| 1 | Drug ineffective | FAERS: 41 | | US FAERS |
| 2 | Product quality issue | FAERS: 18 | | US FAERS |
| 3 | Erythema | FAERS: 15 | | US FAERS |
| 4 | Burning sensation | FAERS: 13 | | US FAERS |
| 5 | Hypersensitivity | FAERS: 12 | | US FAERS |
| 6 | Pruritus | FAERS: 11 | | US FAERS |
| 7 | Poor quality drug administered | FAERS: 10 | | US FAERS |
| 8 | Accidental exposure to product | FAERS: 9 | | US FAERS |
| 9 | Vaginal Discharge | FAERS: 9 | | US FAERS |
| 10 | Dry skin | FAERS: 7 | | US FAERS |
| 11 | Nausea | FAERS: 7 | | US FAERS |
| 12 | Pain | FAERS: 7 | | US FAERS |
| 13 | Acute kidney injury | FAERS: 6 | | US FAERS |
| 14 | Drug administration error | FAERS: 6 | | US FAERS |
| 15 | Eye pain | FAERS: 6 | | US FAERS |
| 16 | Infection | FAERS: 6 | | OFFSIDES US FAERS |
| 17 | Urticaria | FAERS: 6 | | US FAERS |
| 18 | Vulvovaginal burning sensation | FAERS: 6 | | US FAERS |
| 19 | Abdominal Pain | FAERS: 5 | | OFFSIDES US FAERS |
| 20 | Acne | FAERS: 5 | | OFFSIDES US FAERS |
| 21 | Incorrect dose administered | FAERS: 5 | | US FAERS |
| 22 | Malaise | FAERS: 5 | | US FAERS |
| 23 | Skin irritation | FAERS: 5 | | US FAERS |
| 24 | Therapeutic response unexpected | FAERS: 5 | | US FAERS |
| 25 | Tracheitis | FAERS: 5 | | US FAERS |
| 26 | Chills | FAERS: 4 | | US FAERS |
| 27 | Circumstance or information capable of leading to medication error | FAERS: 4 | | US FAERS |
| 28 | Drug ineffective for unapproved indication | FAERS: 4 | | US FAERS |
| 29 | Expired product administered | FAERS: 4 | | US FAERS |
| 30 | Foreign body aspiration | FAERS: 4 | | US FAERS |
| 31 | Product container issue | FAERS: 4 | | US FAERS |
| 32 | Skin tightness | FAERS: 4 | | US FAERS |
| 33 | Vulvovaginal pruritus | FAERS: 4 | | US FAERS |
| 34 | Accidental overdose | FAERS: 3 | | US FAERS |
| 35 | Anaphylactic shock | FAERS: 3 | | US FAERS |
| 36 | Angioedema | FAERS: 3 | | OFFSIDES US FAERS |
| 37 | Application site pain | FAERS: 3 | | US FAERS |
| 38 | Dehydration | FAERS: 3 | | OFFSIDES US FAERS |
| 39 | Drug dispensing error | FAERS: 3 | | US FAERS |
| 40 | Drug exposure during pregnancy | FAERS: 3 | | US FAERS |
| 41 | Dysphonia | FAERS: 3 | | US FAERS |
| 42 | Excoriation | FAERS: 3 | | US FAERS |
| 43 | Product container seal issue | FAERS: 3 | | US FAERS |
| 44 | Product leakage | FAERS: 3 | | US FAERS |
| 45 | Product packaging issue | FAERS: 3 | | US FAERS |
| 46 | Product packaging quantity issue | FAERS: 3 | | US FAERS |
| 47 | Rash erythematous | FAERS: 3 | | US FAERS |
| 48 | Subcutaneous Abscess | FAERS: 3 | | OFFSIDES US FAERS |
| 49 | Syncope | FAERS: 3 | | US FAERS |
| 50 | Vomiting | FAERS: 3 | | US FAERS |
| 51 | Vulvovaginal injury | FAERS: 3 | | US FAERS |
| 52 | Wrong technique in product usage process | FAERS: 3 | | US FAERS |
