|
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
|
|
Somnolence
|
Somnolence
|
2.63% - 57%
|
3.8% - 15%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
Headache
|
6.2% - 21%
|
7.92% - 18%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malnutrition
|
Malnutrition
|
very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dizziness
|
Dizziness
|
1% - 19%
|
0% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
postmarketing, 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
Constipation
|
2% - 11%
|
0% - 6.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
Fatigue
|
2.6% - 14.3%
|
2% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
1% - 17.6%
|
1% - 4%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
Fatigue
|
2.6% - 14.3%
|
2% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth
|
Dry mouth
|
1.4% - 44%
|
0% - 13%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
2% - 13.3%
|
2.5% - 15.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
1% - 11.6%
|
1% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
Increased appetite
|
infrequent — 2% - 12.4%
|
0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
Insomnia
|
4.5% - 19.5%
|
14.4% - 17.1%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nasopharyngitis
|
Nasopharyngitis
|
2.7% - 9.9%
|
3.7% - 6.5%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
0.8% - 12.2%
|
0% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
Pain
|
1% - 7%
|
0% - 5%
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
common, 1% - 11%
|
0% - 5%
|
x
|
x
|
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
|
2% - 7%
|
2%
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pharyngitis
|
Pharyngitis
|
frequent, 2% - 8.1%
|
3%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight increased
|
Weight increased
|
0.3% - 13.4%
|
0% - 3.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
Agitation
|
1% - 20%
|
0% - 17%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Extrapyramidal disorder
|
Extrapyramidal symptoms
|
4% - 8%
|
1% - 5%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrapyramidal disorder
|
2% - 3%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
0.7% - 8%
|
1.7% - 6.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia
|
frequent, 1% - 3%
|
0%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
2%
|
1%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspepsia
|
Dyspepsia
|
0.6% - 7%
|
0.7% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing — 0% - 3%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza
|
Influenza
|
frequent, 1% - 2%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lethargy
|
Lethargy
|
1% - 5%
|
0% - 2%
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasal congestion
|
Nasal congestion
|
3% - 6%
|
1% - 3%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
5% - 7%
|
1% - 2%
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
Cough increased
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
2% - 3%
|
1%
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
1% - 7%
|
0% - 3%
|
x
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
1% - 7%
|
0% - 3%
|
x
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
Rash
|
4%
|
2% - 3%
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash
|
Rash
|
4%
|
2% - 3%
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Irritability
|
Irritability
|
1% - 6.1%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertonia
|
Hypertonia
|
frequent, 4%
|
3%
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Palpitations
|
Palpitations
|
postmarketing — 1% - 4%
|
0% - 1%
|
x
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
frequent, 4%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Edema hands
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Viral diarrhoea
|
Viral diarrhoea
|
4%
|
1%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
infrequent, 1% - 4%
|
0% - 2%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
infrequent, 1% - 4%
|
0% - 2%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
2% - 5%
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
1% - 5%
|
0% - 3%
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depression
|
Depression
|
1% - 3%
|
1% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressive episode
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute depression
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Dysarthria
|
frequent, 1% - 5%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteoarthritis
|
Dysarthria
|
frequent, 1% - 5%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthropathy
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypotension
|
Hypotension
|
postmarketing, 3%
|
1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
Rhinitis
|
frequent, 3% - 4%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Speech disorder
|
Speech disorder
|
3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toothache
|
Toothache
|
2% - 3%
|
0% - 1%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremor
|
Tremor
|
2% - 8%
|
1% - 7%
|
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
Hormone level abnormal
|
Hormone level abnormal
|
3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
3% - 4%
|
1%
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vision blurred
|
Vision blurred
|
1% - 5.1%
|
0% - 2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypersomnia
|
Hypersomnia
|
1% - 3%
|
0%
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
2% - 5%
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aggression
|
Aggression
|
1% - 3%
|
0% - 1%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amblyopia
|
Amblyopia
|
2% - 3%
|
1% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety
|
Anxiety
|
2% - 4%
|
0% - 3%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing, 2%
|
1%
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
1% - 4%
|
0% - 1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Seasonal allergy
|
Seasonal allergy
|
2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis seasonal
|
Seasonal allergy
|
2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis
|
Hyperhidrosis
|
2%
|
1%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating
|
frequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
1% - 2%
|
0% - 1%
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia
|
Hypoaesthesia
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia
|
Leukopenia
|
postmarketing — 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain in extremity
|
Pain in extremity
|
2%
|
1%
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia
|
Paraesthesia
|
0% - 3%
|
0% - 2%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Restless legs syndrome
|
Restless legs syndrome
|
postmarketing, 1% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Schizophrenia
|
Schizophrenia
|
2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute schizophrenia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus headache
|
Sinus headache
|
2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle spasms
|
Muscle spasms
|
1% - 3%
|
1%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramps of lower extremities
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
postmarketing, 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
Syncope
|
postmarketing, 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
postmarketing, 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
2%
|
0% - 1%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinus congestion
|
Sinus congestion
|
0% - 3%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disorientation
|
Disorientation
|
2%
|
0%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disturbance in attention
|
Disturbance in attention
|
2%
|
1%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Upset stomach
|
2% - 4%
|
1%
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Parkinsonism
|
Parkinsonism
|
0% - 7.8%
|
0.7% - 7.8%
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Akathisia
|
Akathisia
|
0% - 7.8%
|
0% - 8%
|
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
Balance disorder
|
Balance disorder
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acne
|
Acne
|
2% - 3%
|
0% - 1%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sluggishness
|
Sluggishness
|
2%
|
1%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Musculoskeletal stiffness
|
1% - 3%
|
1%
