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Drug

Vinorelbine

302 flagged reaction(s) · 19,272 total co-reports · max PRR 72.5
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 Breast Cancer Metastatic 249 72.5 75.2 signal
2 Metastases To Lung 183 49.2 50.5 signal
3 Metastases To Bone 252 47.8 49.5 signal
4 Metastases To Liver 254 44.9 46.6 signal
5 Haematotoxicity 133 44.4 45.3 signal
6 Metastases To Central Nervous System 173 41.8 42.8 signal
7 Palmar-plantar Erythrodysaesthesia Syndrome 239 31.5 32.6 signal
8 Mucosal Inflammation 203 24.0 24.7 signal
9 Malignant Neoplasm Progression 699 21.1 23.4 signal
10 Disease Progression 776 20.2 22.7 signal
11 Ejection Fraction Decreased 91 17.9 18.2 signal
12 Polyneuropathy 68 17.5 17.7 signal
13 Febrile Neutropenia 371 17.2 18.1 signal
14 Therapy Partial Responder 80 16.3 16.5 signal
15 Osteonecrosis Of Jaw 129 15.9 16.2 signal
16 Pneumonitis 139 15.8 16.1 signal
17 Bone Marrow Failure 105 15.7 16.0 signal
18 Neutropenia 668 15.1 16.6 signal
19 Pneumocystis Jirovecii Pneumonia 49 15.0 15.1 signal
20 Neoplasm Progression 144 12.6 12.8 signal
21 Leukopenia 200 12.3 12.6 signal
22 Ascites 110 11.5 11.6 signal
23 Neurotoxicity 63 11.1 11.2 signal
24 Nephropathy Toxic 40 11.0 11.1 signal
25 Oesophagitis 39 10.9 11.0 signal
26 Pleural Effusion 210 10.6 10.9 signal
27 Thrombocytopenia 375 10.3 10.8 signal
28 Clostridium Difficile Colitis 32 9.2 9.3 signal
29 Hepatotoxicity 65 9.0 9.1 signal
30 Pneumothorax 46 8.9 8.9 signal
31 Blood Lactate Dehydrogenase Increased 46 8.8 8.9 signal
32 Acute Myeloid Leukaemia 41 8.1 8.1 signal
33 Thrombotic Microangiopathy 25 7.9 7.9 signal
34 Drug Resistance 64 7.6 7.7 signal
35 Myelodysplastic Syndrome 36 7.6 7.6 signal
36 Myelosuppression 81 7.3 7.4 signal
37 Anaemia 452 7.2 7.7 signal
38 Interstitial Lung Disease 114 7.2 7.3 signal
39 Neuropathy Peripheral 221 7.2 7.4 signal
40 Pericardial Effusion 52 6.9 7.0 signal
41 Breast Pain 24 6.9 6.9 signal
42 Pancytopenia 125 6.9 7.0 signal
43 Hyperbilirubinaemia 23 6.8 6.8 signal
44 Sputum Discoloured 21 6.8 6.8 signal
45 Hypomagnesaemia 30 6.6 6.6 signal
46 Agranulocytosis 39 6.5 6.5 signal
47 Cytopenia 25 6.4 6.4 signal
48 Disease Recurrence 98 6.3 6.4 signal
49 Osteonecrosis 68 6.3 6.3 signal
50 Atelectasis 19 6.0 6.0 signal
51 Brain Oedema 24 5.8 5.8 signal
52 Posterior Reversible Encephalopathy Syndrome 18 5.8 5.8 signal
53 General Physical Health Deterioration 214 5.7 5.8 signal
54 Candida Infection 31 5.7 5.7 signal
55 Hepatic Failure 56 5.7 5.7 signal
56 Lymphopenia 26 5.7 5.7 signal
57 Dyspnoea Exertional 68 5.5 5.6 signal
58 Tooth Extraction 22 5.4 5.4 signal
59 Neutrophil Count Increased 18 5.4 5.4 signal
60 Pulmonary Mass 26 5.3 5.4 signal
61 Jaundice 47 5.3 5.4 signal
62 Hypercalcaemia 21 5.2 5.2 signal
63 Septic Shock 72 5.1 5.1 signal
64 Lymphadenopathy 57 4.9 5.0 signal
65 Blood Alkaline Phosphatase Increased 40 4.9 4.9 signal
66 Toxic Skin Eruption 16 4.8 4.8 signal
67 Bone Disorder 29 4.8 4.8 signal
68 Gamma-glutamyltransferase Increased 35 4.8 4.8 signal
69 Stomatitis 95 4.8 4.8 signal
70 Breast Cancer 146 4.7 4.8 signal
