Alprazolam
Side effects
Options:
Hide MedDRA Preferred Terms
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display all 44 labels
MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
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3
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4
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5
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6
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7
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8
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9
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10
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11
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12
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13
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14
|
15
|
16
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17
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18
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19
|
20
|
Coordination abnormal
|
Coordination abnormal
|
1.9% - 40.1%
|
0.3% - 18%
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
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x
|
x
|
x
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x
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x
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x
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
frequent, 33% - 33.1%
|
30% - 30.1%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
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x
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x
|
x
|
x
|
x
|
Memory impairment
|
Memory impairment
|
1.5% - 33.1%
|
0.3% - 22.1%
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
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x
|
x
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x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivation
|
32.8%
|
34.2%
|
|
|
|
|
|
|
|
x
|
x
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x
|
x
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x
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x
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x
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x
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x
|
x
|
|
|
|
Salivary hypersecretion
|
infrequent, 4% - 6%
|
2% - 4.4%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
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x
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x
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x
|
x
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x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
7% - 33%
|
6% - 23%
|
|
|
|
|
x
|
x
|
|
x
|
x
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x
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x
|
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
Cognitive disorder
|
Cognitive disorder
|
28.8% - 29%
|
20.5% - 21%
|
|
|
|
|
x
|
x
|
|
x
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x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
|
|
|
Decreased appetite
|
Decreased appetite
|
7.3% - 28%
|
3.8% - 24.1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
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x
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x
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x
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x
|
x
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x
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x
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x
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x
|
x
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Anorexia
|
1.5%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
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x
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x
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x
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x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysarthria
|
Dysarthria
|
2.1% - 23.3%
|
0% - 6.3%
|
|
x
|
x
|
|
x
|
x
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x
|
x
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x
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x
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x
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x
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x
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x
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x
|
x
|
x
|
x
|
x
|
x
|
Slurred speech
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
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x
|
x
|
x
|
x
|
x
|
x
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x
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x
|
x
|
|
|
|
Osteoarthritis
|
Dysarthria
|
2.1% - 23.3%
|
0% - 6.3%
|
|
x
|
x
|
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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x
|
x
|
Dizziness
|
Lightheadedness
|
1.2% - 29.8%
|
19% - 36.9%
|
x
|
|
x
|
x
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x
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x
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x
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|
|
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x
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x
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x
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x
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x
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x
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|
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Syncope
|
infrequent, 3.1% - 4.8%
|
4% - 4.8%
|
|
|
|
|
|
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x
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|
x
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x
|
x
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x
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x
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x
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x
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x
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x
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x
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x
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x
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Dizziness
|
frequent, 1.8% - 29.8%
|
0.8% - 36.9%
|
x
|
|
|
|
x
|
x
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x
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|
|
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x
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x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
Abdominal distress
|
18.3% - 21.5%
|
21.5%
|
|
|
|
|
|
|
|
|
|
|
|
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x
|
|
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x
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x
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|
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Anxiety
|
Anxiety
|
1.1% - 16.6%
|
0.6% - 24.9%
|
|
|
|
|
|
|
|
|
|
|
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|
|
|
|
x
|
x
|
|
|
x
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Somnolence
|
Drowsiness
|
1.8% - 76.8%
|
21.6% - 42.7%
|
x
|
x
|
x
|
x
|
|
|
x
|
x
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x
|
x
|
x
|
x
|
x
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x
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x
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x
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x
|
|
|
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Somnolence
|
3.2% - 23%
|
0.3% - 6%
|
|
|
|
|
|
|
|
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|
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|
|
|
|
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x
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x
|
x
