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
|
Application site reaction
|
Application site reaction
|
common, 2.79% - 33%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
Pruritus
|
Pruritus
|
uncommon, 0.4% - 32.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
uncommon, 0% - 100%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
uncommon, 0.1% - 15.3%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Excoriation
|
Excoriation
|
0% - 26%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Abrasion NOS
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sinusitis
|
Sinusitis
|
1% - 7.44%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Application site erythema
|
Application site erythema
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site pain
|
Application site burn
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
Application site pain
|
common — 0% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Application site burn
|
Application site burn
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
Application site pruritus
|
Application site pruritus
|
very common, 0.629% - 4.38%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Headache
|
Headache
|
common, 0.4% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Application site irritation
|
Application site irritation
|
common, 0% - 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Instillation site pain
|
Application site pain
|
common — 0% - 7%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Scab
|
Scab
|
0% - 83%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
2.26% - 3.72%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Application site rash
|
Application site rash
|
uncommon, common
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Application site haemorrhage
|
Application site haemorrhage
|
uncommon, common
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Application site paraesthesia
|
Application site paraesthesia
|
uncommon, common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site papules
|
Application site papules
|
uncommon, common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Fungal infection
|
Fungal infection
|
uncommon, 0.1% - 11.1%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Ulcer
|
Ulcer
|
0% - 48%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Induration
|
Induration
|
0% - 84%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Pain
|
Pain
|
uncommon, 0% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stinging
|
0.905% - 2.79%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
1.4%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Asthenia
|
Fatigue
|
common, 0% - 4.38%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
uncommon, 0.2% - 0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Fatigue
|
Fatigue
|
common, 0% - 4.38%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
1% - 2%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Bone pain
|
Bone pain
|
1.12% - 1.62%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eczema
|
Eczema
|
uncommon, 0.1% - 1.86%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
0% - 3.42%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Influenza like illness
|
uncommon, 0% - 3.75%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
Vaginitis bacterial
|
Vaginitis bacterial
|
0.99% - 1.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Vaginal infection
|
Vaginitis bacterial
|
0.99% - 1.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Vaginal inflammation
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Viral infection
|
Viral infection
|
0.905% - 1.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Back pain
|
Back pain
|
uncommon — 0.2% - 4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
1% - 2%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Nausea
|
Nausea
|
uncommon — 0% - 3.75%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tenderness
|
Tenderness
|
0% - 4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy
|
uncommon — 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
1% - 1.1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Oedema
|
Oedema
|
0% - 78%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Papule
|
Papule
|
0% - 1.62%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
0.452% - 1.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, 0.905% - 1.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Diarrhoea
|
Diarrhoea
|
uncommon, 0% - 2.79%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
common, 0% - 2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
common, 0% - 2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
postmarketing — 0% - 2.5%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
Pustule
|
uncommon — 0.4% - 1.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Hypersensitivity
|
Allergy aggravated
|
0.559% - 1.08%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Body temperature increased
|
Body temperature increased
|
uncommon, 0% - 3.12%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemorrhage
|
Haemorrhage
|
0% - 3.26%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Haemoglobin
|
Haemorrhage
|
0% - 3.26%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
0% - 1.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Discomfort
|
uncommon, 0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Malaise
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Chills
|
Rigors
|
uncommon, 0% - 1.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
Dizziness
|
Dizziness
|
uncommon, 0% - 2.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Tooth disorder
|
Tooth disorder
|
0% - 1.12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pharyngitis
|
Pharyngitis
|
uncommon, 0.1% - 1.08%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
uncommon, 0.1% - 0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Dermatitis
|
Rash
|
uncommon, 0.1% - 1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dermatitis
|
uncommon, 0.2% - 0.5%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
uncommon, 0.1% - 1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
uncommon, 0.1% - 0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
uncommon, 0.4% - 1.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Tingling sensation
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
uncommon, 0.1% - 3%
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Application site oedema
|
Application site oedema
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site ulcer
|
Application site ulcer
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site warmth
|
Application site warmth
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site vesicles
|
Application site vesicles
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site inflammation
|
Application site inflammation
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site hyperaesthesia
|
Application site hyperaesthesia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site discharge
|
Application site discharge
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site scab
|
Application site scab
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site erosion
|
Application site skin breakdown
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Application site excoriation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Application site swelling
|
Application site swelling
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
Application site scar
|
Application site scar
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Gout
|
Gout
|
0% - 1.08%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Malnutrition
|
Malnutrition
|
0% - 1.08%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
uncommon, 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Lethargy
|
Lethargy
|
uncommon, 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
Dry mouth
|
Dry mouth
|
uncommon, 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Vomiting
|
Vomiting
|
uncommon, 0.2% - 1.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inflammation
|
Inflammation
|
uncommon, 0.4% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Skin disorder
|
Skin breakdown
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Skin disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Crying
|
Tearfulness
|
0% - 22%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Tearfulness
|
Tearfulness
|
0% - 22%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Influenza
|
Influenza
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Actinic keratosis
|
