| 1 | Product substitution issue | FAERS: 7 | | US FAERS |
| 2 | Drug ineffective | FAERS: 5 Canada Vigilance: 1 | | Canada Vigilance US FAERS |
| 3 | Nausea | FAERS: 4 Canada Vigilance: 1 | | Canada Vigilance OFFSIDES SIDER US FAERS |
| 4 | Pharmaceutical product complaint | FAERS: 3 | | US FAERS |
| 5 | Urticaria | FAERS: 3 | | SIDER US FAERS |
| 6 | Abdominal discomfort | FAERS: 2 | | OFFSIDES US FAERS |
| 7 | Dyspepsia | FAERS: 2 Canada Vigilance: 1 | 7769203 | CTD OFFSIDES SIDER Canada Vigilance US FAERS |
| 8 | Medication Error | FAERS: 2 | | US FAERS |
| 9 | Therapeutic response unexpected with drug substitution | FAERS: 2 | | US FAERS |
| 10 | Throat irritation | FAERS: 2 | | US FAERS |
| 11 | Alopecia | FAERS: 1 | | OFFSIDES US FAERS |
| 12 | Arthralgia | FAERS: 1 | | US FAERS |
| 13 | Blepharospasm | FAERS: 1 | | US FAERS |
| 14 | Constipation | FAERS: 1 | | SIDER US FAERS |
| 15 | Cyst | FAERS: 1 | | OFFSIDES US FAERS |
| 16 | Dehydration | FAERS: 1 | | US FAERS |
| 17 | Diet refusal | FAERS: 1 | | US FAERS |
| 18 | Drug prescribing error | FAERS: 1 | | US FAERS |
| 19 | Euphoric mood | FAERS: 1 | | US FAERS |
| 20 | Feeling abnormal | FAERS: 1 | | SIDER US FAERS |
| 21 | Incorrect dose administered | FAERS: 1 | | US FAERS |
| 22 | Medication residue | FAERS: 1 | | US FAERS |
| 23 | Multiple allergies | FAERS: 1 | | OFFSIDES US FAERS |
| 24 | Non-cardiac chest pain | FAERS: 1 | | OFFSIDES US FAERS |
| 25 | Pain | FAERS: 1 | | OFFSIDES SIDER US FAERS |
| 26 | Pharmaceutical product counterfeit | FAERS: 1 | | OFFSIDES US FAERS |
| 27 | Product quality issue | FAERS: 1 | | US FAERS |
| 28 | Product taste abnormal | FAERS: 1 | | US FAERS |
| 29 | Pruritus | FAERS: 1 | 7769203 | CTD SIDER US FAERS |
| 30 | Rash erythematous | FAERS: 1 | | US FAERS |
| 31 | Sepsis | FAERS: 1 | | US FAERS |
| 32 | Skin Ulcer | FAERS: 1 | | US FAERS |
| 33 | Therapy non-responder | FAERS: 1 | | US FAERS |
| 34 | Tongue pruritus | FAERS: 1 | | US FAERS |
| 35 | Toxic Epidermal Necrolysis | FAERS: 1 | | US FAERS |
| 36 | Vomiting | FAERS: 1 | | SIDER US FAERS |
| 37 | Abdominal Pain | Canada Vigilance: 2 | | Canada Vigilance OFFSIDES SIDER |
| 38 | Abnormal cervical smear | | | OFFSIDES |
| 39 | Abnormal vision | | | OFFSIDES |
| 40 | Abscess | | | OFFSIDES |
| 41 | Accidental overdose | | | OFFSIDES |
| 42 | Acid reflux | | | OFFSIDES |
| 43 | Acidosis | | | OFFSIDES |
| 44 | Actinomycosis | | | OFFSIDES |
| 45 | Activities of daily living impaired | | | OFFSIDES |
| 46 | Acute bronchitis | | | OFFSIDES |
| 47 | Acute myocardial infarction | | | OFFSIDES |
| 48 | Adenocarcinoma | | | OFFSIDES |
| 49 | Adnexitis | | | OFFSIDES |
| 50 | Agoraphobia | | | OFFSIDES |
| 51 | Akathisia, Drug-Induced | | 15303455 | CTD |
| 52 | Alanine Aminotransferase Increased | | | OFFSIDES |
