| 1 | Product use issue | FAERS: 229 | | US FAERS |
| 2 | Drug ineffective | FAERS: 186 | | US FAERS |
| 3 | Medication Error | FAERS: 97 | | US FAERS |
| 4 | Therapeutic response unexpected | FAERS: 65 | | US FAERS |
| 5 | Somnolence | FAERS: 56 | | US FAERS |
| 6 | Product use in unapproved indication | FAERS: 51 | | US FAERS |
| 7 | Drug ineffective for unapproved indication | FAERS: 26 | | US FAERS |
| 8 | Feeling abnormal | FAERS: 24 | | US FAERS |
| 9 | Incorrect drug administration duration | FAERS: 23 | | US FAERS |
| 10 | Expired product administered | FAERS: 19 | | US FAERS |
| 11 | Intentional product misuse | FAERS: 19 | | US FAERS |
| 12 | Poor quality sleep | FAERS: 19 | | US FAERS |
| 13 | Incorrect dose administered | FAERS: 18 | | US FAERS |
| 14 | Fatigue | FAERS: 14 | | US FAERS |
| 15 | Drug effective for unapproved indication | FAERS: 13 | | US FAERS |
| 16 | Dizziness | FAERS: 12 | | US FAERS |
| 17 | Headache | FAERS: 11 | | US FAERS |
| 18 | Nausea | FAERS: 11 | | US FAERS |
| 19 | Drug effect incomplete | FAERS: 9 | | US FAERS |
| 20 | Pruritus | FAERS: 9 | | US FAERS |
| 21 | Restless Legs Syndrome | FAERS: 9 | | US FAERS |
| 22 | Wrong technique in product usage process | FAERS: 9 | | US FAERS |
| 23 | Agitation | FAERS: 8 | | US FAERS |
| 24 | Anxiety | FAERS: 8 | | US FAERS |
| 25 | Dyspepsia | FAERS: 7 | | US FAERS |
| 26 | Feeling jittery | FAERS: 7 | | US FAERS |
| 27 | Incorrect product administration duration | FAERS: 7 | | US FAERS |
| 28 | Initial insomnia | FAERS: 7 | | US FAERS |
| 29 | Malaise | FAERS: 7 | | US FAERS |
| 30 | Palpitations | FAERS: 7 | | US FAERS |
| 31 | Vomiting | FAERS: 7 | | US FAERS |
| 32 | Abdominal discomfort | FAERS: 6 | | US FAERS |
| 33 | Drug Dependence | FAERS: 6 | | US FAERS |
| 34 | Erythema | FAERS: 6 | | US FAERS |
| 35 | Extra dose administered | FAERS: 6 | | US FAERS |
| 36 | Middle insomnia | FAERS: 6 | | US FAERS |
| 37 | Nervousness | FAERS: 6 | | US FAERS |
| 38 | Pain | FAERS: 5 | | US FAERS |
| 39 | Restlessness | FAERS: 5 | | US FAERS |
| 40 | Accidental exposure to product | FAERS: 4 | | US FAERS |
| 41 | Accidental exposure to product by child | FAERS: 4 | | US FAERS |
| 42 | Asthenia | FAERS: 4 | | US FAERS |
| 43 | Circumstance or information capable of leading to medication error | FAERS: 4 | | US FAERS |
| 44 | Product use complaint | FAERS: 4 | | US FAERS |
| 45 | Urticaria | FAERS: 4 | | US FAERS |
| 46 | Chromaturia | FAERS: 3 | | US FAERS |
| 47 | Constipation | FAERS: 3 | | US FAERS |
| 48 | Drug effect delayed | FAERS: 3 | | US FAERS |
| 49 | Formication | FAERS: 3 | | US FAERS |
| 50 | Hypersensitivity | FAERS: 3 | | US FAERS |
| 51 | Inappropriate schedule of drug administration | FAERS: 3 | | US FAERS |
| 52 | Intentional product use issue | FAERS: 3 | | US FAERS |
| 53 | Product package associated injury | FAERS: 3 | | US FAERS |
| 54 | Throat irritation | FAERS: 3 | | US FAERS |
| 55 | Ulcer | FAERS: 3 | | US FAERS |
| 56 | Unevaluable event | FAERS: 3 | | US FAERS |
| 57 | Adverse event | FAERS: 2 | | US FAERS |
| 58 | Anger | FAERS: 2 | | US FAERS |
| 59 | Asthma | FAERS: 2 | | US FAERS |
| 60 | Choking sensation | FAERS: 2 | | US FAERS |
| 61 | Discomfort | FAERS: 2 | | US FAERS |
| 62 | Disorientation | FAERS: 2 | | US FAERS |
| 63 | Drug screen positive | FAERS: 2 | | US FAERS |
| 64 | Dysgeusia | FAERS: 2 | | US FAERS |
| 65 | Dysuria | FAERS: 2 | | US FAERS |
| 66 | Hypersomnia | FAERS: 2 | | US FAERS |
| 67 | Multiple allergies | FAERS: 2 | | US FAERS |
| 68 | Musculoskeletal discomfort | FAERS: 2 | | US FAERS |
| 69 | Nasopharyngitis | FAERS: 2 | | US FAERS |
| 70 | Product container seal issue | FAERS: 2 | | US FAERS |
| 71 | Product packaging quantity issue | FAERS: 2 | | US FAERS |
| 72 | Product physical issue | FAERS: 2 | | US FAERS |
| 73 | Product prescribing issue | FAERS: 2 | | US FAERS |
| 74 | Product quality issue | FAERS: 2 | | US FAERS |
