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Table 3 Summary of all reported adverse events in the included trials

From: Selective serotonin reuptake inhibitors versus placebo in patients with major depressive disorder. A systematic review with meta-analysis and Trial Sequential Analysis

Event No. of trials reporting the event SSRI Placebo Relative risk (95% CI) Number needed to harm (NNH) P value
Number of participants with the event Number of participants randomised Number of participants with the event Number of participants randomised
Abnormal ejaculation 15 183 3236 7 1903 5.43 [3.22, 9.14] 19 P < 0.00001
Tremor 28 301 3502 61 2929 3.16 [2.37, 4.21] 16 P < 0.00001
Anorexia 19 220 2350 42 1680 2.78 [2.03, 3.79] 15 P < 0.00001
Nausea 78 2524 12,257 779 8491 2.48 [2.22, 2.77] 9 P < 0.00001
Somnolence 59 1336 10,351 345 6674 2.25 [2.00, 2.53] 13 P < 0.00001
Sweating 34 440 5274 124 3478 2.20 [1.80, 2.70] 21 P < 0.00001
Asthenia 23 497 3968 155 2265 1.71 [1.43, 2.04] 18 P < 0.00001
Diarrhoea 58 1458 11,056 561 7099 1.66 [1.51, 1.83] 19 P < 0.00001
Constipation 50 606 6698 273 4892 1.60 [1.35, 1.89] 29 P < 0.00001
Insomnia 69 1500 11,934 582 7956 1.49 [1.35, 1.64] 19 P < 0.00001
Dizziness 55 849 8900 398 6161 1.39 [1.24, 1.57] 33 P < 0.00001
Dry mouth 73 1376 11,303 693 7904 1.37 [1.25, 1.49] 30 P < 0.00001
Libido decreased 8 78 1481 11 1083 3.48 [1.92, 6.32] 24 P < 0.0001
Sexual dysfunction 6 96 719 16 389 2.85 [1.77, 4.59] 11 P = 0.0001
Appetite decreased 8 68 932 24 885 2.63 [1.66, 4.17] 22 P < 0.0001
Fatigue 26 409 5098 153 3545 1.69 [1.32, 2.17] 27 P < 0.0001
Vomiting or upset stomach 20 189 2376 101 2037 1.55 [1.16, 2.08] 34 P = 0.003
Flu syndrome 7 57 1069 19 822 2.13 [1.28, 3.54] 34 P = 0.004
Drowsiness 5 38 253 19 256 1.90 [1.18, 3.04] 14 P = 0.004
Blurred/abnormal vision or dry eyes 17 116 1862 55 1566 1.55 [1.15, 2.10] 37 P = 0.004
Nervousness 22 484 3863 147 2043 1.35 [1.10, 1.66] 19 P = 0.004
Back pain 11 85 2404 71 1594 0.66 [0.48, 0.91] 109 P = 0.01
Headache 72 2386 11,085 1427 7805 1.08 [1.01, 1.14] 31 P = 0.02
Dyspepsia 23 331 4304 159 2956 1.29 [1.04, 1.59] 44 P = 0.02
Weight loss 3 26 562 9 560 2.48 [1.17, 5.25] 34 P = 0.02
Hypertension 4 17 933 25 761 0.51 [0.28, 0.93] 69 P = 0.03
Central or peripheral nervous system 4 104 221 16 57 1.58 [1.03, 2.43] 6 P = 0.04
Lightedness/faint feeling 3 9 147 1 144 4.81 [1.06, 21.72] 19 P = 0.04
Accidental injury 3 15 672 23 516 0.50 [0.25, 0.99] 45 P = 0.05
Agitation 5 67 613 22 398 1.60 [1.01, 2.54] 19 P = 0.05
Impotence 3 19 868 1 603 3.12 [0.99, 9.88] 50 P = 0.05
Taste perversion 2 9 389 1 390 5.80 [1.02, 33.03] 49 P = 0.05
Shaking 2 7 121 0 116 7.19 [0.91, 57.03] 18 P = 0.06
Rhinitis 14 197 3004 171 1969 0.78 [0.63, 0.97] 47 P = 0.06
Palpitations 10 63 1572 30 1292 1.55 [0.97, 2.50] 60 P = 0.07
Infection 7 104 997 57 612 1.31 [0.97, 1.75] 90 P = 0.08
