MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
Headache
|
Headache
|
common, 8% - 30%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
17.2%
|
17.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Pain
|
Pain
|
8%
|
5%
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
7.4%
|
5.7%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
Diarrhoea
|
Diarrhoea
|
6%
|
4%
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Back pain
|
Back pain
|
4.2% - 6%
|
2% - 4%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
Palpitations
|
Palpitations
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngeal disorder
|
Pharyngeal disorder
|
2% - 9%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
4.6%
|
4.3%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
Acute bronchitis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
2.7% - 5%
|
1.7% - 4%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
3.5%
|
2.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Chest pain
|
Chest pain
|
1.9% - 7%
|
1.3% - 6%
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
2.1% - 4%
|
1.7% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Influenza
|
Influenza
|
3%
|
1%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Tremor
|
Tremor
|
common, 1.9% - 4%
|
0.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor muscle
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscle spasms
|
Cramps of lower extremities
|
1.7% - 4%
|
0.5% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Cramp muscle
|
uncommon, 1.7% - 4%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
2.7%
|
0.4%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Body temperature increased
|
Body temperature increased
|
2.2%
|
1.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Lung disorder
|
Lung disorder
|
2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
very rare, 3%
|
2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sputum increased
|
Sputum increased
|
1.5%
|
1.2%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Increased bronchial secretion
|
Sputum increased
|
1.5%
|
1.2%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Tonsillitis
|
Tonsillitis
|
1.2%
|
0.7%
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Anxiety
|
Anxiety
|
uncommon, 1.5%
|
1.2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
Insomnia
|
uncommon, 1.5%
|
0.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
1%
|
0.9%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Dry mouth
|
Dry mouth
|
uncommon, 1.2%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disturbance
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
|
Tachycardia
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Myalgia
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm paradoxical
|
Bronchospasm paradoxical
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Throat irritation
|
Throat irritation
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dizziness
|
Dizziness
|
very rare — 1.6%
|
1.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Exacerbation of asthma
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, rare
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing — uncommon
|
|
x
|
|
x
|
|
|
|
|
|
x
|
|
|
Cough
|
Cough
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
Dermatitis
|
Rash
|
postmarketing — 1.1% - 4%
|
0.7% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 1.1% - 4%
|
0.7% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
rare
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Pruritus
|
Pruritus
|
rare, 1.5%
|
1%
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
rare
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing, rare
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Tachyarrhythmia
|
Tachyarrhythmia
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Oedema mouth
|
Oedema mouth
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Extrasystoles
|
Extrasystoles
|
rare
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Angina pectoris
|
Angina pectoris
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
very rare
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arteriosclerosis
|
Arteriosclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Asthenia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fatigue
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Atrial flutter
|
Atrial flutter
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrioventricular block
|
Atrioventricular block
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Block heart
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Candida infection
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Central nervous system disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervous system disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cerebral infarction
|
Cerebral infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infection
|
Infection
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Constipation
|
Constipation
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dehydration
|
Dehydration
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis contact
|
Dermatitis contact
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dyspepsia
|
Dyspepsia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Oedema
|
Oedema
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Fatigue
|
Fatigue
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Gastritis
|
Gastritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glycosuria
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gout
|
Gout
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x
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Cardiac failure congestive
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Cardiac failure congestive
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x
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Haematuria
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Haematuria
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x
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Hernia
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Hernia
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x
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Herpes simplex
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Herpes simplex
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x
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Herpes zoster
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Herpes zoster
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x
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Hyperkalaemia
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Hyperkalaemia
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x
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Hyperlipidaemia
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Hyperlipidaemia
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x
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Hypoglycaemia
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Hypoglycaemia
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x
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Inflammation
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Inflammation
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x
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x
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x
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x
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Nephrolithiasis
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Calculus of kidney
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x
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Leukocytosis
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Leukocytosis
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x
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Melaena
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Melaena
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x
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Myocardial infarction
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Myocardial infarction
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x
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Acute coronary syndrome
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Myocardial infarction
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x
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Nasal congestion
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Nasal congestion
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x
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Nasopharyngitis
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Nasopharyngitis
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x
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x
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x
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Neoplasm
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Neoplasm
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x
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Nocturia
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Nocturia
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x
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Pelvic pain
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Pelvic pain
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x
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Tooth abscess
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Abscess periodontal
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x
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Pyuria
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Pyuria
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x
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Respiratory tract infection
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Respiratory tract infection
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x
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Rhinitis
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Rhinitis
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x
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x
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x
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x
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Pharyngitis streptococcal
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Pharyngitis streptococcal
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x
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Urinary tract infection
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Urinary tract infection
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x
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Urethral disorder
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Urinary tract disorder
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x
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Urinary tract disorder
|
Urinary tract disorder
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x
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Vomiting
|
Vomiting
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x
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x
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x
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x
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Injury
|
Trauma
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0%
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x
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Hypokinesia
|
Hypokinesia
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x
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Acute sinusitis
|
Acute sinusitis
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x
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Tracheobronchitis
|
Acute bronchitis
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x
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Musculoskeletal stiffness
|
Neck stiffness
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x
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Nuchal rigidity
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Neck stiffness
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x
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Hypercalciuria
|
Crystalluria calcium
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x
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Toxicity to various agents
|
Digitalis intoxication (NOS)
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x
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Glucose tolerance decreased
|
Glucose tolerance decreased
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x
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Retroperitoneal haemorrhage
|
Retroperitoneal haemorrhage
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x
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Skin hypertrophy
|
Skin hypertrophy
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x
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Injection site pain
|
Injection site pain
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x
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Paraesthesia oral
|
Circumoral paresthesia
|
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x
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Skin discolouration
|
Skin discolouration
|
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x
|
Dry skin
|
Dry skin
|
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x
|
Viral diarrhoea
|
Viral diarrhoea
|
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x
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|
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|
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Tendinous contracture
|
Tendinous contracture
|
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x
|
Eyelid oedema
|
Eyelid oedema
|
|
|
|
|
|
|
|
|
|
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x
|
|
Respiratory arrest
|
Respiratory arrest
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Metabolic acidosis
|
Metabolic acidosis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Malaise
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Discomfort
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Feeling abnormal
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
Urine abnormality
|
Urine abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urine analysis abnormal
|
Urine abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctival irritation
|
Conjunctival irritation
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral upper respiratory tract infection
|
Viral upper respiratory tract infection
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Electrocardiogram T wave inversion
|
Electrocardiogram T wave inversion
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lung neoplasm malignant
|
Carcinoma of lung
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chronic obstructive pulmonary disease
|
COPD exacerbation
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Excoriation
|
Abrasion NOS
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Breast neoplasm
|
Breast neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinitis allergic
|
Rhinitis allergic
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Visual impairment
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|