1.4 | no signal |
| 217 | Hepatocellular Injury | 5 | 1.4 | 1.4 | no signal |
| 218 | Full Blood Count Decreased | 7 | 1.4 | 1.4 | no signal |
| 219 | Eosinophilia | 6 | 1.4 | 1.4 | no signal |
| 220 | Lactic Acidosis | 11 | 1.4 | 1.4 | no signal |
| 221 | Haemorrhage Intracranial | 5 | 1.3 | 1.3 | no signal |
| 222 | Ovarian Cancer | 3 | 1.3 | 1.3 | no signal |
| 223 | Emotional Distress | 39 | 1.3 | 1.3 | no signal |
| 224 | Extrapyramidal Disorder | 8 | 1.3 | 1.3 | no signal |
| 225 | Angioedema | 14 | 1.3 | 1.3 | no signal |
| 226 | Death | 264 | 1.2 | 1.2 | no signal |
| 227 | Breast Cancer Metastatic | 3 | 1.1 | 1.1 | no signal |
| 228 | Myelodysplastic Syndrome | 4 | 1.1 | 1.1 | no signal |
| 229 | Pulmonary Arterial Hypertension | 4 | 1.1 | 1.1 | no signal |
| 230 | Blood Count Abnormal | 4 | 1.0 | 1.0 | no signal |
| 231 | Underdose | 18 | 1.0 | 1.0 | no signal |
| 232 | Pancreatic Carcinoma | 7 | 1.0 | 1.0 | no signal |
| 233 | Dystonia | 4 | 0.8 | 0.8 | no signal |
| 234 | Osteonecrosis Of Jaw | 5 | 0.8 | 0.8 | no signal |
| 235 | Premature Delivery | 3 | 0.7 | 0.7 | no signal |
| 236 | Oesophageal Carcinoma | 5 | 0.7 | 0.7 | no signal |
| 237 | Injection Site Mass | 6 | 0.7 | 0.7 | no signal |
| 238 | Application Site Erythema | 3 | 0.5 | 0.5 | no signal |