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
|
Decreased appetite
|
Appetite absent
|
very common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Decreased appetite
|
frequent, 1% - 9%
|
1% - 5%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Anorexia
|
1% - 17%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very rare — 1% - 47%
|
0% - 12%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
common — 1% - 19%
|
1% - 11%
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
common — 1% - 23%
|
1% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Trembling
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Application site erythema
|
Application site erythema
|
common, 1% - 13%
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Anaemia
|
Anaemia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rheumatoid arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ataxia
|
Ataxia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Basal cell carcinoma
|
Basal cell carcinoma
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
rare — frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retrosternal pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infection
|
Infection
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
uncommon — 8%
|
7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
uncommon — 8%
|
7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
uncommon — 4% - 5%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
frequent, 5%
|
4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
postmarketing — 1% - 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
common, 2% - 6%
|
1% - 4%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Anxiety depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dyskinesia
|
Dyskinesia
|
common — 3%
|
1%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Movement disorder
|
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
common — 8% - 9%
|
4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
infrequent — 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
infrequent — frequent
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Rash
|
Rash
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
frequent
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Extrapyramidal symptoms
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Faecal incontinence
|
Faecal incontinence
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Multiple fractures
|
Fracture
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Fracture
|
Fracture
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
frequent
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent — frequent
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cramp muscle
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Pain in extremity
|
Leg pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
frequent
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
frequent
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Prostatic disorder
|
Prostatic disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Convulsion
|
Convulsion
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin disorder
|
Skin disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
very rare — 1% - 10%
|
1% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
frequent, 0% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vomiting
|
Vomiting
|
very rare — 0.4% - 31%
|
0% - 6%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Trauma
|
frequent, 10%
|
9%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing — 1% - 14%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cataract
|
Cataract
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
Paranoid reaction
|
frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
uncommon — 4% - 5%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Unwell
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Discomfort
|
Malaise
|
uncommon — 4% - 5%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon — 4% - 5%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination, visual
|
Hallucination, visual
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Chills
|
Rigors
|
frequent
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
frequent, 4%
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
uncommon — 1% - 6%
|
1% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
common, 1% - 13%
|
1% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomach ache
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
common, 1% - 13%
|
1% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
common, 1% - 5%
|
1% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
common, 0% - 9%
|
0% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
common, 0% - 6%
|
0% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
common, 0% - 9%
|
0% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
frequent, 4%
|
2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
very rare — 2% - 5%
|
3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 1% - 17%
|
2% - 12%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
4%
|
3%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
4%
|
3%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
4%
|
3%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
1% - 4%
|
1% - 2%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Stomach ache
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hyperhidrosis
|
Sweating increased
|
common — 2% - 4%
|
1%
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
uncommon — 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Sweating
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
3%
|
2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Unspecified circulatory system disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
common, 0% - 21%
|
0% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
uncommon — 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
very rare — 1% - 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parkinson's disease
|
Parkinson's disease
|
postmarketing — 3%
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Parkinsonism
|
Parkinson's disease
|
postmarketing — 3%
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Parkinsonism
|
2%
|
1%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
uncommon — 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
uncommon — 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope vasovagal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
uncommon — 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
common — 1% - 8%
|
0% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cogwheel rigidity
|
Cogwheel rigidity
|
common, 3%
|
0%
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
Bradykinesia
|
Bradykinesia
|
common — 2% - 4%
|
2%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
frequent, 3%
|
2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
infrequent — 1% - 9%
|
2% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggressive reaction
|
3%
|
2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
postmarketing — 0.4% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
infrequent, frequent
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Stinging
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
Application site pruritus
|
Application site pruritus
|
common, 1% - 4%
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Eructation
|
Eructation
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing — 1.7% - 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Pollakiuria
|
Pollakiuria
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Disorder sight
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
infrequent — 1% - 3%
|
2%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abscess
|
Abscess
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Adams-Stokes syndrome
|
Adams-Stokes syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Adenocarcinoma
|
Adenocarcinoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Albuminuria
|
Albuminuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypochromic anaemia
|
Hypochromic anaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Aneurysm
|
Aneurysm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphasia
|
Aphasia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Apnoea
|
Apnoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Apraxia
|
Apraxia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
very rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrioventricular block
|
Atrioventricular block
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder disorder
|
Bladder disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neurogenic bladder
|
Neurogenic bladder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharospasm
|
Blepharospasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Brain disorder NOS
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Breast cancer
|
Breast cancer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm
|
Bronchospasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bundle branch block
|
Bundle branch block
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bursitis
|
Bursitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cachexia
|
Cachexia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
Candida infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm malignant
|
Carcinoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin cancer
|
Skin cancer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cellulitis
|
Cellulitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholecystitis
|
Cholecystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholelithiasis
|
Cholelithiasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Coma
|
Coma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Libido decreased
|
Libido decreased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
infrequent, uncommon
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dental caries
|
Dental caries
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis contact
|
Dermatitis contact
|
infrequent, uncommon
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diverticulitis
|
Diverticulitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Duodenal ulcer
|
Duodenal ulcer
|
rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear disorder
|
Ear disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Epilepsy
|
Epilepsy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Congenital eye disorder
|
Congenital eye disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye disorder
|
Congenital eye disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Eyelid disorder
|
Eyelid disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Flushing
|
Flushing
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Furuncle
|
Furunculosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastroenteritis
|
Gastroenteritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
very rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Glaucoma
|
Glaucoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Goitre
|
Goitre
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breath odour
|
Breath odour
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematemesis
|
Haematemesis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematochezia
|
Haematochezia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Haematoma
|
Haematoma
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Subdural haematoma
|
Subdural haematoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Hemiparesis
|
Hemiparesis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hernia
|
Hernia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hiccups
|
Hiccups
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hip fracture
|
Hip fracture
