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
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
2% - 21%
|
5% - 16%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Throat irritation
|
Throat irritation
|
1% - 22%
|
5% - 8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
1.81% - 16.1%
|
4% - 14.6%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
7%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Epistaxis
|
Epistaxis
|
3.99% - 6.9%
|
4.13% - 5.4%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
postmarketing, 3% - 7.8%
|
3% - 7.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
0.905% - 10%
|
1% - 6%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
4.93% - 13%
|
4.9% - 5%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
Common cold
|
2.3% - 4.07%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Asthma
|
Asthma
|
3.3% - 7.2%
|
2.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Exacerbation of asthma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Inflammation
|
Inflammation
|
0% - 5%
|
1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
1% - 7%
|
1.63% - 4%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
Candida infection
|
2% - 5%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oral candidiasis
|
1% - 9%
|
0% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Candida albicans infection
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
postmarketing, 0% - 6%
|
2.8% - 5%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
2% - 5%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Gastrointestinal infection
|
Gastrointestinal infection
|
3% - 5%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nausea
|
Nausea
|
1% - 8%
|
2% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rhinitis
|
Common cold
|
2.3% - 4.07%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rhinitis
|
0.452% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
1% - 9%
|
0% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Dysphonia
|
Hoarseness
|
2% - 6%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysphonia
|
2% - 6%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Respiratory tract infection
|
Respiratory tract infection
|
1% - 5%
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Toothache
|
Toothache
|
3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Viral diarrhoea
|
Viral diarrhoea
|
3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Oropharyngeal candidiasis
|
Oropharyngeal candidiasis
|
3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Oropharyngeal pain
|
Oropharyngeal pain
|
3% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
1.95% - 4.34%
|
1.03% - 3.26%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Vomiting
|
Vomiting
|
0.922% - 8%
|
2% - 4%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Abdominal discomfort
|
Gastrointestinal discomfort
|
2% - 4%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nasal discomfort
|
Nasal irritation
|
postmarketing, 2.4% - 3.2%
|
2.6%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Nasal burning
|
postmarketing, 2.4% - 3.2%
|
2.6%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Nasal soreness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Nasal discomfort
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
0% - 7%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Bronchitis
|
Bronchitis
|
0% - 12%
|
1% - 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Excoriation
|
Excoriation
|
2%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Pain
|
Pain
|
postmarketing, 2% - 4%
|
3%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Stinging
|
0% - 5%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
Ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Viral infection
|
Viral infection
|
0% - 5%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Procedural pain
|
Procedural pain
|
1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pain of skin
|
Stinging skin
|
1.38% - 1.81%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
Muscle injury
|
Muscle injury
|
0% - 5%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ulcer
|
Ulcer
|
1.43%
|
0.388%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Ear infection
|
Ear infection
|
1.36% - 1.38%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing, 0.452% - 5.13%
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
1.17% - 3%
|
0.904%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
Seasonal allergy
|
Seasonal allergy
|
0.905% - 1.38%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rhinitis seasonal
|
Seasonal allergy
|
0.905% - 1.38%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rash
|
Eruption
|
0.905% - 1.38%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rash
|
postmarketing, 0.452% - 1.38%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin irritation
|
Skin irritation
|
0% - 2.86%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
0% - 1.36%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eczema
|
Eczema
|
0% - 1.9%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Folliculitis
|
Folliculitis
|
0% - 0.905%
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
x
|
Eczema infected
|
Eczema infected
|
0% - 0.985%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
postmarketing, 0.452% - 1.38%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Dermatitis perioral
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Dermatitis contact
|
Dermatitis contact
|
0% - 0.461%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Dermatitis irritant contact
|
0% - 0.461%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Allergic contact dermatitis
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Rash pustular
|
Pustule
|
0% - 0.452%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Aggression
|
Aggression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Aphonia
|
Aphonia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Allergic granulomatous angiitis
|
Allergic granulomatous angiitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Leukocytoclastic vasculitis
|
Allergic granulomatous angiitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Secondary infection
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Contusion
|
Contusion
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Cushing's syndrome
|
Cushing's syndrome
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
Dental caries
|
Dental caries
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Ecchymosis
|
Ecchymosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Glycosuria
|
Glycosuria
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Type IV hypersensitivity reaction
|
