| 1 | Product use issue | FAERS: 84 | | US FAERS |
| 2 | Drug ineffective | FAERS: 58 | | US FAERS |
| 3 | Septic Shock | FAERS: 23 | | OFFSIDES US FAERS |
| 4 | Blood creatinine increased | FAERS: 15 | | US FAERS |
| 5 | Incorrect product storage | FAERS: 14 | | US FAERS |
| 6 | Sepsis | FAERS: 14 | | US FAERS |
| 7 | Infection | FAERS: 13 | | US FAERS |
| 8 | Aspartate Aminotransferase Increased | FAERS: 12 | | US FAERS |
| 9 | Alanine Aminotransferase Increased | FAERS: 10 | | OFFSIDES US FAERS |
| 10 | Drug resistance | FAERS: 10 | | OFFSIDES US FAERS |
| 11 | Intentional product misuse | FAERS: 10 | | US FAERS |
| 12 | Respiratory Failure | FAERS: 10 | | OFFSIDES US FAERS |
| 13 | treatment failure | FAERS: 10 | | US FAERS |
| 14 | Overdose | FAERS: 9 | | US FAERS |
| 15 | Bronchopulmonary Aspergillosis | FAERS: 8 | | US FAERS |
| 16 | Pneumonia | FAERS: 8 | 19148589 | CTD US FAERS |
| 17 | Product quality issue | FAERS: 8 | | US FAERS |
| 18 | Vomiting | FAERS: 8 | | US FAERS |
| 19 | Candidiasis | FAERS: 7 | 20606829 | CTD US FAERS |
| 20 | Cardiac Arrest | FAERS: 7 | | US FAERS |
| 21 | Product storage error | FAERS: 7 | | US FAERS |
| 22 | Abdominal Pain | FAERS: 6 | | US FAERS |
| 23 | Candida sepsis | FAERS: 6 | | US FAERS |
| 24 | Neutropenia | FAERS: 6 | | US FAERS |
| 25 | Palpitations | FAERS: 6 | | US FAERS |
| 26 | Chest discomfort | FAERS: 5 | | US FAERS |
| 27 | Hypersensitivity | FAERS: 5 | | US FAERS |
| 28 | No adverse event | FAERS: 5 | | US FAERS |
| 29 | Pancreatitis | FAERS: 5 | | US FAERS |
| 30 | Peritonitis | FAERS: 5 | | US FAERS |
| 31 | Atrial Fibrillation | FAERS: 4 | | US FAERS |
| 32 | Device related infection | FAERS: 4 | | US FAERS |
| 33 | Leukopenia | FAERS: 4 | | US FAERS |
| 34 | Nausea | FAERS: 4 | 19148589 | CTD US FAERS |
| 35 | Product preparation error | FAERS: 4 | | US FAERS |
| 36 | Sinus bradycardia | FAERS: 4 | | US FAERS |
| 37 | Trichosporon infection | FAERS: 4 | | OFFSIDES US FAERS |
| 38 | Wrong technique in product usage process | FAERS: 4 | | US FAERS |
| 39 | Abdominal wound dehiscence | FAERS: 3 | | US FAERS |
| 40 | Agranulocytosis | FAERS: 3 | | US FAERS |
| 41 | Altered state of consciousness | FAERS: 3 | | US FAERS |
| 42 | Anaphylactic shock | FAERS: 3 | | US FAERS |
| 43 | Aspergillosis | FAERS: 3 | | OFFSIDES US FAERS |
| 44 | Blood potassium decreased | FAERS: 3 | | OFFSIDES US FAERS |
| 45 | Capillary Leak Syndrome | FAERS: 3 | | US FAERS |
| 46 | Chills | FAERS: 3 | | US FAERS |
| 47 | Cholestasis | FAERS: 3 | 19325554 | CTD US FAERS |
| 48 | Disease Progression | FAERS: 3 | | OFFSIDES US FAERS |
| 49 | Disseminated Intravascular Coagulation | FAERS: 3 | | OFFSIDES US FAERS |
| 50 | Dizziness | FAERS: 3 | | US FAERS |
| 51 | Drug ineffective for unapproved indication | FAERS: 3 | | US FAERS |