| 53 | Albumin globulin ratio increased | | | OFFSIDES |
| 54 | Alkalosis | | | OFFSIDES |
| 55 | Altered bowel function | | | OFFSIDES |
| 56 | Alveolitis | | | OFFSIDES |
| 57 | Alveoloplasty | | | OFFSIDES |
| 58 | Amblyopia | | | SIDER |
| 59 | Analgesia | | | OFFSIDES |
| 60 | Anaphylactic shock | | | SIDER |
| 61 | Anastomotic stenosis | | | OFFSIDES |
| 62 | Angiolipoma | | | OFFSIDES |
| 63 | Angioplasty | | | OFFSIDES |
| 64 | Anhedonia | | | OFFSIDES |
| 65 | Anhidrosis | | | OFFSIDES |
| 66 | Anorectal discomfort | | | OFFSIDES |
| 67 | Anorexia | | | OFFSIDES SIDER |
| 68 | Anticonvulsant drug level increased | | | OFFSIDES |
| 69 | Antithrombin III decreased | | | OFFSIDES |
| 70 | Anxiety | | | OFFSIDES SIDER |
| 71 | Apallic syndrome | | | OFFSIDES |
| 72 | Arteriosclerosis Obliterans | | | OFFSIDES |
| 73 | Arteriosclerosis | | | OFFSIDES |
| 74 | Arteriovenous fistula | | | OFFSIDES |
| 75 | Artificial crown procedure | | | OFFSIDES |
| 76 | Aspiration Pneumonia | | | OFFSIDES |
| 77 | Asthenia | | | OFFSIDES SIDER |
| 78 | Asthma | | | OFFSIDES |
| 79 | Atelectasis | | | OFFSIDES |
| 80 | Autoimmune hepatitis | | | OFFSIDES |
| 81 | Back Pain | | | SIDER |
| 82 | Back disorder | | | OFFSIDES |
| 83 | Bacterial disease carrier | | | OFFSIDES |
| 84 | Basal Ganglia Diseases | | 15303455 | CTD |
| 85 | Beckwith-Wiedemann Syndrome | | | OFFSIDES |
| 86 | Benign neoplasm of adrenal gland | | | OFFSIDES |
| 87 | Beta 2 microglobulin increased | | | OFFSIDES |
| 88 | Beta 2 microglobulin urine increased | | | OFFSIDES |
| 89 | Biliary Dyskinesia | | | OFFSIDES |
| 90 | Biliary tract infection | | | OFFSIDES |
| 91 | Biopsy bone abnormal | | | OFFSIDES |
| 92 | Bipolar I disorder | | | OFFSIDES |
| 93 | Blepharitis | | | OFFSIDES |
| 94 | Blood Glucose | | | OFFSIDES |
| 95 | Blood albumin decreased | | | OFFSIDES |
| 96 | Blood albumin increased | | | OFFSIDES |
| 97 | Blood alkaline phosphatase increased | | | OFFSIDES |
| 98 | Blood alkaline phosphatase | | | OFFSIDES |
| 99 | Blood chloride increased | | | OFFSIDES |
| 100 | Blood cholinesterase decreased | | | OFFSIDES |
| 101 | Blood creatine phosphokinase MB increased | | | OFFSIDES |
| 102 | Blood creatine phosphokinase increased | | | OFFSIDES |
| 103 | Blood creatinine decreased | | | OFFSIDES |
| 104 | Blood creatinine increased | | | OFFSIDES |
| 105 | Blood immunoglobulin A increased | | | OFFSIDES |
| 106 | Blood immunoglobulin G increased | | | OFFSIDES |
| 107 | Blood iron decreased | | | OFFSIDES |
| 108 | Blood lactate dehydrogenase increased | | | OFFSIDES |
| 109 | Blood phosphorus decreased | | | OFFSIDES |
| 110 | Blood potassium increased | | | OFFSIDES |
| 111 | Blood sodium | | | OFFSIDES |
| 112 | Blood triglycerides increased | | | OFFSIDES |
| 113 | Blood urea increased | | | OFFSIDES |
| 114 | Blood uric acid | | | OFFSIDES |
