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Drug

Enfortumab Vedotin

240 flagged reaction(s) · 15,279 total co-reports · max PRR 35.5
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 Taste Disorder 242 35.5 36.7 signal
2 Toxic Epidermal Necrolysis 156 30.3 31.0 signal
3 Stevens-johnson Syndrome 203 26.7 27.4 signal
4 Neuropathy Peripheral 852 26.4 29.8 signal
5 Skin Disorder 291 25.6 26.6 signal
6 Therapy Partial Responder 126 24.5 24.9 signal
7 Malignant Neoplasm Progression 837 24.0 27.1 signal
8 Hyperglycaemia 254 20.4 21.1 signal
9 Adrenal Insufficiency 66 16.1 16.2 signal
10 Skin Reaction 71 14.7 14.9 signal
11 Myelosuppression 143 12.2 12.5 signal
12 Drug Eruption 72 11.9 12.0 signal
13 Metastases To Lung 46 11.6 11.7 signal
14 Interstitial Lung Disease 190 11.5 11.7 signal
15 Erythema Multiforme 36 11.2 11.3 signal
16 Ileus 46 10.9 11.0 signal
17 Pneumonitis 101 10.9 11.0 signal
18 Myocarditis 41 10.5 10.6 signal
19 Metastases To Liver 58 9.6 9.7 signal
20 Hepatic Function Abnormal 121 9.5 9.6 signal
21 Rash Maculo-papular 64 8.4 8.5 signal
22 Diabetic Ketoacidosis 69 8.4 8.4 signal
23 Polyneuropathy 34 8.3 8.4 signal
24 Colitis 101 7.8 7.9 signal
25 Hepatic Cytolysis 32 7.6 7.6 signal
26 Blood Pressure Systolic Increased 51 7.6 7.6 signal
27 Metastases To Central Nervous System 30 6.8 6.8 signal
28 Cytokine Release Syndrome 44 6.7 6.8 signal
29 Metastases To Bone 37 6.6 6.6 signal
30 Pneumocystis Jirovecii Pneumonia 22 6.4 6.4 signal
31 Rash 945 6.3 7.1 signal
32 Blister 122 6.3 6.4 signal
33 Neutrophil Count Decreased 86 6.2 6.2 signal
34 Hepatitis 54 6.1 6.2 signal
35 Multiple Organ Dysfunction Syndrome 58 6.0 6.1 signal
36 Mucosal Inflammation 54 6.0 6.1 signal
37 Toxic Skin Eruption 20 5.8 5.8 signal
38 Poor Venous Access 20 5.6 5.6 signal
39 Lacrimation Increased 57 5.5 5.6 signal
40 Dry Eye 91 5.5 5.5 signal
41 Urosepsis 17 5.4 5.4 signal
42 Cytopenia 22 5.4 5.4 signal
43 Ageusia 46 5.3 5.4 signal
44 Febrile Neutropenia 116 5.1 5.2 signal
45 Decreased Appetite 396 5.0 5.2 signal
46 Device Related Infection 26 4.9 4.9 signal
47 Rash Pruritic 90 4.8 4.9 signal
48 Hypothyroidism 51 4.7 4.7 signal
49 Hypomagnesaemia 22 4.6 4.6 signal
50 Alopecia 307 4.5 4.7 signal
51 Haematuria 53 4.5 4.5 signal
52 Hypercalcaemia 19 4.5 4.5 signal
53 Rash Erythematous 71 4.4 4.4 signal
54 Blood Pressure Fluctuation 36 4.3 4.4 signal
55 Pneumonia Aspiration 37 4.3 4.3 signal
56 Liver Disorder 64 4.2 4.2 signal
57 Bacteraemia 17 4.2 4.2 signal
58 Cholestasis 27 4.1 4.1 signal
59 Liver Function Test Increased 30 4.1 4.1 signal
60 Electrolyte Imbalance 16 4.0 4.0 signal
61 Hepatotoxicity 30 3.9 3.9 signal
62 Dry Mouth 109 3.9 4.0 signal
63 Pneumothorax 21 3.8 3.9 signal
64 Dermatitis 27 3.8 3.8 signal
65 Neutropenia 170 3.6 3.7 signal
66 Weight Fluctuation 13 3.6 3.6 signal
67 Hyperthyroidism 18 3.6 3.6 signal
68 Tubulointerstitial Nephritis 23 3.6 3.6 signal
69 Renal Impairment 102 3.5 3.6 signal
70 Neurotoxicity 21 3.5 3.5 signal
71 Skin Exfoliation 97 3.4 3.4 signal
72 Palmar-plantar Erythrodysaesthesia Syndrome 27 3.4 3.4 signal
73 Drug-induced Liver Injury 35 3.3 3.3 signal
74 Septic Shock 49 3.3 3.3 signal
75 Disseminated Intravascular Coagulation 16 3.3 3.3 signal
76 Diabetes Mellitus Inadequate Control 20 3.3 3.3 signal
77 C-reactive Protein Increased 41 3.3 3.3 signal
78 Sudden Death 12 3.3 3.3 signal
79 Underdose 82 3.3 3.3 signal