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Hyperhidrosis
|
Sweating
|
15.1% - 23.5%
|
23.5%
|
|
|
|
|
|
|
|
|
|
|
|
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x
|
|
|
x
|
x
|
|
|
|
Sweating increased
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyskinesia
|
Abnormal involuntary movements
|
14.8%
|
21%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
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Dyskinesia
|
1.7%
|
1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
6% - 14.4%
|
2.3% - 8%
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
6% - 14.4%
|
2.3% - 8%
|
|
|
|
x
|
x
|
x
|
|
x
|
x
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x
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x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
Libido increased
|
frequent, 7.7% - 8%
|
4% - 4.1%
|
|
|
|
|
x
|
x
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|
x
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x
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x
|
x
|
x
|
x
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x
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x
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x
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x
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x
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x
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x
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Headache
|
Headache
|
frequent, 1.1% - 29.2%
|
12.6% - 35.6%
|
x
|
x
|
|
x
|
|
|
x
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x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
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x
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x
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x
|
x
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Dysuria
|
Strangury
|
frequent, 8.6% - 12.2%
|
8.6% - 9%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
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x
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x
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x
|
x
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x
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x
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x
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x
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x
|
x
|
Strangury
|
Strangury
|
frequent, 8.6% - 12.2%
|
8.6% - 9%
|
|
|
|
|
x
|
x
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|
x
|
x
|
x
|
x
|
x
|
x
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
2.4% - 13.9%
|
1.2% - 18.1%
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
infrequent, 8.1% - 11%
|
8% - 8.1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
0.6% - 4%
|
3% - 3.1%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Rash
|
Rash
|
infrequent, 8.1% - 11%
|
8% - 8.1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
frequent, 10.6% - 18.1%
|
18.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
0.9% - 26.2%
|
4.3% - 15.4%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
8.7% - 10.4%
|
8.7% - 9%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dry mouth
|
Dry mouth
|
0.7% - 15%
|
9.7% - 13.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
frequent, 1.2% - 22.8%
|
3.1% - 22.8%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
0.9% - 10.4%
|
0.9% - 10%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
0.9% - 10.4%
|
0.9% - 10%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperventilation
|
Hyperventilation
|
frequent, 8.5% - 14.5%
|
2.7% - 14.5%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
1.7% - 31.8%
|
3.2% - 31.8%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Vomiting
|
Vomiting
|
frequent, 1.7% - 31.8%
|
12.8% - 31.8%
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
9.5%
|
3.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
frequent, 1.3% - 29.4%
|
9.6% - 41.8%
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
frequent, 7.4% - 7.9%
|
2.7% - 11.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
frequent, 7.7% - 8%
|
4% - 4.1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
0.4% - 26.8%
|
15.6% - 26.8%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Sexual dysfunction
|
Sexual dysfunction
|
2.4% - 7.4%
|
1.1% - 4%
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
frequent, 7.3% - 17.4%
|
9.3% - 16.5%
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
7.2%
|
3.2%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mental retardation
|
Mental disability
|
7.2%
|
5.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mental disability
|
Mental disability
|
7.2%
|
5.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebration impaired
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Tinnitus
|
Tinnitus
|
infrequent, 6.6% - 21%
|
10.4% - 21.4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
frequent, 0.4% - 21.4%
|
6.2% - 21.4%
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
infrequent — 7.1% - 8.4%
|
8.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
1.7% - 49%
|
0.6% - 42.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
2.7% - 27.2%
|
2.7% - 18%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Back pain
|
Back pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depersonalisation
|
Depersonalisation
|
frequent, 5.7%
|
1.9%
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nightmare
|
Nightmare
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
frequent, 0.4% - 7.7%
|
15.6%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oedema
|
Oedema
|
infrequent, 4.9% - 5.6%
|
5.6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent, 4.7% - 5%
|
2% - 2.2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.9% - 4.3%
|
1.7% - 3.7%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
2.3% - 23%
|
3% - 17%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle rigidity
|
Muscle rigidity
|
0.4% - 4.2%
|
5.3%
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Nervousness
|
Nervousness
|
frequent, 1.1% - 21.8%
|
8.8% - 10.3%
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tension
|
Nervousness
|
frequent, 1.1% - 21.8%
|
8.8% - 10.3%
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
frequent, 0.4% - 28.2%
|
8.8% - 10.7%
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
0.6% - 4%
|
3% - 3.1%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
3.6%
|
2.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Disturbance in attention
|
Disturbance in attention
|
3.2%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebration impaired
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
3.2%
|
2.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Shock
|
Syncope
|
infrequent, 3.1% - 4.8%
|
4% - 4.8%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
infrequent, 3.1% - 4.8%
|
4% - 4.8%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
infrequent, 3.1% - 4.8%
|
4% - 4.8%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
frequent, 2.6% - 2.9%
|
2.6%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Disinhibition
|
Disinhibition
|
1.5% - 3%
|
1.5% - 2%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Arthralgia
|
Arthralgia
|
2.4%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
2.4%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
1.5%
|
1.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Influenza
|
Influenza
|
2.4%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
frequent, 2.4%
|
2.4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
2.4% - 7.1%
|
1.7% - 3.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
Musculoskeletal stiffness
|
Muscle stiffness
|
2.2% - 3.3%
|
3.3%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Logorrhoea
|
Talkativeness
|
1% - 2.2%
|
1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Logorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Derealisation
|
Derealisation
|
frequent, 1.2% - 8%
|
1% - 3.8%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
1.7% - 49%
|
0.6% - 42.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
1.7%
|