| 53 | jaundice | FAERS: 3 | | US FAERS |
| 54 | Application site reaction | FAERS: 2 | | US FAERS |
| 55 | Asthenia | FAERS: 2 | | US FAERS |
| 56 | Cardiac Arrest | FAERS: 2 | | US FAERS |
| 57 | Catheter related infection | FAERS: 2 | | OFFSIDES US FAERS |
| 58 | Chest discomfort | FAERS: 2 | | US FAERS |
| 59 | Dizziness | FAERS: 2 | | US FAERS |
| 60 | Drug dose omission | FAERS: 2 | | US FAERS |
| 61 | Drug prescribing error | FAERS: 2 | | US FAERS |
| 62 | Dry gangrene | FAERS: 2 | | US FAERS |
| 63 | Dysgeusia | FAERS: 2 | | US FAERS |
| 64 | Dyspepsia | FAERS: 2 | | OFFSIDES US FAERS |
| 65 | Eye irritation | FAERS: 2 | | US FAERS |
| 66 | Headache | FAERS: 2 | | US FAERS |
| 67 | Hepatotoxicity | FAERS: 2 | | US FAERS |
| 68 | House dust allergy | FAERS: 2 | | US FAERS |
| 69 | Inflammation | FAERS: 2 | | US FAERS |
| 70 | Intentional drug misuse | FAERS: 2 | | US FAERS |
| 71 | Medication Error | FAERS: 2 | | US FAERS |
| 72 | Muscle Spasticity | FAERS: 2 | | US FAERS |
| 73 | No adverse event | FAERS: 2 | | US FAERS |
| 74 | Osteomyelitis | FAERS: 2 | | US FAERS |
| 75 | Penile burning sensation | FAERS: 2 | | US FAERS |
| 76 | Pre-existing condition improved | FAERS: 2 | | US FAERS |
| 77 | Product physical consistency issue | FAERS: 2 | | US FAERS |
| 78 | Product taste abnormal | FAERS: 2 | | US FAERS |
| 79 | Product use in unapproved indication | FAERS: 2 | | US FAERS |
| 80 | Reaction to drug excipients | FAERS: 2 | | US FAERS |
| 81 | Respiratory distress | FAERS: 2 | | US FAERS |
| 82 | Septic Shock | FAERS: 2 | | OFFSIDES US FAERS |
| 83 | Skin Ulcer | FAERS: 2 | | US FAERS |
| 84 | Skin reaction | FAERS: 2 | | US FAERS |
| 85 | Thermal burn | FAERS: 2 | | US FAERS |
| 86 | Tinnitus | FAERS: 2 | | US FAERS |
| 87 | Toxic Epidermal Necrolysis | FAERS: 2 | | US FAERS |
| 88 | Urinary tract infection | FAERS: 2 | | US FAERS |
| 89 | Weight decreased | FAERS: 2 | | US FAERS |
| 90 | Wheezing | FAERS: 2 | | US FAERS |
| 91 | Abdominal discomfort | FAERS: 1 | | OFFSIDES US FAERS |
| 92 | Abscess | FAERS: 1 | | US FAERS |
| 93 | Acarodermatitis | FAERS: 1 | | US FAERS |
| 94 | Accidental exposure | FAERS: 1 | | US FAERS |
| 95 | Acidosis | FAERS: 1 | | OFFSIDES US FAERS |
| 96 | Activities of daily living impaired | FAERS: 1 | | US FAERS |
| 97 | Alanine Aminotransferase Increased | FAERS: 1 | | OFFSIDES US FAERS |
| 98 | Alopecia | FAERS: 1 | | US FAERS |
| 99 | Anal Fissure | FAERS: 1 | | OFFSIDES US FAERS |
| 100 | Antiacetylcholine receptor antibody positive | FAERS: 1 | | US FAERS |
| 101 | Antibiotic level below therapeutic | FAERS: 1 | | US FAERS |
| 102 | Antibody test positive | FAERS: 1 | | US FAERS |
| 103 | Application site burn | FAERS: 1 | | US FAERS |
| 104 | Application site dryness | FAERS: 1 | | US FAERS |
