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Drug

Palonosetron Hydrochloride

238 flagged reaction(s) · 11,170 total co-reports · max PRR 23.3
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