| Name | Number of Reports | Reference(s) | Data Source | |
|---|---|---|---|---|
| 1 | Drug ineffective | FAERS: 5609 Canada Vigilance: 164 | Canada Vigilance OFFSIDES US FAERS | |
| 2 | Drug administration error | FAERS: 1739 | OFFSIDES US FAERS | |
| 3 | Incorrect drug administration duration | FAERS: 825 | US FAERS | |
| 4 | Product quality issue | FAERS: 597 Canada Vigilance: 4 | Canada Vigilance US FAERS | |
| 5 | Inappropriate schedule of drug administration | FAERS: 503 | US FAERS | |
| 6 | Lip swelling | FAERS: 435 Canada Vigilance: 4 | Canada Vigilance US FAERS | |
| 7 | Application site pain | FAERS: 412 | US FAERS | |
| 8 | Wrong technique in product usage process | FAERS: 352 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 9 | Hypersensitivity | FAERS: 259 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 10 | Incorrect product administration duration | FAERS: 237 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 11 | Application site erythema | FAERS: 221 | US FAERS | |
| 12 | Application site irritation | FAERS: 213 | OFFSIDES US FAERS | |
| 13 | Application site swelling | FAERS: 189 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 14 | Inappropriate schedule of product administration | FAERS: 158 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 15 | Application site scab | FAERS: 153 | US FAERS | |
| 16 | Intentional drug misuse | FAERS: 151 | OFFSIDES US FAERS | |
| 17 | Cheilitis | FAERS: 129 | OFFSIDES US FAERS | |
| 18 | Expired product administered | FAERS: 116 | US FAERS | |
| 19 | Application site reaction | FAERS: 113 | OFFSIDES SIDER US FAERS | |
| 20 | Product complaint | FAERS: 112 Canada Vigilance: 13 | Canada Vigilance US FAERS | |
| 21 | Application site scar | FAERS: 94 | US FAERS | |
| 22 | Burning sensation | FAERS: 81 | US FAERS | |
| 23 | Product use in unapproved indication | FAERS: 78 | US FAERS | |
| 24 | Product use issue | FAERS: 78 Canada Vigilance: 5 | Canada Vigilance US FAERS | |
| 25 | Application site vesicles | FAERS: 77 | US FAERS | |
| 26 | Application site pruritus | FAERS: 76 | US FAERS | |
| 27 | Scab | FAERS: 73 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 28 | Pain | FAERS: 67 | US FAERS | |
| 29 | Erythema | FAERS: 66 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 30 | Pruritus | FAERS: 64 Canada Vigilance: 2 | Canada Vigilance SIDER US FAERS | |
| 31 | Accidental exposure to product | FAERS: 59 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 32 | Application site dryness | FAERS: 59 | OFFSIDES US FAERS | |
| 33 | Lip exfoliation | FAERS: 43 | US FAERS | |
| 34 | Application site burn | FAERS: 36 | US FAERS | |
| 35 | Drug effective for unapproved indication | FAERS: 34 | US FAERS | |
| 36 | Drug administered at inappropriate site | FAERS: 33 | US FAERS | |
| 37 | Application site exfoliation | FAERS: 32 | US FAERS | |
| 38 | Drug effect delayed | FAERS: 32 | US FAERS | |
| 39 | Application site infection | FAERS: 31 | US FAERS | |
| 40 | Headache | FAERS: 31 | SIDER US FAERS | |
| 41 | Product administered at inappropriate site | FAERS: 30 | US FAERS | |
| 42 | Oral pain | FAERS: 29 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 43 | Adverse event | FAERS: 28 | US FAERS | |
| 44 | Drug ineffective for unapproved indication | FAERS: 28 | US FAERS | |
