MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
14
|
Intermittent claudication
|
Intermittent claudication
|
7% - 8%
|
6%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
rare — 6.5% - 7%
|
4.6% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis aggravated
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Osteoarthritis
|
Arthropathy
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity
|
Leg pain
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
Nervousness
|
Nervousness
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unspecified disorder of skin and subcutaneous tissue
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Skin ulcer
|
Skin ulcer
|
3% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
common, 1.7%
|
1.5%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
rare — 2.2% - 3%
|
1.9% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
common, 0.6%
|
1%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sciatica
|
Sciatica
|
uncommon, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
rare, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
rare, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing — 1.1%
|
0.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
1%
|
1.7%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension worsened
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pharyngitis
|
Pharyngitis
|
rare — 1% - 1.1%
|
0% - 0.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
1%
|
1.2%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Edema of lower extremities
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Leg edema
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
very rare — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Muscle spasms
|
Muscle spasms
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Cramps of lower extremities
|
postmarketing, common
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cramp muscle
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
rare — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
uncommon
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Visual disturbance
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
Disorder sight
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
postmarketing — 2.7% - 3%
|
0.9% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 2.6% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
rare — 0.4%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal specific
|
0.2%
|
1%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
rare, common
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
postmarketing, 3.2%
|
3.3%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Mental disorder
|
Mental disorder
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
postmarketing — 1.3%
|
1.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Cough
|
Cough
|
very rare — 1.4% - 1.6%
|
1.6% - 1.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug eruption
|
Drug eruption
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing — 3.6%
|
4.6%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
rare
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Dyspepsia
|
Dyspepsia
|
postmarketing — 1.6%
|
1.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
rare, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing, common
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Eosinophilia
|
Eosinophilia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
rare, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 3.2%
|
3.3%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing — 8%
|
15.6%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperhidrosis
|
Hyperhidrosis
|
rare, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Sweating increased
|
postmarketing, uncommon
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing, uncommon
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Liver disorder
|
Liver disorder
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Hepatocellular injury
|
Liver disorder
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Foetor hepaticus
|
Liver disorder
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
postmarketing — 1.1%
|
1.4%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Pain
|
Pain
|
postmarketing — 3.5%
|
4.3%
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Shock
|
Syncope
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tendonitis
|
Tendonitis
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Tenosynovitis
|
Tenosynovitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
rare, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Dry mouth
|
Dry mouth
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
postmarketing — 1.1%
|
0.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tendon pain
|
Tendon pain
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
Upset stomach
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Blood uric acid increased
|
Blood uric acid increased
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Uric acid increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperuricaemia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Raised serum uric acid
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Blood creatinine increased
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Diabetes mellitus
|
Diabetic
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Sepsis
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Depression
|
Anxiety depression
|
rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Bradycardia
|
Bradycardia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Toxic skin eruption
|
Toxic skin eruption
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Blood creatine phosphokinase increased
|
Blood creatine phosphokinase increased
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Renal failure
|
Renal impairment
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Renal impairment
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
rare — 0.4%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
very rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lung disorder
|
Lung disorder
|
very rare
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Abscess
|
Abscess
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Decreased appetite
|
Anorexia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Enteritis
|
Enteritis
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melaena
|
Melaena
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertonia
|
Hypertonia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myositis
|
Myositis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Otitis media
|
Otitis media
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purpura
|
Purpura
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal inflammation
|
Vaginal inflammation
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal infection
|
Vaginal inflammation
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plantar fasciitis
|
Plantar fasciitis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine aggravated
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscular weakness
|
Muscular weakness
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interstitial lung disease
|
Interstitial lung disease
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gravitational oedema
|
Gravitational oedema
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Genital candidiasis
|
Genital candidiasis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
Enlargement abdomen
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
Rigors
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood cholesterol increased
|
Cholesterol serum elevated
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Autonomic neuropathy
|
Unspecified disorder of autonomic nervous system
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|