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
|
Pneumonia klebsiella
|
Pneumonia klebsiella
|
40%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
common, 5%
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
Bad taste
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Endophthalmitis
|
Ocular hyperaemia
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endophthalmitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal deposits
|
Corneal deposits
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ocular discomfort
|
Ocular discomfort
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
Nasopharyngitis
|
2.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Nausea
|
Nausea
|
uncommon — 1.3% - 5.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
1.6% - 2.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Vaginal inflammation
|
Vaginal inflammation
|
2%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
2%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginitis bacterial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Vaginal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pollakiuria
|
Micturition urgency
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sensation of foreign body
|
Sensation of foreign body
|
1.8% - 2%
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discomfort
|
Discomfort
|
1.7% - 9.7%
|
7.9%
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Malaise
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 1% - 2.3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
uncommon, 1% - 3%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
1.3%
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Hyperaemia
|
Hyperaemia
|
1.2%
|
1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
Erythema
|
1.2%
|
1.4%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Redness
|
1.2%
|
1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
rare — 1% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — 1% - 1.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash
|
Rash
|
postmarketing — 1% - 1.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eruption
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Vomiting
|
Vomiting
|
postmarketing — 1% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
uncommon, 1.1% - 1.2%
|
1.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
postmarketing — 0.6%
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
rare, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
rare, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Decreased appetite
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye pruritus
|
Eye pruritus
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Superinfection
|
Superinfection
|
uncommon
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photophobia
|
Photophobia
|
uncommon
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctival oedema
|
Conjunctival oedema
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chemosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye pain
|
Eye pain
|
uncommon
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Lacrimation increased
|
Lacrimation increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Visual acuity reduced
|
Visual acuity reduced
|
uncommon
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Keratopathy
|
Keratopathy
|
uncommon
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema of eyelid
|
Erythema of eyelid
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye swelling
|
Eye swelling
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dry eye
|
Dry eye
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye discharge
|
Eye discharge
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vital dye staining cornea present
|
Corneal staining
|
uncommon
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Corneal infiltrates
|
Corneal infiltrates
|
uncommon
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foreign body sensation in eyes
|
Foreign body sensation in eyes
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid margin crusting
|
Eyelid margin crusting
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure
|
Renal impairment
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
Renal impairment
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Kidney function abnormal
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
Eyelid exfoliation
|
Eyelid exfoliation
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukopenia
|
Leukopenia
|
postmarketing — 0.4%
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
postmarketing — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Disorientation
|
Disorientation
|
postmarketing — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysaesthesia
|
Dysaesthesia
|
postmarketing — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver disorder
|
Hepatic impairment
|
postmarketing — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Acidosis
|
Acidosis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare — rare
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Anaemia
|
Anaemia
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Haemolytic anaemia
|
Haemolytic anaemia
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anosmia
|
Anosmia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anthrax
|
Anthrax
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
Anxiety
|
Anxiety
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Phobia
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ache wrists
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
Asthenia
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Asthenopia
|
Asthenopia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ataxia
|
Ataxia
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial flutter
|
Atrial flutter
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blister
|
Blister
|
rare
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Blister
|
rare
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Vesiculobullous rash
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Bone disorder
|
Bone disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
Candida infection
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oral candidiasis
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
postmarketing, 1% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
postmarketing, 1% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Corneal disorder
|
Corneal disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing, rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
postmarketing, rare
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Drowsiness
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Dyspepsia
|
Dyspepsia
|
postmarketing — 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Oedema
|
Oedema
|
postmarketing — uncommon
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Panophthalmitis
|
Endophthalmitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Necrolysis epidermal
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Grand mal convulsion
|
Grand mal convulsion
|
postmarketing
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme minor
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema nodosum
|
Erythema nodosum
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Drug fever
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Flatulence
|
Flatulence
|
postmarketing, uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Flushing
|
Flushing
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Gout flare
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cardiac murmur
|
Cardiac murmur
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
postmarketing — 1.2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hiccups
|
Hiccups
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hordeolum