71 Aspartate Aminotransferase Increased 81 4.7 4.7 signal
72 Hypokalaemia 70 4.7 4.7 signal
73 Blood Bilirubin Increased 41 4.6 4.6 signal
74 Pulmonary Embolism 144 4.6 4.7 signal
75 Cytomegalovirus Infection 25 4.6 4.6 signal
76 Mouth Ulceration 31 4.5 4.5 signal
77 C-reactive Protein Increased 53 4.5 4.5 signal
78 Transaminases Increased 32 4.4 4.4 signal
79 Neuralgia 34 4.3 4.3 signal
80 Mass 19 4.1 4.2 signal
81 Haemoptysis 37 4.0 4.1 signal
82 Hepatic Function Abnormal 49 4.0 4.1 signal
83 Alanine Aminotransferase Increased 81 4.0 4.1 signal
84 Cholestasis 25 4.0 4.0 signal
85 Ocular Discomfort 14 3.9 3.9 signal
86 Respiratory Failure 94 3.9 4.0 signal
87 Bacteraemia 15 3.9 3.9 signal
88 Lung Infection 20 3.9 3.9 signal
89 Fracture 24 3.9 3.9 signal
90 Therapy Non-responder 56 3.8 3.9 signal
91 Sepsis 140 3.8 3.9 signal
92 Sensory Disturbance 20 3.8 3.8 signal
93 Musculoskeletal Chest Pain 19 3.7 3.8 signal
94 Neutrophil Count Decreased 49 3.7 3.7 signal
95 Hypocalcaemia 22 3.6 3.6 signal
96 Skin Fissures 22 3.6 3.6 signal
97 Colitis 43 3.5 3.5 signal
98 Bacterial Infection 21 3.5 3.5 signal
99 Splenomegaly 13 3.4 3.4 signal
100 Vaginal Discharge 11 3.3 3.3 signal
101 Bone Pain 64 3.3 3.4 signal
102 Ileus 13 3.2 3.2 signal
103 Pulmonary Fibrosis 20 3.2 3.2 signal
104 Neoplasm 12 3.2 3.2 signal
105 Blood Creatinine Increased 68 3.2 3.2 signal
106 Hypokinesia 15 3.2 3.2 signal
107 Pyrexia 352 3.1 3.2 signal
108 Drug Intolerance 96 3.0 3.1 signal
109 Hypotonia 10 3.0 3.0 signal
110 Osteomyelitis 18 3.0 3.0 signal
111 Infection 141 3.0 3.0 signal
112 Generalised Tonic-clonic Seizure 16 3.0 3.0 signal
113 Squamous Cell Carcinoma 9 2.9 2.9 signal
114 Hypothyroidism 30 2.9 2.9 signal
115 Ulcer 15 2.9 2.9 signal
116 Spinal Pain 11 2.9 2.9 signal
117 Liver Disorder 41 2.8 2.8 signal
118 Product Use In Unapproved Indication 226 2.8 2.9 signal
119 Aspiration 10 2.8 2.8 signal
120 Hip Arthroplasty 14 2.8 2.8 signal
121 Deep Vein Thrombosis 60 2.8 2.8 signal
122 Pain In Jaw 26 2.8 2.8 signal
123 Multi-organ Failure 16 2.8 2.8 signal
124 Tubulointerstitial Nephritis 17 2.8 2.8 signal
125 White Blood Cell Count Decreased 98 2.8 2.8 signal
126 Hepatitis 23 2.7 2.8 signal
127 Constipation 193 2.7 2.8 signal
128 Lower Limb Fracture 17 2.7 2.7 signal
129 No Therapeutic Response 11 2.7 2.7 signal
130 Respiratory Tract Infection 23 2.7 2.7 signal
131 Decreased Appetite 205 2.7 2.8 signal
132 Hypoxia 31 2.7 2.7 signal
133 Mitral Valve Incompetence 10 2.7 2.7 signal
134 Skin Lesion 24 2.7 2.7 signal
135 Drug Toxicity 12 2.7 2.7 signal
136 Liver Injury 21 2.7 2.7 signal
137 Urosepsis 8 2.7 2.7 signal
138 Angina Pectoris 25 2.6 2.7 signal
139 Tenderness 9 2.6 2.6 signal
140 Oedema 46 2.6 2.6 signal
141 Therapeutic Product Effect Incomplete 60 2.6 2.6 signal
142 Lymphocyte Count Decreased 15 2.6 2.6 signal
143 Restlessness 31 2.6 2.6 signal
144 Vomiting 395 2.6 2.7 signal
145 Sudden Death 9 2.6 2.6 signal
146 Anorexia 11 2.6 2.6 signal
147 Cytokine Release Syndrome 16 2.6 2.6 signal
148 Renal Impairment 70 2.6 2.6 signal
149 Nervous System Disorder 26 2.5 2.5 signal
150 Dermatitis 17 2.5 2.5 signal
151 Conjunctivitis 15 2.5 2.5 signal