| 75 | Suicide attempt | FAERS: 2 | | US FAERS |
| 76 | Tachycardia | FAERS: 2 | | US FAERS |
| 77 | Thirst | FAERS: 2 | | US FAERS |
| 78 | Wheezing | FAERS: 2 | | US FAERS |
| 79 | Wrong technique in drug usage process | FAERS: 2 | | US FAERS |
| 80 | Acute kidney injury | FAERS: 1 | | US FAERS |
| 81 | Angiodysplasia | FAERS: 1 | | US FAERS |
| 82 | Arthralgia | FAERS: 1 | | US FAERS |
| 83 | Back Pain | FAERS: 1 | | US FAERS |
| 84 | Blood count abnormal | FAERS: 1 | | US FAERS |
| 85 | Breast discomfort | FAERS: 1 | | US FAERS |
| 86 | Burning sensation | FAERS: 1 | | US FAERS |
| 87 | Cardiac Arrest | FAERS: 1 | | US FAERS |
| 88 | Circumstance or information capable of leading to device use error | FAERS: 1 | | US FAERS |
| 89 | Contraindicated product administered | FAERS: 1 | | US FAERS |
| 90 | Depressed mood | FAERS: 1 | | US FAERS |
| 91 | Device Failure | FAERS: 1 | | US FAERS |
| 92 | Drug abuse | FAERS: 1 | | US FAERS |
| 93 | Drug administration error | FAERS: 1 | | US FAERS |
| 94 | Duodenal Ulcer | FAERS: 1 | | US FAERS |
| 95 | Emotional distress | FAERS: 1 | | US FAERS |
| 96 | Enuresis | FAERS: 1 | | US FAERS |
| 97 | Epigastric discomfort | FAERS: 1 | | US FAERS |
| 98 | Epistaxis | FAERS: 1 | | US FAERS |
| 99 | Exsanguination | FAERS: 1 | | US FAERS |
| 100 | Eye irritation | FAERS: 1 | | US FAERS |
| 101 | Failure of child resistant mechanism for pharmaceutical product | FAERS: 1 | | US FAERS |
| 102 | False positive investigation result | FAERS: 1 | | US FAERS |
| 103 | Flatulence | FAERS: 1 | | US FAERS |
| 104 | Flushing | FAERS: 1 | | US FAERS |
| 105 | General physical condition abnormal | FAERS: 1 | | US FAERS |
| 106 | General physical health deterioration | FAERS: 1 | | US FAERS |
| 107 | Head discomfort | FAERS: 1 | | US FAERS |
| 108 | Hearing disability | FAERS: 1 | | US FAERS |
| 109 | Intentional self-injury | FAERS: 1 | | US FAERS |
| 110 | Lethargy | FAERS: 1 | | US FAERS |
| 111 | Maternal exposure during pregnancy | FAERS: 1 | | US FAERS |
| 112 | Medical device site pain | FAERS: 1 | | US FAERS |
| 113 | Medication residue present | FAERS: 1 | | US FAERS |
| 114 | Morbid thoughts | FAERS: 1 | | US FAERS |
| 115 | Musculoskeletal stiffness | FAERS: 1 | | US FAERS |
| 116 | Mydriasis | FAERS: 1 | | US FAERS |
| 117 | Neck Pain | FAERS: 1 | | US FAERS |
| 118 | Nocturia | FAERS: 1 | | US FAERS |
| 119 | Oropharyngeal pain | FAERS: 1 | | US FAERS |
| 120 | Overdose | FAERS: 1 | | US FAERS |
| 121 | Patient dissatisfaction with treatment | FAERS: 1 | | US FAERS |
| 122 | Poor quality drug administered | FAERS: 1 | | US FAERS |
| 123 | Poor quality product administered | FAERS: 1 | | US FAERS |
| 124 | Pre-existing condition improved | FAERS: 1 | | US FAERS |
| 125 | Product closure removal difficult | FAERS: 1 | | US FAERS |
| 126 | Product commingling | FAERS: 1 | | US FAERS |
| 127 | Product container issue | FAERS: 1 | | US FAERS |
| 128 | Product label issue | FAERS: 1 | | US FAERS |
| 129 | Product label on wrong product | FAERS: 1 | | US FAERS |
| 130 | Product name confusion | FAERS: 1 | | US FAERS |
| 131 | Product used for unknown indication | FAERS: 1 | | US FAERS |
| 132 | Productive Cough | FAERS: 1 | | US FAERS |
| 133 | Renal pain | FAERS: 1 | | US FAERS |
| 134 | Self-induced vomiting | FAERS: 1 | | US FAERS |
| 135 | Sluggishness | FAERS: 1 | | US FAERS |
| 136 | Swelling | FAERS: 1 | | US FAERS |
| 137 | Syncope | FAERS: 1 | | US FAERS |
| 138 | Tension | FAERS: 1 | | US FAERS |
| 139 | Therapeutic product effect incomplete | FAERS: 1 | | US FAERS |
| 140 | Therapeutic product ineffective for unapproved indication | FAERS: 1 | | US FAERS |
| 141 | Tinnitus | FAERS: 1 | | US FAERS |
| 142 | Tremor | FAERS: 1 | | US FAERS |
| 143 | Vitreous floaters | FAERS: 1 | | US FAERS |
| 144 | Weight decreased | FAERS: 1 | | US FAERS |
| 145 | Wrong drug administered | FAERS: 1 | | US FAERS |