| 1 | Drug ineffective | FAERS: 4 Canada Vigilance: 2 | | Canada Vigilance US FAERS |
| 2 | Product substitution issue | FAERS: 3 | | US FAERS |
| 3 | Agitation | FAERS: 1 | | US FAERS |
| 4 | Anxiety | FAERS: 1 | | OFFSIDES US FAERS |
| 5 | Aura | FAERS: 1 | | OFFSIDES US FAERS |
| 6 | Bradyphrenia | FAERS: 1 | | US FAERS |
| 7 | Delirium | FAERS: 1 | | US FAERS |
| 8 | Dermatitis | FAERS: 1 | | SIDER US FAERS |
| 9 | Drug Dependence | FAERS: 1 Canada Vigilance: 2 | | Canada Vigilance US FAERS |
| 10 | Drug effective for unapproved indication | FAERS: 1 | | US FAERS |
| 11 | Drug ineffective for unapproved indication | FAERS: 1 | | US FAERS |
| 12 | Drug withdrawal syndrome | FAERS: 1 | | US FAERS |
| 13 | Drug-disease interaction | FAERS: 1 | | US FAERS |
| 14 | Dysgeusia | FAERS: 1 | | US FAERS |
| 15 | Dyspepsia | FAERS: 1 | | US FAERS |
| 16 | Emotional disorder | FAERS: 1 | | US FAERS |
| 17 | Feeling abnormal | FAERS: 1 | | SIDER US FAERS |
| 18 | Fibromyalgia | FAERS: 1 | | US FAERS |
| 19 | General physical health deterioration | FAERS: 1 | | OFFSIDES US FAERS |
| 20 | Incorrect drug administration duration | FAERS: 1 | | US FAERS |
| 21 | Lethargy | FAERS: 1 | | OFFSIDES US FAERS |
| 22 | Malaise | FAERS: 1 | | US FAERS |
| 23 | Product formulation issue | FAERS: 1 | | US FAERS |
| 24 | Product quality issue | FAERS: 1 | | US FAERS |
| 25 | Reaction to preservatives | FAERS: 1 | | US FAERS |
| 26 | Somnolence | FAERS: 1 Canada Vigilance: 2 | | Canada Vigilance SIDER US FAERS |
| 27 | Stress | FAERS: 1 | | US FAERS |
| 28 | Therapeutic response unexpected with drug substitution | FAERS: 1 | | OFFSIDES US FAERS |
| 29 | Tremor | FAERS: 1 | | SIDER US FAERS |
| 30 | Visual disturbance | FAERS: 1 | | US FAERS |
| 31 | nervous system disorder | FAERS: 1 | | US FAERS |
| 32 | Abdominal Abscess | | | OFFSIDES |
| 33 | Abdominal discomfort | | | OFFSIDES |
| 34 | Abscess soft tissue | | | OFFSIDES |
| 35 | Abuse | | | OFFSIDES |
| 36 | Accidental overdose | | | OFFSIDES |
| 37 | Activities of daily living impaired | | | OFFSIDES |
| 38 | Acute Coronary Syndrome | | | OFFSIDES |
| 39 | Acute myocardial infarction | | | OFFSIDES |
| 40 | Adenoma | | | OFFSIDES |
| 41 | Agnosia | | | OFFSIDES |
| 42 | Agoraphobia | | | OFFSIDES |
| 43 | Alanine Aminotransferase Increased | | | OFFSIDES |
| 44 | Alcohol withdrawal syndrome | | | OFFSIDES |
| 45 | Alcoholic Intoxication | | | OFFSIDES |
| 46 | Alopecia | | | OFFSIDES |
| 47 | Alveolitis | | | OFFSIDES |
| 48 | Amenorrhea | | | OFFSIDES |
| 49 | Amimia | | | OFFSIDES |
| 50 | Amnesia | | | OFFSIDES |
| 51 | Anal abscess | | | OFFSIDES |
| 52 | Anhidrosis | | | OFFSIDES |
| 53 | Anorexia | | | OFFSIDES |
| 54 | Anticholinergic Syndrome | | | OFFSIDES |
| 55 | Anticonvulsant drug level below therapeutic | | | OFFSIDES |
| 56 | Antipsychotic drug level above therapeutic | | | OFFSIDES |
| 57 | Antiviral drug level above therapeutic | | | OFFSIDES |