| 105 | Application site erythema | FAERS: 1 | | US FAERS |
| 106 | Application site irritation | FAERS: 1 | | US FAERS |
| 107 | Application site pruritus | FAERS: 1 | | US FAERS |
| 108 | Application site rash | FAERS: 1 | | US FAERS |
| 109 | Application site scar | FAERS: 1 | | US FAERS |
| 110 | Arthritis | FAERS: 1 | | US FAERS |
| 111 | Arthropathy | FAERS: 1 | | US FAERS |
| 112 | Aspartate Aminotransferase Increased | FAERS: 1 | | US FAERS |
| 113 | Atrioventricular Septal Defect | FAERS: 1 | | US FAERS |
| 114 | Bedridden | FAERS: 1 | | US FAERS |
| 115 | Blood creatinine increased | FAERS: 1 | | OFFSIDES US FAERS |
| 116 | Blood iron decreased | FAERS: 1 | | US FAERS |
| 117 | Borrelia burgdorferi serology positive | FAERS: 1 | | US FAERS |
| 118 | Bronchitis | FAERS: 1 | | US FAERS |
| 119 | Bruxism | FAERS: 1 | | US FAERS |
| 120 | Capsule physical issue | FAERS: 1 | | US FAERS |
| 121 | Catheter site pain | FAERS: 1 | | US FAERS |
| 122 | Central line infection | FAERS: 1 | | US FAERS |
| 123 | Choking | FAERS: 1 | | OFFSIDES US FAERS |
| 124 | Chromaturia | FAERS: 1 | | US FAERS |
| 125 | Clostridium difficile infection | FAERS: 1 | | US FAERS |
| 126 | Clostridium test positive | FAERS: 1 | | US FAERS |
| 127 | Conjunctivitis | FAERS: 1 | | US FAERS |
| 128 | Constipation | FAERS: 1 | | US FAERS |
| 129 | Cyanosis | FAERS: 1 | | US FAERS |
| 130 | Deafness Neurosensory | FAERS: 1 | | US FAERS |
| 131 | Deafness | FAERS: 1 | | OFFSIDES US FAERS |
| 132 | Device breakage | FAERS: 1 | | US FAERS |
| 133 | Disease Progression | FAERS: 1 | | US FAERS |
| 134 | Drooling | FAERS: 1 | | US FAERS |
| 135 | Drug effect incomplete | FAERS: 1 | | US FAERS |
| 136 | Drug level below therapeutic | FAERS: 1 | | US FAERS |
| 137 | Drug resistance | FAERS: 1 | | US FAERS |
| 138 | Dysarthria | FAERS: 1 | | US FAERS |
| 139 | Economic problem | FAERS: 1 | | US FAERS |
| 140 | Eczema | FAERS: 1 | | US FAERS |
| 141 | Educational problem | FAERS: 1 | | US FAERS |
| 142 | Emotional disorder | FAERS: 1 | | US FAERS |
| 143 | Enterocolitis | FAERS: 1 | | US FAERS |
| 144 | Exophthalmos | FAERS: 1 | | US FAERS |
| 145 | Exposure via eye contact | FAERS: 1 | | US FAERS |
| 146 | Exposure via partner | FAERS: 1 | | US FAERS |
| 147 | Extravasation | FAERS: 1 | | US FAERS |
| 148 | Facial Pain | FAERS: 1 | | US FAERS |
| 149 | Fatigue | FAERS: 1 | | OFFSIDES US FAERS |
| 150 | Feeling abnormal | FAERS: 1 | | US FAERS |
| 151 | Feeling jittery | FAERS: 1 | | US FAERS |
| 152 | Folliculitis | FAERS: 1 | | OFFSIDES US FAERS |
| 153 | Foreign body trauma | FAERS: 1 | | US FAERS |
| 154 | Gastroenteritis | FAERS: 1 | | US FAERS |
| 155 | Gastrointestinal Pain | FAERS: 1 | | US FAERS |
| 156 | Gastrointestinal ulcer | FAERS: 1 | | US FAERS |