| 52 | Ecchymosis | FAERS: 3 | | US FAERS |
| 53 | Gamma-Glutamyltransferase Increased | FAERS: 3 | | US FAERS |
| 54 | Hypotension | FAERS: 3 | 19148589 | CTD US FAERS |
| 55 | Hypoxia | FAERS: 3 | | OFFSIDES US FAERS |
| 56 | Injection site extravasation | FAERS: 3 | | US FAERS |
| 57 | Intentional product use issue | FAERS: 3 | | US FAERS |
| 58 | Liver transplant rejection | FAERS: 3 | | US FAERS |
| 59 | Mucormycosis | FAERS: 3 | | OFFSIDES US FAERS |
| 60 | Phlebitis | FAERS: 3 | | US FAERS |
| 61 | Product use in unapproved indication | FAERS: 3 | | US FAERS |
| 62 | Thrombosis | FAERS: 3 | | US FAERS |
| 63 | Unresponsive to stimuli | FAERS: 3 | | US FAERS |
| 64 | White blood cell count decreased | FAERS: 3 | | US FAERS |
| 65 | Accidental exposure to product | FAERS: 2 | | US FAERS |
| 66 | Acute respiratory failure | FAERS: 2 | | US FAERS |
| 67 | Bacillus infection | FAERS: 2 | | US FAERS |
| 68 | Blood alkaline phosphatase increased | FAERS: 2 | | US FAERS |
| 69 | Blood urea increased | FAERS: 2 | | US FAERS |
| 70 | Candida test positive | FAERS: 2 | | US FAERS |
| 71 | Cardiomegaly | FAERS: 2 | | US FAERS |
| 72 | Cerebrovascular accident | FAERS: 2 | | US FAERS |
| 73 | Chest Pain | FAERS: 2 | | US FAERS |
| 74 | Chromaturia | FAERS: 2 | | US FAERS |
| 75 | Cyanosis | FAERS: 2 | | OFFSIDES US FAERS |
| 76 | Delirium | FAERS: 2 | | US FAERS |
| 77 | Disease recurrence | FAERS: 2 | | OFFSIDES US FAERS |
| 78 | Dyspepsia | FAERS: 2 | | US FAERS |
| 79 | Erythema | FAERS: 2 | | US FAERS |
| 80 | Extravasation | FAERS: 2 | | US FAERS |
| 81 | Febrile bone marrow aplasia | FAERS: 2 | | US FAERS |
| 82 | Fluid overload | FAERS: 2 | | US FAERS |
| 83 | General physical health deterioration | FAERS: 2 | | US FAERS |
| 84 | Graft infection | FAERS: 2 | | OFFSIDES US FAERS |
| 85 | Hepatitis | FAERS: 2 | | US FAERS |
| 86 | Hepatotoxicity | FAERS: 2 | | US FAERS |
| 87 | Hydrocephalus | FAERS: 2 | | US FAERS |
| 88 | Hypoglossal nerve paralysis | FAERS: 2 | | US FAERS |
| 89 | Incorrect storage of drug | FAERS: 2 | | US FAERS |
| 90 | Klebsiella sepsis | FAERS: 2 | | US FAERS |
| 91 | Large intestine perforation | FAERS: 2 | | US FAERS |
| 92 | Mediastinitis | FAERS: 2 | | US FAERS |
| 93 | Metabolic alkalosis | FAERS: 2 | | US FAERS |
| 94 | Myocardial Infarction | FAERS: 2 | | US FAERS |
| 95 | Neutrophil count decreased | FAERS: 2 | | US FAERS |
| 96 | Oropharyngeal pain | FAERS: 2 | | US FAERS |
| 97 | Osteolysis | FAERS: 2 | | US FAERS |
| 98 | Pain | FAERS: 2 | | US FAERS |
| 99 | Pericardial effusion | FAERS: 2 | | US FAERS |
| 100 | Petechiae | FAERS: 2 | | US FAERS |
| 101 | Pneumothorax | FAERS: 2 | | US FAERS |
| 102 | Prescribed overdose | FAERS: 2 | | US FAERS |
| 103 | Productive Cough | FAERS: 2 | | US FAERS |
