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
|
Dry skin
|
Dry skin
|
postmarketing, 0% - 41.9%
|
0.301% - 6.86%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
6% - 9%
|
6%
|
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Gastrointestinal symptom NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Induration
|
Induration
|
2% - 9%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin exfoliation
|
Skin exfoliation
|
4% - 24%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Application site reaction
|
Application site reaction
|
1.13% - 84%
|
0.904% - 2.17%
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Decreased appetite
|
Anorexia
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
|
Decreased appetite
|
postmarketing, common
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Appetite absent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
common, 2% - 3.84%
|
0% - 2%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing — 0% - 32.7%
|
2% - 26.9%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 3% - 9%
|
1% - 12%
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site reaction
|
Injection site reaction
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injection site pain
|
Injection site pain
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash
|
Eruption
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
Rash
|
postmarketing — 0% - 46%
|
1.51% - 2.86%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Transaminases increased
|
Transaminases increased
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Injection site induration
|
Injection site induration
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
postmarketing — 0% - 46%
|
1.51% - 2.86%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
1% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
2% - 8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Influenza
|
Influenza
|
0% - 10%
|
4.57%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Infection
|
Infection
|
2.71% - 11.5%
|
2.41% - 4.57%
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cough increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
postmarketing, 2% - 8%
|
3.92% - 6.86%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus
|
Pruritus
|
very rare — 1% - 59%
|
0.602% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Osteoarthritis
|
2.6% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Arthropathy
|
0% - 7.69%
|
12% - 15.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site rash
|
Application site rash
|
3.5%
|
0.685%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
0.775% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bronchitis
|
Bronchitis
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 0% - 6%
|
2.11% - 3%
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 0% - 27%
|
0.904% - 37%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal pain upper
|
Abdominal pain upper
|
3%
|
1%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Epigastric pain
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Procedural pain
|
Procedural pain
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervous system disorder
|
Nervous system disorder
|
2% - 3%
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Ecchymosis
|
Ecchymosis
|
2.09%
|
0.301%
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 0% - 5.93%
|
3.01% - 5.14%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal cramps
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 0% - 5.93%
|
3.01% - 5.14%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 40.4%
|
37.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 40.4%
|
37.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Back pain
|
Back pain
|
postmarketing, 0% - 15.4%
|
7.43%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dermatitis contact
|
Dermatitis contact
|
postmarketing, 0% - 33%
|
0% - 1.81%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing — 0% - 9.62%
|
1% - 4%
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Heartburn
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Pain
|
Pain
|
postmarketing, 0% - 30%
|
10.9%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stinging
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
2%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
2%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood creatinine increased
|
Blood creatinine increased
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Creatinine increased
|
postmarketing, 0% - 2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin cancer
|
Skin carcinoma
|
0% - 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Contusion
|
Contusion
|
0.775% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
0% - 4%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Sinus congestion
|
Sinus congestion
|
0.775% - 1.54%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site induration
|
Application site induration
|
0.775% - 1.54%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
postmarketing, 0% - 4%
|
2.11%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
postmarketing — 0% - 10%
|
0.5% - 16%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Lightheadedness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
very rare — 0% - 20%
|
0.904% - 10.3%
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tingling sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
rare, 1%
|
1% - 1.83%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Drowsiness
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Application site pruritus
|
Application site pruritus
|
0.767%
|
0.114%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthritis
|
Rheumatoid arthritis
|
0.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
0.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Application site erythema
|
Application site erythema
|
0.657%
|
0.342%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breath odour
|
Breath odour
|
postmarketing, 1.21%
|
0.301%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
0% - 5%
|
0.602% - 1%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Application site paraesthesia
|
Application site paraesthesia
|
0.548%
|
0.342%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
very rare — 0% - 3.81%
|
4.57%
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
Bad taste
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Skin ulcer
|
Skin ulcer
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash pustular
|
Vesiculobullous rash
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rash pustular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis bullous
|
Vesiculobullous rash
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis bullous
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Bullous eruption
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Scab
|
Scab
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne
|
Acne
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site dryness
|
Application site dryness
|
0.438%
|
0.342%
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site vesicles
|
Application site vesicles
|
0.329%
|
0%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site irritation
|
Application site irritation
|
common, 0.219%
|
0%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Flushing
|
Flushing
|
0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Application site papules
|
Application site papules
|
0.11%
|
0%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
postmarketing — 0% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Exacerbation of asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing — 0% - 2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
postmarketing — 0% - 33%
|
0% - 32%
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
Gastritis
|
Gastritis
