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Drug

Palonosetron

156 flagged reaction(s) · 5,539 total co-reports · max PRR 27.8
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