| 115 | Blue Toe Syndrome | | | OFFSIDES |
| 116 | Blunted affect | | | OFFSIDES |
| 117 | Blurred vision | | | OFFSIDES |
| 118 | Body Temperature | | | OFFSIDES |
| 119 | Bone lesion | | | OFFSIDES |
| 120 | Bone marrow depression | | | OFFSIDES |
| 121 | Bone pain | | | OFFSIDES |
| 122 | Brain Death | | | OFFSIDES |
| 123 | Breast adenoma | | | OFFSIDES |
| 124 | Bronchiectasis | | | OFFSIDES |
| 125 | Bronchoscopy | | | OFFSIDES |
| 126 | Bronchospasm | | | SIDER |
| 127 | Bruxism | | | OFFSIDES |
| 128 | Bulbar palsy | | | OFFSIDES |
| 129 | Burning sensation | | | OFFSIDES |
| 130 | Bursitis | | | OFFSIDES |
| 131 | Cardiac stress test abnormal | | | OFFSIDES |
| 132 | Cataract | | | OFFSIDES |
| 133 | Catheter placement | | | OFFSIDES |
| 134 | Cellulitis | | | OFFSIDES |
| 135 | Cerebral artery occlusion | | | OFFSIDES |
| 136 | Cerebral artery stenosis | | | OFFSIDES |
| 137 | Charles Bonnet Syndrome | | | OFFSIDES |
| 138 | Chemotherapeutic drug level increased | | | OFFSIDES |
| 139 | Chest Pain | | | OFFSIDES SIDER |
| 140 | Cholangiolitis | | | OFFSIDES |
| 141 | Cholecystitis infective | | | OFFSIDES |
| 142 | Chronic Fatigue Syndrome | | | OFFSIDES |
| 143 | Chronic sinusitis | | | OFFSIDES |
| 144 | Cirrhosis | | | OFFSIDES |
| 145 | Clostridium colitis | | | OFFSIDES |
| 146 | Colectomy | | | OFFSIDES |
| 147 | Colitis | | | OFFSIDES |
| 148 | Confabulation | | | OFFSIDES |
| 149 | Congenital tricuspid valve incompetence | | | OFFSIDES |
| 150 | Conjunctival deposit | | | OFFSIDES |
| 151 | Deafness Neurosensory | | | OFFSIDES |
| 152 | Debridement | | | OFFSIDES |
| 153 | Delirium | | 9269259 | CTD |
| 154 | Demyelination | | | OFFSIDES |
| 155 | Dental Fistula | | | OFFSIDES |
| 156 | Dental alveolar anomaly | | | OFFSIDES |
| 157 | Dental caries | | | OFFSIDES |
| 158 | Dental examination | | | OFFSIDES |
| 159 | Depressed Level of Consciousness | | | OFFSIDES |
| 160 | Dermatitis | | | SIDER |
| 161 | Device Failure | | | OFFSIDES |
| 162 | Device dislocation | | | OFFSIDES |
| 163 | Device related infection | | | OFFSIDES |
| 164 | Diabetes mellitus inadequate control | | | OFFSIDES |
| 165 | Diplopia | | | OFFSIDES |
| 166 | Disease Progression | | | OFFSIDES |
| 167 | Disease recurrence | | | OFFSIDES |
| 168 | Disseminated Intravascular Coagulation | | | OFFSIDES |
| 169 | Disturbance in sexual arousal | | | SIDER |
| 170 | Dizziness | | | OFFSIDES SIDER |
| 171 | Drug Tolerance | | | OFFSIDES |
| 172 | Drug abuser | | | OFFSIDES |
| 173 | Drug addict | | | OFFSIDES |
| 174 | Drug screen positive | | | OFFSIDES |
| 175 | Drug withdrawal headache | | | OFFSIDES |
| 176 | Duodenal Ulcer | | 15235935 | CTD |
| 177 | Duodenitis | | | OFFSIDES |
| 178 | Dysgeusia | | | OFFSIDES |
| 179 | Dyslalia | | | OFFSIDES |
| 180 | Economic problem | | | OFFSIDES |