152 Immunodeficiency 12 2.5 2.5 signal
153 Cough 227 2.5 2.5 signal
154 Hepatomegaly 8 2.5 2.5 signal
155 Fistula 9 2.4 2.4 signal
156 Proteinuria 15 2.4 2.4 signal
157 Acute Respiratory Distress Syndrome 14 2.4 2.4 signal
158 Diarrhoea 508 2.4 2.5 signal
159 Drug Ineffective For Unapproved Indication 44 2.4 2.4 signal
160 Multiple Organ Dysfunction Syndrome 22 2.4 2.4 signal
161 Peritonitis 16 2.4 2.4 signal
162 Ventricular Extrasystoles 8 2.3 2.4 signal
163 Acute Kidney Injury 117 2.3 2.4 signal
164 Asthenia 288 2.3 2.4 signal
165 Hyponatraemia 43 2.3 2.3 signal
166 Off Label Use 656 2.3 2.4 signal
167 Adrenal Insufficiency 9 2.3 2.3 signal
168 Haematocrit Decreased 15 2.3 2.3 signal
169 Urinary Retention 25 2.3 2.3 signal
170 Liver Function Test Increased 16 2.3 2.3 signal
171 Lethargy 43 2.3 2.3 signal
172 Blindness 30 2.3 2.3 signal
173 Hepatic Cytolysis 9 2.2 2.3 signal
174 Skin Ulcer 19 2.2 2.3 signal
175 Pneumonia 237 2.2 2.3 signal
176 Musculoskeletal Disorder 14 2.2 2.2 signal
177 Rash Maculo-papular 16 2.2 2.2 signal
178 Hyperglycaemia 26 2.2 2.2 signal
179 Eye Infection 8 2.2 2.2 no signal
180 Intentional Product Use Issue 62 2.2 2.2 signal
181 Red Blood Cell Count Decreased 20 2.1 2.1 signal
182 Paralysis 10 2.1 2.1 signal
183 Electrolyte Imbalance 8 2.1 2.1 no signal
184 Toxicity To Various Agents 116 2.1 2.1 signal
185 Hypothermia 7 2.1 2.1 no signal
186 Cardiac Failure 55 2.1 2.1 signal
187 Liver Function Test Abnormal 20 2.1 2.1 signal
188 Wound 19 2.1 2.1 signal
189 Night Sweats 22 2.1 2.1 signal
190 Epistaxis 51 2.1 2.1 signal
191 Herpes Zoster 39 2.1 2.1 signal
192 Psychotic Disorder 20 2.1 2.1 signal
193 Cardiomyopathy 10 2.1 2.1 signal
194 Cholecystitis 8 2.1 2.1 no signal
195 Intestinal Obstruction 25 2.0 2.0 signal
196 Platelet Count Decreased 71 2.0 2.0 signal
197 Alopecia 130 2.0 2.0 signal
198 Treatment Failure 54 2.0 2.0 signal
199 Renal Failure Acute 28 2.0 2.0 no signal
200 Device Related Infection 10 2.0 2.0 no signal
201 Lymphoma 10 2.0 2.0 no signal
202 Dysphagia 61 2.0 2.0 no signal
203 Circulatory Collapse 11 2.0 2.0 no signal
204 Haemoglobin Decreased 66 2.0 2.0 no signal
205 Nausea 503 1.9 2.0 no signal
206 Leukaemia 6 1.9 1.9 no signal
207 Hair Colour Changes 8 1.9 1.9 no signal
208 Dental Caries 7 1.9 1.9 no signal
209 Cold Sweat 11 1.9 1.9 no signal
210 Intestinal Perforation 7 1.9 1.9 no signal
211 Blood Calcium Decreased 7 1.9 1.9 no signal
212 Myocarditis 7 1.9 1.9 no signal
213 Dysphonia 36 1.9 1.9 no signal
214 Ischaemic Stroke 11 1.9 1.9 no signal
215 Dehydration 82 1.9 1.9 no signal
216 Gastrointestinal Disorder 54 1.9 1.9 no signal
217 Impaired Healing 20 1.9 1.9 no signal
218 Thrombosis 49 1.9 1.9 no signal
219 Lung Neoplasm Malignant 25 1.8 1.9 no signal
220 Quality Of Life Decreased 8 1.8 1.8 no signal
221 Cellulitis 30 1.8 1.8 no signal
222 Hair Texture Abnormal 8 1.8 1.8 no signal
223 Inappropriate Antidiuretic Hormone Secretion 6 1.8 1.8 no signal
224 Tooth Abscess 6 1.8 1.8 no signal
225 Dyspnoea 332 1.8 1.8 no signal
226 Fatigue 452 1.8 1.8 no signal
227 Folliculitis 6 1.8 1.8 no signal
228 Oral Pain 13 1.8 1.8 no signal