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neck stiffness
|
1%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental retardation
|
Mental disability
|
2%
|
0%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disability
|
Mental disability
|
2%
|
0%
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thinking abnormal
|
infrequent, 2%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle rigidity
|
Muscle rigidity
|
0% - 3%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pallor
|
Pallor
|
1% - 2%
|
0%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Abdominal distension
|
Abdominal distension
|
0% - 1%
|
0%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enlargement abdomen
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Contusion
|
Contusion
|
1%
|
0%
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear disorder
|
Ear disorder
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ear pain
|
Ear pain
|
0% - 2%
|
0% - 1%
|
x
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Haemoglobin
|
Haemorrhage
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypothyroidism
|
Hypothyroidism
|
infrequent, 1% - 2%
|
0% - 1%
|
x
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthropathy
|
Arthropathy
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
1%
|
0%
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
1%
|
0%
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nuchal rigidity
|
Neck stiffness
|
1%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Accidental overdose
|
Accidental overdose
|
0% - 2%
|
0%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Dizziness postural
|
Dizziness postural
|
1%
|
0%
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry throat
|
Dry throat
|
1%
|
0%
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tooth abscess
|
Tooth abscess
|
1% - 3%
|
0%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bipolar I disorder
|
Bipolar I disorder
|
1%
|
0%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amenorrhoea
|
Amenorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypochromic anaemia
|
Hypochromic anaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthritis
|
Arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ataxia
|
Ataxia
|
infrequent, 2%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blepharitis
|
Blepharitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bruxism
|
Bruxism
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bundle branch block
|
Bundle branch block
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Candida infection
|
Candida infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neck pain
|
Neck pain
|
infrequent, 2%
|
0%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
infrequent, 1% - 2%
|
0%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state
|
infrequent, 1% - 2%
|
0%
|
|
|
|
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
|
|
Conjunctivitis
|
Conjunctivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cyanosis
|
Cyanosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder pain
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis noninfective
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphagia
|
Dysphagia
|
infrequent, 1% - 2%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delusion
|
Delusion
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dental caries
|
Dental caries
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis contact
|
Dermatitis contact
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
Dysgeusia
|
infrequent, 1%
|
0%
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyskinesia
|
Dyskinesia
|
infrequent, 0% - 3%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Movements involuntary
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Buccoglossal syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Movement disorder
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ecchymosis
|
Ecchymosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
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
|
x
|
x
|
|
Eosinophilia
|
Eosinophilia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis
|
Epistaxis
|
infrequent, 0% - 3%
|
1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Faecal incontinence
|
Faecal incontinence
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence
|
Flatulence
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis
|
Gastroenteritis
|
infrequent, 2%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingival bleeding
|
Gingival bleeding
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingivitis
|
Gingivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hallucination
|
Hallucination
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
uncommon, common
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hemiplegia
|
Hemiplegia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
Hypoglycaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido decreased
|
rare, 0% - 2%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
Leukocytosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal discharge
|
Leukorrhea
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myoclonus
|
Myoclonus
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orchitis
|
Orchitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orchitis noninfective
|
Orchitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pelvic pain
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin ulcer
|
Skin ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stomatitis
|
Stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, infrequent
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thirst
|
Thirst
|
infrequent, 0% - 2%
|
0%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
Tinnitus
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pollakiuria
|
Pollakiuria
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vulvovaginitis
|
Vulvovaginitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
infrequent
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary retention
|
Urinary retention
|
postmarketing, infrequent
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
Chills
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stupor
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressed level of consciousness
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Migraine
|
Migraine
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alcohol intolerance
|
Alcohol intolerance
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
Creatinine increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tongue disorder
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tongue oedema
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
infrequent, 1% - 2%
|
0% - 1%
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Galactorrhoea
|
Lactation female
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Galactorrhoea
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Mania
|
Manic psychosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone pain
|
Bone pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye pain
|
Eye pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paranoia
|
Paranoid reaction
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
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
|
|
Ill-defined disorder
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle twitching
|
Muscle twitching
|
infrequent, 4%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
Thinking abnormal
|
infrequent, 2%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
infrequent, 2% - 3%
|
0% - 1%
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erectile dysfunction
|
Erectile dysfunction
|
infrequent, 1%
|
0%
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Heart rate irregular
|
Pulse irregular
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bradycardia
|
Bradycardia
|
postmarketing — uncommon
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram T wave inversion
|
Electrocardiogram T wave inversion
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coordination abnormal
|
Coordination abnormal
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Face oedema
|
Face oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gait disturbance
|
Gait disturbance
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebral ischaemia
|