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Haematemesis
|
Haematemesis
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing — 0% - 3%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
Hypotension
|
Hypotension
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Jaundice
|
Jaundice
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laryngospasm
|
Laryngospasm
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngitis
|
Laryngitis
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver disorder
|
Liver disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Hepatocellular injury
|
Liver disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Foetor hepaticus
|
Liver disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Melaena
|
Melaena
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Proctitis
|
Proctitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shock
|
Shock
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing — 0.2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Skin odour abnormal
|
Body odor
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cataract
|
Cataract
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Stomatitis
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stomatitis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Musculoskeletal stiffness
|
Neck stiffness
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nuchal rigidity
|
Neck stiffness
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diarrhoea haemorrhagic
|
Diarrhoea haemorrhagic
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
Injection site necrosis
|
Injection site necrosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug ineffective
|
Lack of drug effect
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
postmarketing, 0% - 2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Intestinal ulcer
|
Intestinal ulcer
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Swollen tongue
|
Swollen tongue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal ulcer
|
Gastrointestinal ulcer
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Lip swelling
|
Lip swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Skin burning sensation
|
Skin burning sensation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Anaphylactic shock
|
Anaphylactoid reaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Abnormal vision
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Visual disturbance
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
x
|
Visual impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
Agranulocytosis
|
Agranulocytosis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
very rare, 0% - 2%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Secondary anemia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Aplastic anaemia
|
Aplastic anaemia
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemolytic anaemia
|
Haemolytic anaemia
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
|
Angioedema
|
Angioedema
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety
|
Anxiety
|
very rare, 0% - 2%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
very rare — 0% - 2%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Colitis
|
Colitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis ulcerative
|
Colitis ulcerative
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Proctocolitis
|
Colitis ulcerative
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Constipation
|
Constipation
|
very rare, 0% - 8%
|
0.301% - 4%
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Crohn's disease
|
Crohn's disease
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diplopia
|
Diplopia
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Eczema
|
Eczema
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophageal disorder
|
Oesophageal disorder
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Glossitis
|
Glossitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Cardiac failure
|
Cardiac failure
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Haematuria
|
Haematuria
|
very rare, 0% - 2%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhoids
|
Haemorrhoids
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Hemorrhoids aggravated
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
very rare — 0% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal failure acute
|
Renal failure acute
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal papillary necrosis
|
Renal papillary necrosis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Leukopenia
|
Leukopenia
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
Meningitis aseptic
|
Meningitis aseptic
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Myocardial infarction
|
Myocardial infarction
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Tubulointerstitial nephritis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Nephrotic syndrome
|
Nephrotic syndrome
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Nightmare
|
Nightmare
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Palpitations
|
Palpitations
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
very rare, 0% - 2%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Proteinuria
|
Proteinuria
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Protein urine present
|
Proteinuria
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Purpura
|
Purpura
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Purpuric rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Henoch-Schonlein purpura
|
Henoch-Schonlein purpura
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Convulsion
|
Convulsion
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
Tinnitus
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tremor
|
Tremor
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erythema
|
Erythema
|
very rare — 4%
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Redness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vasculitis
|
Vasculitis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Encephalopathy
|
Encephalopathy
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
Hepatic failure
|
Hepatic failure
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
Injection site abscess
|
Injection site abscess
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enterocolitis haemorrhagic
|
Hemorrhagic colitis
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Hepatic necrosis
|
Hepatic necrosis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
very rare, 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Photosensitivity
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Disorientation
|
Disorientation
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Memory impairment
|
Memory impairment
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Hepatitis fulminant
|
Hepatitis fulminant
|
very rare, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Vision blurred
|
Vision blurred
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
x
|
Toxic shock syndrome
|
Toxic shock syndrome
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Insomnia
|
Insomnia
|
very rare
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Hearing impaired
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hearing impaired
|
Hearing impaired
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Partial hearing loss
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Intestinal diaphragm disease
|
Intestinal diaphragm disease
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Abdominal distension
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Aphasia
|
Aphasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
Arteriosclerosis
|
Arteriosclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Asthenia
|
postmarketing, 0% - 2%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Fatigue