Actinic keratosis
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Seborrhoeic keratosis
|
Actinic keratosis
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Eyelid oedema
|
Eyelid oedema
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Conjunctival irritation
|
Conjunctival irritation
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Face oedema
|
Face oedema
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Swelling
|
Swelling
|
0.4% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Urticaria
|
Urticaria
|
uncommon, 0.1% - 0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Feeling hot
|
Warmth
|
0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Scar
|
Scar
|
0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Decreased appetite
|
Anorexia
|
uncommon — 0% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
Penis disorder
|
Penis disorder
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Malaise
|
Malaise
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Genital candidiasis
|
Genital candidiasis
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Genital pain
|
Genital pain male
|
uncommon, 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Folliculitis
|
Folliculitis
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Anorectal disorder
|
Rectal disorder
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Tinnitus
|
Tinnitus
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Vulval disorder
|
Vulval disorder
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Vulvitis
|
Vulvitis
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Migraine
|
Migraine
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Uterovaginal prolapse
|
Uterovaginal prolapse
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Atrophic vulvovaginitis
|
Vaginitis atrophic
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Proctalgia
|
Rectal tenesmus
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rectal tenesmus
|
Rectal tenesmus
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Anorectal discomfort
|
Rectal tenesmus
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Vulvovaginal pain
|
Vaginal pain
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Dyspareunia
|
Dyspareunia
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Somnolence
|
Somnolence
|
uncommon, 0.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 0.3% - 1.12%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 0.3% - 1.12%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Arthralgia
|
Arthralgia
|
postmarketing — 0% - 2.5%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing, 0% - 1.08%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
Infection
|
Infection
|
postmarketing — 0% - 1.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Febrile convulsion
|
Febrile convulsion
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing
|
|
|
|
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
|
|
|
Dysuria
|
Dysuria
|
postmarketing — 0.4%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Herpes simplex
|
Herpes simplex
|
postmarketing — 0% - 2.5%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Ischaemia
|
Ischaemia
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Lymphoma
|
Lymphoma
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Hepatic lymphoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Multiple sclerosis
|
Multiple sclerosis
|
postmarketing
|
|
|
|
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
|
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Paresis
|
Paresis
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Proteinuria
|
Proteinuria
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Protein urine present
|
Proteinuria
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Henoch-Schonlein purpura
|
Henoch-Schonlein purpura
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Completed suicide
|
Suicide
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Shock
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Thyroiditis
|
Thyroiditis
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Purpura
|
Idiopathic thrombocytopenic purpura
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Idiopathic thrombocytopenic purpura
|
Idiopathic thrombocytopenic purpura
|
postmarketing
|
|
|
|
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
|
|
|
|
|
|
|
Agitation
|
Agitation
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Hypertrophic scar
|
Hypertrophic scar
|
postmarketing
|
|
|
|
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
|
x
|
Leukoderma
|
Leukoderma
|
postmarketing, 1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Capillary leak syndrome
|
Capillary leak syndrome
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
Cardiomyopathy
|
Cardiomyopathy
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
Insomnia
|
Insomnia
|
postmarketing — 0.2% - 0.4%
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Basal cell carcinoma
|
Basal cell carcinoma
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cheilitis
|
Cheilitis
|
0% - 1.88%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Cyst
|
Cyst
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Congenital eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Eye infection
|
Eye infection
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hernia
|
Hernia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Cutaneous lupus erythematosus
|
Cutaneous lupus erythematosus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Procedural pain
|
Postoperative pain
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pancytopenia
|
Pancytopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Pregnancy
|
Pregnancy
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Psoriasis
|
Psoriasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Psoriasis flare-up
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Skin infection
|
Skin infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Visual impairment
|
Disorder sight
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Skin papilloma
|
Common wart
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Warts
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Scrotal oedema
|
Scrotal oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Phototoxicity
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Immobile
|
Immobile
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Teratogenicity
|
Teratogenicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Scrotal pain
|
Scrotal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Skin exfoliation
|
Skin exfoliation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Low set ears
|
Low set ears
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Scrotal erythema
|
Scrotal erythema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Pulmonary congestion
|
Pulmonary congestion
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Respiratory tract congestion
|
Pulmonary congestion
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Congenital central nervous system anomaly
|
Exencephaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Scrotal ulcer
|
Scrotal ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Oral herpes
|
Oral herpes
|
0% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Skin oedema
|
Skin oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pre-existing disease
|
Pre-existing disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Injury
|
Inflicted injury
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Procedural site reaction
|
Procedural site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Blood glucose increased
|
Blood glucose increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
White blood cell count decreased
|
White blood cell count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Neutrophil count decreased
|
Neutrophil count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Absolute neutrophil count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Local reaction
|
Local reaction
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Hyperkeratosis
|
Hyperkeratosis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Application site dryness
|
Application site dryness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tinea cruris
|
Tinea cruris
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
Application site exfoliation
|
Application site exfoliation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Application site cellulitis
|
Application site cellulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|