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
|
Dizziness
|
Dizziness
|
5% - 7%
|
1% - 5.58%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing, 6.39%
|
9.91% - 16.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
3.01% - 6%
|
2.43% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
3.01% - 6%
|
2.43% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Headache
|
Headache
|
5.02% - 6%
|
3% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
5.66%
|
6.96%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Inflicted injury
|
|
6.94%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Anaemia
|
Anaemia
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
frequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
postmarketing, frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
frequent
|
0.347%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
3% - 5%
|
1% - 4.51%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug hypersensitivity
|
Drug hypersensitivity
|
common
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
postmarketing, frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
frequent
|
1.74%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Shock
|
Syncope
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Vertigo
|
Vertigo
|
frequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
frequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
frequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Cataract
|
Cataract
|
frequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
frequent
|
1.39%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggressive reaction
|
frequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
2%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
4.37% - 5%
|
4% - 4.86%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
4.15%
|
3.95%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
3.14% - 4%
|
2.76% - 5.56%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
3.98% - 4%
|
2% - 2.63%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension worsened
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Influenza
|
Influenza
|
4%
|
3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
3.53%
|
4.14% - 7.64%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
2% - 3.36%
|
1% - 6.6%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
3% - 3.2%
|
1% - 3.57%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
3.14%
|
2.51% - 3.47%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
3.03%
|
4.45% - 4.86%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
2.47% - 3%
|
1% - 2.88%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing, 3%
|
2% - 2.08%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
2.07% - 3%
|
1% - 1.25%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
2% - 3%
|
1% - 2.08%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
3% - 3.42%
|
1% - 3.12%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
2.86%
|
2.76% - 4.51%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
2.69%
|
2.43% - 3.26%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
2.01% - 2.69%
|
0.694% - 2.07%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
2.63% - 4%
|
1.04% - 3%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
2.58%
|
2.08% - 2.38%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
2.58%
|
2.08% - 2.38%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nausea
|
Nausea
|
2.52%
|
2.08% - 2.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
2.02%
|
1.82% - 2.08%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
2.02%
|
1.76%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
2%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
2%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
2% - 2.69%
|
1% - 1.94%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Asthenia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
2% - 2.69%
|
1% - 1.94%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphasia
|
Aphasia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apnoea
|
Apnoea
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Cellulitis
|
Cellulitis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Corneal opacity
|
Corneal opacity
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Delusion
|
Delusion
|
infrequent
|
1.39%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Diplopia
|
Diplopia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Diverticulitis
|
Diverticulitis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Glaucoma
|
Glaucoma
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Partial hearing loss
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hemiplegia
|
Hemiplegia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent, 2%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
postmarketing, 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
|
|
|
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing, infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Macular degeneration
|
Macular degeneration
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hypertonia
|
Hypertonia
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopia
|
Myopia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Nervousness
|
Nervousness
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Neurosis
|
Neurosis
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Nightmare
|
Nightmare
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Personality disorder
|
Personality disorder
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Pruritus
|
Pruritus
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Retinal detachment
|
Retinal detachment
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Retinal haemorrhage
|
Retinal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Tremor
|
Tremor
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Xerophthalmia
|
Xerophthalmia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Urinary retention
|
Urinary retention
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stupor
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Mood swings
|
Mood swings
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Affect lability
|
Mood swings
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Eye pain
|
Eye pain
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Paranoia
|
Paranoid reaction
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Oesophageal ulcer
|
Oesophageal ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Increased appetite
|
Increased appetite
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus exacerbated
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Crying
|
Crying abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Neuropathy peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
infrequent
|
1.04%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Atrioventricular block
|
Atrioventricular block
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Block heart
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Carpal tunnel syndrome
|
Carpal tunnel syndrome
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Cerebral infarction
|
Cerebral infarction
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholelithiasis
|
Cholelithiasis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Colitis
|
Colitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Coma
|
Coma
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Sudden death
|
Sudden death
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Multiple fractures
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Fracture
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Gastritis
|
Gastritis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing
|
1.74%
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Myoclonus
|
Myoclonus
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pneumonia aspiration
|
Pneumonia aspiration
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
Skin disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Encephalopathy
|
Encephalopathy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Creatinine increased
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
Haemorrhage intracranial
|
Haemorrhage intracranial
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Electrocardiogram QT corrected interval prolonged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Renal function test abnormal
|
Renal function test abnormal
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Parkinsonism
|
Parkinsonism
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Sepsis
|
Sepsis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Suicidal ideation
|
Suicidal ideation
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Altered state of consciousness
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
International normalised ratio increased
|
International normalised ratio increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
