MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
Blood urea increased
|
Blood urea increased
|
9%
|
7.6%
|
x
|
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
6.4%
|
6%
|
x
|
|
|
x
|
x
|
x
|
Dizziness
|
Syncope
|
5.9%
|
3.3%
|
x
|
|
x
|
x
|
x
|
x
|
Dizziness
|
1.7% - 23%
|
1.4% - 17%
|
x
|
x
|
|
x
|
x
|
x
|
Shock
|
Syncope
|
5.9%
|
3.3%
|
x
|
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
5.9%
|
3.3%
|
x
|
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
5.9%
|
3.3%
|
x
|
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
5.3%
|
2.8%
|
x
|
x
|
x
|
x
|
x
|
|
Hypocalcaemia
|
Hypocalcaemia
|
4.7%
|
3.9%
|
|
|
|
x
|
x
|
|
Blood creatinine increased
|
Creatinine increased
|
4.7%
|
2.4%
|
x
|
|
|
x
|
x
|
|
Blood creatinine increased
|
|
|
|
|
|
|
|
x
|
Myalgia
|
Myalgia
|
postmarketing, 4.7%
|
3.1%
|
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
postmarketing, 4.7%
|
3.1%
|
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
|
|
|
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
postmarketing, 4.7%
|
4.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
4.2%
|
3.6%
|
|
|
|
x
|
x
|
x
|
Cough
|
Cough
|
2.6% - 35%
|
0.9% - 22%
|
x
|
x
|
|
x
|
x
|
x
|
Intermittent claudication
|
Intermittent claudication
|
3.8%
|
2%
|
|
|
|
x
|
x
|
|
Cardiogenic shock
|
Cardiogenic shock
|
3.8%
|
2%
|
|
|
|
x
|
x
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
3.3%
|
3.2%
|
|
|
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing, 2.6% - 3.9%
|
0.9% - 2.6%
|
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
2.3% - 4.9%
|
0.5%
|
x
|
x
|
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
2.01% - 3.3%
|
2.01% - 2.6%
|
|
x
|
|
x
|
x
|
x
|
Fatigue
|
|
|
x
|
|
|
|
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing, 2.1%
|
0.6%
|
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, 1.9% - 2.31%
|
0.5% - 1.4%
|
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
0.2% - 3.4%
|
|
x
|
|
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
0.5% - 11%
|
0.6% - 6.8%
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension symptomatic
|
|
|
x
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 1.15%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
0% - 1.5%
|
|
|
|
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
0.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
0% - 1.4%
|
|
|
|
|
x
|
x
|
|
Gastrointestinal pain
|
Gastrointestinal pain
|
0.1% - 1.2%
|
|
|
|
|
x
|
x
|
x
|
Abdominal pain
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing, 0.5% - 1.15%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, 0.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
0.5% - 1.1%
|
|
|
x
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
0.5% - 1.1%
|
|
|
x
|
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
0.5% - 1.1%
|
|
|
x
|
|
x
|
x
|
x
|
Feeling abnormal
|
|
|
|
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
0.5% - 1.1%
|
|
|
x
|
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 0.4% - 1.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 0.4% - 1.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
postmarketing, 0.3% - 3.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 0.2% - 1.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
x
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
|
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
x
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
Sweating
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
|
|
|
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
x
|
x
|
|
|
x
|
Haematocrit decreased
|
Haematocrit decreased
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
Abdominal distension
|
Abdominal distension
|
|
|
x
|
|
|
|
|
|
Anaemia
|
Anaemia
|
|
|
|
|
|
|
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
|
|
|
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
|
|
x
|
|
|
|
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
x
|
Atrial flutter
|
Atrial flutter
|
|
|
|
|
|
|
|
x
|
Atrioventricular block
|
Atrioventricular block
|
|
|
|
x
|
|
x
|
x
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
x
|
Blepharitis
|
Blepharitis
|
|
|
|
|
|
|
|
x
|
Platelet disorder
|
Platelet disorder
|
|
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
|
|
|
|
x
|
|
|
|
Somnolence
|
Drowsiness
|
|
|
x
|
|
|
|
|
|
Somnolence
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