| 45 | Nonspecific reaction | FAERS: 27 | US FAERS | |
| 46 | Swelling | FAERS: 26 | US FAERS | |
| 47 | Urticaria | FAERS: 26 | US FAERS | |
| 48 | Therapeutic response unexpected | FAERS: 25 | US FAERS | |
| 49 | Drug effect incomplete | FAERS: 24 | US FAERS | |
| 50 | Application site rash | FAERS: 23 | US FAERS | |
| 51 | Pharmaceutical product complaint | FAERS: 23 | US FAERS | |
| 52 | Application site discharge | FAERS: 19 | US FAERS | |
| 53 | Dizziness | FAERS: 19 | US FAERS | |
| 54 | Expired drug administered | FAERS: 19 | US FAERS | |
| 55 | Skin laceration | FAERS: 19 | US FAERS | |
| 56 | Facial Pain | FAERS: 18 | US FAERS | |
| 57 | Lip pruritus | FAERS: 17 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 58 | Product package associated injury | FAERS: 17 | US FAERS | |
| 59 | Infection | FAERS: 16 | US FAERS | |
| 60 | Application site discomfort | FAERS: 15 | US FAERS | |
| 61 | Application site inflammation | FAERS: 14 | US FAERS | |
| 62 | Lip erythema | FAERS: 14 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 63 | Malaise | FAERS: 14 | US FAERS | |
| 64 | Skin irritation | FAERS: 14 | US FAERS | |
| 65 | Stomatitis | FAERS: 14 | US FAERS | |
| 66 | Laceration | FAERS: 13 | US FAERS | |
| 67 | Acne | FAERS: 12 | SIDER US FAERS | |
| 68 | Application site papules | FAERS: 12 | US FAERS | |
| 69 | Drug administered to patient of inappropriate age | FAERS: 12 | US FAERS | |
| 70 | Dry skin | FAERS: 12 | SIDER US FAERS | |
| 71 | Eye pain | FAERS: 12 | US FAERS | |
| 72 | Inadequate aseptic technique in use of product | FAERS: 12 | US FAERS | |
| 73 | Mouth swelling | FAERS: 12 | US FAERS | |
| 74 | Feeling abnormal | FAERS: 11 | US FAERS | |
| 75 | Intentional product use issue | FAERS: 11 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 76 | Lymphadenopathy | FAERS: 11 | US FAERS | |
| 77 | Medication Error | FAERS: 11 | US FAERS | |
| 78 | Application site erosion | FAERS: 10 | US FAERS | |
| 79 | Application site warmth | FAERS: 10 | US FAERS | |
| 80 | Incorrect dose administered | FAERS: 10 | US FAERS | |
| 81 | Lip Infection | FAERS: 10 | US FAERS | |
| 82 | Nausea | FAERS: 10 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 83 | Pallor | FAERS: 10 | OFFSIDES US FAERS | |
| 84 | Eye irritation | FAERS: 9 | US FAERS | |
| 85 | Incorrect route of drug administration | FAERS: 9 | US FAERS | |
| 86 | Skin Ulcer | FAERS: 9 | US FAERS | |
| 87 | Thermal burn | FAERS: 9 | US FAERS | |
| 88 | Application site ulcer | FAERS: 8 | US FAERS | |
| 89 | Discomfort | FAERS: 8 | US FAERS | |
| 90 | Drug exposure during pregnancy | FAERS: 8 | US FAERS | |
| 91 | Dysgeusia | FAERS: 8 | US FAERS | |
| 92 | Product physical consistency issue | FAERS: 8 | US FAERS | |
| 93 | Intentional misuse | FAERS: 7 | OFFSIDES US FAERS | |
| 94 | Intentional product misuse | FAERS: 7 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 95 | Pigmentation lip | FAERS: 7 | US FAERS | |
| 96 | Circumstance or information capable of leading to medication error | FAERS: 6 | US FAERS | |
| 97 | Emergency care examination | FAERS: 6 | US FAERS | |
| 98 | Hypoaesthesia facial | FAERS: 6 | US FAERS | |
| 99 | Product storage error | FAERS: 6 | US FAERS | |
| 100 | Aphasia | FAERS: 5 | US FAERS | |
| 101 | Blood blister | FAERS: 5 | US FAERS | |
