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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
33% - 34%
|
35%
|
|
|
|
|
|
x
|
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
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing, 0% - 40%
|
0% - 41%
|
|
|
|
x
|
|
|
|
|
|
|
|
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
|
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
|
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
|
x
|
Central nervous system disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
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
|
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
|
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
|
|
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
|
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
|
|
Automatism
|
Automatism
|
7%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thirst
|
Thirst
|
infrequent, 7%
|
4%
|
|
x
|
|
|
|
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
|
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
|
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
|
x
|
Infection
|
Infection
|
2% - 25%
|
1% - 26%
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salivary hypersecretion
|
Salivation
|
frequent
|
|
|
|
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
|
Injection site pain
|
Injection site pain
|
frequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain during injection
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paranoia
|
Paranoid reaction
|
frequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal dryness
|
Vaginal dryness
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
x
|
Hypersomnia
|
Hypersomnia
|
frequent, 0.6% - 1.1%
|
0.9%
|
|
|
|
|
|
x
|
|
|
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
|
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
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
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
|
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
|
x
|
Skin disorder
|
|
|
|
|
|
|
|
x
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
frequent, 1.5% - 4%
|
0% - 3%
|
|
|
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
|
Myalgia
|
infrequent, 0% - 5%
|
0% - 2%
|
|
|
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
|
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
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigability
|
|
|
|
|
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
|
x
|
Pharyngitis
|
Pharyngitis
|
0% - 6%
|
0% - 2%
|
|
|
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
|
x
|
x
|
Vision blurred
|
Vision blurred
|
1% - 7%
|
0% - 1%
|
|
|
|
|
|
|
x
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
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
|
x
|
x
|
Visual impairment
|
Disorder sight
|
2.53%
|
1.47%
|
|
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
|
|
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
|
Hypertension
|
Hypertension
|
postmarketing — 1% - 3%
|
1% - 2%
|
|
|
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
|
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
|
|
Chest discomfort
|
0.3% - 1.1%
|
0%
|
|
|
|
|
|
x
|
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
|
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
|
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
|
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
|
|
x
|
Bone pain
|
Bone pain
|
rare — 1% - 2%
|
1%
|
|
|
|
|
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
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
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
|
x
|
Suicide attempt
|
Suicide attempt
|
1% - 2%
|
1% - 3%
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
postmarketing, 1% - 55%
|
0% - 56%
|
|
x
|
|
|
|
x
|
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
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
0% - 3%
|
|
|
|
|
|
|
x
|
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
|
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
|
Sinusitis
|
Sinusitis
|
0% - 4%
|
0% - 1%
|
|
|
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
|
Reflex tachycardia
|
|
|
|
|
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
|
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
|
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
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent, 1.15%
|
0.244%
|
|
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
|
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
|
x
|
Cerebration impaired
|
infrequent, 0% - 2%
|
0% - 1%
|
|
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
|
|
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
|
|
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
|
Decreased appetite
|
0% - 6%
|
1% - 1.4%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Arrhythmia
|
Arrhythmia
|
0% - 1%
|
0%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ataxia
|
Ataxia
|
infrequent, 1%
|
|
|
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
|
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
|
|
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
|
Pain in extremity
|
Leg pain
|
1% - 4%
|
1%
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity
|
1% - 6%
|
1% - 2.2%
|
|
|
|
|
|
|
x
|
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
|
|
|
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
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
x
|
Toothache
|
Toothache
|
0% - 4%
|
0%
|
|
|
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
|
Bundle branch block right
|
Bundle branch block right
|
1%
|
|
|
|
|
|
|
x
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oculogyration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
infrequent, 1% - 7%
|
0% - 1%
|
|
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
|
|
x
|
Seborrhoeic dermatitis
|
Dandruff
|
0.2% - 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
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
|
Dandruff
|
Dandruff
|
0.2% - 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
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
|
x
|
Balance disorder
|
Balance disorder
|
0.9% - 1.1%
|
0%
|
|
|
|
|
|
x
|
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
|
x
|
Aggression
|
Aggressive reaction
|
1% - 3%
|
1% - 3%
|
|
|
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
|
x
|
Sinus congestion
|
Sinus congestion
|
0% - 2%
|
0% - 0.6%
|
|
|
|
|
|
x
|
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
|
x
|
Chest discomfort
|
Chest discomfort
|
0.3% - 1.1%
|
0%
|
|
|
|
|
|
x
|
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
|
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
|
x
|
Respiratory tract congestion
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Apraxia
|
Apraxia
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthritis
|
Arthritis
|
rare, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrioventricular block
|
Atrioventricular block
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bundle branch block
|
Bundle branch block
|
infrequent
|
|
|
x
|
|
|
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
|
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
|
x
|
Libido increased
|
infrequent
|
|
|
|
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
|
x
|
Delirium
|
Delirium
|
rare, infrequent
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
infrequent
|
|
|
|
|
|
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
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
rare, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingivitis
|
Gingivitis
|
rare, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoptysis
|
Haemoptysis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
rare, infrequent
|
|
|
|
|
|
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
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
infrequent
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal discharge
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mastitis
|
Mastitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain
|
Breast pain
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain female
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain male
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute coronary syndrome
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
rare, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
infrequent
|
|
|
|
|
|
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
|
Purpura
|
Purpura
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing, infrequent
|
|
|
x
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stridor
|
Stridor
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tendonitis
|
Tendonitis
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetany
|
Tetany
|
infrequent
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