Ileus
|
Ileus
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Intermittent claudication
|
Claudication
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Renal failure
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
Renal impairment
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
Kidney function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pancreatitis acute
|
Pancreatitis acute
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Aortic valve incompetence
|
Aortic valve incompetence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Aortic valve stenosis
|
Aortic valve stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Apraxia
|
Apraxia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arteriosclerosis
|
Arteriosclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arthritis aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Atelectasis
|
Atelectasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pneumothorax
|
Atelectasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Coagulopathy
|
Coagulopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bundle branch block
|
Bundle branch block
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bursitis
|
Bursitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Candida infection
|
Candida infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Basal cell carcinoma
|
Basal cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cognitive disorder
|
Cognitive disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dental caries
|
Dental caries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ear disorder
|
Ear disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Ectropion
|
Ectropion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Oedema
|
Oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Embolism
|
Embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Thromboembolism
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Grand mal convulsion
|
Grand mal convulsion
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Eructation
|
Eructation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Congenital eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Faecal incontinence
|
Faecal incontinence
|
|
2.78%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Foetal disorder
|
Foetal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Flushing
|
Flushing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Food poisoning
|
Food poisoning
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiomegaly
|
Cardiomegaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac murmur
|
Cardiac murmur
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac valve disease
|
Cardiac valve disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Haematoma
|
Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hernia
|
Hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Inguinal hernia
|
Inguinal hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypernatraemia
|
Hypernatraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperthyroidism
|
Hyperthyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Irritability
|
Irritability
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pain in extremity
|
Leg pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pain in extremity
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Chronic obstructive pulmonary disease
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bronchial hyperreactivity
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Lymphatic disorder
|
Lymphatic disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Melanosis
|
Melanosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mitral valve incompetence
|
Mitral valve incompetence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Musculoskeletal disorder
|
Musculoskeletal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Necrosis
|
Necrosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Melanocytic naevus
|
Nevus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood urea increased
|
NPN increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood urea increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sensory loss
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Osteoporosis
|
Osteoporosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Otitis externa
|
Otitis externa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Otitis media
|
Otitis media
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
Pallor
|
Pallor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Phlebitis
|
Phlebitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Polycythaemia
|
Polycythaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Prostatic disorder
|
Prostatic disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Purpura
|
Purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pyuria
|
Pyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Reflexes abnormal
|
Reflexes abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Respiratory failure
|
Respiratory insufficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sinusitis
|
Sinusitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Speech disorder
|
Speech disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Completed suicide
|
Suicide
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Embolism venous
|
Thromboembolism
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Onychomycosis
|
Onychomycosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Varicose vein
|
Varicose vein
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Venous thrombosis
|
Venous thrombosis
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Disorder sight
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dry mouth
|
Dry mouth
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Polydipsia
|
Polydipsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arrhythmia supraventricular
|
Atrial arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
|
1.74%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyporeflexia
|
Hyporeflexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sensory disturbance
|
Sensory disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pulse abnormal
|
Thready pulse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pulse pressure decreased
|
Thready pulse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Disturbance in attention
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Gravitational oedema
|
Gravitational oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Breast cancer female
|
Breast cancer female
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dermatitis bullous
|
Bullous eruption
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hernia congenital
|
Hernia congenital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Condition aggravated
|
Condition aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Benign breast neoplasm
|
Breast neoplasm benign female
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal specific
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Frequent bowel movements
|
Frequent bowel movements
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Change of bowel habit
|
Change of bowel habit
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mania
|
Mania
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Chills
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Benign gastrointestinal neoplasm
|
Benign gastrointestinal neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sciatica
|
Ischial neuralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Feeling of body temperature change
|
Feeling of body temperature change
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Surgery
|
Surgical intervention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Balance disorder
|
Balance disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood thyroid stimulating hormone increased
|
Thyrotropin high
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Electrocardiogram change
|
Electrocardiogram change
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Blood antidiuretic hormone abnormal
|
Antidiuretic hormone abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Antidiuretic hormone abnormality
|
Antidiuretic hormone abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Liver function test abnormal
|
Raised liver function tests
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Excoriation
|
Abrasion NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Deafness
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Diverticulum
|
Diverticulum intestinal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Diverticulum intestinal
|
Diverticulum intestinal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Coronary artery disease
|
Coronary artery disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Renal cyst
|
Renal cyst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|