| 102 | Fatigue | FAERS: 5 | US FAERS | |
| 103 | Purulent discharge | FAERS: 5 | US FAERS | |
| 104 | Rash erythematous | FAERS: 5 | US FAERS | |
| 105 | Tension | FAERS: 5 | US FAERS | |
| 106 | Application site induration | FAERS: 4 | US FAERS | |
| 107 | Application site pustules | FAERS: 4 | US FAERS | |
| 108 | Drug effect variable | FAERS: 4 | US FAERS | |
| 109 | Extra dose administered | FAERS: 4 | US FAERS | |
| 110 | Inflammation | FAERS: 4 | US FAERS | |
| 111 | Nasopharyngitis | FAERS: 4 | US FAERS | |
| 112 | Oropharyngeal pain | FAERS: 4 | US FAERS | |
| 113 | Overdose | FAERS: 4 | US FAERS | |
| 114 | Product packaging quantity issue | FAERS: 4 | US FAERS | |
| 115 | Accidental exposure to product by child | FAERS: 3 | US FAERS | |
| 116 | Anxiety | FAERS: 3 | US FAERS | |
| 117 | Blister rupture | FAERS: 3 | US FAERS | |
| 118 | Breast Feeding | FAERS: 3 | US FAERS | |
| 119 | Concomitant disease aggravated | FAERS: 3 | US FAERS | |
| 120 | Dermatitis | FAERS: 3 | SIDER US FAERS | |
| 121 | Disease recurrence | FAERS: 3 | US FAERS | |
| 122 | Glossitis | FAERS: 3 | US FAERS | |
| 123 | Intercepted medication error | FAERS: 3 | US FAERS | |
| 124 | Medication residue present | FAERS: 3 | US FAERS | |
| 125 | Muscle tightness | FAERS: 3 | US FAERS | |
| 126 | Pharyngolaryngeal Pain | FAERS: 3 | US FAERS | |
| 127 | Poor quality sleep | FAERS: 3 | US FAERS | |
| 128 | Product packaging issue | FAERS: 3 | US FAERS | |
| 129 | Product use complaint | FAERS: 3 | US FAERS | |
| 130 | Sunburn | FAERS: 3 | US FAERS | |
| 131 | Therapeutic product effect delayed | FAERS: 3 | US FAERS | |
| 132 | Toothache | FAERS: 3 | US FAERS | |
| 133 | VIIth nerve paralysis | FAERS: 3 | OFFSIDES US FAERS | |
| 134 | Vomiting | FAERS: 3 | US FAERS | |
| 135 | Weight decreased | FAERS: 3 | US FAERS | |
| 136 | Abdominal discomfort | FAERS: 2 | US FAERS | |
| 137 | Accidental exposure | FAERS: 2 | US FAERS | |
| 138 | Aphthous Stomatitis | FAERS: 2 | US FAERS | |
| 139 | Application site injury | FAERS: 2 | US FAERS | |
| 140 | Application site laceration | FAERS: 2 | US FAERS | |
| 141 | Application site urticaria | FAERS: 2 | US FAERS | |
| 142 | Application site wound | FAERS: 2 | US FAERS | |
| 143 | Arthralgia | FAERS: 2 | US FAERS | |
| 144 | Auricular swelling | FAERS: 2 | US FAERS | |
| 145 | Blunted affect | FAERS: 2 | US FAERS | |
| 146 | Cerebrovascular accident | FAERS: 2 | US FAERS | |
| 147 | Dysphonia | FAERS: 2 | US FAERS | |
| 148 | Exposure during breast feeding | FAERS: 2 | US FAERS | |
| 149 | Feeling Cold | FAERS: 2 | US FAERS | |
| 150 | Gingivitis | FAERS: 2 | US FAERS | |
| 151 | Induration | FAERS: 2 | US FAERS | |
| 152 | Live Birth | FAERS: 2 | US FAERS | |
| 153 | Nasal discomfort | FAERS: 2 | US FAERS | |
| 154 | Nasal pruritus | FAERS: 2 | US FAERS | |
| 155 | Neck Pain | FAERS: 2 | US FAERS | |
| 156 | Neuralgia | FAERS: 2 | US FAERS | |
| 157 | Oral infection | FAERS: 2 | US FAERS | |
| 158 | Oral pruritus | FAERS: 2 | US FAERS | |
| 159 | Osteitis | FAERS: 2 | US FAERS | |
| 160 | Pain of skin | FAERS: 2 | US FAERS | |
| 161 | Penile burning sensation | FAERS: 2 | US FAERS | |
| 162 | Peripheral swelling | FAERS: 2 | US FAERS | |
| 163 | Product administered to patient of inappropriate age | FAERS: 2 | US FAERS | |