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
|
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
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site reaction
|
Injection site reaction
|
postmarketing, infrequent
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscular weakness
|
Muscular weakness
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Accommodation disorder
|
Accommodation disorder
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
infrequent
|
|
|
x
|
|
|
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
|
x
|
Discomfort
|
|
|
|
|
|
|
|
x
|
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
|
x
|
Bradykinesia
|
Bradykinesia
|
infrequent, 0% - 3%
|
|
|
|
|
|
x
|
|
|
|
|
|
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
|
x
|
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disability
|
Cerebration impaired
|
infrequent, 0% - 2%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thinking abnormal
|
|
2%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy cervical
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
rare, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin exfoliation
|
Skin exfoliation
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Perineal pain
|
Perineal pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
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
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hypohidrosis
|
Sweating decreased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal pain
|
Renal pain
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait disturbance
|
Gait disturbance
|
infrequent, 0% - 4%
|
1.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
infrequent
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkeratosis
|
Hyperkeratosis
|
infrequent, 0% - 1%
|
0.3% - 1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Catatonia
|
Catatonic reaction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Catatonia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
postmarketing, 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Electrocardiogram QT corrected interval prolonged
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing — 0.1% - 1%
|
0% - 0.1%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Allergy aggravated
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
infrequent, 0% - 3%
|
0% - 0.1%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
0% - 1%
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
0% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
rare — 0.2% - 1.15%
|
0.2% - 1%
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
infrequent, 0.2%
|
0.2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abscess
|
Abscess
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing — infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing, infrequent
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
Anaphylactoid reaction
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angina pectoris
|
Angina pectoris
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
C1 esterase deficiency acquired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Aphasia
|
Aphasia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Apnoea
|
Apnoea
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ascites
|
Ascites
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bipolar disorder
|
Bipolar disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bipolar I disorder
|
Bipolar disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blepharitis
|
Blepharitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing, 45% - 46%
|
47%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bursitis
|
Bursitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cachexia
|
Cachexia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Transient ischaemic attack
|
Transient ischaemic attack
|
postmarketing, 1.6%
|
0.6%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholecystitis
|
Cholecystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholelithiasis
|
Cholelithiasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coma
|
Coma
|
rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cystitis
|
Cystitis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sudden death
|
Sudden death
|
postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Sudden death, cause unknown
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Dehydration
|
Dehydration
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Diabetes mellitus exacerbated
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetic
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetic ketoacidosis
|
Diabetic ketoacidosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diverticulitis
|
Diverticulitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
Taste bitter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oesophagitis
|
Oesophagitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic steatosis
|
Liver fatty
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Flushing
|
Flushing
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial septal defect
|
Foramen ovale patent
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Furuncle
|
Furunculosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastroenteritis
|
Gastroenteritis
|
rare
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 0% - 16%
|
2% - 17%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haematemesis
|
Haematemesis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood disorder
|
Blood disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
Haematoma
|
Haematoma
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
rare
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
rare
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hereditary angioedema
|
Hereditary angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing, 1%
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
Hypertrichosis
|
Hypertrichosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood triglycerides increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
rare, 0% - 2%
|
0% - 1%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Numbness
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoproteinaemia
|
Hypoproteinaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Body temperature decreased
|
Body temperature decreased
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothermia
|
Body temperature decreased
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
Intermittent claudication
|
Intermittent claudication
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intestinal obstruction
|
Intestinal obstruction
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngeal oedema
|
Laryngeal oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukopenia
|
Leukopenia
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Long QT syndrome
|
Long QT syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Lymphopenia
|
Lymphopenia
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypotonia
|
Hypotonia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle relaxant therapy
|
Hypotonia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocarditis
|
Myocarditis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Necrosis
|
Necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug withdrawal syndrome neonatal
|
Drug withdrawal syndrome neonatal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malignant syndrome NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Nodule
|
Nodule
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pallor
|
Pallor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pituitary tumour benign
|
Pituitary adenoma
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Pregnancy
|
Pregnancy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Priapism
|
Priapism
|
postmarketing
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus genital
|
Pruritus genital
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Precocious puberty
|
Precocious puberty
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Pulmonary oedema
|
Pulmonary oedema
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
postmarketing
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Retinal artery occlusion
|
Retinal artery occlusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sarcoidosis
|
Sarcoidosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, 1.1%
|
0.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Withdrawal syndrome
|
Withdrawal syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ulcer
|
Ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin papilloma
|
Common wart
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Water intoxication
|
Water intoxication
|
postmarketing
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Yawning
|
Yawning
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary retention