| 181 | Ejection Fraction Decreased | | | OFFSIDES |
| 182 | Embolic stroke | | | OFFSIDES |
| 183 | Emotional distress | | | OFFSIDES |
| 184 | Endocarditis enterococcal | | | OFFSIDES |
| 185 | Endocarditis | | | OFFSIDES |
| 186 | Endodontic procedure | | | OFFSIDES |
| 187 | Enterocolitis | | | OFFSIDES |
| 188 | Eosinophil percentage increased | | | OFFSIDES |
| 189 | Eosinophilia | | | SIDER |
| 190 | Erectile dysfunction | | | OFFSIDES SIDER |
| 191 | Erosive gastritis | | | OFFSIDES |
| 192 | Erythema Multiforme | | | OFFSIDES |
| 193 | Erythema | | | OFFSIDES |
| 194 | Esophageal Stenosis | | | OFFSIDES |
| 195 | Exanthema | | 7769203 | CTD |
| 196 | Extremity necrosis | | | OFFSIDES |
| 197 | Fanconi Syndrome | | | OFFSIDES |
| 198 | Fever | | 15235935 | CTD |
| 199 | Fistula repair | | | OFFSIDES |
| 200 | Flatulence | | | SIDER |
| 201 | Fluid overload | | | OFFSIDES |
| 202 | Foreign body sensation in eyes | | | OFFSIDES |
| 203 | Formication | | | OFFSIDES |
| 204 | Gamma-Glutamyltransferase Increased | | | OFFSIDES |
| 205 | Gamma-glutamyltransferase abnormal | | | OFFSIDES |
| 206 | Gastric ulcer | | | OFFSIDES |
| 207 | Gastrointestinal Pain | | | SIDER |
| 208 | General physical health deterioration | | | OFFSIDES |
| 209 | Gliosis | | | OFFSIDES |
| 210 | Gout | | | SIDER |
| 211 | Granulocyte count increased | | | OFFSIDES |
| 212 | Granuloma | | | OFFSIDES |
| 213 | Headache | | | SIDER |
| 214 | Hemiparesis | | | OFFSIDES |
| 215 | Hepatitis | | | SIDER |
| 216 | Hoarseness | | | OFFSIDES |
| 217 | Human herpes virus 6 serology positive | | | OFFSIDES |
| 218 | Hydrocephalus | | | OFFSIDES |
| 219 | Hydronephrosis | | | OFFSIDES |
| 220 | Hypercapnia | | | OFFSIDES |
| 221 | Hyperkeratosis | | | OFFSIDES |
| 222 | Hyperparathyroidism | | | OFFSIDES |
| 223 | Hypokinesia | | 15303455 | CTD OFFSIDES |
| 224 | Hypoxia | | | OFFSIDES |
| 225 | Hysterectomy | | | OFFSIDES |
| 226 | Impetigo | | | OFFSIDES |
| 227 | Induration | | | OFFSIDES |
| 228 | Infection | | | OFFSIDES SIDER |
| 229 | Intention tremor | | | OFFSIDES |
| 230 | Intervertebral Disc Degeneration | | | OFFSIDES |
| 231 | Intervertebral disc compression | | | OFFSIDES |
| 232 | Intestinal Obstruction | | | OFFSIDES |
| 233 | Intestinal mucosal hypertrophy | | | OFFSIDES |
| 234 | Intracranial Aneurysm | | | OFFSIDES |
| 235 | Intubation | | | OFFSIDES |
| 236 | Joint warmth | | | OFFSIDES |
| 237 | Keratitis sicca | | | OFFSIDES |
| 238 | Klebsiella sepsis | | | OFFSIDES |
| 239 | Large intestine perforation | | | OFFSIDES |
| 240 | Legionella | | | OFFSIDES |
| 241 | Leukoencephalopathy | | | OFFSIDES |
| 242 | Leukopenia neonatal | | | OFFSIDES |
| 243 | Limb injury | | | OFFSIDES |
| 244 | Limb operation | | | OFFSIDES |
| 245 | Liver Abscess | | | OFFSIDES |
| 246 | Liver Cirrhosis | | 7769203 | CTD |
