MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
Injection site reaction
|
Injection site reaction
|
33%
|
|
x
|
|
|
|
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
10%
|
|
|
|
|
|
|
x
|
Cramp muscle
|
0% - 29.4%
|
|
|
|
|
|
x
|
x
|
Infection
|
Infection
|
8%
|
|
|
|
|
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing, 0.4% - 23%
|
|
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 2% - 35%
|
|
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
6%
|
|
|
|
|
|
|
x
|
Asthenia
|
0% - 7%
|
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
6%
|
|
|
|
|
|
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
6%
|
|
|
|
|
|
|
x
|
Rhinitis
|
Rhinitis
|
6%
|
|
|
|
|
|
|
x
|
Dizziness
|
Syncope
|
postmarketing, 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
Dizziness
|
postmarketing, 0% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
postmarketing
|
|
|
|
|
|
x
|
x
|
Shock
|
Syncope
|
postmarketing, 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
Shock
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing, 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing, 6%
|
|
x
|
x
|
x
|
x
|
|
x
|
Loss of consciousness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
6%
|
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
2.6% - 10.9%
|
|
|
|
|
|
x
|
x
|
Leg edema
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing, 5% - 17%
|
|
x
|
x
|
x
|
x
|
|
x
|
Generalised oedema
|
Generalised oedema
|
5%
|
|
|
|
|
|
|
x
|
Fluid retention
|
Generalised oedema
|
5%
|
|
|
|
|
|
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
2.2% - 16%
|
|
|
|
|
|
x
|
|
Nausea
|
Nausea
|
postmarketing, 1.2% - 14.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
0% - 6.5%
|
|
|
|
|
|
x
|
|
Pain in arm
|
|
|
|
|
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
2.2% - 16%
|
|
|
|
|
|
x
|
x
|
Sinusitis
|
Sinusitis
|
2.2% - 16%
|
|
|
|
|
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
2.2% - 16%
|
|
|
|
|
|
x
|
x
|
Peritonitis
|
Peritonitis
|
4%
|
|
|
|
|
|
x
|
|
Viral infection
|
Viral infection
|
4%
|
|
|
|
|
|
x
|
|
Vomiting
|
Vomiting
|
postmarketing, 0.4% - 11%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing, 1.4% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing, 1.4% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, 1.4% - 4.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, 1.4% - 4.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, 0% - 3.6%
|
|
x
|
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 0% - 24%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
0% - 6%
|
|
|
|
|
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, 0% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing, 0% - 39.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arteriovenous fistula thrombosis
|
Arteriovenous fistula thrombosis
|
2%
|
|
|
|
|
|
x
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 1.3% - 11%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
postmarketing, 0.4% - 4.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, 0% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
0% - 2.2%
|
|
|
|
|
|
x
|
|
Fluid overload
|
Fluid overload
|
0% - 3%
|
|
|
|
|
|
x
|
x
|
Constipation
|
Constipation
|
0.5% - 3.2%
|
|
|
x
|
|
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
0% - 4%
|
|
|
|
|
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 0.7% - 10%
|
|
|
|
|
x
|
|
x
|
Ache
|
postmarketing
|
|
|
|
|
|
x
|
|
Chest pain
|
Chest pain
|
postmarketing, 0% - 10%
|
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
postmarketing
|
|
|
x
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, 0.5%
|
|
x
|
x
|
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0% - 1.1%
|
|
|
x
|
|
|
|
|
Menopausal symptoms
|
Hot flush
|
0% - 3.6%
|
|
|
x
|
|
|
|
|
Hot flush
|
Hot flush
|
0% - 3.6%
|
|
|
x
|
|
|
|
|
Blood phosphorus decreased
|
Phosphorus low
|
0% - 2.1%
|
|
|
x
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
|
|
x
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
postmarketing
|
|
|
|
|
|
x
|
|
Feeling abnormal
|
Confusional state
|
postmarketing
|
|
|
|
|
|
x
|
|
Malaise
|
|
|
|
|
x
|
x
|
|
x
|
Feeling abnormal
|
0% - 3%
|
|
|
|
|
|
x
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 0% - 7.9%
|
|
|
x
|
|
|
x
|
x
|
Taste altered
|
|
|
|
|
x
|
x
|
|
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
x
|
x
|
Extravasation
|
Extravasation
|
postmarketing
|
|
|
|
|
|
x
|
|
Flushing
|
Flushing
|
postmarketing, 0% - 3.6%
|
|
x
|
x
|
x
|
x
|
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
|
|
|
|
x
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
postmarketing
|
|
|
|
|
|
x
|
|
Sweating
|
|
|
x
|
|
x
|
x
|
|
|
Sweating increased
