MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
15
|
16
|
17
|
18
|
19
|
20
|
Neuropathy peripheral
|
Neuropathy peripheral
|
46.1%
|
24.2%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
33% - 34%
|
35%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
0.3% - 32%
|
8% - 37%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
2% - 25%
|
1% - 26%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing, 0% - 40%
|
0% - 41%
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
Mental state abnormal
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing, 21% - 22%
|
23%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal symptoms
|
1.4% - 34%
|
0% - 16%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
7% - 19.6%
|
6.11% - 7%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Enuresis
|
Enuresis
|
1.1% - 16%
|
5.2% - 10%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing, 16% - 43%
|
10% - 44%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing, 16% - 43%
|
10% - 44%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, 14% - 37%
|
8% - 38%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Central nervous system disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
0.7% - 16%
|
0% - 5%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drooling
|
Drooling
|
0% - 16%
|
0% - 5%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
3% - 22.4%
|
7.33% - 15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
Rhinorrhoea
|
1.5% - 16%
|
0.8% - 13%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
1% - 21%
|
1% - 10%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
1.5% - 16%
|
0.8% - 13%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
1% - 21%
|
1% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory tract infection
|
Respiratory tract infection
|
8%
|
3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
1% - 36%
|
1.22% - 23%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Akathisia
|
Akathisia
|
0% - 16%
|
0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
1% - 18%
|
1% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
frequent, 0% - 20%
|
0% - 15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Automatism
|
Automatism
|
7%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirst
|
Thirst
|
infrequent, 7%
|
4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
infrequent, 3.2% - 49%
|
0% - 19%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
infrequent — 1% - 6.41%
|
1% - 7.14%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
infrequent — 1% - 10%
|
1% - 7.14%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
0.2% - 16%
|
0% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
1% - 16%
|
0% - 8%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
2% - 13%
|
1.3% - 5%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal oedema
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
0% - 24%
|
0% - 16%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing, 4% - 44%
|
2% - 32%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
2% - 25%
|
1% - 26%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
frequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menorrhagia
|
Menorrhagia
|
frequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
frequent, 0% - 16%
|
0% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
frequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
frequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salivary hypersecretion
|
Salivation
|
frequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salivary hypersecretion
|
0% - 22%
|
0% - 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
frequent, 0% - 25%
|
0% - 21%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polydipsia
|
Polydipsia
|
frequent
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
frequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain during injection
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paranoia
|
Paranoid reaction
|
frequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal dryness
|
Vaginal dryness
|
frequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity
|
frequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
2.1% - 10%
|
1.7% - 5%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hypersomnia
|
Hypersomnia
|
frequent, 0.6% - 1.1%
|
0.9%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Feeling abnormal
|
0% - 5%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Confusional state
|
infrequent, 0% - 5%
|
0% - 0.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
0% - 67%
|
0% - 23%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
frequent, 0% - 11%
|
0.9% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash
|
Rash
|
frequent, 0% - 11%
|
0.9% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
4%
|
4.6%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Redness
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry mouth
|
Dry mouth
|
0% - 15%
|
1% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertonia
|
Hypertonia
|
frequent, 3.69%
|
0.978%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, 0% - 52%
|
2% - 53%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
3.23%
|
2.93%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
frequent, 1.5% - 4%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
frequent, 1.5% - 4%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
infrequent, 0% - 5%
|
0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
0% - 24%
|
0% - 18%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
infrequent, 0.5% - 8%
|
1% - 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
frequent, 0% - 42%
|
0% - 19%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
frequent, 0% - 4%
|
1%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
frequent, 0% - 42%
|
0% - 19%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lassitude
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigability
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing, 3% - 49%
|
5% - 50%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
0% - 6%
|
0% - 2%
|
|
x
|
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
|
0% - 34%
|
1% - 15%
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
1% - 7%
|
0% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Hyperkinesia
|
0.6% - 8.53%
|
0% - 2.44%
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Agitation
