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
|
Diabetes mellitus
|
Diabetic
|
postmarketing, very common
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Headache
|
Headache
|
postmarketing, 7.9% - 16.1%
|
|
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
|
7.1% - 8.3%
|
5.5%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Fatigue
|
common
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Fatigue
|
Fatigue
|
common
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
common
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Nausea
|
Nausea
|
common, 0.4% - 3.2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 0.4% - 3.2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
common, 0.4% - 7.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness postural
|
Dizziness postural
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngitis
|
Pharyngitis
|
2.3% - 2.9%
|
1.7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
1.6% - 2%
|
2.5%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
0.8% - 1.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
0.8% - 1.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Trauma
|
0.8% - 2%
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Hypotension
|
Hypotension
|
uncommon, 2.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 1.3%
|
2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 1.3%
|
2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
0.5% - 1.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
0.5% - 1.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
0.5% - 1.7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
uncommon, 0.9% - 2.6%
|
3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Distention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Chest pain
|
Chest pain
|
uncommon
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
uncommon, 1.1% - 3.4%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
uncommon, 0.3% - 2.1%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Heartburn
|
uncommon, 0.3% - 2.1%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac murmur
|
Cardiac murmur
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Muscle spasms
|
Cramp muscle
|
postmarketing — 0.8% - 2.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Numbness
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory loss
|
Numbness
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disturbance
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
uncommon, 0.4% - 1.2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Dry mouth
|
Dry mouth
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Malaise
|
Malaise
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Discomfort
|
Malaise
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Feeling abnormal
|
Malaise
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Arrhythmia supraventricular
|
Atrial rhythm
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Erythema
|
Erythema facial
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Erythema
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Bradycardia
|
Bradycardia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Oedema peripheral
|
Upper limb oedema
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Visual impairment
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Anorectal disorder
|
Anorectal disorder
|
0% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia
|
Anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
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
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
rare
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Bad taste
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Oesophagitis
|
Oesophagitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gout
|
Gout
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing, very common
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Hypertension
|
Hypertension
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
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
|
x
|
Nephropathy
|
Nephropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Pain
|
Pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Proteinuria
|
Proteinuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Protein urine present
|
Proteinuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Renal failure
|
Renal failure
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stress
|
Stress
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Swelling
|
Swelling
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
Syncope
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Tremor
|
Tremor
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Essential hypertension
|
Essential hypertension
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral disorder
|
Oral lesion
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Hair disorder
|
Abnormalities of the hair
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Abnormal faeces
|
Abnormal faeces
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
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
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Decreased appetite
|
Decreased appetite
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Anorexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Feeling cold
|
Feeling cold
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Localised oedema
|
Neck oedema of
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Conduction disorder
|
Conduction disorder
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Stiffness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Feeling hot
|
Sensation of warmth
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Muscular weakness
|
Limb paresis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Muscular weakness
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Myasthenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Monoparesis
|
Limb paresis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Menopausal symptoms
|
Hot flush
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Hot flush
|
Hot flush
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Coordination abnormal
|
Coordination disturbance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
Liver function test abnormal
|
Raised liver function tests
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
Renal impairment
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Chronic renal insufficiency
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Asthma
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Breast feeding
|
Breast feeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Transient ischaemic attack
|
Transient ischaemic attack
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Nasopharyngitis
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Infection
|
Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Oedema
|
Oedema
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Emotional disorder
|
Emotional disturbance NOS
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glycosuria
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Seasonal allergy
|
Seasonal allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Rhinitis seasonal
|
Seasonal allergy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertensive crisis
|
Hypertensive crisis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyponatraemia
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Inner ear disorder
|
Labyrinthine disorder
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukopenia
|
Leukopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphopenia
|
Lymphopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle atrophy
|
Muscle atrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Myositis
|
Myositis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Prostatic disorder
|
Prostatic disorder
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Reflexes abnormal
|
Reflexes abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sialoadenitis
|
Sialoadenitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Tracheobronchitis
|
Tracheobronchitis
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Angiopathy
|
Angiopathy
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Chills
|
Chills
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Excitement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Affect lability
|
Mood swings
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Local swelling
|
Swelling of limb
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Joint stiffness
|
Joint stiffness
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Xanthopsia
|
Xanthopsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abdominal pain upper
|
Epigastric pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tenderness
|
Tenderness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pulmonary congestion
|
Pulmonary congestion
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Respiratory tract congestion
|
Pulmonary congestion
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Cutaneous vasculitis
|
Cutaneous vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Electrolyte imbalance
|
Electrolyte imbalance
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Epigastric discomfort
|
Gastric irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure chronic
|
Chronic renal insufficiency
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blindness
|
Blindness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Respiratory distress
|
Respiratory distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal chest pain
|
Musculoskeletal chest pain
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Vasculitis necrotising
|
Angiitis necrotising
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardio-respiratory arrest
|
Cardio-respiratory arrest
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Ventricular arrhythmia
|
Rhythm idioventricular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhythm idioventricular
|
Rhythm idioventricular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin discomfort
|
Skin discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chromaturia
|
Brown urine
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|