| 157 | General physical condition abnormal | FAERS: 1 | | US FAERS |
| 158 | Genital injury | FAERS: 1 | | US FAERS |
| 159 | Hypertrichosis | FAERS: 1 | | US FAERS |
| 160 | Hypophagia | FAERS: 1 | | US FAERS |
| 161 | Impaired work ability | FAERS: 1 | | US FAERS |
| 162 | Inappropriate schedule of drug administration | FAERS: 1 | | US FAERS |
| 163 | Inappropriate schedule of product administration | FAERS: 1 | | US FAERS |
| 164 | Incorrect dose administered by device | FAERS: 1 | | US FAERS |
| 165 | Incorrect drug administration duration | FAERS: 1 | | US FAERS |
| 166 | Incorrect route of drug administration | FAERS: 1 | | US FAERS |
| 167 | Increased upper airway secretion | FAERS: 1 | | US FAERS |
| 168 | Infantile apnoeic attack | FAERS: 1 | | US FAERS |
| 169 | Intestinal congestion | FAERS: 1 | | US FAERS |
| 170 | Irritable Bowel Syndrome | FAERS: 1 | | US FAERS |
| 171 | Kounis Syndrome | FAERS: 1 | | US FAERS |
| 172 | Laryngeal Obstruction | FAERS: 1 | | US FAERS |
| 173 | Limb injury | FAERS: 1 | | US FAERS |
| 174 | Local reaction | FAERS: 1 | | US FAERS |
| 175 | Malabsorption | FAERS: 1 | | US FAERS |
| 176 | Malnutrition | FAERS: 1 | | US FAERS |
| 177 | Maternal exposure during breast feeding | FAERS: 1 | | US FAERS |
| 178 | Metrorrhagia | FAERS: 1 | | US FAERS |
| 179 | Myasthenic Syndrome | FAERS: 1 | | OFFSIDES US FAERS |
| 180 | Necrosis | FAERS: 1 | | US FAERS |
| 181 | Nerve injury | FAERS: 1 | | US FAERS |
| 182 | Nocturia | FAERS: 1 | | US FAERS |
| 183 | Open wound | FAERS: 1 | | US FAERS |
| 184 | Ophthalmoplegia | FAERS: 1 | | US FAERS |
| 185 | Oropharyngeal cancer stage unspecified | FAERS: 1 | | US FAERS |
| 186 | Oropharyngeal plaque | FAERS: 1 | | US FAERS |
| 187 | Pancytopenia | FAERS: 1 | | US FAERS |
| 188 | Pathogen resistance | FAERS: 1 | | US FAERS |
| 189 | Pericardial effusion | FAERS: 1 | | OFFSIDES US FAERS |
| 190 | Peripheral swelling | FAERS: 1 | | US FAERS |
| 191 | Pharmaceutical product complaint | FAERS: 1 | | US FAERS |
| 192 | Positron emission tomogram abnormal | FAERS: 1 | | US FAERS |
| 193 | Post procedural complication | FAERS: 1 | | OFFSIDES US FAERS |
| 194 | Postoperative wound complication | FAERS: 1 | | US FAERS |
| 195 | Product dispensing error | FAERS: 1 | | US FAERS |
| 196 | Product dosage form issue | FAERS: 1 | | US FAERS |
| 197 | Product formulation issue | FAERS: 1 | | US FAERS |
| 198 | Product physical issue | FAERS: 1 | | US FAERS |
| 199 | Product preparation error | FAERS: 1 | | US FAERS |
| 200 | Product solubility abnormal | FAERS: 1 | | US FAERS |
| 201 | Product substitution issue | FAERS: 1 | | US FAERS |
| 202 | Refusal of treatment by relative | FAERS: 1 | | US FAERS |
| 203 | Renal tubular disorder | FAERS: 1 | | US FAERS |
| 204 | Respiratory Failure | FAERS: 1 | | US FAERS |
