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. 2025 Jan 2;16:20420986241311231. doi: 10.1177/20420986241311231

Table 2.

AE signals detected and strength of clarithromycin.

No. PT SOC N ROR025 PRR χ2 IC − 2 SD EB05 Whether included in the package insert
0–17 Years
 1 Product taste abnormal Product issues 14 12.91 21.74 245.81 0.07 12.14 No
 2 Dysgeusia Nervous system disorders 17 12.69 20.25 280.74 0.41 11.92 Yes
 3 Lip swelling Gastrointestinal disorders 15 5.38 8.85 95.18 0.16 5.2 No
 4 Drug interaction General disorders and administration site conditions 38 4.27 5.66 140.95 1.58 4.04 Yes
 5 Stevens-Johnson syndrome Skin and subcutaneous tissue disorders 15 3.33 5.48 50.13 0.08 3.24 Yes
 6 Urticaria Skin and subcutaneous tissue disorders 35 3.09 4.18 81.88 1.08 2.95 Yes
 7 Vomiting Gastrointestinal disorders 89 2.79 3.16 134.21 1.31 2.52 Yes
 8 Drug hypersensitivity Immune system disorders 15 2.4 3.94 29.93 0.05 2.34 Yes
 9 Dyspnea Respiratory, thoracic and mediastinal disorders 36 2.32 3.14 50.81 0.88 2.23 No
 10 Erythema Skin and subcutaneous tissue disorders 20 2.08 3.19 27.98 0.23 2.03 No
 11 Abdominal pain upper Gastrointestinal disorders 23 2.07 3.08 30.33 0.37 2.02 Yes
18–44 Years
 1 Taste disorder Nervous system disorders 23 21.8 32.87 645.85 0.02 20.53 Yes
 2 Dysgeusia Nervous system disorders 150 18.9 20.85 2734.49 3.34 17.08 Yes
 3 Nightmare Psychiatric disorders 51 7.31 9.46 373.06 0.86 7.06 No
 4 Lip swelling Gastrointestinal disorders 44 7.29 9.66 328.75 0.57 7.05 No
 5 Hallucination Psychiatric disorders 62 6.37 8.01 369.87 1.07 6.14 Yes
 6 Tinnitus Ear and labyrinth disorders 49 6.2 8.07 293.76 0.72 6.00 Yes
 7 Psychotic disorder Psychiatric disorders 58 5.76 7.31 307.21 0.92 5.57 Yes
 8 Panic attack Psychiatric disorders 63 5.54 6.94 312.6 1.06 5.35 No
 9 Rash maculopapular Skin and subcutaneous tissue disorders 24 5.36 7.96 137.61 0.05 5.25 No
 10 Disorientation Psychiatric disorders 37 5.2 7.11 186.46 0.36 5.08 Yes
 11 Angioedema Skin and subcutaneous tissue disorders 42 5.12 6.84 201.96 0.48 4.98 Yes
 12 Adverse drug reaction General disorders and administration site conditions 38 4.8 6.53 171.13 0.39 4.69 Yes
 13 Palpitations Cardiac disorders 102 4.86 5.69 389.57 1.69 4.63 Yes
 14 Mania Psychiatric disorders 27 4.36 6.31 114.55 0.1 4.27 Yes
 15 Insomnia Psychiatric disorders 166 4.42 4.85 507.56 1.94 4.11 Yes
 16 Vertigo Ear and labyrinth disorders 45 4.09 5.41 156.62 0.51 3.99 Yes
 17 Paranoia Psychiatric disorders 26 3.81 5.55 91.99 0.07 3.74 No
 18 Drug interaction General disorders and administration site conditions 90 3.83 4.58 248.8 1.4 3.68 Yes
 19 Confusional state Psychiatric disorders 76 3.79 4.63 212.98 1.13 3.66 Yes
 20 Swelling face General disorders and administration site conditions 38 3.35 4.56 101.77 0.3 3.29 No
 21 Diarrhea Gastrointestinal disorders 179 3.39 3.7 355.83 1.62 3.16 Yes
 22 Abdominal pain upper Gastrointestinal disorders 88 3.05 3.67 168.91 1.13 2.95 Yes
 23 Peripheral swelling General disorders and administration site conditions 32 2.88 4.04 70.03 0.14 2.83 No
 24 Erythema Skin and subcutaneous tissue disorders 63 2.7 3.4 104.64 0.72 2.63 No
 25 Heart rate increased Investigations 48 2.68 3.52 84.1 0.44 2.63 No