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Hyperventilation
|
Hyperventilation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyponatraemia
|
Hyponatraemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature decreased
|
Body temperature decreased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothermia
|
Body temperature decreased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inflammation
|
Inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Osteoarthritis
|
Arthropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysarthria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngitis
|
Laryngitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lung disorder
|
Lung disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mastitis
|
Mastitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Meniere's disease
|
Meniere's disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myoclonus
|
Myoclonus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Nail disorder
|
Nail disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuralgia
|
Neuralgia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neurosis
|
Neurosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nocturia
|
Nocturia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oliguria
|
Oliguria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Osteoporosis
|
Osteoporosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis externa
|
Otitis externa
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis media
|
Otitis media
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pallor
|
Pallor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
very rare — infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paresis
|
Paresis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Peptic ulcer
|
Peptic ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Peritonitis
|
Peritonitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Personality disorder
|
Personality disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Phlebitis
|
Phlebitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
infrequent
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Pruritus genital
|
Pruritus genital
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Psychotic disorder
|
Psychotic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Emphysema
|
Emphysema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Purpura
|
Purpura
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pyuria
|
Pyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anorectal disorder
|
Rectal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure
|
Renal failure
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Respiratory failure
|
Respiratory insufficiency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Restless legs syndrome
|
Restless legs syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Retinal disorder
|
Retinal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent — 2%
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sick sinus syndrome
|
Sick sinus syndrome
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Speech disorder
|
Speech disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastric ulcer
|
Gastric ulcer
|
infrequent, uncommon
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Ulcerative stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
infrequent, uncommon
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sunburn
|
Sunburn
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Sunburn
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tendonitis
|
Tendonitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Onychomycosis
|
Onychomycosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erythema
|
Erythema
|
postmarketing — 1.1%
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Urethral disorder
|
Urethral disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary tract disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing, infrequent
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uterine disorder
|
Uterine disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Varicose vein
|
Varicose vein
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Angiopathy
|
Angiopathy
|
infrequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Presyncope
|
Syncope vasovagal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Vestibular disorder
|
Vestibular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin papilloma
|
Common wart
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Weight increased
|
Weight increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry mouth
|
Dry mouth
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary retention
|
Urinary retention
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sudden cardiac death
|
Sudden cardiac death
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
infrequent — 2% - 4%
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Periorbital oedema
|
Periorbital oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemorrhage intracranial
|
Haemorrhage intracranial
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Skin hypertrophy
|
Skin hypertrophy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Kidney function abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscular weakness
|
Muscular weakness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hyporeflexia
|
Hyporeflexia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperreflexia
|
Hyperreflexia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin discolouration
|
Skin discolouration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry skin
|
Dry skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendon disorder
|
Tendon disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Spine malformation
|
Spine malformation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breath sounds abnormal
|
Abnormal chest sounds NOS
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal stiffness
|
Muscle stiffness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Stiffness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal stiffness
|
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrophic vulvovaginitis
|
Vaginitis atrophic
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Proctalgia
|
Rectal tenesmus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rectal tenesmus
|
Rectal tenesmus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorectal discomfort
|
Rectal tenesmus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Disturbance in attention
|
Cerebration impaired
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Cerebration impaired
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Bullous eruption
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blister
|
postmarketing
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cold sweat
|
Skin cold clammy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin exfoliation
|
Skin exfoliation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermal cyst
|
Dermal cyst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Sepsis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Suicidal ideation
|
Suicidal ideation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dementia
|
Dementia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Prostatic adenoma
|
Prostatic adenoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Congenital joint malformation
|
Congenital joint malformation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lipase increased
|
Lipase increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Heart sounds abnormal
|
Heart sounds abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Colon cancer
|
Carcinoma colon
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder cancer
|
Bladder carcinoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infection parasitic
|
Infection parasitic
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood prolactin increased
|
Increased prolactin level
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Amylase increased
|
Blood amylase increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
Blood creatine phosphokinase increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Endometrial hypertrophy
|
Endometrial hypertrophy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Large intestine polyp
|
Large intestine polyp
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Freezing phenomenon
|
Freezing phenomenon
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Coronary artery disease
|
Coronary artery disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia vitamin B12 deficiency
|
Anaemia vitamin B12 deficiency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal cyst
|
Renal cyst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ageusia
|
Ageusia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blister
|
Blister
|
postmarketing
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Dermatitis atopic
|
postmarketing
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cutaneous hypersensitivity
|
postmarketing, rare
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Raised liver function tests
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
Application site hypersensitivity
|
Application site hypersensitivity
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Oesophageal rupture
|
Oesophageal rupture
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
Coagulopathy
|
Coagulopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Collagen disorder
|
Collagen disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Drooling
|
Drooling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysarthria
|
Dysarthria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Chronic obstructive pulmonary disease
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Bronchial hyperreactivity
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Movement disorder
|
Movement disorder
|
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle rigidity
|
Muscle rigidity
|
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal disorder
|
Musculoskeletal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin irritation
|
Skin irritation
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Motor dysfunction
|
Motor dysfunction
|
|
0%
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site oedema
|
Application site oedema
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Duodenitis haemorrhagic
|
Duodenitis haemorrhagic
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hyperpyrexia
|
Hyperpyrexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Application site irritation
|
Application site irritation
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Application site rash
|
Application site rash
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Balance disorder
|
Balance disorder
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Application site pain
|
Application site burn
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
Application site burn
|
Application site burn
|
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x
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x
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x
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Application site eczema
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Application site eczema
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x
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x
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Benign prostatic hyperplasia
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Benign prostatic hyperplasia
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x
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x
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