229 Central Nervous System Lesion 8 1.8 1.8 no signal
230 Gastritis 15 1.7 1.7 no signal
231 Full Blood Count Abnormal 6 1.7 1.7 no signal
232 Disseminated Intravascular Coagulation 8 1.7 1.7 no signal
233 Abscess 9 1.7 1.7 no signal
234 Therapeutic Response Decreased 34 1.7 1.7 no signal
235 Hepatocellular Injury 8 1.7 1.7 no signal
236 Cardiogenic Shock 8 1.7 1.7 no signal
237 Pain Of Skin 15 1.7 1.7 no signal
238 Haematemesis 14 1.7 1.7 no signal
239 Skin Disorder 18 1.7 1.7 no signal
240 Pericarditis 9 1.6 1.6 no signal
241 Hypertensive Crisis 6 1.6 1.6 no signal
242 Incorrect Route Of Product Administration 9 1.6 1.6 no signal
243 Hemiparesis 9 1.6 1.6 no signal
244 Epilepsy 16 1.6 1.6 no signal
245 Atrial Fibrillation 51 1.6 1.6 no signal
246 Muscle Twitching 12 1.6 1.6 no signal
247 Infusion Related Reaction 34 1.6 1.6 no signal
248 Vasculitis 6 1.6 1.6 no signal
249 Madarosis 6 1.6 1.6 no signal
250 Gingival Bleeding 7 1.6 1.6 no signal
251 Acute Myocardial Infarction 15 1.5 1.5 no signal
252 Lacrimation Increased 15 1.5 1.5 no signal
253 Diplopia 13 1.5 1.5 no signal
254 Blindness Unilateral 7 1.5 1.5 no signal
255 Vertigo 30 1.5 1.5 no signal
256 Drug Effect Incomplete 18 1.5 1.5 no signal
257 Paraesthesia Oral 7 1.5 1.5 no signal
258 Drug Effective For Unapproved Indication 14 1.5 1.5 no signal
259 Paraesthesia 74 1.4 1.4 no signal
260 Toxic Epidermal Necrolysis 7 1.4 1.4 no signal
261 Clostridium Difficile Infection 10 1.4 1.4 no signal
262 Haematoma 12 1.4 1.4 no signal
263 Melaena 10 1.4 1.4 no signal
264 Basal Cell Carcinoma 7 1.4 1.4 no signal
265 Dysgeusia 33 1.3 1.4 no signal
266 Acute Hepatic Failure 6 1.3 1.3 no signal
267 Pelvic Pain 8 1.3 1.3 no signal
268 Shock 10 1.3 1.3 no signal
269 Hypoglycaemia 21 1.3 1.3 no signal
270 Skin Reaction 6 1.3 1.3 no signal
271 Limb Discomfort 13 1.3 1.3 no signal
272 Neoplasm Malignant 28 1.3 1.3 no signal
273 Bronchospasm 6 1.3 1.3 no signal
274 Depressed Mood 22 1.3 1.3 no signal
275 Hepatitis C 5 1.2 1.2 no signal
276 Rash Pruritic 22 1.2 1.2 no signal
277 Throat Irritation 18 1.2 1.2 no signal
278 Anaphylactic Reaction 22 1.2 1.2 no signal
279 Eczema 20 1.2 1.2 no signal
280 Local Swelling 7 1.2 1.2 no signal
281 Death 332 1.2 1.2 no signal
282 Complication Associated With Device 5 1.2 1.2 no signal
283 Skin Exfoliation 30 1.1 1.1 no signal
284 Prostatic Specific Antigen Increased 5 1.1 1.1 no signal
285 Colitis Ulcerative 16 1.1 1.1 no signal
286 Status Epilepticus 4 1.1 1.1 no signal
287 Pulmonary Arterial Hypertension 5 1.0 1.0 no signal
288 Brain Neoplasm 3 1.0 1.0 no signal
289 Ovarian Cancer 3 1.0 1.0 no signal
290 Grand Mal Convulsion 3 1.0 1.0 no signal
291 Gynaecomastia 10 1.0 1.0 no signal
292 Poisoning 4 1.0 1.0 no signal
293 Breast Cancer Female 8 0.9 0.9 no signal
294 Suicide Attempt 18 0.9 0.9 no signal
295 Adverse Event 27 0.9 0.9 no signal
296 Skin Cancer 6 0.9 0.8 no signal
297 Injection Site Extravasation 3 0.7 0.7 no signal
298 Tooth Loss 5 0.7 0.7 no signal
299 Aggression 12 0.7 0.7 no signal
300 Injection Site Irritation 3 0.7 0.7 no signal
301 Skin Burning Sensation 16 0.7 0.7 no signal
302 Amenorrhoea 3 0.5 0.5 no signal