| 164 | Product container issue | FAERS: 2 | US FAERS | |
| 165 | Product dispensing error | FAERS: 2 | US FAERS | |
| 166 | Product expiration date issue | FAERS: 2 | US FAERS | |
| 167 | Product outer packaging issue | FAERS: 2 | US FAERS | |
| 168 | Skin Induration | FAERS: 2 | US FAERS | |
| 169 | Skin tightness | FAERS: 2 | US FAERS | |
| 170 | Squamous cell carcinoma | FAERS: 2 | US FAERS | |
| 171 | Therapeutic product effect incomplete | FAERS: 2 Canada Vigilance: 2 | Canada Vigilance US FAERS | |
| 172 | Tongue discomfort | FAERS: 2 | US FAERS | |
| 173 | Tongue erythema | FAERS: 2 | US FAERS | |
| 174 | Tongue pruritus | FAERS: 2 | US FAERS | |
| 175 | Upper respiratory tract congestion | FAERS: 2 | US FAERS | |
| 176 | furuncle | FAERS: 2 | US FAERS | |
| 177 | Abdominal Pain | FAERS: 1 | US FAERS | |
| 178 | Abscess | FAERS: 1 | US FAERS | |
| 179 | Ageusia | FAERS: 1 | US FAERS | |
| 180 | Agitation | FAERS: 1 | US FAERS | |
| 181 | Alcohol test false positive | FAERS: 1 | US FAERS | |
| 182 | Alopecia | FAERS: 1 | US FAERS | |
| 183 | Amblyopia | FAERS: 1 | US FAERS | |
| 184 | Anaphylactic shock | FAERS: 1 | US FAERS | |
| 185 | Angular cheilitis | FAERS: 1 | US FAERS | |
| 186 | Anorectal discomfort | FAERS: 1 | US FAERS | |
| 187 | Application site excoriation | FAERS: 1 | US FAERS | |
| 188 | Asthma | FAERS: 1 | US FAERS | |
| 189 | Biopsy | FAERS: 1 | US FAERS | |
| 190 | Blood glucose decreased | FAERS: 1 | US FAERS | |
| 191 | Bone pain | FAERS: 1 | US FAERS | |
| 192 | Buccal mucosal roughening | FAERS: 1 | US FAERS | |
| 193 | Cellulitis | FAERS: 1 | US FAERS | |
| 194 | Chemical injury | FAERS: 1 | US FAERS | |
| 195 | Chest Pain | FAERS: 1 | US FAERS | |
| 196 | Cystitis | FAERS: 1 | US FAERS | |
| 197 | Deformity | FAERS: 1 | US FAERS | |
| 198 | Dehydration | FAERS: 1 | US FAERS | |
| 199 | Device operational issue | FAERS: 1 | US FAERS | |
| 200 | Device use error | FAERS: 1 | US FAERS | |
| 201 | Disability | FAERS: 1 | US FAERS | |
| 202 | Drug Dependence | FAERS: 1 | US FAERS | |
| 203 | Drug abuse | FAERS: 1 | US FAERS | |
| 204 | Drug dose omission | FAERS: 1 | US FAERS | |
| 205 | Dysarthria | FAERS: 1 | US FAERS | |
| 206 | Ear discomfort | FAERS: 1 | US FAERS | |
| 207 | Emergency Care | FAERS: 1 | US FAERS | |
| 208 | Enlarged uvula | FAERS: 1 | US FAERS | |
| 209 | Epistaxis | FAERS: 1 | US FAERS | |
| 210 | Essential Hypertension | FAERS: 1 | US FAERS | |
| 211 | Excoriation | FAERS: 1 | US FAERS | |
| 212 | Eye Infection | FAERS: 1 | US FAERS | |
| 213 | Eye inflammation | FAERS: 1 | US FAERS | |
| 214 | Eyelid Function Disorder | FAERS: 1 | US FAERS | |
| 215 | Eyelids pruritus | FAERS: 1 | US FAERS | |
| 216 | Feeling jittery | FAERS: 1 | US FAERS | |
| 217 | Foreign body sensation in eyes | FAERS: 1 | US FAERS | |
| 218 | Genital burning sensation | FAERS: 1 | US FAERS | |
| 219 | Genital pain | FAERS: 1 | US FAERS | |
| 220 | Genital rash | FAERS: 1 | US FAERS | |
| 221 | Gingival Atrophy | FAERS: 1 | US FAERS | |
| 222 | Gingival erythema | FAERS: 1 | US FAERS | |
| 223 | Head discomfort | FAERS: 1 | US FAERS | |
| 224 | Impaired work ability | FAERS: 1 | US FAERS | |
| 225 | Impetigo | FAERS: 1 | US FAERS | |
| 226 | Initial insomnia | FAERS: 1 | US FAERS | |
| 227 | Keratitis | FAERS: 1 | US FAERS | |
| 228 | Lethargy | FAERS: 1 | US FAERS | |
