Drug
Enfortumab Vedotin
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 |