0.6%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Premenstrual syndrome
|
Premenstrual syndrome
|
1.7%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Akathisia
|
Akathisia
|
1.6% - 4.3%
|
1% - 4.3%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Mental disorder
|
Mental disorder
|
postmarketing — 2.5%
|
1.2%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
1.5%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Incontinence
|
Incontinence
|
0.6% - 2%
|
0.6% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Road traffic accident
|
Road traffic accident
|
1.5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
1.5%
|
1.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Disorientation
|
Disorientation
|
1.5%
|
0%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Menopausal symptoms
|
Hot flush
|
1.5% - 5.9%
|
1.4% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hot flush
|
Hot flush
|
1.5% - 5.9%
|
1.4% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Fear
|
Fear
|
1% - 1.4%
|
1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Infection
|
Infection
|
1.3% - 1.9%
|
1.7%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
1.3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoaesthesia
|
Hypoaesthesia
|
1.3% - 7.8%
|
0.3% - 2.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depressed mood
|
Depressed mood
|
1.3%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypersomnia
|
Hypersomnia
|
1.3%
|
0%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
1.1%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
1.1%
|
0.9%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis allergic
|
Rhinitis allergic
|
1.1%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Aggression
|
Aggression
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Amnesia transient
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Anger
|
Anger
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
infrequent, 7.4%
|
2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
infrequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
infrequent, 8.5%
|
2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypotonia
|
Hypotonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Muscle relaxant therapy
|
Hypotonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mydriasis
|
Mydriasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Panic disorder
|
Panic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Convulsion
|
Convulsion
|
infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
infrequent, 1.5% - 5.9%
|
1.4% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Stupor
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depressed level of consciousness
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depressed level of consciousness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
infrequent
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
infrequent
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing — 1.1%
|
0.9%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hangover
|
Hangover
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Chest discomfort
|
Chest tightness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Clumsiness
|
Clumsiness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abnormal dreams
|
Abnormal dreams
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cold sweat
|
Sticky skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sticky skin
|
Sticky skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Suicidal ideation
|
Suicidal ideation
|
infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Psychomotor retardation
|
Psychomotor retardation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Chills
|
Rigors
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Homicidal ideation
|
Homicidal ideation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Energy increased
|
Energy increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Loss of control of legs
|
Loss of control of legs
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Feeling of relaxation
|
Feeling of relaxation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Feeling drunk
|
Feeling drunk
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sleep talking
|
Sleep talking
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Choking sensation
|
Choking sensation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Feeling jittery
|
Feeling jittery
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Altered state of consciousness
|
Depressed level of consciousness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bradyphrenia
|
Bradyphrenia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sluggishness
|
Sluggishness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nasopharyngitis
|
Rhinorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Feeling hot
|
Feeling hot
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing, uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing — 12.1%
|
3.1%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal symptom NOS
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
Menstruation irregular
|
Menstruation irregular
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Galactorrhoea
|
Galactorrhoea
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypomania
|
Hypomania
|
postmarketing, infrequent
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Mania
|
Mania
|
postmarketing, infrequent
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hostility
|
Hostility
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasticity
|
Muscle spasticity
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Panic reaction
|
Panic reaction
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disturbance
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Withdrawal syndrome
|
Withdrawal syndrome
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Completed suicide
|
Suicide
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Urinary retention
|
Urinary retention
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscular weakness
|
Muscular weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Intraocular pressure increased
|
Intraocular pressure increased
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug withdrawal convulsions
|
Withdrawal seizures
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Balance disorder
|
Balance disorder
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Substance abuse
|
Substance abuse
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Major depression
|
Major depression
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Indications
Information about indications was extracted from the indications and usage sections of the labels.
Side effects: | 31 |
Source: | Medsafe |
---|
Side effects: | 34 |
Source: | FDA Structured Product Label |
---|
Side effects: | 37 |
Source: | FDA Structured Product Label |
---|
Side effects: | 45 |
Source: | medicines.org.au |
---|
Side effects: | 51 |
Source: | FDA Structured Product Label |
---|
Side effects: | 52 |
Source: | FDA Structured Product Label |
---|
Side effects: | 54 |
Source: | FDA Structured Product Label |
---|
Side effects: | 64 |
Source: | Health Canada |
---|
Side effects: | 68 |
Source: | FDA Structured Product Label |
---|
Side effects: | 79 |
Source: | FDA Structured Product Label |
---|
Side effects: | 79 |
Source: | FDA |
---|
Side effects: | 80 |
Source: | FDA Structured Product Label |
---|
Side effects: | 82 |
Source: | FDA |
---|
Side effects: | 86 |
Source: | FDA Structured Product Label |
---|
Side effects: | 86 |
Source: | FDA Structured Product Label |
---|
Side effects: | 90 |
Source: | FDA Structured Product Label |
---|
Side effects: | 93 |
Source: | FDA Structured Product Label |
---|
Side effects: | 145 |
Source: | FDA |
---|
Side effects: | 147 |
Source: | FDA Structured Product Label |
---|
Side effects: | 153 |
Source: | FDA Structured Product Label |
---|
Color scheme:
standard – alternative
|
|
100%
|
|
|
75%
|
|
|
50%
|
|
|
10%
|
|
|
frequent (1% to 100%)
|
|
|
infrequent (0.1% to 1%)
|
|
|
rare (<0.1%)
|
|
|
postmarketing
|
|
|
0%
|
|
|
no frequency information
|
|
|
not found on label
|