|
Hordeolum
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperaesthesia
|
Hyperaesthesia
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
rare
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Hyperhidrosis
|
Hyperhidrosis
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Hypotension
|
Hypotension
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Intestinal perforation
|
Intestinal perforation
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Keratitis
|
Keratitis
|
rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Keratoconjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephrolithiasis
|
Calculus of kidney
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Methaemoglobinaemia
|
Methaemoglobinaemia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Night cramps
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypertonia
|
Hypertonia
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myasthenia gravis
|
Myasthenia gravis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myoclonus
|
Myoclonus
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nephritis
|
Nephritis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tubulointerstitial nephritis
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Neutropenia
|
Neutropenia
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stinging
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
very rare — rare
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
very rare — 0.1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone marrow depression
|
very rare — rare
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing, rare
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tingling sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Petechiae
|
Petechiae
|
very rare — rare
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pleural effusion
|
Pleural effusion
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
Convulsion
|
Convulsion
|
postmarketing — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Convulsive seizure
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Shock
|
Shock
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Status epilepticus
|
Status epilepticus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tendonitis
|
Tendonitis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Trembling
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood uric acid increased
|
Uric acid level increased
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uveitis
|
Uveitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Vulvovaginal pruritus
|
Vaginal itching
|
postmarketing, 1%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Vasculitis
|
Vasculitis
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Cerebral thrombosis
|
Cerebral thrombosis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary retention
|
Urinary retention
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hepatic failure
|
Hepatic failure
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
Agitation
|
Agitation
|
postmarketing — 1.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photopsia
|
Photopsia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Cystitis haemorrhagic
|
Cystitis haemorrhagic
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Clostridium difficile colitis
|
Antibiotic associated colitis
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stomatitis
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Mouth ulceration
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Ulcerative stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
very rare — rare
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amylase increased
|
Amylase increased
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Crystalluria
|
Crystalluria
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fixed eruption
|
Fixed eruption
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular bigeminy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mania
|
Manic psychosis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic necrosis
|
Hepatic necrosis
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Tendon rupture
|
Tendon rupture
|
very rare — rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyneuropathy
|
Polyneuropathy
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
Polyneuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Pneumonia anthrax
|
Pneumonia anthrax
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
x
|
Respiratory arrest
|
Respiratory arrest
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Joint stiffness
|
Joint stiffness
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
rare
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
Photosensitivity
|
postmarketing
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Phototoxicity
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Serum sickness-like reaction
|
Serum sickness-like reaction
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal dreams
|
Abnormal dreams
|
rare
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
Eye irritation
|
Eye irritation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral haemorrhage
|
Urethral haemorrhage
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Punctate keratitis
|
Punctate keratitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Punctate epithelial erosion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug intolerance
|
Drug intolerance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epidermolysis
|
Epidermolysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phobia
|
Phobia
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Candiduria
|
Candiduria
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laboratory test abnormal
|
Laboratory test abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromatopsia
|
Chromatopsia
|
postmarketing
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory distress
|
Respiratory distress
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Visual disturbance
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Abnormal vision
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Blood potassium increased
|
Serum potassium increased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Prothrombin time shortened
|
Prothrombin time shortened
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood albumin decreased
|
Serum albumin decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood glucose decreased
|
Blood glucose decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood potassium decreased
|
Serum potassium decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypercalcaemia
|
Serum calcium increased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypercalcaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Blood cholesterol increased
|
Cholesterol serum elevated
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardio-respiratory arrest
|
Cardio-respiratory arrest
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytosis
|
Thrombocytosis
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Allergic oedema
|
Allergic oedema
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoaesthesia eye
|
Hypoaesthesia eye
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal epithelium defect
|
Corneal epithelium defect
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prothrombin level abnormal
|
Prothrombin level abnormal
|
rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Protein total decreased
|
Serum total protein decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Monocyte count increased
|
Blood monocytes increased
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
Acute generalised exanthematous pustulosis
|
Acute generalised exanthematous pustulosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|