| 247 | Liver Failure | | 7769203 | CTD |
| 248 | Lung Injury | | | OFFSIDES |
| 249 | Lymphocyte count abnormal | | | OFFSIDES |
| 250 | Lymphocyte count decreased | | | OFFSIDES |
| 251 | Lymphocyte percentage decreased | | | OFFSIDES |
| 252 | Lymphocyte stimulation test positive | | | OFFSIDES |
| 253 | Lymphocytic infiltration | | | OFFSIDES |
| 254 | Macroglossia | | | OFFSIDES |
| 255 | Malignant Hypertension | | | OFFSIDES |
| 256 | Malignant neoplasm progression | | | OFFSIDES |
| 257 | Mandibular prosthesis user | | | OFFSIDES |
| 258 | Mastication disorder | | | OFFSIDES |
| 259 | Mechanical ventilation | | | OFFSIDES |
| 260 | Metabolic acidosis | | | OFFSIDES |
| 261 | Metaplasia | | | OFFSIDES |
| 262 | Monocyte percentage decreased | | | OFFSIDES |
| 263 | Mucormycosis | | | OFFSIDES |
| 264 | Multiple Myeloma | | | OFFSIDES |
| 265 | Multiple Sclerosis | | | OFFSIDES |
| 266 | Multiple sclerosis relapse | | | OFFSIDES |
| 267 | Muscle Rigidity | | 15303455 | CTD |
| 268 | Muscle necrosis | | | OFFSIDES |
| 269 | Muscle tightness | | | OFFSIDES |
| 270 | Muscular Dystrophy | | | OFFSIDES |
| 271 | Musculoskeletal Pain | | | OFFSIDES |
| 272 | Musculoskeletal discomfort | | | SIDER |
| 273 | Myalgia | | | SIDER |
| 274 | Myelitis | | | OFFSIDES |
| 275 | Myeloma recurrence | | | OFFSIDES |
| 276 | Myotonia Congenita | | | OFFSIDES |
| 277 | Nasopharyngitis | | | OFFSIDES SIDER |
| 278 | Nephrolithiasis | | | OFFSIDES SIDER |
| 279 | Nephrotic Syndrome | | | OFFSIDES |
| 280 | Nervous tension | | | OFFSIDES |
| 281 | Nervousness | | | SIDER |
| 282 | Neuroleptic Malignant Syndrome | | | OFFSIDES |
| 283 | Neuropathic pain | | | OFFSIDES |
| 284 | Nocturia | | | OFFSIDES |
| 285 | Nuclear magnetic resonance imaging brain | | | OFFSIDES |
| 286 | Ocular Hypertension | | | OFFSIDES |
| 287 | Oliguria | | | OFFSIDES |
| 288 | Optic Neuritis | | | OFFSIDES |
| 289 | Oral infection | | | OFFSIDES |
| 290 | Osteolysis | | | OFFSIDES |
| 291 | Osteomyelitis | | | OFFSIDES |
| 292 | Osteopenia | | | OFFSIDES |
| 293 | Osteosclerosis | | | OFFSIDES |
| 294 | Pallor | | | OFFSIDES |
| 295 | Pancreatectomy | | | OFFSIDES |
| 296 | Pancreatic Cyst | | | OFFSIDES |
| 297 | Pancreatitis | | | OFFSIDES |
| 298 | Pancytopenia | | 15235935 | CTD |
| 299 | Periarthritis | | | OFFSIDES |
| 300 | Peripheral arterial occlusive disease | | | OFFSIDES |
| 301 | Pharyngitis | | | SIDER |
| 302 | Physical disability | | | OFFSIDES |
| 303 | Pneumocystis jiroveci pneumonia | | | OFFSIDES |
| 304 | Pneumonia | | | SIDER |
| 305 | Polysubstance dependence | | | OFFSIDES |
| 306 | Poor quality sleep | | | OFFSIDES |
| 307 | Post procedural complication | | | OFFSIDES |
| 308 | Prescribed overdose | | | OFFSIDES |
| 309 | Primary sequestrum | | | OFFSIDES |