 26 Nervousness Psychiatric disorders 25 2.66 3.91 51.2 0.01 2.62 Yes
 27 Urticaria Skin and subcutaneous tissue disorders 78 2.69 3.28 122.17 0.93 2.61 Yes
 28 Anxiety Psychiatric disorders 158 2.75 3.06 221.87 1.3 2.59 Yes
 29 Dyspnea Respiratory, thoracic, and mediastinal disorders 150 2.66 2.99 200.18 1.22 2.52 No
 30 Chest discomfort General disorders and administration site conditions 44 2.49 3.3 68.5 0.33 2.44 Yes
 31 Decreased appetite Metabolism and nutrition disorders 49 2.48 3.24 73.77 0.45 2.43 Yes
 32 Dyspepsia Gastrointestinal disorders 32 2.29 3.21 46.51 0.1 2.25 Yes
 33 Tachycardia Cardiac disorders 50 2.12 2.77 54.93 0.39 2.08 Yes
 34 Chest pain General disorders and administration site conditions 65 2.1 2.64 64.92 0.57 2.05 Yes
45–64 Years
 1 Labeled drug–drug interaction medication error Injury, poisoning, and procedural complications 55 39.06 50.16 2474.46 1.22 36.29 Yes
 2 Erythema multiforme Skin and subcutaneous tissue disorders 37 20.77 28.43 925.23 0.5 19.88 No
 3 Mania Psychiatric disorders 42 15.32 20.49 744.36 0.71 14.76 Yes
 4 Dysgeusia Nervous system disorders 159 15.72 17.27 2388.76 3.57 14.44 Yes
 5 Drug interaction General disorders and administration site conditions 265 13.97 14.15 3206.48 3.55 12.27 Yes
 6 Drug level increased Investigations 35 12.11 16.71 493.24 0.42 11.74 No
 7 Electrocardiogram QT prolonged Investigations 53 9.47 12.19 527.59 1.03 9.16 Yes
 8 Paranoia Psychiatric disorders 27 8.67 12.57 272.73 0.13 8.48 No
 9 Face edema General disorders and administration site conditions 27 8.07 11.7 250.76 0.13 7.9 No
 10 Psychotic disorder Psychiatric disorders 32 7.31 10.25 255.59 0.29 7.15 Yes
 11 Drug eruption Skin and subcutaneous tissue disorders 23 7.21 10.8 192.96 0.03 7.08 Yes
 12 Hallucination Psychiatric disorders 53 7.21 9.29 381 0.95 7 Yes
 13 Nightmare Psychiatric disorders 40 6.82 9.19 281.61 0.54 6.65 No
 14 Ageusia Nervous system disorders 23 6.73 10.07 177.31 0.03 6.6 Yes
 15 Swollen tongue Gastrointestinal disorders 39 6.58 8.9 263.77 0.51 6.42 No
 16 Lip swelling Gastrointestinal disorders 33 5.71 7.96 192.79 0.3 5.6 No
 17 Rhabdomyolysis Musculoskeletal and connective tissue disorders 47 5.54 7.27 246.83 0.73 5.41 Yes
 18 Tinnitus Ear and labyrinth disorders 41 5.54 7.43 220.56 0.54 5.41 Yes
 19 Disorientation Psychiatric disorders 35 5.17 7.13 177.38 0.35 5.07 Yes
 20 Confusional state Psychiatric disorders 102 5.04 5.92 412.47 1.91 4.82 Yes
 21 Dysarthria Nervous system disorders 34 4.91 6.81 162.02 0.3 4.82 No
 22 Hypoglycemia Metabolism and nutrition disorders 28 3.52 5.06 87.05 0.09 3.47 Yes
 23 Adverse drug reaction General disorders and administration site conditions 29 3.47 4.96 87.45 0.13 3.42 Yes
 24 Agitation Psychiatric disorders 38 3.33 4.53 100.95 0.35 3.27 No
 25 Arrhythmia Cardiac disorders 26 3.21 4.69 71.75 0.04 3.17 Yes
 26 Erythema Skin and subcutaneous tissue disorders 75 3.26 4 166.29 1.19 3.16 No
 27 Acute kidney injury Renal and urinary disorders 66 3.18 3.98 144.65 0.96 3.1 No
 28 Palpitations Cardiac disorders 60 2.99 3.79 121.09 0.8 2.93 Yes
 29 Anxiety Psychiatric disorders 99 2.57 3.05 136.25 1.13 2.49 Yes
 30 Abdominal pain upper Gastrointestinal disorders 71 2.43 3.01 94.21 0.84 2.37 Yes
