MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
Cough
|
Cough
|
1.8% - 7.5%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Dry cough
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 3.2% - 5.1%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 3% - 8.2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing, 2.1% - 2.6%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Asthenia
|
0.3% - 1.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 2.1% - 2.6%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
0.3% - 2.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing, 1.3% - 2.9%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension symptomatic
|
1.2%
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Hypotension
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing, 1.2%
|
|
|
|
x
|
|
x
|
x
|
|
Palpitations
|
Palpitations
|
postmarketing, 0.2% - 1.2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing, 0.1% - 0.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing, 0.1% - 0.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
0.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
postmarketing, 0.09% - 0.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal impairment
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Scleroderma
|
Scleroderma
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Digestion impaired
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Digestion impaired
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Decompensation cardiac
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
|
|
x
|
|
x
|
|
|
Blood disorder
|
Blood disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Nephropathy
|
Nephropathy
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Laryngeal oedema
|
Laryngeal oedema
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Systemic lupus erythematosus
|
Systemic lupus erythematosus
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Necrosis
|
Necrosis
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pemphigus
|
Pemphigus
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal artery stenosis
|
Renal artery stenosis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
Liver function test abnormal
|
Raised liver function tests
|
postmarketing
|
|
x
|
|
|
|
|
x
|
x
|
Renal impairment
|
Renal impairment
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
postmarketing, 0.04%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
0.02%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrioventricular block
|
Atrioventricular block
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Bronchitis
|
Bronchitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory tract infection
|
Respiratory tract infection
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiogenic shock
|
Cardiogenic shock
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Azotaemia
|
Uremia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Rigors
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine abnormal
|
Serum creatinine abnormal
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|