|
frequent, 0% - 26%
|
0% - 20%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
Hyperkinesia
|
0.6% - 8.53%
|
0% - 2.44%
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Mania
|
Manic psychosis
|
infrequent, 3% - 8%
|
2.69% - 6%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mania
|
postmarketing
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parkinsonism
|
Parkinsonism
|
0% - 28%
|
0% - 11%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug-induced parkinsonism
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Confusional state
|
Confusional state
|
infrequent, 0% - 5%
|
0% - 0.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
2.7%
|
1.1%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Disorder sight
|
2.53%
|
1.47%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal vision
|
0% - 7%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
0% - 4%
|
0% - 0.3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
postmarketing — 1% - 3%
|
1% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Back pain
|
Back pain
|
frequent, 0% - 4%
|
1% - 1.6%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
frequent, 0.8% - 3%
|
0.4% - 2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest discomfort
|
0.3% - 1.1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
infrequent, 0.5% - 6%
|
0% - 1.7%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing, 0.4% - 13%
|
0% - 14%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
0% - 20%
|
0% - 19%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug fever
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lethargy
|
Lethargy
|
0% - 7.6%
|
0% - 3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle rigidity
|
Muscle rigidity
|
1% - 11%
|
2%
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
0% - 4%
|
0%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
0.5% - 12.9%
|
0% - 10.3%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
2%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
infrequent, 1% - 8%
|
0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
0.4% - 2%
|
0.1% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Bone pain
|
Bone pain
|
rare — 1% - 2%
|
1%
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Upset stomach
|
0% - 6%
|
1% - 2%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
1% - 3%
|
0.9% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood prolactin increased
|
Blood prolactin increased
|
0% - 3.8%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Serum prolactin increased
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
1% - 10%
|
0% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Myalgia
|
Myalgia
|
infrequent, 0% - 5%
|
0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Posture abnormal
|
Posture abnormal
|
0% - 1.8%
|
0.8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, 1% - 7%
|
0% - 8%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
1% - 2%
|
1% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
postmarketing, 1% - 55%
|
0% - 56%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Joint swelling
|
Joint swelling
|
1.5%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
0% - 3%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Pitting edema
|
1.5%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
postmarketing — 1% - 1.15%
|
0% - 1%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
0% - 4%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
frequent, 0% - 7%
|
0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Reflex tachycardia
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Altered state of consciousness
|
Depressed level of consciousness
|
1.3%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
Depressed level of consciousness
|
1.3%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Stupor
|
infrequent
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Galactorrhoea
|
Galactorrhoea
|
infrequent, 0.6% - 5%
|
0%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent, 1.15%
|
0.244%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Cellulitis
|
Cellulitis
|
postmarketing, 1.1%
|
1.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent — 0.9% - 1.1%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent — 0.9% - 1.1%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
Disturbance in attention
|
0.9% - 4%
|
0% - 0.6%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Cerebration impaired
|
infrequent, 0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
frequent, 0% - 18%
|
0% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
frequent, 0% - 18%
|
0% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
infrequent — 0% - 8%
|
0% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
0% - 6%
|
1% - 1.4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia
|
Arrhythmia
|
0% - 1%
|
0%
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ataxia
|
Ataxia
|
infrequent, 1%
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyskinesia
|
Dyskinesia
|
infrequent, 1% - 7%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Movement disorder
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal involuntary movements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
frequent, 0% - 5%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
0.1% - 1%
|
0% - 0.3%
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing, 0% - 2.56%
|
1% - 7.14%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent — 0% - 5%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Leg pain
|
1% - 4%
|
1%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity
|
1% - 6%
|
1% - 2.2%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervousness
|
Nervousness
|
frequent, 0.4% - 2%
|
0.1% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tension
|
Nervousness
|
frequent, 0.4% - 2%
|
0.1% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Palpitations
|
Palpitations
|
infrequent, 0.6% - 2.1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
postmarketing — 1%
|
0%
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
Syncope
|
0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toothache
|
Toothache
|
0% - 4%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
postmarketing — 0% - 22%
|
0% - 20%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
infrequent, 1% - 4%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Bundle branch block right