| 310 | Productive Cough | | | OFFSIDES |
| 311 | Progressive multiple sclerosis | | | OFFSIDES |
| 312 | Protein total abnormal | | | OFFSIDES |
| 313 | Prothrombin level decreased | | | OFFSIDES |
| 314 | Pulmonary Hypertension | | | OFFSIDES |
| 315 | Pulmonary Infarction | | | OFFSIDES |
| 316 | Pulmonary congestion | | | OFFSIDES |
| 317 | Pulmonary vascular disorder | | | OFFSIDES |
| 318 | Purulent discharge | | | OFFSIDES |
| 319 | Quadriplegia | | | OFFSIDES |
| 320 | Radiation skin injury | | | OFFSIDES |
| 321 | Rectal polyp | | | OFFSIDES |
| 322 | Respiratory Failure | | | OFFSIDES |
| 323 | Retinal exudates | | | OFFSIDES |
| 324 | Rhinitis | | | SIDER |
| 325 | Right Ventricular Hypertrophy | | | OFFSIDES |
| 326 | Sarcoidosis | | | OFFSIDES |
| 327 | Seizures | | 8619239 | CTD |
| 328 | Septic Shock | | | OFFSIDES |
| 329 | Sequestrectomy | | | OFFSIDES |
| 330 | Serum Sickness | | | SIDER |
| 331 | Sick Sinus Syndrome | | | OFFSIDES |
| 332 | Sinus antrostomy | | | OFFSIDES |
| 333 | Sinus bradycardia | | | OFFSIDES |
| 334 | Sinus operation | | | OFFSIDES |
| 335 | Sinus rhythm | | | OFFSIDES |
| 336 | Sinusitis | | | OFFSIDES SIDER |
| 337 | Sjogren's Syndrome | | 18478182 | CTD |
| 338 | Skin laceration | | | OFFSIDES |
| 339 | Somnolence | | | SIDER |
| 340 | Spinal column stenosis | | | OFFSIDES |
| 341 | Splenectomy | | | OFFSIDES |
| 342 | Stem cell transplant | | | OFFSIDES |
| 343 | Submandibular mass | | | OFFSIDES |
| 344 | Sweating | | | SIDER |
| 345 | Synovial Cyst | | | OFFSIDES |
| 346 | Systolic hypertension | | | OFFSIDES |
| 347 | Talipes | | | OFFSIDES |
| 348 | Temperature intolerance | | | OFFSIDES |
| 349 | Tenosynovitis | | | OFFSIDES |
| 350 | Tension | | | SIDER |
| 351 | Therapeutic procedure | | | OFFSIDES |
| 352 | Thrombectomy | | | OFFSIDES |
| 353 | Thrombocytopenia | | | SIDER |
| 354 | Thrombocytopenic purpura | | | SIDER |
| 355 | Thrombosis in device | | | OFFSIDES |
| 356 | Thrombotic stroke | | | OFFSIDES |
| 357 | Tooth Extraction | | | OFFSIDES |
| 358 | Tremor | | 15303455 | CTD |
| 359 | Ulcer | | | OFFSIDES |
| 360 | Umbilical hernia perforation | | | OFFSIDES |
| 361 | Unemployment | | | OFFSIDES |
| 362 | Urethral stricture | | | OFFSIDES |
| 363 | Vaginal mycosis | | | OFFSIDES |
| 364 | Vasculitis | | | SIDER |
| 365 | Vena cava filter insertion | | | OFFSIDES |
| 366 | Venous stasis | | | OFFSIDES |
| 367 | Visual disturbance | | | OFFSIDES |
| 368 | Weight Gain | | 15303455 | CTD OFFSIDES |
| 369 | Wound Debridement | | | OFFSIDES |
| 370 | Wound Infection | | | OFFSIDES |
| 371 | Wound abscess | | | OFFSIDES |
| 372 | Wound closure | | | OFFSIDES |
| 373 | Xerostomia | | 18478182 | CTD |
| 374 | effusion | | | OFFSIDES |
| 375 | fibroma | | | OFFSIDES |
| 376 | jaundice | | 7769203 | CTD SIDER |
| 377 | prostatitis | | | OFFSIDES |