| 58 | Anuria | | | OFFSIDES |
| 59 | Apparent death | | | OFFSIDES |
| 60 | Arthroscopy | | | OFFSIDES |
| 61 | Ascites | | | OFFSIDES |
| 62 | Aseptic Meningitis | | | OFFSIDES |
| 63 | Asphyxia | | | OFFSIDES |
| 64 | Aspiration Pneumonia | | | OFFSIDES |
| 65 | Asthenia | | | OFFSIDES SIDER |
| 66 | Asthma | | | OFFSIDES |
| 67 | Ataxia | Canada Vigilance: 1 | | Canada Vigilance SIDER |
| 68 | Atherosclerosis | | | OFFSIDES |
| 69 | Atrial Flutter | | | OFFSIDES |
| 70 | Autoimmune thyroiditis | | | OFFSIDES |
| 71 | Automatism | | | OFFSIDES |
| 72 | B-cell lymphoma stage I | | | OFFSIDES |
| 73 | Bacteria stool identified | | | OFFSIDES |
| 74 | Bacterial test positive | | | OFFSIDES |
| 75 | Biopsy breast abnormal | | | OFFSIDES |
| 76 | Biopsy | | | OFFSIDES |
| 77 | Bipolar II disorder | | | OFFSIDES |
| 78 | Blood Glucose | | | OFFSIDES |
| 79 | Blood alcohol increased | | | OFFSIDES |
| 80 | Blood alkaline phosphatase increased | | | OFFSIDES |
| 81 | Blood amylase increased | | | OFFSIDES |
| 82 | Blood blister | | | OFFSIDES |
| 83 | Blood cholesterol | | | OFFSIDES |
| 84 | Blood osmolarity decreased | | | OFFSIDES |
| 85 | Blood potassium decreased | | | OFFSIDES |
| 86 | Blood sodium increased | | | OFFSIDES |
| 87 | Blood sodium | | | OFFSIDES |
| 88 | Blood thyroid stimulating hormone | | | OFFSIDES |
| 89 | Body Temperature | | | OFFSIDES |
| 90 | Bronchitis | | | OFFSIDES |
| 91 | Bulimia | | | OFFSIDES |
| 92 | Burning sensation | | | OFFSIDES |
| 93 | Calcinosis | | | OFFSIDES |
| 94 | Candida sepsis | | | OFFSIDES |
| 95 | Cardiac Death | | | OFFSIDES |
| 96 | Cardioactive drug level above therapeutic | | | OFFSIDES |
| 97 | Cardioactive drug level increased | | | OFFSIDES |
| 98 | Carotid artery occlusion | | | OFFSIDES |
| 99 | Catatonia | | | OFFSIDES |
| 100 | Cerebral disorder | | | OFFSIDES |
| 101 | Chemotherapeutic drug level increased | | | OFFSIDES |
| 102 | Choking sensation | | | OFFSIDES |
| 103 | Cholangiolitis | | | OFFSIDES |
| 104 | Cholecystitis | | | OFFSIDES |
| 105 | Cholestatic liver injury | | | OFFSIDES |
| 106 | Chronic Obstructive Airway Disease | | | OFFSIDES |
| 107 | Chronic active hepatitis | | | OFFSIDES |
| 108 | Cirrhosis | | | OFFSIDES |
| 109 | Claustrophobia | | | OFFSIDES |
| 110 | Cogwheel Rigidity | | | OFFSIDES |
| 111 | Colitis | | | OFFSIDES |
| 112 | Completed Suicide | | | OFFSIDES |
| 113 | Complications of maternal exposure to therapeutic drugs | | | OFFSIDES |
| 114 | Confabulation | | | OFFSIDES |
| 115 | Congenital tricuspid valve incompetence | | | OFFSIDES |
| 116 | Conjunctival deposit | | | OFFSIDES |
| 117 | Consciousness fluctuating | | | OFFSIDES |
| 118 | Cor pulmonale | | | OFFSIDES |
| 119 | Creatinine renal clearance decreased | | | OFFSIDES |
| 120 | Crying | | | OFFSIDES |
| 121 | Cyanosis | | | OFFSIDES |
| 122 | Cytolytic hepatitis | | | OFFSIDES |
| 123 | Depressed Level of Consciousness | | | OFFSIDES |
