domized, double-blind, placebo-controlled studies, 199 of 813 patients (25%) receiving POTIGA and 45 of 427 patients (11%) receiving placebo discontinued treatment because of adverse reactions. The most common adverse reactions leading to withdrawal in patients receiving POTIGA were dizziness (6%), confusional state (4%), fatigue (3%), and somnolence (3%).
Common Adverse Reactions in All Controlled Clinical Studies: Overall, the most frequently reported adverse reactions in patients receiving POTIGA (≥4% and occurring approximately twice the placebo rate) were dizziness (23%), somnolence (22%), fatigue (15%), confusional state (9%), vertigo (8%), tremor (8%), abnormal coordination (7%), diplopia (7%), disturbance in attention (6%), memory impairment (6%), asthenia (5%), blurred vision (5%), gait disturbance (4%), aphasia (4%), dysarthria (4%), and balance disorder (4%). In most cases the reactions were of mild or moderate intensity.
Table 4. Adverse Reaction Incidence in Placebo-Controlled Adjunctive Trials in Adult Patients With Partial Onset Seizures (Adverse reactions in at least 2% of patients treated with POTIGA in any treatment group and numerically more frequent than in the placebo group.) Body System/Adverse Reaction
Placebo
POTIGA
600 mg/day
900 mg/day
1,200 mg/day
All
(N = 427)
%
(N = 281)
%
(N = 273)
%
(N = 259)
%
(N = 813)
%
Eye
Diplopia
2
8
6
7
7
Blurred vision
2
2
4
10
5
Gastrointestinal
Nausea
5
6
6
9
7
Constipation
1
1
4
5
3
Dyspepsia
2
3
2
3
2
General
Fatigue
6
16
15
13
15
Asthenia
2
4
6
4
5
Infections and infestations
Influenza
2
4
1
5
3
Investigations
Weight increased
1
2
3
3
3
Nervous system
Dizziness
9
15
23
32
23
Somnolence
12
15
25
27
22
Memory impairment
3
3
6
9
6
Tremor
3
3
10
12
8
Vertigo
2
8
8
9
8
Abnormal coordination
3
5
5
12
7
Disturbance in attention
<1
6
6
7
6
Gait disturbance
1
2
5
6
4
Aphasia
<1
1
3
7
4
Dysarthria
<1
4
2
8
4
Balance disorder
<1
3
3
5
4
Paresthesia
2
3
2
5
3
Amnesia
<1
<1
3
3
2
Dysphasia
<1
1
1
3
2
Psychiatric
Confusional state
3
4
8
16
9
Anxiety
2
3
2
5
3
Disorientation
<1
<1
<1
5
2
Psychotic disorder
0
0
|