| 205 | Respiratory arrest | FAERS: 1 | | US FAERS |
| 206 | Retching | FAERS: 1 | | US FAERS |
| 207 | Secretion discharge | FAERS: 1 | | US FAERS |
| 208 | Skin Papilloma | FAERS: 1 | | US FAERS |
| 209 | Skin necrosis | FAERS: 1 | | US FAERS |
| 210 | Sperm count decreased | FAERS: 1 | | US FAERS |
| 211 | Stomatitis | FAERS: 1 | | US FAERS |
| 212 | Swelling | FAERS: 1 | | US FAERS |
| 213 | Therapy cessation | FAERS: 1 | | US FAERS |
| 214 | Thirst | FAERS: 1 | | US FAERS |
| 215 | Throat irritation | FAERS: 1 | | US FAERS |
| 216 | Thrombocytopenia | FAERS: 1 | | US FAERS |
| 217 | Thrombophlebitis | FAERS: 1 | | US FAERS |
| 218 | Thrombosis | FAERS: 1 | | US FAERS |
| 219 | Tremor | FAERS: 1 | | US FAERS |
| 220 | Trismus | FAERS: 1 | | US FAERS |
| 221 | Unevaluable event | FAERS: 1 | | US FAERS |
| 222 | Upper respiratory tract congestion | FAERS: 1 | | US FAERS |
| 223 | Varicella zoster virus serology positive | FAERS: 1 | | US FAERS |
| 224 | Vasculitis | FAERS: 1 | | US FAERS |
| 225 | Visual disturbance | FAERS: 1 | | OFFSIDES US FAERS |
| 226 | Vulvovaginal discomfort | FAERS: 1 | | US FAERS |
| 227 | Vulvovaginal mycotic infection | FAERS: 1 | | OFFSIDES US FAERS |
| 228 | Vulvovaginal swelling | FAERS: 1 | | US FAERS |
| 229 | Wound necrosis | FAERS: 1 | | US FAERS |
| 230 | Wrong technique in drug usage process | FAERS: 1 | | US FAERS |
| 231 | Zygomycosis | FAERS: 1 | | US FAERS |
| 232 | furuncle | FAERS: 1 | | OFFSIDES US FAERS |
| 233 | Abdominal strangulated hernia | | | OFFSIDES |
| 234 | Abdominal tenderness | | | OFFSIDES |
| 235 | Acute bronchitis | | | OFFSIDES |
| 236 | Anal Fistula | | | OFFSIDES |
| 237 | Anorexia | | | OFFSIDES |
| 238 | Anoxia | | | OFFSIDES |
| 239 | Antidepressant drug clearance decreased | | | OFFSIDES |
| 240 | Aphthous Stomatitis | | | OFFSIDES |
| 241 | Arteriosclerosis | | | OFFSIDES |
| 242 | Atherosclerosis | | | OFFSIDES |
| 243 | Automatism | | | OFFSIDES |
| 244 | Bacteroides Infections | | 4609237 | CTD |
| 245 | Basophilia | | | OFFSIDES |
| 246 | Blood alkaline phosphatase increased | | | OFFSIDES |
| 247 | Blood bilirubin unconjugated increased | | | OFFSIDES |
| 248 | Blood lactate dehydrogenase increased | | | OFFSIDES |
| 249 | Blood potassium increased | | | OFFSIDES |
| 250 | Blood pressure immeasurable | | | OFFSIDES |
| 251 | Blood sodium increased | | | OFFSIDES |
| 252 | Blood urine present | | | OFFSIDES |
| 253 | Brain natriuretic peptide increased | | | OFFSIDES |
| 254 | Cardiac Tamponade | | | OFFSIDES |
| 255 | Cardiovascular insufficiency | | | OFFSIDES |
| 256 | Central Nervous System Infection | | | OFFSIDES |
| 257 | Chest Pain | | | OFFSIDES |
| 258 | Cholangiolitis | | | OFFSIDES |
| 259 | Chronic ulcerative colitis | | | OFFSIDES |