| 124 | Diabetes mellitus inadequate control | | | OFFSIDES |
| 125 | Diabetic Foot | | | OFFSIDES |
| 126 | Diabetic Nephropathy | | | OFFSIDES |
| 127 | Diet refusal | | | OFFSIDES |
| 128 | Diplopia | | | SIDER |
| 129 | Disease recurrence | | | OFFSIDES |
| 130 | Diverticulosis | | | OFFSIDES |
| 131 | Dizziness | | | SIDER |
| 132 | Drowsiness | | | OFFSIDES SIDER |
| 133 | Drug abuser | | | OFFSIDES |
| 134 | Drug addict | | | OFFSIDES |
| 135 | Drug exposure during pregnancy | | | OFFSIDES |
| 136 | Drug screen positive | | | OFFSIDES |
| 137 | Drug toxicity | | | OFFSIDES |
| 138 | Duodenitis | | | OFFSIDES |
| 139 | Dysarthria | | | SIDER |
| 140 | Dysphonia | | | OFFSIDES |
| 141 | Dysthymic Disorder | | | OFFSIDES |
| 142 | Dystonia | | | OFFSIDES |
| 143 | Economic problem | | | OFFSIDES |
| 144 | Ejection Fraction Decreased | | | OFFSIDES |
| 145 | Electrocardiogram change | | | OFFSIDES |
| 146 | Electrocardiogram poor R-wave progression | | | OFFSIDES |
| 147 | Electromyogram abnormal | | | OFFSIDES |
| 148 | Enteral Nutrition | | | OFFSIDES |
| 149 | Enterocolitis | | | OFFSIDES |
| 150 | Epistaxis | | | OFFSIDES |
| 151 | Erectile dysfunction | | | OFFSIDES |
| 152 | Erythema | | | OFFSIDES |
| 153 | Erythrosis | | | OFFSIDES |
| 154 | Escherichia infection | | | OFFSIDES |
| 155 | Excoriation | | | OFFSIDES |
| 156 | Exophthalmos | | | OFFSIDES |
| 157 | External ear pain | | | OFFSIDES |
| 158 | Extremity necrosis | | | OFFSIDES |
| 159 | Factor V deficiency | | | OFFSIDES |
| 160 | Familial Mediterranean Fever | | | OFFSIDES |
| 161 | Fascial infection | | | OFFSIDES |
| 162 | Fatigue | | | SIDER |
| 163 | Febrile bone marrow aplasia | | | OFFSIDES |
| 164 | Feeding disorder neonatal | | | OFFSIDES |
| 165 | Feeling Cold | | | OFFSIDES |
| 166 | Fluid overload | | | OFFSIDES |
| 167 | Galactorrhea | | | OFFSIDES |
| 168 | Gambling | | | OFFSIDES |
| 169 | Gamma-Glutamyltransferase Increased | | | OFFSIDES |
| 170 | Gangrene | | | OFFSIDES |
| 171 | Gastric ulcer | | | OFFSIDES |
| 172 | Gastrointestinal hypomotility | | | OFFSIDES |
| 173 | Gastrointestinal obstruction | | | OFFSIDES |
| 174 | Gastrointestinal sounds abnormal | | | OFFSIDES |
| 175 | Glasgow coma scale | | | OFFSIDES |
| 176 | Granulocytosis | | | OFFSIDES |
| 177 | Granuloma Annulare | | | OFFSIDES |
| 178 | Headache | | | SIDER |
| 179 | Hemiparesis | | | OFFSIDES |
| 180 | Hemiplegia | | | OFFSIDES |
| 181 | Hepatitis | | | OFFSIDES |
| 182 | Hepatosplenomegaly | | | OFFSIDES |
| 183 | Histiocytosis haematophagic | | | OFFSIDES |
| 184 | Hydrocephalus | | | OFFSIDES |
| 185 | Hypercapnia | | | OFFSIDES |
| 186 | Hyperreflexia | | | OFFSIDES |
| 187 | Hyperventilation | | | OFFSIDES |
| 188 | Hypoaesthesia facial | | | OFFSIDES |
| 189 | Hypomania | | | OFFSIDES |
| 190 | Hyporeflexia | | | OFFSIDES |
| 191 | Hypoxia | | | OFFSIDES |
| 192 | Hysteroscopy | | | OFFSIDES |