| 104 | Pseudomonal sepsis | FAERS: 2 | | US FAERS |
| 105 | Rales | FAERS: 2 | | US FAERS |
| 106 | Respiratory distress | FAERS: 2 | | US FAERS |
| 107 | Skin necrosis | FAERS: 2 | | US FAERS |
| 108 | Somnolence | FAERS: 2 | | US FAERS |
| 109 | Stevens-Johnson Syndrome | FAERS: 2 | 25811541 | CTD US FAERS |
| 110 | Tachycardia | FAERS: 2 | | US FAERS |
| 111 | Thrombocytopenia | FAERS: 2 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 112 | Transaminases increased | FAERS: 2 | | US FAERS |
| 113 | Tremor | FAERS: 2 | | US FAERS |
| 114 | Urinary tract infection | FAERS: 2 | | US FAERS |
| 115 | Urticaria | FAERS: 2 | | US FAERS |
| 116 | Vasculitis | FAERS: 2 | | US FAERS |
| 117 | Venous Thrombosis | FAERS: 2 | | US FAERS |
| 118 | Vocal Cord Paralysis | FAERS: 2 | | US FAERS |
| 119 | jaundice | FAERS: 2 | | US FAERS |
| 120 | nervous system disorder | FAERS: 2 | | US FAERS |
| 121 | Abdominal discomfort | FAERS: 1 | | US FAERS |
| 122 | Acidosis | FAERS: 1 | | OFFSIDES US FAERS |
| 123 | Acute Coronary Syndrome | FAERS: 1 | | US FAERS |
| 124 | Administration site extravasation | FAERS: 1 | | US FAERS |
| 125 | Alanine aminotransferase decreased | FAERS: 1 | | US FAERS |
| 126 | Alkalosis | FAERS: 1 | | US FAERS |
| 127 | Angioedema | FAERS: 1 | | US FAERS |
| 128 | Aortic Rupture | FAERS: 1 | | US FAERS |
| 129 | Aphasia | FAERS: 1 | | US FAERS |
| 130 | Arthralgia | FAERS: 1 | | US FAERS |
| 131 | Asphyxia | FAERS: 1 | | US FAERS |
| 132 | Asthenia | FAERS: 1 | | US FAERS |
| 133 | Asthma | FAERS: 1 | | US FAERS |
| 134 | Back Pain | FAERS: 1 | | US FAERS |
| 135 | Blood albumin decreased | FAERS: 1 | | OFFSIDES US FAERS |
| 136 | Blood calcitonin increased | FAERS: 1 | | US FAERS |
| 137 | Blood creatine increased | FAERS: 1 | | OFFSIDES US FAERS |
| 138 | Blood fibrinogen decreased | FAERS: 1 | | US FAERS |
| 139 | Blood glucose increased | FAERS: 1 | | US FAERS |
| 140 | Blood lactate dehydrogenase increased | FAERS: 1 | | US FAERS |
| 141 | Blood potassium increased | FAERS: 1 | | US FAERS |
| 142 | Blood pressure fluctuation | FAERS: 1 | | OFFSIDES US FAERS |
| 143 | Blood sodium increased | FAERS: 1 | | OFFSIDES US FAERS |
| 144 | Blood urea abnormal | FAERS: 1 | | US FAERS |
| 145 | Bradycardia | FAERS: 1 | | US FAERS |
| 146 | Bronchopulmonary Dysplasia | FAERS: 1 | | US FAERS |
| 147 | Bronchospasm | FAERS: 1 | | US FAERS |
| 148 | Bulbar palsy | FAERS: 1 | | US FAERS |
| 149 | Candida pneumonia | FAERS: 1 | | US FAERS |
| 150 | Cerebral Infarction | FAERS: 1 | | US FAERS |
| 151 | Circumstance or information capable of leading to medication error | FAERS: 1 | | US FAERS |
| 152 | Citrobacter infection | FAERS: 1 | | US FAERS |
| 153 | Clostridium difficile colitis | FAERS: 1 | | US FAERS |
