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Table 3 Prolactin-related adverse events

From: Prolactin-related adverse events and change in prolactin levels in pediatric patients given antipsychotics for schizophrenia and schizophrenia spectrum disorders: A systematic review

Study N (ITT) Treatment Prolactin-related adverse events, n (%) Gynecomastia/ galactorrhea, n (%) Amenorrhea/ dysmenorrhea, n (%) Impotence/decreased libido, n (%)
Randomized controlled trials
Findling et al. 2012 [21] 73 Quetiapine 400 mg/day NR NR NR NR
74 Quetiapine 800 mg/day NR NR NR NR
73 Placebo NR NR NR NR
Findling et al. 2008 [22] 100 Aripiprazole 10 mg/day 0 (0.0) NR NR NR
102 Aripiprazole 30 mg/day 0 (0.0) NR NR NR
100 Placebo 0 (0.0) NR NR NR
Haas et al. 2009a [23] 55 Risperidone 1–3 mg/day 0 (0.0) NR NR NR
51 Risperidone 4–6 mg/day 0 (0.0) NR NR NR
54 Placebo 0 (0.0) NR NR NR
Haas et al. 2009b [26] 125 Risperidone 1.5–6 mg/day 7 (5.6) 3 (2.4) 1 (1.0) NR
132 Risperidone 0.15–0.6 mg/day 2 (1.5) 2 (1.5) 0 (0.0) NR
Kryzhanovskaya et al. 2009 [24] 72 Olanzapine 2.5–20 mg/day NR NR NR NR
35 Placebo NR NR NR NR
Singh et al. 2011 [25] 54 Paliperidone 1.5 mg/day NR NR NR NR
48 Paliperidone 3–6 mg/day NR NR NR NR
47 Paliperidone 6–12 mg/day NR NR NR NR
51 Placebo NR NR NR NR
Observational studies
Duval et al. 2008 [27] 16 Risperidone 1–6 mg/day NR NR NR NR
Kumra et al. 2008 [28] 14 Clozapine 25–900 mg/day NR NR NR NR
19 Olanzapine 30 mg/day NR NR NR NR
Pandina et al. 2012a [29] 48 Risperidone 2–6 mg/day (treatment-naïve) 36 (9.3) 14 (3.6) 3 (1.0) 1 (<0.5)
292 Risperidone 2–6 mg/day (treatment-experienced)
50 Risperidone 2–6 mg/day (open-label)
Ruan et al. 2010 [30] 31 Risperidone 25–50 mg biweekly 5 (16.1) 2 (6.5) 3 (9.7) NR
Schimmelmann et al. 2007 [31] 56 Quetiapine 200–800 mg/day NR 3 (5.4) 4 (7.1) 9 (16.1)
  1. ITT Intent to treat, NR Not reported
  2. aIncidence of adverse events reported across all treatment arms
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