|
Urinary retention
|
postmarketing — infrequent
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Normochromic normocytic anaemia
|
Normocytic anemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Choreoathetosis
|
Choreoathetosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photopsia
|
Photopsia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photophobia
|
Photophobia
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperphosphataemia
|
Hyperphosphataemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Periorbital oedema
|
Periorbital oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Injection site abscess
|
Injection site abscess
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site cyst
|
Injection site cyst
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue discolouration
|
Tongue discolouration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tongue disorder
|
Tongue oedema
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tongue oedema
|
Tongue oedema
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hepatocellular injury
|
Hepatocellular injury
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver injury
|
Hepatocellular injury
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site necrosis
|
Injection site necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperreflexia
|
Hyperreflexia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lichenoid keratosis
|
Eruption lichenoid
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Platelet production decreased
|
Platelet production decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tongue paralysis
|
Tongue paralysis
|
rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Faeces discoloured
|
Faeces discoloured
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngotracheal oedema
|
Laryngotracheal oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Psoriasis
|
Psoriasis flare-up
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Bullous eruption
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood iron decreased
|
Serum iron decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oedema mouth
|
Oedema mouth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Circumoral oedema
|
Circumoral oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Cholinergic syndrome
|
Cholinergic syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Toxicity to various agents
|
Cholinergic syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
Enlargement abdomen
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Dementia
|
Dementia
|
postmarketing, infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram ST segment depression
|
Electrocardiogram ST segment depression
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram T wave inversion
|
Electrocardiogram T wave inversion
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site ulcer
|
Injection site ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site haematoma
|
Injection site haematoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Surgery
|
Surgical intervention
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood cholesterol increased
|
Blood cholesterol increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Cardio-respiratory arrest
|
Cardio-respiratory arrest
|
postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
postmarketing, 0% - 1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperuricaemia
|
Hyperuricaemia
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phlebitis superficial
|
Phlebitis superficial
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Parkinson's disease
|
Parkinson's disease aggravated
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Elevated liver enzyme levels
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Injection site cellulitis
|
Injection site cellulitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Small bowel angioedema
|
Small bowel angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Long QT syndrome congenital
|
Long QT syndrome congenital
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ileus
|
Ileus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oculorespiratory syndrome
|
Oculo-respiratory syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Oculorespiratory syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Electrocardiogram QT interval abnormal
|
Electrocardiogram QT interval abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Renal failure
|
Renal impairment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Renal impairment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Function kidney decreased
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plateletcrit decreased
|
Plateletcrit decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Floppy iris syndrome
|
Floppy iris syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Adenocarcinoma
|
Adenocarcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adenoma benign
|
Adenoma benign
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Albinism
|
Albinism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus arrhythmia
|
Sinus arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Athetosis
|
Athetosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blepharospasm
|
Blepharospasm
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Coagulopathy
|
Clotting
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coagulopathy
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Brain neoplasm
|
Brain neoplasm
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast feeding
|
Breast feeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchopneumonia
|
Bronchopneumonia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cheilitis
|
Cheilitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chorea
|
Chorea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Muscle contracture
|
Muscle contracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Deafness
|
Deafness
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hearing impaired
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depression
|
Depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Drug eruption
|
Drug eruption
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Drug hypersensitivity
|
Drug hypersensitivity
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear disorder
|
Ear disorder
|
|
0%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grand mal convulsion
|
Grand mal convulsion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophageal motility disorder
|
Oesophageal motility disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye infection
|
Eye infection
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Localised infection
|
Localised infection
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glycosuria
|
Glycosuria
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hearing impaired
|
Partial hearing loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hearing impaired
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Heat stroke
|
Heat stroke
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperinsulinism
|
Hyperinsulinism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood insulin increased
|
Hyperinsulinism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperphagia
|
Hyperphagia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure acute
|
Renal failure acute
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngospasm
|
Laryngospasm
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
Bundle branch block left
|
Bundle branch block left
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Movement disorder
|
Movement disorder
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal disorder
|
Musculoskeletal disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Buttock pain
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Fungal infection
|
Fungal infection
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myoclonus
|
Myoclonus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myoglobinuria
|
Myoglobinuria
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myoglobin urine present
|
Myoglobinuria
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myotonia
|
Myotonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensory loss
|
Numbness
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity
|
Obesity
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye movement disorder
|
Eye movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye rolling
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oligomenorrhoea
|
Oligomenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis media
|
Otitis media
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatic neoplasm
|
Pancreatic neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phenylketonuria
|
Phenylketonuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Pneumonia aspiration