| 154 | Concomitant disease progression | FAERS: 1 | | OFFSIDES US FAERS |
| 155 | Conjunctival pallor | FAERS: 1 | | US FAERS |
| 156 | Constipation | FAERS: 1 | | US FAERS |
| 157 | Culture positive | FAERS: 1 | | OFFSIDES US FAERS |
| 158 | Deafness | FAERS: 1 | | US FAERS |
| 159 | Depressed Level of Consciousness | FAERS: 1 | | US FAERS |
| 160 | Depressed mood | FAERS: 1 | | US FAERS |
| 161 | Diaphragmatic Hernia | FAERS: 1 | | US FAERS |
| 162 | Drug administration error | FAERS: 1 | | US FAERS |
| 163 | Drug dispensing error | FAERS: 1 | | US FAERS |
| 164 | Drug prescribing error | FAERS: 1 | | US FAERS |
| 165 | Dysphonia | FAERS: 1 | | US FAERS |
| 166 | Electrolyte imbalance | FAERS: 1 | | US FAERS |
| 167 | End stage AIDS | FAERS: 1 | | US FAERS |
| 168 | Endophthalmitis | FAERS: 1 | | US FAERS |
| 169 | Engraftment syndrome | FAERS: 1 | | US FAERS |
| 170 | Enterococcal sepsis | FAERS: 1 | | US FAERS |
| 171 | Expired product administered | FAERS: 1 | | US FAERS |
| 172 | Febrile Neutropenia | FAERS: 1 | | OFFSIDES US FAERS |
| 173 | Feeling Cold | FAERS: 1 | | US FAERS |
| 174 | Feeling abnormal | FAERS: 1 | | US FAERS |
| 175 | Fistula of small intestine | FAERS: 1 | | US FAERS |
| 176 | Fungal test positive | FAERS: 1 | | US FAERS |
| 177 | Gastrointestinal hypermotility | FAERS: 1 | | US FAERS |
| 178 | Gastrointestinal perforation | FAERS: 1 | | US FAERS |
| 179 | Graft versus host disease in skin | FAERS: 1 | | US FAERS |
| 180 | Grip strength decreased | FAERS: 1 | | US FAERS |
| 181 | Headache | FAERS: 1 | 19148589 | CTD US FAERS |
| 182 | Hepatic Encephalopathy | FAERS: 1 | | US FAERS |
| 183 | Hepatic candidiasis | FAERS: 1 | | US FAERS |
| 184 | Hepatitis C | FAERS: 1 | | US FAERS |
| 185 | Hepatomegaly | FAERS: 1 | | US FAERS |
| 186 | Histiocytosis haematophagic | FAERS: 1 | | US FAERS |
| 187 | Hyperpyrexia | FAERS: 1 | | US FAERS |
| 188 | Ileus | FAERS: 1 | | US FAERS |
| 189 | Incorrect dose administered | FAERS: 1 | | US FAERS |
| 190 | Incorrect drug administration rate | FAERS: 1 | | US FAERS |
| 191 | Infection reactivation | FAERS: 1 | | US FAERS |
| 192 | Infectious disease carrier | FAERS: 1 | | US FAERS |
| 193 | Infectious peritonitis | FAERS: 1 | | US FAERS |
| 194 | Intercepted medication error | FAERS: 1 | | US FAERS |
| 195 | Intestinal Obstruction | FAERS: 1 | | US FAERS |
| 196 | Intestinal Perforation | FAERS: 1 | | US FAERS |
| 197 | Ketosis | FAERS: 1 | | US FAERS |
| 198 | Klebsiella test positive | FAERS: 1 | | US FAERS |
| 199 | Ligament rupture | FAERS: 1 | | US FAERS |
| 200 | Liquid product physical issue | FAERS: 1 | | US FAERS |
| 201 | Lung transplant rejection | FAERS: 1 | | US FAERS |
| 202 | Lymphadenopathy | FAERS: 1 | | US FAERS |
| 203 | Malignant neoplasm progression | FAERS: 1 | | US FAERS |
