|
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
|
very common, 3% - 39.1%
|
3% - 16.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
13% - 18%
|
6% - 17%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
common — 1% - 29%
|
0% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervousness
|
16%
|
14%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Hallucination
|
very common, 0% - 3%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Lethargy
|
very common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
PRL increased
|
very common, 47.4%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hypersomnia
|
very common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Bilirubin total decreased
|
very common, 22.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Bilirubin total low
|
very common, 22.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hostility
|
15%
|
14%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Weight increased
|
common — 1% - 43.5%
|
1% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Accidental injury
|
12%
|
8%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Parkinsonism
|
0% - 20%
|
0% - 15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
postmarketing, 12% - 20%
|
11% - 19%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
common, 2% - 27%
|
1% - 23%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
0% - 10%
|
0% - 9%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Anxiety
|
postmarketing, 9%
|
8%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Constipation
|
common, 4% - 14.5%
|
0% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness
|
common, 1% - 18%
|
2% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Personality disorder
|
8%
|
4% - 8%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
8%
|
3%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
3% - 11%
|
1% - 5%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
7% - 10%
|
6%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
common, 1.5% - 14%
|
2% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Gamma-glutamyltransferase increased
|
very common, 2% - 10.1%
|
1%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Abdominal pain
|
infrequent, 3% - 6%
|
2% - 7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth
|
common, 2% - 22%
|
0% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough increased
|
5% - 6%
|
3%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gait disturbance
|
infrequent — 6%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
3% - 5%
|
2% - 4%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Conjunctivitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Cough
|
3% - 9%
|
5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Delusion
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dyspnoea
|
frequent
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Ecchymosis
|
5%
|
3%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eosinophilia
|
common
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Body temperature increased
|
rare — 0% - 6%
|
0% - 3%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence
|
frequent, 1% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Orthostatic hypotension
|
common — 1% - 5%
|
0% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pain in extremity
|
5% - 6%
|
0% - 3%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Paraesthesia
|
frequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
common
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Salivary hypersecretion
|
frequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thirst
|
frequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Toothache
|
frequent, 3% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vaginal inflammation
|
frequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mood swings
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Manic psychosis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Injection site pain
|
frequent, 2% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Schizophrenic reaction
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Joint stiffness
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Akathisia
|
infrequent, 0% - 27%
|
0% - 23%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasopharyngitis
|
1% - 6%
|
2%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Pharyngitis
|
1.6% - 10.1%
|
1.5% - 3%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Speech disorder
|
4%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tremor
|
postmarketing, 0% - 7%
|
0% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal discharge
|
0% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amblyopia
|
3% - 5%
|
2% - 4%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
uncommon — 2% - 5%
|
0% - 3%
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
3% - 4%
|
1% - 2%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
infrequent, 2% - 7%
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertonia
|
3% - 4%
|
2% - 3%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection
|
3%
|
2%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Sinusitis
|
3%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Tachycardia
|
3% - 4%
|
1%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
1% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Agitation
|
1% - 23%
|
2% - 17%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
Hepatic enzyme increased
|
1% - 4%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngolaryngeal pain
|
2% - 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia
|
uncommon — 2%
|
0%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phonological disorder
|
infrequent, 2%
|
1%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Blepharitis
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Fungal skin infection
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Oedema
|
2%
|
0%
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye disorder
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Hypertension
|
0% - 3%
|
0% - 1%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypotension
|
common — 2%
|
0% - 1%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Arthropathy
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Menstrual disorder
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Nasal congestion
|
1% - 7%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
1% - 3%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Urinary incontinence
|
very rare — 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
2%
|
1%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
common, 1% - 3%
|
0% - 1%
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neck stiffness
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vesiculobullous rash
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Aspartate aminotransferase increased
|
very common, 2% - 27.6%
|
0%
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Muscle twitching
|
infrequent — 2%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Euphoric mood
|
frequent, 2%
|
0%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acne
|
0% - 2%
|
0%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Musculoskeletal stiffness
|
1% - 4%
|
0% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Drug dependence
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Abnormal dreams
|
frequent, 0% - 4.3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Neurosis
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Corneal lesion
|
rare, 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Intentional injury
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Abdominal distension
|
uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acidosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Alopecia
|
very rare — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amenorrhoea
|
infrequent
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Anaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Apnoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Asthma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Ataxia
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Atrioventricular block
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Candida infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oral candidiasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Neck pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Confusional state
|
infrequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cyanosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Deafness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Libido decreased
|
infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dysphagia
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Delirium
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dental caries
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dermatitis contact
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Diabetes mellitus
|
very rare — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Diplopia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dysarthria
|
infrequent, 0% - 2%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Ear pain
|
infrequent, 1% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eczema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Endophthalmitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Epistaxis
|
infrequent — 3%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Oesophagitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eye haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Facial paralysis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Faecal incontinence
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Faecalith
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Gastritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Gastroenteritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Gingivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Glycosuria
|
infrequent, common
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Gynaecomastia
|
infrequent
|
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cardiac arrest
|
infrequent
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Block heart
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac failure congestive
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Haematuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Haemoptysis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hyperbilirubinaemia
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hypercholesterolaemia
|
postmarketing — common
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Hyperventilation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypoaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypoglycaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypokalaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hyponatraemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypoproteinaemia
|
rare, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Laryngitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cramps of lower extremities
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Leukocytosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Leukopenia
|
postmarketing — 1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast pain
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Melaena
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Menorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Hypotonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Nausea
|
postmarketing — 0% - 9%
|
2% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pallor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Palpitations
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Abscess periodontal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Premenstrual syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Seborrhoeic dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Skin ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cerebrovascular accident
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Stuttering
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Withdrawal syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Suicide
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
|
|
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Sweating
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Thrombocytopenia
|
very rare — infrequent
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pollakiuria
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Vertigo
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vomiting
|
postmarketing — 1% - 6%
|
2% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary retention