| 229 | Limb injury | FAERS: 1 | US FAERS | |
| 230 | Lymphadenitis | FAERS: 1 | US FAERS | |
| 231 | Medication residue | FAERS: 1 | US FAERS | |
| 232 | Mole excision | FAERS: 1 | US FAERS | |
| 233 | Musculoskeletal stiffness | FAERS: 1 | US FAERS | |
| 234 | Nervousness | FAERS: 1 | US FAERS | |
| 235 | No adverse event | FAERS: 1 | US FAERS | |
| 236 | Onychoclasis | FAERS: 1 | US FAERS | |
| 237 | Open wound | FAERS: 1 | US FAERS | |
| 238 | Oral discharge | FAERS: 1 | US FAERS | |
| 239 | Oral fungal infection | FAERS: 1 | US FAERS | |
| 240 | Oral mucosal eruption | FAERS: 1 | US FAERS | |
| 241 | Oral mucosal erythema | FAERS: 1 | US FAERS | |
| 242 | Oral mucosal exfoliation | FAERS: 1 | US FAERS | |
| 243 | Oropharyngeal discomfort | FAERS: 1 | US FAERS | |
| 244 | Osteomyelitis | FAERS: 1 | US FAERS | |
| 245 | Pharyngolaryngeal discomfort | FAERS: 1 | US FAERS | |
| 246 | Physical assault | FAERS: 1 | US FAERS | |
| 247 | Piloerection | FAERS: 1 | US FAERS | |
| 248 | Product dispensing issue | FAERS: 1 | US FAERS | |
| 249 | Product lot number issue | FAERS: 1 Canada Vigilance: 1 | Canada Vigilance US FAERS | |
| 250 | Product packaging difficult to open | FAERS: 1 | US FAERS | |
| 251 | Product physical issue | FAERS: 1 | US FAERS | |
| 252 | Product residue present | FAERS: 1 | US FAERS | |
| 253 | Product tampering | FAERS: 1 | US FAERS | |
| 254 | Productive Cough | FAERS: 1 | US FAERS | |
| 255 | Pulmonary congestion | FAERS: 1 | US FAERS | |
| 256 | Saliva altered | FAERS: 1 | US FAERS | |
| 257 | Sensation of blood flow | FAERS: 1 | US FAERS | |
| 258 | Skin hypertrophy | FAERS: 1 | US FAERS | |
| 259 | Skin lesion | FAERS: 1 | US FAERS | |
| 260 | Soft Tissue Infection | FAERS: 1 | US FAERS | |
| 261 | Somnolence | FAERS: 1 | US FAERS | |
| 262 | Submandibular mass | FAERS: 1 | US FAERS | |
| 263 | Swelling of eyelid | FAERS: 1 | US FAERS | |
| 264 | Symptom recurrence | FAERS: 1 | US FAERS | |
| 265 | Therapy non-responder | FAERS: 1 | US FAERS | |
| 266 | Throat irritation | FAERS: 1 | US FAERS | |
| 267 | Tinnitus | FAERS: 1 | US FAERS | |
| 268 | Tongue blistering | FAERS: 1 | US FAERS | |
| 269 | Tremor | FAERS: 1 | US FAERS | |
| 270 | Ulcer | FAERS: 1 | US FAERS | |
| 271 | Unevaluable event | FAERS: 1 | US FAERS | |
| 272 | Wheezing | FAERS: 1 | US FAERS | |
| 273 | Wrong technique in device usage process | FAERS: 1 | US FAERS | |
| 274 | Apnea | OFFSIDES | ||
| 275 | Bacterial sepsis | OFFSIDES | ||
| 276 | Bronchomalacia | OFFSIDES | ||
| 277 | Congenital heart disease | OFFSIDES | ||
| 278 | Congenital tracheomalacia | OFFSIDES | ||
| 279 | Conjunctival deposit | OFFSIDES | ||
| 280 | Erythema Multiforme | OFFSIDES | ||
| 281 | Facial paralysis | Canada Vigilance: 1 | Canada Vigilance | |
| 282 | Laryngomalacia | OFFSIDES | ||
| 283 | Mechanical ventilation | OFFSIDES | ||
| 284 | Mucosal erosion | OFFSIDES | ||
| 285 | PROTHROMBIN TIME | OFFSIDES | ||
| 286 | Product administration error | Canada Vigilance: 3 | Canada Vigilance | |
| 287 | Renal tubular disorder | OFFSIDES | ||
| 288 | Renal tubular necrosis | OFFSIDES | ||
| 289 | Respiratory Failure | OFFSIDES | ||
| 290 | Right Ventricular Hypertrophy | OFFSIDES | ||
| 291 | Testicular mass | OFFSIDES |
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