 31 Swelling face General disorders and administration site conditions 28 2.36 3.39 44.94 0.03 2.33 No
 32 Toxicity to various agents Injury, poisoning, and procedural complications 67 2.34 2.92 83.46 0.75 2.29 No
 33 Urticaria Skin and subcutaneous tissue disorders 56 2.31 2.96 71.1 0.57 2.26 Yes
 34 Insomnia Psychiatric disorders 91 2.26 2.71 98.05 0.92 2.2 Yes
 35 Tachycardia Cardiac disorders 31 2.19 3.09 41.92 0.08 2.16 Yes
 36 Heart rate increased Investigations 35 2.17 3 44.69 0.15 2.14 No
 37 Dry mouth Gastrointestinal disorders 27 2.12 3.07 35.72 0 2.1 Yes
⩾65 Years
 1 Labeled drug–drug interaction medication error Injury, poisoning, and procedural complications 62 17.67 22.26 1207.73 1.66 16.83 Yes
 2 Drug interaction General disorders and administration site conditions 487 20.16 18.08 7764.35 3.95 16.04 Yes
 3 Torsade de pointes Cardiac disorders 32 14.29 20.09 548.97 0.32 13.81 Yes
 4 Erythema multiforme Skin and subcutaneous tissue disorders 30 13.72 19.51 497.45 0.24 13.27 No
 5 Dysgeusia Nervous system disorders 97 10.26 12.14 969.6 2.55 9.77 Yes
 6 Electrocardiogram QT prolonged Investigations 58 8.71 11.07 515.77 1.29 8.42 Yes
 7 Drug resistance General disorders and administration site conditions 26 8.04 11.74 241.78 0.11 7.86 Yes
 8 Gout Metabolism and nutrition disorders 32 7.85 11.02 278.36 0.32 7.67 No
 9 Nightmare Psychiatric disorders 32 7.29 10.23 254.61 0.3 7.13 No
 10 Chromaturia Renal and urinary disorders 29 7.02 10.04 224.61 0.18 6.87 No
 11 Rhabdomyolysis Musculoskeletal and connective tissue disorders 68 7.03 8.74 455.17 1.55 6.8 Yes
 12 International normalized ratio increased Investigations 62 5.44 6.86 303.18 1.31 5.29 Yes
 13 Hallucination Psychiatric disorders 26 5.2 7.59 141.14 0.08 5.11 Yes
 14 Hypoglycemia Metabolism and nutrition disorders 60 5.17 6.54 275.25 1.16 5.03 Yes
 15 Oral pain Gastrointestinal disorders 23 4.99 7.48 121.72 0.01 4.91 Yes
 16 Lip swelling Gastrointestinal disorders 25 4.11 6.05 99.77 0.04 4.05 No
 17 Delirium Psychiatric disorders 39 3.85 5.22 128.4 0.41 3.78 No
 18 Renal failure acute Renal and urinary disorders 47 3.74 4.92 142.52 0.61 3.66 No
 19 Pancytopenia Blood and lymphatic system disorders 47 3.71 4.88 140.69 0.63 3.63 No
 20 Hallucination Psychiatric disorders 49 3.48 4.55 131.9 0.7 3.41 Yes
 21 Toxicity to various agents Injury, poisoning, and procedural complications 62 3.02 3.82 126.32 0.89 2.95 No
 22 Hyperkalemia Metabolism and nutrition disorders 36 2.95 4.06 79.85 0.27 2.91 No
 23 Agitation Psychiatric disorders 27 2.65 3.84 53.79 0.04 2.62 No
 24 Bradycardia Cardiac disorders 41 2.55 3.43 68.32 0.37 2.51 No
 25 Acute kidney injury Renal and urinary disorders 85 2.52 3.05 116.02 1.03 2.45 No
 26 Palpitations Cardiac disorders 39 2.46 3.33 61.47 0.27 2.42 Yes
 27 Confusional state Psychiatric disorders 80 2.28 2.79 91.03 0.89 2.23 Yes
 28 Insomnia Psychiatric disorders 70 2.22 2.77 77.66 0.8 2.17 Yes
 29 Muscular weakness Musculoskeletal and connective tissue disorders 41 2.07 2.79 45.48 0.27 2.04 No
 30 Hyperhidrosis Skin and subcutaneous tissue disorders 35 2.04 2.83 39.68 0.14 2.02 Yes

AE, adverse event; IC, Information Component; PT, preferred term; PRR, proportional reporting ratio; ROR, reporting odds ratio; SOC, system organ class.