| 193 | Idiosyncratic drug reaction | | | OFFSIDES |
| 194 | Inappropriate affect | | | OFFSIDES |
| 195 | Infection in an immunocompromised host | | | OFFSIDES |
| 196 | Initial insomnia | | | OFFSIDES |
| 197 | Injection site burning | | | OFFSIDES |
| 198 | Injection site erythema | | | OFFSIDES |
| 199 | Injection site irritation | | | OFFSIDES |
| 200 | Insulin-requiring type 2 diabetes mellitus | | | OFFSIDES |
| 201 | Intention tremor | | | OFFSIDES |
| 202 | Intentional drug misuse | | | OFFSIDES |
| 203 | Intentional misuse | | | OFFSIDES |
| 204 | Intentional self-injury | | | OFFSIDES |
| 205 | Joint Range of Motion Decreased | | | OFFSIDES |
| 206 | Joint injury | | | OFFSIDES |
| 207 | Joint sprain | | | OFFSIDES |
| 208 | Laceration | | | OFFSIDES |
| 209 | Laryngitis bacterial | | | OFFSIDES |
| 210 | Laryngitis fungal | | | OFFSIDES |
| 211 | Laryngomalacia | | | OFFSIDES |
| 212 | Left Ventricular Hypertrophy | | | OFFSIDES |
| 213 | Legionella | | | OFFSIDES |
| 214 | Leukoencephalopathy | | | OFFSIDES |
| 215 | Leukoplakia | | | OFFSIDES |
| 216 | Limb injury | | | OFFSIDES |
| 217 | Lipase | | | OFFSIDES |
| 218 | Livedo Reticularis | | | OFFSIDES |
| 219 | Locked-In Syndrome | | | OFFSIDES |
| 220 | Loss of proprioception | | | OFFSIDES |
| 221 | Lymphocele | | | OFFSIDES |
| 222 | Malignant neoplasm progression | | | OFFSIDES |
| 223 | Meningioma | | | OFFSIDES |
| 224 | Meniscus operation | | | OFFSIDES |
| 225 | Metabolic acidosis | | | OFFSIDES |
| 226 | Metamorphopsia | | | OFFSIDES |
| 227 | Microcephaly | | | OFFSIDES |
| 228 | Microlithiasis | | | OFFSIDES |
| 229 | Migraine with Aura | | | OFFSIDES |
| 230 | Moaning | | | OFFSIDES |
| 231 | Monocytosis | | | OFFSIDES |
| 232 | Morbid thoughts | | | OFFSIDES |
| 233 | Multiple Sclerosis | | | OFFSIDES |
| 234 | Multiple drug overdose | | | OFFSIDES |
| 235 | Multiple drug overdose intentional | | | OFFSIDES |
| 236 | Muscular Dystrophy | | | OFFSIDES |
| 237 | Mutism | | | OFFSIDES |
| 238 | Negativism | | | OFFSIDES |
| 239 | Neonatal aspiration | | | OFFSIDES |
| 240 | Nephrogenic Diabetes Insipidus | | | OFFSIDES |
| 241 | Nephrolithiasis | | | OFFSIDES |
| 242 | Nervous tension | | | OFFSIDES |
| 243 | Nervousness | | | SIDER |
| 244 | Neuroleptic Malignant Syndrome | | | OFFSIDES |
| 245 | Nicotine Dependence | | | OFFSIDES |
| 246 | Obsessive thoughts | | | OFFSIDES |
| 247 | Ocular icterus | | | OFFSIDES |
| 248 | Oculogyration | | | OFFSIDES |
| 249 | Onycholysis | | | OFFSIDES |
| 250 | Optic Atrophy | | | OFFSIDES |
| 251 | Optic Disc Edema | | | OFFSIDES |
| 252 | Orthopnea | | | OFFSIDES |
| 253 | Overdose | | | OFFSIDES |
| 254 | Pain of skin | | | OFFSIDES |
| 255 | Pain | | | OFFSIDES |
| 256 | Pallor | | | OFFSIDES |
| 257 | Pancreatic enzymes increased | | | OFFSIDES |
| 258 | Pancreatitis | | | OFFSIDES |
| 259 | Panic Disorder | | | OFFSIDES |
| 260 | Parotitis | | | OFFSIDES |
| 261 | Partner stress | | | OFFSIDES |
