XR 400 mg/day (N=227)
SEROQUEL XR 600 mg/day (N=310)
SEROQUEL XR 800 mg/day (N=323)
All Doses (N=951)
n
%
n
%
n
%
n
%
n
%
n
%
Dystonic event*
0
0.0
3
3.3
0
0.0
4
1.3
1
0.3
8
0.8
Parkinsonism†
4
1.3
1
1.1
3
1.3
11
3.6
7
2.2
22
2.3
Akathisia‡
4
1.3
0
0.0
3
1.3
7
2.3
7
2.2
17
1.8
Dyskinetic event§
2
0.6
2
2.2
1
0.4
1
0.3
1
0.3
5
0.5
Other extrapyramidal event¶
7
2.2
3
3.3
4
1.8
7
2.3
12
3.7
26
2.7
In a placebo-controlled clinical trial for the treatment of bipolar mania, utilizing the dose range of 400-800 mg/day of SEROQUEL XR, the incidence of any adverse reactions potentially related to EPS was 6.6% for SEROQUEL XR and 3.8% in the placebo group. In this study, the incidence of the individual adverse reactions (akathisia, extrapyramidal disorder, tremor, dystonia, restlessness, and cogwheel rigidity) did not exceed 2.0% for any adverse reaction.
Table 15: Adverse Experiences Associated with Extrapyramidal Symptoms in a Placebo-controlled Clinical Trial for Bipolar Mania *
There were no adverse experiences with the preferred term of dyskinetic event.
†
: Patients with the following terms were counted in this category: nuchal rigidity, hypertonia, dystonia, muscle rigidity, oculogyration
‡
: Patients with the following terms were counted in this category: cogwheel rigidity, tremor, drooling, hypokinesia
§
: Patients with the following terms were counted in this category: akathisia, psychomotor agitation
¶
: Patients with the following terms were counted in this category: restlessness; extrapyramidal disorder, movement disorder
Preferred term*
Placebo
(N=160)
SEROQUEL XR
(N=151)
n
%
n
%
Dystonic event†
0
0.0
1
0.7
Parkinsonism‡
3
1.9
4
2.7
Akathisia§
1
0.6
2
1.3
Other extrapyramidal event¶
2
1.3
3
2.0
In a placebo-controlled clinical trial for the treatment of bipolar depression utilizing 300 mg of SEROQUEL XR, the incidence of any adverse reactions potentially related to EPS was 4.4% for SEROQUEL XR and 0.7% in the placebo group. In this study, the incidence of the individual adverse reactions (akathisia, extrapyramidal disorder, tremor, dystonia, hypertonia) did not exceed 1.5% for any individual adverse reaction.
Table 16: Adverse Experiences Associated with Extrapyramidal Symptoms in a Placebo-controlled Clin
