MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
Cough
|
Cough increased
|
46.1%
|
47.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cough
|
very common, 31.1% - 48.4%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
38%
|
39.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Sputum increased
|
Sputum increased
|
37.6%
|
39.7%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Increased bronchial secretion
|
Sputum increased
|
37.6%
|
39.7%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Asthenia
|
Asthenia
|
35.7%
|
39.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
34.5%
|
33.6%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
very common, 12.4% - 33.7%
|
38.5%
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Body temperature increased
|
Body temperature increased
|
very common, 12.4% - 32.9%
|
43.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lung disorder
|
Lung disorder
|
30.1% - 33.8%
|
31.3%
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Headache
|
Headache
|
uncommon, 11.4% - 26.7%
|
32.1%
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Chest pain
|
Chest pain
|
26%
|
29.8%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Chest discomfort
|
common, 2.9% - 6.5%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Haemoptysis
|
Haemoptysis
|
very common, 12.4% - 19.4%
|
23.7%
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia
|
18.6%
|
27.9%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Productive cough
|
Productive cough
|
very common, 18.2% - 19.6%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Respiratory depression
|
Respiratory depression
|
rare, 16.3%
|
15.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Pulmonary function test decreased
|
Respiratory depression
|
rare, 16.3%
|
15.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Pulmonary function test decreased
|
6.8% - 8.1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
15.9%
|
20.2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Renal impairment
|
Function kidney decreased
|
very common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vomiting
|
Vomiting
|
common, 5.7% - 14%
|
22.1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
12.8%
|
23.7%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
12.8%
|
23.7%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Oropharyngeal pain
|
Oropharyngeal pain
|
10.5% - 14%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
common, 7.5% - 11.2%
|
16%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
10.1%
|
15.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dysphonia
|
Dysphonia
|
very common, 3.8% - 13.6%
|
1.74%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
8.42%
|
5.22%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
very common, 8.1%
|
12.6%
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Stinging
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
8.1%
|
9.2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
6.8% - 8.6%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ear pain
|
Ear pain
|
7.4%
|
8.8%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Nasal congestion
|
Nasal congestion
|
common, 7.2% - 8.1%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
7%
|
8%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Rales
|
Rales
|
common, 6.2% - 18.9%
|
15.7%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
common, 0.5% - 6.6%
|
6.9%
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
6.2%
|
5.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Discomfort
|
Malaise
|
6.2%
|
5.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Feeling abnormal
|
Malaise
|
6.2%
|
5.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Ill-defined disorder
|
Malaise
|
6.2%
|
5.3%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
common, 1.9% - 7%
|
0% - 6.5%
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
common, 5.8%
|
7.6%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
5.8%
|
8%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Wheezing
|
Wheezing
|
common, 5.26% - 6.8%
|
3.48%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
common, 1.58% - 6.2%
|
0.87% - 10.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperventilation
|
Hyperventilation
|
5.4%
|
9.9%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
rare — 2.3% - 5.4%
|
6.1%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Rash
|
Rash
|
rare — 2.3% - 5.4%
|
6.1%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
common
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Deafness
|
High frequency deafness
|
common
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
Hearing impaired
|
postmarketing, common
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Deafness
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
common
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endophthalmitis
|
Ocular hyperaemia
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Chest discomfort
|
Chest discomfort
|
common, 2.9% - 6.5%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Ocular discomfort
|
Ocular discomfort
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal chest pain
|
Musculoskeletal chest pain
|
common, 4.5% - 4.8%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Throat irritation
|
Throat irritation
|
common, 1.9% - 4.5%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Forced expiratory volume decreased
|
Forced expiratory volume decreased
|
1% - 31.1%
|
28.7%
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
2.63%
|
0.87%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
2.63%
|
1.74%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Aphonia
|
Aphonia
|
postmarketing, common
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Tonsillitis
|
Tonsillitis
|
2.11%
|
0%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Blood glucose increased
|
Blood glucose increased
|
0.5% - 2.9%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Eosinophilia
|
Eosinophilia
|
1.58%
|
0%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Immunoglobulins increased
|
Immunoglobulins increased
|
1.58%
|
0%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Conjunctival disorder
|
Conjunctival disorder
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Corneal abrasion
|
Corneal abrasion
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid disorder
|
Eyelid disorder
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Eye pruritus
|
Eye pruritus
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Keratitis
|
Keratitis
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing — common
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear roaring
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
uncommon
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctival oedema
|
Conjunctival oedema
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Eye pain
|
Eye pain
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation increased
|
Lacrimation increased
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Leukoderma
|
Leukoderma
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Erythema of eyelid
|
Erythema of eyelid
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Madarosis
|
Madarosis
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dry eye
|
Dry eye
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Eye discharge
|
Eye discharge
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Serum creatinine increased