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Neoplasm malignant
|
Carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neck pain
|
Neck pain
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue coated
|
Tongue coated
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Coma
|
Coma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Confusional state
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Conjunctivitis allergic
|
Conjunctivitis allergic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal disorder
|
Corneal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal oedema
|
Corneal oedema
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal opacity
|
Corneal opacity
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ulcerative keratitis
|
Ulcerative keratitis
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Dental caries
|
Dental caries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Depression
|
Depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysthymic disorder
|
Dysthymic disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Eructation
|
Eructation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Fatigue
|
Fatigue
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Vitreous floaters
|
Vitreous floaters
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Furuncle
|
Furunculosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hair disorder
|
Hair disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hallucination
|
Hallucination
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Hepatorenal syndrome
|
Hepatorenal syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hernia
|
Hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes simplex
|
Herpes simplex
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperventilation
|
Hyperventilation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Intestinal perforation
|
Intestinal perforation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Iritis
|
Iritis
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye pruritus
|
Eye pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
0% - 7.69%
|
12% - 15.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Keratitis
|
Keratitis
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimal disorder
|
Lacrimal disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lacrimal structural disorder
|
Lacrimal disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal oedema
|
Laryngeal oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Meningitis
|
Meningitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Hypertonia
|
Hypertonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nail disorder
|
Nail disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervousness
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Tension
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
Neuritis
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuropathy peripheral
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Night blindness
|
Night blindness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Nocturia
|
Nocturia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Oliguria
|
Oliguria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Pancytopenia
|
Pancytopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Peptic ulcer
|
Peptic ulcer
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Tooth abscess
|
Abscess periodontal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Phlebitis
|
Phlebitis
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure
|
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Scotoma
|
Scotoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin mass
|
Skin nodule
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Speech disorder
|
Speech disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
Hyperhidrosis
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Sweating increased
|
|
0.612%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Tachycardia
|
Tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
Testicular disorder
|
Testicular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ulcer
|
Ulcer
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Vasodilation procedure
|
Vasodilation
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral infection
|
Viral infection
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Weight decreased
|
Weight decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
0% - 2%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Burning sensation
|
Burning sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokinesia
|
Hypokinesia
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Bleeding time prolonged
|
Bleeding time prolonged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hyperchlorhydria
|
Hyperchlorhydria
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Gastric pH decreased
|
Hyperchlorhydria
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Skin hypertrophy
|
Skin hypertrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Kidney function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin irritation
|
Skin irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endophthalmitis
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal deposits
|
Corneal deposits
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Swelling of eyelid
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Prostatic specific antigen increased
|
Prostatic specific antigen increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mental disability
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Respiratory depression
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Pulmonary function test decreased
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Disturbance in attention
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
Eye irritation
|
Eye irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Erythema of eyelid
|
Erythema of eyelid
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Azotaemia
|
Azotaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Sepsis
|
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Punctate keratitis
|
Punctate keratitis
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Fluid retention
|
Fluid retention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Water retention
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Epidermolysis
|
Epidermolysis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Atrophy
|
Atrophy
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal perforation
|
Corneal perforation
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal erosion
|
Corneal erosion
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation increased
|
Lacrimation
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Hyperkinesia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkinesia
|
Hyperkinesia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bradycardia
|
Bradycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Gait disturbance
|
Gait disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine abnormal
|
Creatinine abnormal NOS
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelids pruritus
|
Eyelids pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye allergy
|
Eye allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal infiltrates
|
Corneal infiltrates
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Allergic skin reaction
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscular weakness
|
Myasthenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Corneal thinning
|
Corneal thinning
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Excoriation
|
Abrasion NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctival hyperaemia
|
Conjunctival hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|