|
very rare, infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Akinesia
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hypokinesia
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cataract
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Migraine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cogwheel rigidity
|
infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Creatine phosphokinase increased
|
very rare — 1%
|
0%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Ventricular extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Lactation female
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eye pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Phosphatase alkaline increased
|
very rare — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin discolouration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dry skin
|
infrequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Uterine fibroids enlarged
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Accommodation disorder
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Photosensitivity reaction
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urination impaired
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Antisocial behaviour
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Edema of lower extremities
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Erectile dysfunction
|
infrequent
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dry eye
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Phobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Enlargement abdomen
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Bradycardia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dementia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Coordination abnormal
|
infrequent
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Upper limb oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Face oedema
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Tardive dyskinesia
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperuricaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Myasthenia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Abnormal ejaculation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Chills
|
rare, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Albuminuria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Angioedema
|
postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arteritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Atelectasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Bursitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Coma
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Sudden death
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
Diabetic ketoacidosis
|
very rare — rare
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enteritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eructation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Rash
|
postmarketing — 2%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glaucoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Glossitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Goitre
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Gout
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cardiac failure
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hepatitis
|
postmarketing — infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hiccups
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hirsutism
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hyperglycaemia
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Hyperkalaemia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypernatraemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypersensitivity
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertriglyceridaemia
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Intestinal obstruction
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Jaundice
|
very rare, postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Keratoconjunctivitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Ketosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Mastitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Miosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Myopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Mydriasis
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Neuralgia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Neutropenia
|
postmarketing — common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Nystagmus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oliguria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Osteoporosis
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Priapism
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary oedema
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pulmonary embolism
|
very rare — rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhabdomyolysis
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Convulsion
|
postmarketing, rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Aphthous stomatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Stridor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Subarachnoid haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urticaria
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Water intoxication
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Normocytic anemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Encephalopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Rash pustular
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Deep vein thrombosis
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Tongue discolouration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Lenticular pigmentation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Liver fatty deposition
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Bone pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Circumoral paresthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oesophageal ulcer
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urinary hesitation
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukoderma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hangover
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hepatobiliary disease
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Anaphylactoid reaction
|
postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Paralysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Sweating increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Thrombocytosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Thromboembolic event
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Ileus
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Diabetic coma
|
very rare, postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast enlargement
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypoventilation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Neuroleptic malignant syndrome
|
very rare, postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bilirubin total increased
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Venous thromboembolism
|
very rare, postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Dementia Alzheimer's type
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Anorexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infection
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Connective tissue disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depression
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dyskinesia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysmenorrhoea
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrapyramidal disorder
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Fasting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Gastrointestinal disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Body temperature decreased
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myoclonus
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Drug withdrawal syndrome neonatal
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Obesity
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Parkinson's disease
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Pregnancy
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sneezing
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thromboembolism
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torsade de pointes
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torticollis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Unintended pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Erythema
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular tachycardia
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Viral infection
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weight decreased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Choreoathetosis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic failure
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Ventricular arrhythmia
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Apathy
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oculogyric crisis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Lower respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Buccoglossal syndrome
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Injection site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site mass
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Opisthotonus
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Paranoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Generalised spasm
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Malnutrition
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ketoacidosis
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Buttock pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac fibrillation
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Abdominal pain lower
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Psychiatric symptom
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
0% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Hallucination, visual
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Galactorrhoea
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tolerance development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Throat tightness
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Blood pressure systolic decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Dependence psychological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dependence physiological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Induration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Viral upper respiratory tract infection
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkinesia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Masked facies
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sudden death, cause unknown
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site induration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug seeking behavior
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematocrit decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Increased prolactin level
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood and lymphatic system disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear and labyrinth disorders
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
0% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Electrocardiogram change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
|
Electrocardiogram QT corrected interval prolonged
|
0% - 2%
|
1%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Acute schizophrenia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Serum prolactin increased
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glucose increased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Albumin low
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Creatine increased
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth infection
|
0% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory tract infection viral
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Uric acid high
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic impairment
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Oculogyration
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Procedural pain
|
0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mixed liver injury
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Abnormal vision
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