Cerebral ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Myasthenia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ejaculation disorder
|
Abnormal ejaculation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Catatonia
|
Catatonic reaction
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Visual impairment
|
Abnormal vision
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disorder sight
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Retrograde amnesia
|
Retrograde amnesia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris
|
Angina pectoris
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aphasia
|
Aphasia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
Atrial fibrillation
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deafness
|
Deafness
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido decreased
|
Libido decreased
|
rare, 0% - 2%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delirium
|
Delirium
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diabetic ketoacidosis
|
Diabetic ketoacidosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Glaucoma
|
Glaucoma
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glossitis
|
Glossitis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glycosuria
|
Glycosuria
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gout
|
Gout
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gynaecomastia
|
Gynaecomastia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematemesis
|
Haematemesis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Subdural haematoma
|
Subdural haematoma
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hiccups
|
Hiccups
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperthyroidism
|
Hyperthyroidism
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperventilation
|
Hyperventilation
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature decreased
|
Body temperature decreased
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Hypothermia
|
Body temperature decreased
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute
|
Renal failure acute
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Melaena
|
Melaena
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocarditis
|
Myocarditis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuralgia
|
Neuralgia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Nocturia
|
Nocturia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyuria
|
Polyuria
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urine output increased
|
Polyuria
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psoriasis
|
Psoriasis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnambulism
|
Somnambulism
|
postmarketing
|
|
|
|
|
|
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
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphemia
|
Stuttering
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
rare
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombophlebitis
|
Thrombophlebitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Water intoxication
|
Water intoxication
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Choreoathetosis
|
Choreoathetosis
|
rare
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mood swings
|
Mood swings
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Affect lability
|
Mood swings
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cataract
|
Cataract
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Buccoglossal syndrome
|
Buccoglossal syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin discolouration
|
Skin discolouration
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Accommodation disorder
|
Accommodation disorder
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Euphoric mood
|
Euphoric mood
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram QRS complex prolonged
|
Electrocardiogram QRS complex prolonged
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enuresis
|
Nocturnal enuresis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Electrocardiogram ST segment elevation
|
Electrocardiogram ST segment elevation
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiomyopathy
|
Cardiomyopathy
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diabetic hyperglycaemic coma
|
Diabetic coma
|
postmarketing
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetic coma
|
Diabetic coma
|
postmarketing
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Brain neoplasm
|
Brain neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast cancer
|
Breast cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast swelling
|
Breast swelling
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nervous system disorder
|
Central nervous system disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Nervous system disorder
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Drooling
|
Drooling
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Fasting
|
Fasting
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hostility
|
Hostility
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hyperphagia
|
Hyperphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Menorrhagia
|
Menorrhagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menstrual disorder
|
Menstrual disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movement disorder
|
Movement disorder
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Drug withdrawal syndrome neonatal
|
Drug withdrawal syndrome neonatal
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Tension
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Malignant syndrome NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Night sweats
|
Night sweats
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity
|
Obesity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pregnancy
|
Pregnancy
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Priapism
|
Priapism
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Completed suicide
|
Suicide
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus tachycardia
|
Sinus tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
Torsade de pointes
|
Torsade de pointes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Polydipsia
|
Polydipsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Akinesia
|
Akinesia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokinesia
|
Hypokinesia
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug withdrawal syndrome
|
Drug withdrawal syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Throat tightness
|
Throat tightness
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyslipidaemia
|
Dyslipidaemia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure diastolic decreased
|
Blood pressure diastolic decreased
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Suicidal ideation
|
Suicidal ideation
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Parkinsonian gait
|
Parkinsonian gait
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sudden death
|
Sudden death, cause unknown
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
High density lipoprotein decreased
|
Low density lipoprotein increased
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Low density lipoprotein increased
|
Low density lipoprotein increased
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sexual dysfunction
|
Sexual dysfunction
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood glucose increased
|
Blood glucose increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glucose increased
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug screen positive
|
Urine drug screen positive
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Blood prolactin increased
|
Increased prolactin level
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neutrophil count decreased
|
Neutrophil count decreased
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram change
|
Electrocardiogram change
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ileus
|
Ileus
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oculogyric crisis
|
Oculogyration
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Lenticular opacities
|
Lenticular opacities
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood cholesterol increased
|
High cholesterol
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embolism venous
|
Venous thromboembolism
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