| 204 | Malnutrition | FAERS: 1 | | US FAERS |
| 205 | Medication Error | FAERS: 1 | | US FAERS |
| 206 | Mood swings | FAERS: 1 | | US FAERS |
| 207 | Myoglobin blood increased | FAERS: 1 | | US FAERS |
| 208 | Nephrogenic Diabetes Insipidus | FAERS: 1 | | OFFSIDES US FAERS |
| 209 | Neutropenic sepsis | FAERS: 1 | | US FAERS |
| 210 | Night sweats | FAERS: 1 | | US FAERS |
| 211 | Non-cardiac chest pain | FAERS: 1 | | US FAERS |
| 212 | Optic Neuritis | FAERS: 1 | | US FAERS |
| 213 | Oral candidiasis | FAERS: 1 | | US FAERS |
| 214 | Oral pain | FAERS: 1 | | US FAERS |
| 215 | Oropharyngeal candidiasis | FAERS: 1 | | US FAERS |
| 216 | Pallor | FAERS: 1 | | US FAERS |
| 217 | Pancreatic carcinoma | FAERS: 1 | | US FAERS |
| 218 | Pancytopenia | FAERS: 1 | | US FAERS |
| 219 | Pericarditis | FAERS: 1 | | US FAERS |
| 220 | Pneumocystis jiroveci pneumonia | FAERS: 1 | | OFFSIDES US FAERS |
| 221 | Poor quality product administered | FAERS: 1 | | US FAERS |
| 222 | Postoperative respiratory failure | FAERS: 1 | | US FAERS |
| 223 | Prescription form tampering | FAERS: 1 | | US FAERS |
| 224 | Product label issue | FAERS: 1 | | US FAERS |
| 225 | Product preparation issue | FAERS: 1 | | US FAERS |
| 226 | Pruritus | FAERS: 1 | | US FAERS |
| 227 | Pulmonary Embolism | FAERS: 1 | | US FAERS |
| 228 | Pulmonary congestion | FAERS: 1 | | US FAERS |
| 229 | Regurgitation | FAERS: 1 | | US FAERS |
| 230 | Respiratory arrest | FAERS: 1 | | US FAERS |
| 231 | Rhabdomyolysis | FAERS: 1 | | US FAERS |
| 232 | Rhinovirus infection | FAERS: 1 | | US FAERS |
| 233 | Skeletal muscle enzymes | FAERS: 1 | | US FAERS |
| 234 | Skin lesion | FAERS: 1 | | US FAERS |
| 235 | Stomatitis | FAERS: 1 | | US FAERS |
| 236 | Stridor | FAERS: 1 | | US FAERS |
| 237 | Subcutaneous Abscess | FAERS: 1 | | US FAERS |
| 238 | Sudden Cardiac Death | FAERS: 1 | | US FAERS |
| 239 | Syncope | FAERS: 1 | | US FAERS |
| 240 | Tendon discomfort | FAERS: 1 | | US FAERS |
| 241 | Therapeutic response unexpected | FAERS: 1 | | US FAERS |
| 242 | Therapy non-responder | FAERS: 1 Canada Vigilance: 1 | | Canada Vigilance OFFSIDES US FAERS |
| 243 | Throat irritation | FAERS: 1 | | US FAERS |
| 244 | Urinary Retention | FAERS: 1 | | US FAERS |
| 245 | Vascular graft complication | FAERS: 1 | | US FAERS |
| 246 | Venoocclusive disease | FAERS: 1 | | US FAERS |
| 247 | Wound Complication | FAERS: 1 | | US FAERS |
| 248 | Wrong drug administered | FAERS: 1 | | US FAERS |
| 249 | Zygomycosis | FAERS: 1 | | US FAERS |
| 250 | pseudomembranous colitis | FAERS: 1 | | US FAERS |
| 251 | Acute graft versus host disease in liver | | | OFFSIDES |
| 252 | Acute kidney injury | | 19148589 | CTD |
| 253 | Alopecia | | | OFFSIDES |
| 254 | Anticonvulsant drug level below therapeutic | | | OFFSIDES |
| 255 | Antithrombin III decreased | | | OFFSIDES |