|
uncommon
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Foreign body sensation in eyes
|
Foreign body sensation in eyes
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Visual impairment
|
uncommon
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
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rare
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x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
rare
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x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
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x
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x
|
x
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Ototoxicity
|
Ototoxicity
|
postmarketing, rare
|
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x
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x
|
x
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x
|
x
|
x
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Cochlear toxicity
|
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x
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Nephropathy toxic
|
Nephrotoxicity
|
rare
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x
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Nephropathy toxic
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x
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Hearing impaired
|
Hearing impaired
|
postmarketing, common
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x
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x
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Deafness unilateral
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x
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Agranulocytosis
|
Agranulocytosis
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
|
|
|
|
|
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|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
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x
|
x
|
x
|
Apnoea
|
Apnoea
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x
|
x
|
x
|
Bone disorder
|
Bone disorder
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x
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Confusional state
|
Confusional state
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x
|
x
|
x
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Connective tissue disorder
|
Connective tissue disorder
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x
|
x
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Dehydration
|
Dehydration
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x
|
x
|
x
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Delirium
|
Delirium
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x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
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x
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Gastrointestinal disorder
|
Gastrointestinal disorder
|
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x
|
x
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Hypocalcaemia
|
Hypocalcaemia
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x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
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x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
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x
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x
|
Laryngitis
|
Laryngitis
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x
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Lethargy
|
Lethargy
|
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x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
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x
|
x
|
x
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Leukopenia
|
Leukopenia
|
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x
|
x
|
x
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Mediastinal disorder
|
Mediastinal disorder
|
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x
|
x
|
x
|
x
|
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Oliguria
|
Oliguria
|
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|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
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|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
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|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
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|
x
|
x
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
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|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
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|
x
|
Stomatitis
|
Stomatitis
|
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|
x
|
x
|
x
|
Swelling
|
Swelling
|
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|
x
|
x
|
x
|
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Thrombocytopenia
|
Thrombocytopenia
|
|
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|
|
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|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
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|
|
x
|
x
|
Erythema
|
Erythema
|
|
|
x
|
x
|
x
|
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Urethral disorder
|
Urinary tract disorder
|
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|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
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|
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|
|
x
|
Angiopathy
|
Angiopathy
|
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|
x
|
x
|
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|
Hypophosphataemia
|
Hypophosphataemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hypouricaemia
|
Hypouricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Musculoskeletal discomfort
|
Myalgia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Neurotoxicity
|
Neurotoxicity
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye irritation
|
Eye irritation
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatinine decreased
|
Creatinine low
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypoalbuminaemia
|
Hypoalbuminaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Punctate keratitis
|
Punctate keratitis
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Application site pain
|
Application site pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Instillation site pain
|
Application site pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Metabolic syndrome
|
Metabolic syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Blood calcium decreased
|
Serum calcium decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Eyelids pruritus
|
Eyelids pruritus
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Eye allergy
|
Eye allergy
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Local reaction
|
Local reaction
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Blood bilirubin increased
|
Serum bilirubin increased
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Transaminases increased
|
Serum transaminase increased
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
Ocular toxicity
|
Ocular toxicity
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Deafness unilateral
|
Deafness unilateral
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|