Table 3.

Main adverse drug reactions reported in published clinical trials

	Short term phase II trial (6 weeks)44
	Lurasidone 80 mg/day (n = 90)	Placebo (n = 90)
EPS (%)	NA	NA
Akathisia (%)	8.9	3.3
Mean changes from baseline
QTc prolongation ± SD (msec)	−1.2 ± 17.3	+0.9 ± 16.7
Weight gain (kg)*	+0.9	+0.5
Total cholesterol (mg/dL)	−10.1 ± NA	−7.1 ± NA
Triglycerides (mg/dL)	−24.4	−31.7 ± NA
Glucose (mg/dL)	+2.9 ± NA	+3.4 ± NA
Prolactin (ng/mL)*	+2.4	−0.3
	Short-term phase III efficacy and safety trials (6 weeks)45
	Lurasidone 40 mg/day (n = 119)	Lurasidone 120 mg/day (n = 118)	Olanzapine 15 mg/day (n = 122)	Placebo (n = 114)
Parkinsonism (%)	9.2	11.0	4.9	1.7
Tremor (%)	1.7	7.6	5.7	4.3
Dystonia (%)	3.4	7.6	0.8	0.9
Akathisia (%)	11.8	22.9	7.4	0.9
Mean changes from baseline
QTc prolongation ± SD (msec)	+5.1 ± NA	+4.5 ± NA	+4.4 ± NA	+3.8 ± NA
Weight gain ± SD (kg)	+1.0 ± 2.9	+1.0 ± 2.2	+4.1 ± 4.3	+0.6 ± 2.7
Total cholesterol ± SD (mg/dL)	−8.6 ± 29.8	−7.3 ± 25.3	+9.6 ± 31.2	−6.8 ± 28.7
Triglycerides ± SD (mg/dL)	−8.3 ± 76.2	−5.0 ± 85.5	50.0 ± 115.0	0.1 ± 64.8
Glucose ± SD (mg/dL)	0.0 ± 19.2	+0.5 ± 20.9	+10.3 ± 34.8	+0.4 ± 24.6
Prolactin ± SD (ng/L)	+2.1 ± 13.9	+10.9 ± 28.1	+5.0 ± 12.2	−2.5 ± 16.9
	Short-term phase III efficacy and safety trials (3 weeks)43
	Lurasidone 120 mg/day (n = 150)	Ziprasidone 160 mg/day (n = 151)
EPS (%)	3.3	1.3
Akathisia (%)	3.3	6.6
Mean changes from baseline
QTc prolongation ± SD (msec)	+0.3 ± 19.4	+3.3 ± 18.1
Weight gain ± SD (kg)	−0.27 ± 1.7	−0.41 ± 3.2
Total cholesterol ± SD (mg/dL)	−6.4 ± 24.0	−4.4 ± 30.4
Triglycerides ± SD (mg/dL)	−2.6 ± 86.6	+22.4 ± 258.8
Glucose ± SD (mg/dL)	+4.7 ± 20.8	+4.8 ± 25.0
Prolactin ± SD (ng/mL)*	+3.0	+2.0

Note:

^*Only median changes were available.

Abbreviations: EPS, extrapyramidal symptoms; NA, not available.