| 256 | Bilirubin conjugated increased | | | OFFSIDES |
| 257 | Bladder Neoplasm | | | OFFSIDES |
| 258 | Blood beta-D-glucan increased | | | OFFSIDES |
| 259 | Bronchoalveolar Lavage | | | OFFSIDES |
| 260 | Calcinosis | | | OFFSIDES |
| 261 | Candidemia | | 19325554 20606829 | CTD |
| 262 | Cardiac Tamponade | | | OFFSIDES |
| 263 | Catheter sepsis | | | OFFSIDES |
| 264 | Catheter site pain | | | OFFSIDES |
| 265 | Central line infection | | | OFFSIDES |
| 266 | Chemical and Drug Induced Liver Injury | | 19148589 19325554 | CTD |
| 267 | Chemotherapeutic drug level increased | | | OFFSIDES |
| 268 | Concomitant disease aggravated | | | OFFSIDES |
| 269 | Confabulation | | | OFFSIDES |
| 270 | Corneal thinning | | | OFFSIDES |
| 271 | Cytomegalovirus chorioretinitis | | | OFFSIDES |
| 272 | Delayed engraftment | | | OFFSIDES |
| 273 | Dermatomycoses | | 18608918 | CTD |
| 274 | Diabetes | | | OFFSIDES |
| 275 | Disease complication | | | OFFSIDES |
| 276 | Drug level below therapeutic | | | OFFSIDES |
| 277 | Ejection Fraction Decreased | | | OFFSIDES |
| 278 | Enterococcal infection | | | OFFSIDES |
| 279 | Enterocolitis | | | OFFSIDES |
| 280 | Enterocutaneous Fistula | | | OFFSIDES |
| 281 | Esophageal Stenosis | | | OFFSIDES |
| 282 | Exanthema | | 19148589 | CTD |
| 283 | Eye Infection | | | OFFSIDES |
| 284 | Fungus serology test positive | | | OFFSIDES |
| 285 | Glaucoma | | | OFFSIDES |
| 286 | Granulocytosis | | | OFFSIDES |
| 287 | Grip strength | | | OFFSIDES |
| 288 | Hemoglobinuria | | 19148589 | CTD |
| 289 | Hepatic Infarction | | | OFFSIDES |
| 290 | Hepatitis B | | | OFFSIDES |
| 291 | Hepatoblastoma | | | OFFSIDES |
| 292 | Hepatosplenomegaly | | | OFFSIDES |
| 293 | Injection site macule | | | OFFSIDES |
| 294 | Injection site pallor | | | OFFSIDES |
| 295 | Intraocular inflammation | | | OFFSIDES |
| 296 | Invasive Pulmonary Aspergillosis | | 14661114 | CTD |
| 297 | Kidney Failure | | | OFFSIDES |
| 298 | Large intestine anastomosis | | | OFFSIDES |
| 299 | Leukopenia neonatal | | | OFFSIDES |
| 300 | Lung consolidation | | | OFFSIDES |
| 301 | Malabsorption | | | OFFSIDES |
| 302 | Mental status changes | | | OFFSIDES |
| 303 | Mycoses | | 17015631 | CTD |
| 304 | Osteopenia | | | OFFSIDES |
| 305 | Pathogen resistance | | | OFFSIDES |
| 306 | Plasminogen decreased | | | OFFSIDES |
| 307 | Propofol Infusion Syndrome | | | OFFSIDES |
| 308 | Pyelonephritis | | | OFFSIDES |
| 309 | Respiratory syncytial virus test positive | | | OFFSIDES |
| 310 | Retrograde portal vein flow | | | OFFSIDES |
| 311 | Stenotrophomonas infection | | | OFFSIDES |
| 312 | Urinary tract infection enterococcal | | | OFFSIDES |
| 313 | Ventricular Fibrillation | | 19148589 | CTD |
| 314 | Vitamin K Deficiency | | | OFFSIDES |