Amnesia 2 5 484 12 486 0.44 [0.16, 1.20] 70 P = 0.11
Psychiatric adverse effects 1 19 40 7 26 1.76 [0.87, 3.60] 5 P = 0.12
Sleep distrurbance 3 15 240 7 223 1.98 [0.83, 4.73] 33 P = 0.13
Sinusitis 4 35 751 38 629 0.69 [0.43, 1.11] 73 P = 0.13
Urinary frequency 4 40 695 19 624 1.80 [0.82, 3.96] 37 P = 0.13
Anxiety 17 150 2983 89 2250 1.27 [0.91, 1.77] 94 P = 0.15
Appetie increased 3 5 335 10 330 0.49 [0.17, 1.43] 65 P = 0.19
Coughing 1 8 100 4 96 1.92 [0.60, 6.17] 27 P = 0.27
Tinnitus 2 4 319 1 319 2.84 [0.44, 18.44] 107 P = 0.27
Adverse events overall 4 32 232 14 160 1.36 [0.77, 2.39] 20 P = 0.29
Unpleasant taste 1 2 21 0 20 4.77 [0.24, 93.67] 11 P = 0.30
Congestive heart failure 1 0 335 2 336 0.20 [0.01, 4.16] 168 P = 0.30
Gastrointestial 4 66 194 14 91 1.53 [0.65, 3.62] 6 P = 0.33
Autonomic nervous system 1 10 40 4 26 1.63 [0.57, 4.64] 11 P = 0.36
Respiratory disorder 10 244 2764 107 1276 0.90 [0.73, 1.12] 227 P = 0.36
Vasodialtion 4 11 368 4 355 1.75 [0.44, 6.94] 54 P = 0.43
Flatulence 6 94 1763 34 972 1.24 [0.72, 2.16] 55 P = 0.44
Malaise 1 0 21 1 20 0.32 [0.01, 7.38] 20 P = 0.48
Depression aggrevated 1 6 337 1 180 1.95 [0.31, 12.35] 82 P = 0.48
Female genital disorders 1 7 310 1 149 1.93 [0.31, 12.10] 63 P = 0.48
Weight gain 1 3 129 5 129 0.60 [0.15, 2.46] 65 P = 0.48
Tachycardia 6 9 989 6 996 1.43 [0.52, 3.96] 326 P = 0.49
Arrhythmia 1 0 335 1 336 0.33 [0.01, 8.18] 336 P = 0.50
Atrial fibrillation 1 1 335 0 336 3.01 [0.12, 73.60] 335 P = 0.50
Abnormal electrocardiogram 1 1 335 0 336 3.01 [0.12, 73.60] 335 P = 0.50
Migraine 1 1 129 0 129 3.00 [0.12, 72.96] 129 P = 0.50
Chest discomfort 1 1 21 0 20 2.86 [0.12, 66.44] 21 P = 0.51
Rash 5 9 280 12 282 0.79 [0.37, 1.70] 97 P = 0.55
Vertigo 1 10 337 3 180 1.58 [0.32, 7.68] 77 P = 0.57
Dysuria 1 2 21 1 20 1.90 [0.19, 19.40] 23 P = 0.58
Pruritus (Itching) 3 8 187 10 185 0.79 [0.30, 2.10] 89 P = 0.63
Orthostatic hypotension 2 6 466 3 309 1.37 [0.37, 5.02] 316 P = 0.64
Upper respiratory tract infection 14 164 2380 123 1882 0.95 [0.75, 1.20] 282 P = 0.68
Body as a whole 1 6 40 3 26 1.30 [0.36, 4.75] 29 P = 0.69
Loose stools 1 3 100 2 96 1.44 [0.25, 8.43] 110 P = 0.69
Gastritis 1 3 62 5 138 1.34 [0.33, 5.41] 83 P = 0.69
Cardiovascular disorder 2 10 444 3 355 0.81 [0.22, 2.95] 72 P = 0.75
Pain 5 65 893 59 729 0.95 [0.68, 1.34] 123 P = 0.77
Abnormal thinking 1 7 335 8 336 0.88 [0.32, 2.39] 344 P = 0.80
Abnormal acne 1 3 32 1 14 1.31 [0.15, 11.54] 45 P = 0.81
Confusion 4 5 640 5 621 0.87 [0.28, 2.74] 4187 P = 0.81
Myalgia 5 34 692 26 572 0.93 [0.45, 1.94] 272 P = 0.85
Irritability 6 18 643 20 642 0.92 [0.38, 2.27] 317 P = 0.86
Numbness 2 12 272 8 269 0.77 [0.04, 13.27] 70 P = 0.86
Abdominal pain 9 98 1967 52 1150 1.02 [0.73, 1.44] 218 P = 0.89
Trauma 2 47 883 14 267 0.95 [0.41, 2.20] 1261 P = 0.90
Eructation (burping) 1 5 100 5 96 0.96 [0.29, 3.21] 480 P = 0.95
Over sedation 3 24 677 7 514 1.91 [0.83, 4.39] 46 P =0.13