|
|
|
|
|
|
|
x
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
|
|
x
|
|
|
|
|
x
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
|
|
x
|
|
|
|
|
x
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
|
x
|
Fatigue
|
Fatigue
|
|
|
x
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
x
|
Flushing
|
Flushing
|
|
|
x
|
|
|
|
|
|
Gout
|
Gout
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
|
|
|
|
|
|
|
x
|
Cardiac failure
|
Cardiac failure
|
|
|
|
|
x
|
x
|
x
|
|
Haematemesis
|
Haematemesis
|
|
|
|
|
|
|
|
x
|
Hepatitis
|
Hepatitis
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
|
|
|
|
|
|
|
x
|
Hyponatraemia
|
Hyponatraemia
|
|
|
x
|
|
|
|
|
x
|
Ichthyosis
|
Ichthyosis
|
|
|
|
|
|
|
|
x
|
Ichthyosis acquired
|
Ichthyosis
|
|
|
|
|
|
|
|
x
|
Infarction
|
Infarction
|
|
|
|
|
|
|
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
|
|
x
|
x
|
x
|
|
Renal failure acute
|
Renal failure acute
|
|
|
|
|
x
|
|
x
|
|
Laryngeal oedema
|
Laryngeal oedema
|
|
|
x
|
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
x
|
Muscle spasms
|
Cramp muscle
|
|
|
x
|
|
x
|
x
|
x
|
|
Muscle spasms
|
|
|
|
|
|
|
|
x
|
Myoclonus
|
Myoclonus
|
|
|
|
|
|
|
|
x
|
Neutropenia
|
Neutropenia
|
|
|
|
x
|
|
|
|
|
Osteoarthritis
|
Osteoarthritis
|
|
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
|
|
x
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Pemphigus
|
Pemphigus
|
|
|
x
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
|
|
x
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
x
|
Psoriasis
|
Psoriasis
|
|
|
|
|
x
|
x
|
x
|
x
|
Pulmonary eosinophilia
|
Pulmonary eosinophilia
|
|
|
x
|
|
|
|
|
|
Renal failure
|
Renal failure
|
|
|
|
|
|
x
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
x
|
|
|
|
|
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
|
|
|
|
x
|
x
|
x
|
|
Varicose vein
|
Varicose vein
|
|
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
|
|
|
|
|
|
|
x
|
Vertigo
|
Vertigo
|
|
|
x
|
|
|
|
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
x
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
x
|
|
|
|
|
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
x
|
Apathy
|
Apathy
|
|
|
|
|
|
|
|
x
|
Flat affect
|
Apathy
|
|
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
|
|
|
|
|
|
|
x
|
Migraine
|
Migraine
|
|
|
|
|
|
|
|
x
|
Antinuclear antibody positive
|
Antinuclear antibody positive
|
|
|
|
|
|
|
|
x
|
Conjunctival oedema
|
Conjunctival oedema
|
|
|
|
|
|
|
|
x
|
Enzyme abnormality
|
Enzyme abnormality
|
|
|
|
|
|
|
|
x
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
|
|
|
|
|
|
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
|
|
|
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
x
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
x
|
|
|
|
|
|
Dry skin
|
Dry skin
|
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
x
|
x
|
|
Productive cough
|
Productive cough
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Azotaemia
|
Azotaemia
|
|
|
|
|
|
|
|
x
|
Congenital arterial malformation
|
Congenital arterial malformation
|
|
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
x
|
Migraine without aura
|
Migraine without aura
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
|
|
|
|
|
|
|
x
|
Blood creatinine decreased
|
Serum creatinine decreased
|
|
|
|
|
|
x
|
x
|
|
Arrhythmia supraventricular
|
Arrhythmia supraventricular
|
|
|
|
|
|
|
|
x
|
Laboratory test abnormal
|
Laboratory test abnormal
|
|
|
|
|
|
|
|
x
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
x
|
Visual impairment
|
Visual disturbance
|
|
|
|
|
|
|
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
x
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
x
|
Presyncope
|
Presyncope
|
|
|
x
|
|
|
|
|
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
|
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
|
|
x
|
White blood cell count decreased
|
White blood cell count decreased
|
|
|
x
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
x
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
x
|
Blood potassium increased
|
Potassium increased
|
|
|
x
|
|
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract inflammation
|
Upper respiratory tract inflammation
|
|
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Upper respiratory tract congestion
|
Upper respiratory tract congestion
|
|
|
|
|
|
|
|
x
|
Ileus
|
Ileus
|
|
|
|
|
x
|
x
|
x
|
|