| 260 | Clostridium difficile colitis | | | OFFSIDES |
| 261 | Colon adenoma | | | OFFSIDES |
| 262 | Colonic Stenosis | | | OFFSIDES |
| 263 | Culture positive | | | OFFSIDES |
| 264 | Depressed Level of Consciousness | | | OFFSIDES |
| 265 | Diarrhea | | | OFFSIDES |
| 266 | Disseminated Intravascular Coagulation | | | OFFSIDES |
| 267 | Endocarditis | | | OFFSIDES |
| 268 | Engraft failure | | | OFFSIDES |
| 269 | Epidural Abscess | | | OFFSIDES |
| 270 | Epiglottitis | | | OFFSIDES |
| 271 | Epilepsy | | | OFFSIDES |
| 272 | Episcleritis | | | OFFSIDES |
| 273 | Erosive gastritis | | | OFFSIDES |
| 274 | Facial Neuralgia | | | OFFSIDES |
| 275 | Febrile Neutropenia | | | OFFSIDES |
| 276 | Feeling Cold | | | OFFSIDES |
| 277 | Flank Pain | | | OFFSIDES |
| 278 | Gastrointestinal mucosal disorder | | | OFFSIDES |
| 279 | General physical health deterioration | | | OFFSIDES |
| 280 | Genital discharge | | | OFFSIDES |
| 281 | Goiter | | | OFFSIDES |
| 282 | Graft dysfunction | | | OFFSIDES |
| 283 | Granulocytosis | | | OFFSIDES |
| 284 | Hyperventilation | | | OFFSIDES |
| 285 | Hypoxia | | | OFFSIDES |
| 286 | Ileitis | | | OFFSIDES |
| 287 | Immunosuppressant drug level | | | OFFSIDES |
| 288 | Impetigo | | | OFFSIDES |
| 289 | Implant site erosion | | | OFFSIDES |
| 290 | Intestinal Obstruction | | | OFFSIDES |
| 291 | Kidney Neoplasm | | | OFFSIDES |
| 292 | Leukopenia neonatal | | | OFFSIDES |
| 293 | Lymphocyte stimulation test positive | | | OFFSIDES |
| 294 | Malignant neoplasm progression | | | OFFSIDES |
| 295 | Multi-organ disorder | | | OFFSIDES |
| 296 | Occult blood positive | | | OFFSIDES |
| 297 | Perirectal abscess | | | OFFSIDES |
| 298 | Phlebitis | | | OFFSIDES |
| 299 | Post inflammatory pigmentation change | | | OFFSIDES |
| 300 | Postrenal failure | | | OFFSIDES |
| 301 | Procedural complication | | | OFFSIDES |
| 302 | Proctitis | | | OFFSIDES |
| 303 | Puncture site pain | | | OFFSIDES |
| 304 | Reperfusion Injury | | | OFFSIDES |
| 305 | Sepsis | | 448989 | CTD |
| 306 | Skin test positive | | | OFFSIDES |
| 307 | Sputum culture positive | | | OFFSIDES |
| 308 | Staphylococcal Infections | | 448989 | CTD |
| 309 | Stevens-Johnson Syndrome | | | OFFSIDES |
| 310 | Stress at work | | | OFFSIDES |
| 311 | Superficial Thrombophlebitis | | | OFFSIDES |
| 312 | Tachycardia, Paroxysmal | | 7089634 | CTD |
| 313 | Therapy non-responder | | | OFFSIDES |
| 314 | Transfusion Reaction | | | OFFSIDES |
| 315 | Trichosporon infection | | | OFFSIDES |
| 316 | Uterine Polyp | | | OFFSIDES |
| 317 | Ventricular Fibrillation | | | OFFSIDES |
| 318 | Weight Gain | | | OFFSIDES |
| 319 | Wound infection pseudomonas | | | OFFSIDES |
| 320 | Wound infection staphylococcal | | | OFFSIDES |
| 321 | carbuncle | | | OFFSIDES |