|
Pneumonia aspiration
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension headache
|
Tension headache
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rales
|
Rales
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperacusis
|
Hyperacusis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restless legs syndrome
|
Restless legs syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Reye's syndrome
|
Reye's syndrome
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin lesion
|
Skin lesion
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Speech disorder
|
Speech disorder
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Completed suicide
|
Suicide
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Completed suicide
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Swelling
|
Swelling
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus tachycardia
|
Sinus tachycardia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Onychomycosis
|
Onychomycosis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tonsillitis
|
Tonsillitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tracheobronchitis
|
Tracheobronchitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Trismus
|
Trismus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ventricular fibrillation
|
Ventricular fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus bradycardia
|
Sinus bradycardia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Akinesia
|
Akinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Breast engorgement
|
Breast engorgement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Breast discharge
|
Breast discharge
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cogwheel rigidity
|
Cogwheel rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Fluid retention
|
Generalised oedema
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Injection site swelling
|
Injection site swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial ischaemia
|
Myocardial ischaemia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opisthotonus
|
Opisthotonus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Emprosthotonus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyporeflexia
|
Hyporeflexia
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin discolouration
|
Skin discolouration
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug withdrawal syndrome
|
Drug withdrawal syndrome
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimation increased
|
Lacrimation increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endophthalmitis
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ocular hyperaemia
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstruation irregular
|
Menstruation irregular
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Congenital central nervous system anomaly
|
Corpus callosum agenesis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blunted affect
|
Blunted affect
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
|
2%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anorgasmia
|
Anorgasmia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ejaculation delayed
|
Ejaculation delayed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal spasm
|
Oropharyngeal spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue spasm
|
Tongue spasm
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dizziness postural
|
Dizziness postural
|
0% - 2%
|
0% - 0.1%
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Crying
|
Crying abnormal
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ejaculation disorder
|
Ejaculation disorder
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Swollen tongue
|
Swollen tongue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Throat tightness
|
Throat tightness
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Productive cough
|
Productive cough
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lip swelling
|
Lip swelling
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menstruation delayed
|
Menstruation delayed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Subcutaneous abscess
|
Subcutaneous abscess
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Blood testosterone decreased
|
Testosterone low
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyslipidaemia
|
Dyslipidaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Sepsis
|
Sepsis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autonomic nervous system imbalance
|
Autonomic nervous system imbalance
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Osteodystrophy
|
Osteodystrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conduction disorder
|
Conduction disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye swelling
|
Eye swelling
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Otitis media chronic
|
Otitis media chronic
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Peripheral coldness
|
Peripheral coldness
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Facial spasm
|
Facial spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry eye
|
Dry eye
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Induration
|
Induration
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Risus sardonicus
|
Risus sardonicus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Emprosthotonus
|
Emprosthotonus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Initial insomnia
|
Initial insomnia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Retrograde ejaculation
|
Retrograde ejaculation
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye discharge
|
Eye discharge
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Masked facies
|
Masked facies
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal oedema
|
Nasal oedema
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus generalised
|
Pruritus generalised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal chest pain
|
Musculoskeletal chest pain
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash generalised
|
Rash generalised
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleurothotonus
|
Pleurothotonus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site induration
|
Injection site induration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affective disorder
|
Affective disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood glucose increased
|
Blood glucose increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stillbirth
|
Stillbirth
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematocrit decreased
|
Haematocrit decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
White blood cell count decreased
|
White blood cell count decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram change
|
Electrocardiogram change
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Unresponsive to stimuli
|
Unresponsive to stimuli
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood antidiuretic hormone abnormal
|
Antidiuretic hormone abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Antidiuretic hormone abnormality
|
Antidiuretic hormone abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle tightness
|
Muscle tightness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Breast discomfort
|
Breast discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebral ischaemia
|
Cerebral ischaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eyelid margin crusting
|
Eyelid margin crusting
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal stiffness
|
Musculoskeletal stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
Parkinsonian rest tremor
|
Parkinsonian rest tremor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
Glabellar reflex abnormal
|
Glabellar reflex abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diabetic hyperglycaemic coma
|
Diabetic coma
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetic coma
|
Diabetic coma
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Postural orthostatic tachycardia syndrome
|
Postural orthostatic tachycardia syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nuchal rigidity
|
Nuchal rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Acarodermatitis
|
Acarodermatitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash papular
|
Rash papular
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphonia
|
Dysphonia
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Head titubation
|
Head titubation
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
Procedural pain
|
Procedural pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast enlargement
|
Breast enlargement
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophil count increased
|
Eosinophil count increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Reproductive toxicity
|
Reproductive toxicity
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|