80 Skin Discolouration 51 3.2 3.2 signal
81 Pruritus 419 3.2 3.4 signal
82 Aspiration 12 3.2 3.2 signal
83 Conjunctivitis 20 3.2 3.2 signal
84 Inappropriate Schedule Of Product Administration 191 3.1 3.2 signal
85 Dysgeusia 80 3.1 3.1 signal
86 Cerebral Infarction 26 3.1 3.1 signal
87 Hypocalcaemia 20 3.1 3.1 signal
88 Shock 24 3.1 3.1 signal
89 Dermatitis Allergic 13 3.0 3.0 signal
90 Acute Kidney Injury 156 3.0 3.0 signal
91 Feeding Disorder 20 2.9 2.9 signal
92 Transaminases Increased 22 2.9 2.9 signal
93 Rash Papular 22 2.8 2.9 signal
94 Hyponatraemia 55 2.8 2.9 signal
95 Haematotoxicity 9 2.8 2.8 signal
96 Hyperbilirubinaemia 10 2.8 2.8 signal
97 Sepsis 108 2.8 2.8 signal
98 Flank Pain 9 2.8 2.8 signal
99 Clostridium Difficile Colitis 10 2.7 2.7 signal
100 Pancreatitis Acute 21 2.7 2.7 signal
101 Stomatitis 57 2.7 2.7 signal
102 Dry Skin 123 2.7 2.7 signal
103 Hypoaesthesia 140 2.7 2.7 signal
104 Cholecystitis 11 2.7 2.7 signal
105 Disease Progression 109 2.7 2.7 signal
106 Heart Rate Decreased 32 2.6 2.6 signal
107 Oedema 48 2.6 2.6 signal
108 Skin Lesion 24 2.6 2.6 signal
109 Intestinal Obstruction 33 2.6 2.6 signal
110 Leukopenia 43 2.5 2.5 signal
111 General Physical Health Deterioration 99 2.5 2.5 signal
112 Oral Candidiasis 11 2.5 2.5 signal
113 Aspartate Aminotransferase Increased 44 2.4 2.4 signal
114 Neoplasm Progression 29 2.4 2.4 signal
115 Pyrexia 282 2.4 2.4 signal
116 Erythema 165 2.3 2.4 signal
117 Anaemia 153 2.3 2.4 signal
118 Injection Site Extravasation 10 2.3 2.3 signal
119 Intestinal Perforation 9 2.3 2.3 signal
120 Blood Sodium Decreased 15 2.3 2.3 signal
121 Hypophagia 20 2.3 2.3 signal
122 Gastric Ulcer 15 2.3 2.3 signal
123 Diabetes Mellitus 60 2.3 2.3 signal
124 Infusion Site Pain 10 2.3 2.3 signal
125 Agranulocytosis 14 2.2 2.2 signal
126 Pancreatitis 40 2.2 2.2 signal
127 Brain Fog 11 2.2 2.2 signal
128 Urinary Tract Infection 125 2.1 2.2 signal
129 Oesophagitis 8 2.1 2.1 no signal
130 Autoimmune Disorder 7 2.1 2.1 no signal
131 Thirst 13 2.1 2.1 signal
132 Diarrhoea 468 2.1 2.2 signal
133 Thrombocytopenia 81 2.1 2.1 signal
134 Weight Decreased 201 2.1 2.1 signal
135 Candida Infection 12 2.1 2.1 signal
136 Dehydration 93 2.0 2.0 signal
137 Hepatic Failure 21 2.0 2.0 signal
138 Delirium 24 2.0 2.0 signal
139 Motor Dysfunction 7 2.0 2.0 no signal
140 Eye Discharge 7 2.0 2.0 no signal
141 Alanine Aminotransferase Increased 41 1.9 1.9 no signal
142 Blood Bilirubin Increased 18 1.9 1.9 no signal
143 Pancytopenia 37 1.9 1.9 no signal
144 Rash Macular 23 1.9 1.9 no signal
145 Skin Ulcer 17 1.9 1.9 no signal
146 Small Intestinal Obstruction 8 1.9 1.9 no signal
147 Blood Thyroid Stimulating Hormone Increased 6 1.9 1.9 no signal
148 Hepatic Enzyme Increased 44 1.9 1.9 no signal
149 Ascites 19 1.9 1.9 no signal
150 Muscle Atrophy 8 1.8 1.8 no signal
151 Eczema 32 1.8 1.9 no signal
152 Melaena 14 1.8 1.8 no signal
153 Eosinophilia 11 1.8 1.8 no signal
154 Blood Creatinine Increased 41 1.8 1.8 no signal
155 Oedema Peripheral 76 1.8 1.8 no signal
156 Lymphadenopathy 22 1.8 1.8 no signal
157 Constipation 134 1.8 1.8 no signal
158 Blood Alkaline Phosphatase Increased 15 1.8 1.8 no signal
159 Cardiac Failure 47 1.7 1.7 no signal
160 Product Use Issue 109 1.7 1.7 no signal
161 Blood Urine Present 11 1.7 1.7 no signal
162 Intercepted Product Preparation Error 7 1.7 1.7 no signal
163 Oxygen Saturation Decreased 32 1.7 1.7 no signal
