###### 1.13 Total number of patients experiencing at least some side effects

There was evidence that paroxetine was associated with a lower rate of adverse events than amitriptyline (OR: 0.53, 95% CI 0.39 to 0.72, NNTh = 7, 95% CI 6 to 10, 16 RCTs, 2492 participants), imipramine (OR: 0.62, 95% CI 0.42 to 0.94, NNTh = 10, 95% CI 7 to 19, 9 RCTs, 1189 participants) and than older ADs as a class (OR: 0.64, 95% CI 0.53 to 0.77, NNTh = 11, 95% CI 9 to 14, 41 RCTs, 6099 participants) (see Analysis 13.1).

###### 1.14 Number of patients experiencing specific side effects

(a) Sleepiness/drowsiness. We found a difference in favour of paroxetine over maprotiline (OR: 0.37, 95% CI 0.17 to 0.82, NNTh = 13, 95% CI 7 to 52, 2 RCTs, 358 participants) (see Analysis 79.1).

(b) Insomnia. There was evidence that paroxetine was associated with a higher rate of insomnia than older ADs (OR: 2.17, 95% CI 1.51 to 3.12, NNTh = 17, 95% CI 12 to 29, 15 RCTs, 1986 participants). In head-to-head comparisons, paroxetine was associated with a higher rate of insomnia than amitriptyline (OR: 3.66, 95% CI 1.36 to 9.85, NNTh = 13, 95% CI 8 to 36, 4 RCTs, 352 participants), dothiepin (OR: 2.34, 95% CI 1.03 to 5.31, NNTh = 19, 95% CI 10 to 246, 2 RCTs, 405 participants) and than maprotiline (OR: 4.38, 95% CI 1.72 to 11.15, NNTh = 9, 95% CI 6 to 22, 1 RCTs, 298 participants) (see Analysis 54.1).

(c) Dry mouth. Paroxetine was associated with a lower rate of dry mouth than amitriptyline (OR: 0.27, 95% CI 0.17 to 0.43, NNTh = 4, 95% CI 4 to 5, 12 RCTs, 1576 participants), clomipramine (OR: 0.35, 95% CI 0.26 to 0.48, NNTh = 6, 95% CI 5 to 8, 2 RCTs, 1111 participants), dothiepin (OR: 0.22, 95% CI 0.10 to 0.50, NNTh = 3, 95% CI 3 to 5, 2 RCTs, 405 participants), imipramine (OR: 0.16, 95% CI 0.10 to 0.26, NNTh = 3, 95% CI 2 to 3, 8 RCTs, 835 participants), maprotiline (OR: 0.13, 95% CI 0.08 to 0.23, NNTh = 3, 95% CI 2 to 4, 3 RCTs, 429 participants), and older ADs as a class (OR: 0.23, 95% CI 0.18 to 0.30, NNTh = 4, 95% CI 3 to 5, 29 RCTs, 4578 participants) (see Analysis 38.1).

(d) Constipation. Paroxetine was associated with a lower rate of constipation than older ADs as a class (OR: 0.49, 95% CI 0.40 to 0.60, NNTh = 12, 95% CI 9 to 16, 26 RCTs, 3934 participants). In head-to-head comparisons, paroxetine was associated with a lower rate of constipation than amitriptyline (OR: 0.61, 95% CI 0.37 to 0.99, NNTh = 18, 95% CI 11 to 65, 10 RCTs, 1146 participants), clomipramine (OR: 0.57, 95% CI 0.38 to 0.85, NNTh = 19, 95% CI 12 to 64, 2 RCTs, 1111 participants), dothiepin (OR: 0.57, 95% CI 0.32 to 0.99, NNTh = 10, 95% CI 5 to 378, 1 RCT, 271 participants), imipramine (OR: 0.40, 95% CI 0.25 to 0.63, NNTh = 6, 95% CI 5 to 11, 7 RCTs, 633 participants), and maprotiline (OR: 0.31, 95% CI 0.17 to 0.55, NNTh = 7, 95% CI 5 to 12, 3 RCTs, 429 participants) (see Analysis 31.1).

(e) Urination/Urogenital problems. There was evidence in favour of paroxetine over imipramine for urinary retention (OR: 0.04, 95% CI 0.00 to 0.73, NNTh = 4, 95% CI 3 to 10, 1 RCT, 80 participants) (see Analysis 90.4) and for urogenital problems (Not Otherwise Specified) (OR: 0.10, 95% CI 0.01 to 0.82, NNTh = 10, 95% CI 6 to 38, 1 RCT, 159 participants) (see Analysis 90.5).

(f) Hypotension. We found no difference between paroxetine and older ADs (see Analysis 50.1).

(g) Agitation/anxiety. We found no difference between paroxetine and older ADs (see Analysis 18.1).

(h) Suicide wishes/gestures/attempts. We found no difference between paroxetine and older ADs (see Analysis 96.1; Analysis 96.3).

(i) Completed suicide. We found no difference between paroxetine and older ADs (see Analysis 96.2).

(j) Vomiting/nausea. Paroxetine was associated with a higher rate of vomiting/nausea than older ADs as a class (OR: 2.10, 95% CI 1.59 to 2.77, NNTh = 12, 95% CI 10 to 17, 30 RCTs, 4545 participants). In head-to-head comparisons we found evidence in favour of amitriptyline (OR: 2.17, 95% CI 1.43 to 3.29, NNTh = 15, 95% CI 10 to 29, 10 RCTs, 1282 participants), dothiepin (OR: 3.12, 95% CI 1.1 to 8.78, NNTh = 8, 95% CI 5 to 15, 2 RCTs, 405 participants), imipramine (OR: 2.05, 95% CI 1.23 to 3.42, NNTh = 11, 95% CI 7 to 26, 8 RCTs, 835 participants), and lofepramine (OR: 2.97, 95% CI 1.12 to 7.92, NNTh = 9, 95% CI 5 to 34, 2 RCTs, 228 participants) over paroxetine (see Analysis 59.1).

(k) Diarrhoea. We found that paroxetine was associated with a higher rate of diarrhoea than older ADs as a class (OR: 2.41, 95% CI 1.56 to 3.73, NNTh = 20, 95% CI 14 to 36, 13 RCTs, 1743 participants) and than dothiepin (OR: 3.47, 95% CI 1.23 to 9.75, NNTh = 12, 95% CI 7 to 56, 1 RCTs, 271 participants) and maprotiline (OR: 2.94, 95% CI 1.34 to 6.47, NNTh = 11, 95% CI 7 to 33, 2 RCTs, 358 participants) (see Analysis 36.1).

(l) Other side effects. Other statistically significant side effects are reported in Table 1.