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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