164 Incontinence 6 1.6 1.6 no signal
165 Acute Respiratory Distress Syndrome 10 1.6 1.6 no signal
166 Blood Lactate Dehydrogenase Increased 9 1.6 1.6 no signal
167 Pemphigus 7 1.6 1.6 no signal
168 Asthenia 210 1.6 1.6 no signal
169 Movement Disorder 18 1.6 1.6 no signal
170 Altered State Of Consciousness 12 1.6 1.6 no signal
171 Paralysis 8 1.6 1.6 no signal
172 Jaundice 15 1.6 1.6 no signal
173 Skin Laceration 6 1.6 1.6 no signal
174 Ocular Discomfort 6 1.6 1.6 no signal
175 Infusion Related Reaction 36 1.6 1.6 no signal
176 Retinal Detachment 5 1.6 1.6 no signal
177 Cognitive Disorder 25 1.6 1.6 no signal
178 Cellulitis 27 1.6 1.6 no signal
179 Dyspnoea Exertional 20 1.5 1.5 no signal
180 Leukaemia 5 1.5 1.5 no signal
181 Scab 6 1.5 1.5 no signal
182 Dysphagia 50 1.5 1.5 no signal
183 Fracture 10 1.5 1.5 no signal
184 Blood Pressure Decreased 35 1.5 1.5 no signal
185 Fatigue 404 1.5 1.5 no signal
186 Abdominal Pain Lower 13 1.5 1.5 no signal
187 Body Temperature Decreased 5 1.5 1.5 no signal
188 Nocturia 6 1.4 1.4 no signal
189 Renal Disorder 23 1.4 1.4 no signal
190 Dialysis 7 1.4 1.4 no signal
191 Inappropriate Antidiuretic Hormone Secretion 5 1.4 1.4 no signal
192 Cataract 29 1.4 1.4 no signal
193 Bone Marrow Failure 10 1.4 1.4 no signal
194 Myelodysplastic Syndrome 7 1.4 1.4 no signal
195 Scratch 5 1.4 1.4 no signal
196 Malaise 207 1.4 1.4 no signal
197 Prescribed Overdose 9 1.3 1.4 no signal
198 Death 400 1.3 1.4 no signal
199 Hyperkalaemia 16 1.3 1.3 no signal
200 Prescribed Underdose 9 1.3 1.3 no signal
201 Oral Pain 10 1.3 1.3 no signal
202 Metabolic Acidosis 14 1.3 1.3 no signal
203 Blood Glucose Abnormal 8 1.3 1.3 no signal
204 Device Occlusion 6 1.3 1.3 no signal
205 Paraesthesia 68 1.3 1.3 no signal
206 Proteinuria 8 1.2 1.2 no signal
207 White Blood Cell Count Decreased 46 1.2 1.2 no signal
208 Covid-19 Pneumonia 5 1.2 1.2 no signal
209 Therapy Change 4 1.2 1.2 no signal
210 Drug Ineffective For Unapproved Indication 23 1.2 1.2 no signal
211 Blood Creatine Phosphokinase Increased 12 1.2 1.2 no signal
212 Poisoning 5 1.2 1.2 no signal
213 Blood Glucose Increased 74 1.1 1.1 no signal
214 Thyroid Disorder 6 1.1 1.1 no signal
215 Acute Myeloid Leukaemia 6 1.1 1.1 no signal
216 Deafness 10 1.1 1.1 no signal
217 Uveitis 5 1.1 1.1 no signal
218 Full Blood Count Decreased 7 1.0 1.0 no signal
219 Gastrointestinal Haemorrhage 29 1.0 1.0 no signal
220 Pain Of Skin 9 1.0 1.0 no signal
221 Toxicity To Various Agents 55 1.0 1.0 no signal
222 Skin Irritation 15 0.9 0.9 no signal
223 Diarrhoea Haemorrhagic 3 0.9 0.9 no signal
224 Posterior Reversible Encephalopathy Syndrome 3 0.9 0.9 no signal
225 Complication Associated With Device 4 0.9 0.9 no signal
226 Bladder Cancer 18 0.9 0.9 no signal
227 Eye Haemorrhage 4 0.9 0.9 no signal
228 Blindness Unilateral 4 0.8 0.8 no signal
229 Glycosylated Haemoglobin Increased 7 0.8 0.8 no signal
230 Pelvic Pain 5 0.8 0.8 no signal
231 Eye Pruritus 9 0.8 0.8 no signal
232 Colon Cancer 4 0.8 0.8 no signal
233 Internal Haemorrhage 3 0.8 0.8 no signal
234 Madarosis 3 0.7 0.7 no signal
235 Colitis Ulcerative 11 0.7 0.7 no signal
236 Product Preparation Error 5 0.7 0.7 no signal
237 Drug Reaction With Eosinophilia And Systemic Symptoms 6 0.7 0.7 no signal
238 Skin Burning Sensation 13 0.5 0.5 no signal
239 Device Dislocation 5 0.3 0.3 no signal
240 Pancreatic Carcinoma 3 0.3 0.3 no signal