Type IV hypersensitivity reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Irritability
|
Irritability
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Osteoporosis
|
Osteoporosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Tooth discolouration
|
Tooth discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Erythema
|
Erythema
|
postmarketing, 0% - 2%
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing, 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Vasculitis
|
Vasculitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Weight increased
|
Weight increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Wheezing
|
Wheezing
|
postmarketing, 0% - 1.38%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperkinesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cataract
|
Cataract
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Skin discolouration
|
Skin discolouration
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Dermatitis acneiform
|
Acneiform eruption
|
postmarketing
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Nasal dryness
|
Nasal dryness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Chest discomfort
|
Chest tightness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tenderness
|
Tenderness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal septum perforation
|
Nasal septum perforation
|
postmarketing
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Bronchospasm paradoxical
|
Bronchospasm paradoxical
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oesophageal candidiasis
|
Oesophageal candidiasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sepsis
|
Sepsis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Atrophy
|
Atrophy
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
Hyperkinesia
|
Hyperkinesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dermatitis atopic
|
Cutaneous hypersensitivity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dermatitis atopic
|
0% - 0.476%
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oropharyngeal swelling
|
Oropharyngeal swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rhinalgia
|
Rhinalgia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Food allergy
|
Protein allergy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumocystis jirovecii pneumonia
|
Pneumocystis jirovecii pneumonia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperadrenocorticism
|
Hyperadrenocorticism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
Blepharoconjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Blister
|
Blister
|
0% - 0.493%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Blister
|
0% - 0.493%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Breast cancer
|
Breast cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Cholecystitis
|
Cholecystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Lightheadedness
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
Fatigue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
Haematoma
|
Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes simplex
|
Herpes simplex
|
0% - 0.493%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hypertrichosis
|
Hypertrichosis
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Impetigo
|
Impetigo
|
0% - 0.476%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Keratitis
|
Keratitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Miliaria
|
Miliaria
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle spasms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle rigidity
|
Muscle rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper-airway cough syndrome
|
Postnasal drip
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Rheumatic disorder
|
Rheumatism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Skin infection
|
Skin infection
|
0% - 1.38%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Soft tissue injury
|
Soft tissue injury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Subarachnoid haemorrhage
|
Subarachnoid haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Telangiectasia
|
Telangiectasia
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Telangiectasis facial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Tongue disorder
|
Tongue disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin papilloma
|
Common wart
|
0% - 0.493%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Laceration
|
Laceration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Wound
|
Wound
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injury
|
Trauma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry mouth
|
Dry mouth
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Stomatitis
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mouth ulceration
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Migraine
|
Migraine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Skin atrophy
|
Skin atrophy
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Growth retardation
|
Growth retardation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Impaired healing
|
Impaired healing
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Hypogeusia
|
Hypogeusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Pustular psoriasis
|
Pustular psoriasis
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Skin striae
|
Skin striae
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Leukoderma
|
Leukoderma
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Muscle stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Intraocular pressure increased
|
Intraocular pressure increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Throat tightness
|
Throat tightness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Intervertebral disc protrusion
|
Intervertebral disc protrusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Nasal ulcer
|
Nasal ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Secondary adrenocortical insufficiency
|
Secondary adrenocortical insufficiency
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Influenza like illness
|
Influenza-like symptoms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Oral discomfort
|
Oral discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Psoriasis
|
Plaque psoriasis
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Affective disorder
|
Affective disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hypoaesthesia
|
Numbness in fingers
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eczema herpeticum
|
Eczema herpeticum
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Dental discomfort
|
Dental discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ageusia
|
Ageusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|