| 262 | Periarthritis | | | OFFSIDES |
| 263 | Pharmaceutical product complaint | | | OFFSIDES |
| 264 | Pharyngolaryngeal Pain | | | OFFSIDES |
| 265 | Phimosis | | | OFFSIDES |
| 266 | Phlebitis | | | OFFSIDES |
| 267 | Physical abuse | | | OFFSIDES |
| 268 | Pneumocystis jiroveci pneumonia | | | OFFSIDES |
| 269 | Polyhydramnios | | | OFFSIDES |
| 270 | Polysubstance abuse | | | OFFSIDES |
| 271 | Polyuria | | | OFFSIDES |
| 272 | Poor sucking reflex | | | OFFSIDES |
| 273 | Post-anoxic myoclonus | | | OFFSIDES |
| 274 | Posterior capsule opacification | | | OFFSIDES |
| 275 | Pre-Eclampsia | | | OFFSIDES |
| 276 | Procedural site reaction | | | OFFSIDES |
| 277 | Proctitis | | | OFFSIDES |
| 278 | Proctocolitis | | | OFFSIDES |
| 279 | Productive Cough | | | OFFSIDES |
| 280 | Protein total decreased | | | OFFSIDES |
| 281 | Prothrombin level decreased | | | OFFSIDES |
| 282 | Pseudodementia | | | OFFSIDES |
| 283 | Pseudomonal sepsis | | | OFFSIDES |
| 284 | Pulmonary Valve Stenosis | | | OFFSIDES |
| 285 | Pulmonary arterial pressure increased | | | OFFSIDES |
| 286 | Quality of life decreased | | | OFFSIDES |
| 287 | Renal tubular disorder | | | OFFSIDES |
| 288 | Renal tubular necrosis | | | OFFSIDES |
| 289 | Respiratory Failure | | | OFFSIDES |
| 290 | Respiratory depth decreased | | | OFFSIDES |
| 291 | Retrograde portal vein flow | | | OFFSIDES |
| 292 | Retroperitoneal fibrosis | | | OFFSIDES |
| 293 | Rhabdomyolysis | | | OFFSIDES |
| 294 | Rhinalgia | | | OFFSIDES |
| 295 | Rhonchi | | | OFFSIDES |
| 296 | Schizoaffective Disorder | | | OFFSIDES |
| 297 | Schizophrenia | | | OFFSIDES |
| 298 | Scotoma | | | OFFSIDES |
| 299 | Self-induced vomiting | | | OFFSIDES |
| 300 | Sense of oppression | | | OFFSIDES |
| 301 | Sinoatrial Block | | | OFFSIDES |
| 302 | Skin necrosis | | | OFFSIDES |
| 303 | Slurred speech | | | SIDER |
| 304 | Smoker | | | OFFSIDES |
| 305 | Sopor | | | OFFSIDES |
| 306 | Splenic necrosis | | | OFFSIDES |
| 307 | Splenic vein thrombosis | | | OFFSIDES |
| 308 | Stevens-Johnson Syndrome | | | OFFSIDES |
| 309 | Subileus | | | OFFSIDES |
| 310 | Sudden death | | | OFFSIDES |
| 311 | Sudden onset of sleep | | | OFFSIDES |
| 312 | Supraventricular tachycardia | | | OFFSIDES |
| 313 | Suture rupture | | | OFFSIDES |
| 314 | Talipes | | | OFFSIDES |
| 315 | Tardive Dyskinesia | | | OFFSIDES |
| 316 | Temperature intolerance | | | OFFSIDES |
| 317 | Tension | | | SIDER |
| 318 | Therapeutic response unexpected | | | OFFSIDES |
| 319 | Tinea Pedis | | | OFFSIDES |
| 320 | Tinnitus | | | OFFSIDES |
| 321 | Tongue biting | | | OFFSIDES |
| 322 | Toxicologic test abnormal | | | OFFSIDES |
| 323 | Transaminases increased | | | OFFSIDES |
| 324 | Unresponsive to stimuli | | | OFFSIDES |
| 325 | Ventricular Fibrillation | | | OFFSIDES |
| 326 | Violence-related symptom | | | OFFSIDES |
| 327 | Weight Gain | | | OFFSIDES |
| 328 | colonoscopy | | | OFFSIDES |