|
Bundle branch block right
|
1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oculogyric crisis
|
Oculogyric crisis
|
infrequent, 1%
|
1%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oculogyration
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
infrequent, 1% - 7%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Joint stiffness
|
Joint stiffness
|
1%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Seborrhoeic dermatitis
|
Dandruff
|
0.2% - 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Seborrhoeic dermatitis
|
infrequent, 0% - 2%
|
0%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dandruff
|
Dandruff
|
0.2% - 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Sexual dysfunction
|
Sexual dysfunction
|
1%
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Balance disorder
|
Balance disorder
|
0.9% - 1.1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acne
|
Acne
|
0% - 2%
|
0%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggressive reaction
|
1% - 3%
|
1% - 3%
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sluggishness
|
Sluggishness
|
0.9% - 1.1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
0% - 1.7%
|
1.7%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Middle insomnia
|
Middle insomnia
|
0% - 1.7%
|
0.9%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus congestion
|
Sinus congestion
|
0% - 2%
|
0% - 0.6%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neck pain
|
Neck pain
|
0.3% - 1.1%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest discomfort
|
Chest discomfort
|
0.3% - 1.1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary congestion
|
Pulmonary congestion
|
0.3% - 1.1%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory tract congestion
|
Pulmonary congestion
|
0.3% - 1.1%
|
0.3%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory tract congestion
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia
|
Anaemia
|
infrequent, 0.1% - 1%
|
0% - 0.1%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypochromic anaemia
|
Hypochromic anaemia
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Apraxia
|
Apraxia
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthritis
|
Arthritis
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrioventricular block
|
Atrioventricular block
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bundle branch block
|
Bundle branch block
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Choking
|
Choking
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Libido decreased
|
Libido decreased
|
infrequent, 1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
infrequent, 1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
infrequent, 1.5%
|
1.3%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Dysarthria
|
infrequent, 1.1% - 1.5%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
infrequent, 1.1% - 1.5%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Faecal incontinence
|
Faecal incontinence
|
rare, infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingivitis
|
Gingivitis
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoptysis
|
Haemoptysis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatomegaly
|
Hepatomegaly
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperventilation
|
Hyperventilation
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyponatraemia
|
Hyponatraemia
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramps of lower extremities
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal discharge
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mastitis
|
Mastitis
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain
|
Breast pain
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain female
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain male
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute coronary syndrome
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paraesthesia
|
Paraesthesia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Phlebitis
|
Phlebitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
infrequent, 3.1%
|
2.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
infrequent, 0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stomatitis
|
Stomatitis
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stridor
|
Stridor
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tendonitis
|
Tendonitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetany
|
Tetany
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torticollis
|
Torticollis
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
infrequent, 1.1% - 1.5%
|
0.3%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Xerophthalmia
|
Xerophthalmia
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stupor
|
Stupor
|
infrequent
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affect lability
|
Mood swings
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site reaction
|
Injection site reaction
|
postmarketing, infrequent
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscular weakness
|
Muscular weakness
|
infrequent
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Accommodation disorder
|
Accommodation disorder
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradykinesia
|
Bradykinesia
|
infrequent, 0% - 3%
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disability
|
Cerebration impaired
|
infrequent, 0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thinking abnormal
|
|
2%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy cervical
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
rare, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin exfoliation
|
Skin exfoliation
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Perineal pain
|
Perineal pain
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major depression
|
Psychotic depression
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ejaculation failure
|
Ejaculation failure
|
infrequent, 0.4% - 1%
|
0%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
Influenza-like symptoms
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza like illness
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Rigors
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
Hypohidrosis
|
Sweating decreased
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|