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
|
|
|
x
|
Numbness
|
|
|
|
|
x
|
x
|
|
|
Hypertonia
|
Hypertonia
|
postmarketing
|
|
|
|
|
|
|
x
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
x
|
Tension
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
x
|
Osteomalacia
|
Osteomalacia
|
postmarketing
|
|
|
x
|
|
|
|
|
Pallor
|
Pallor
|
postmarketing
|
|
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing, 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
Erythema
|
Erythema
|
postmarketing
|
|
|
x
|
|
|
|
|
Redness
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
Shivering
|
|
|
|
|
x
|
x
|
|
|
Rigors
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
postmarketing
|
|
|
|
|
|
|
x
|
Chest discomfort
|
Chest discomfort
|
postmarketing
|
|
|
x
|
|
|
|
|
Chest tightness
|
|
|
|
|
x
|
x
|
|
|
Sepsis
|
Sepsis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
Drug intolerance
|
Drug intolerance
|
postmarketing
|
|
|
|
|
|
|
x
|
Bradycardia
|
Bradycardia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
Chromaturia
|
Chromaturia
|
postmarketing
|
|
|
|
|
|
x
|
|
Local swelling
|
Peripheral swelling
|
postmarketing
|
|
|
|
|
|
|
x
|
Injection site discolouration
|
Injection site discolouration
|
postmarketing, 0% - 1.4%
|
|
|
x
|
|
|
x
|
|
Myalgia
|
Myalgia
|
postmarketing, 0% - 3.6%
|
|
x
|
|
x
|
x
|
x
|
x
|
Abscess
|
Abscess
|
|
|
|
|
x
|
x
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
|
|
x
|
|
x
|
x
|
|
|
Anaphylactoid reaction
|
|
|
|
|
x
|
x
|
|
|
Anaemia
|
Anaemia
|
|
|
|
|
|
|
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
x
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
x
|
Arcus lipoides
|
Arcus senilis
|
|
|
|
|
|
|
|
x
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
x
|
x
|
|
|
Arthritis
|
Arthritis
|
|
|
|
|
x
|
x
|
|
|
Rheumatoid arthritis
|
|
|
|
|
x
|
x
|
|
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
|
|
|
|
x
|
x
|
|
|
Neoplasm malignant
|
Carcinoma
|
|
|
|
|
|
|
|
x
|
Cellulitis
|
Cellulitis
|
|
|
|
|
x
|
x
|
|
|
Conjunctivitis
|
Conjunctivitis
|
0% - 2.7%
|
|
|
|
|
|
x
|
x
|
Cyanosis
|
Cyanosis
|
|
|
|
|
x
|
x
|
|
|
Deafness
|
Deafness
|
|
|
|
|
|
|
|
x
|
Diplopia
|
Diplopia
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
0% - 2.2%
|
|
|
|
|
|
x
|
|
Eructation
|
Eructation
|
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Rash
|
Rash
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
x
|
|
Fibrosis
|
Fibrosis
|
|
|
|
|
|
x
|
|
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
x
|
x
|
Gout
|
Gout
|
0% - 2.9%
|
|
|
|
|
|
x
|
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
|
x
|
x
|
|
|
Haematuria
|
Haematuria
|
|
|
|
|
x
|
x
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
0% - 2.9%
|
|
|
|
|
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
x
|
Inflammation
|
Inflammation
|
|
|
x
|
|
x
|
x
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
x
|
x
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
x
|
|
Melaena
|
Melaena
|
|
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
|
|
|
|
|
|
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
x
|
|
Sensory loss
|
Numbness
|
|
|
|
|
x
|
x
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
x
|
Purpura
|
Purpura
|
|
|
|
|
x
|
x
|
|
|
Vascular purpura
|
Purpura
|
|
|
|
|
x
|
x
|
|
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
|
|
|
x
|
Sneezing
|
Sneezing
|
|
|
|
x
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
x
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
x
|
|
Wheezing
|
Wheezing
|
|
|
|
|
x
|
x
|
|
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
x
|
|
|
|
|
Injection site pain
|
Injection site pain
|
|
|
x
|
x
|
|
|
|
|
Respiratory arrest
|
Respiratory arrest
|
|
|
|
|
x
|
x
|
|
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
|
x
|
x
|
Malaise
|
Malaise
|
|
|
|
|
x
|
x
|
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
x
|
x
|
|
x
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
x
|
x
|
|
x
|
Disorientation
|
Disorientation
|
|
|
|
|
x
|
x
|
|
|
Tenderness
|
Tenderness
|
|
|
|
|
|
x
|
|
|
Graft complication
|
Graft complication
|
0% - 9.5%
|
|
|
|
|
|
x
|
|
Atrophy
|
Atrophy
|
|
|
|
|
|
x
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
|
x
|
x
|
|
|
Lymphadenopathy
|
Generalized lymphadenopathy
|
|
|
x
|
|
|
|
|
|
Lymphadenopathy
|
|
|
|
|
x
|
x
|
|
x
|
Lymphadenopathy inguinal
|
|
|
x
|
|
|
|
|
|
Injection site extravasation
|
Injection site extravasation
|
0% - 2.2%
|
|
|
|
|
|
x
|
|
Eyelid oedema
|
Swelling of eyelid
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
x
|
|
Infusion site pain
|
Infusion site pain
|
0% - 5.8%
|
|
|
|
|
|
x
|
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
x
|
Lacrimation increased
|
Tearing eyes
|
|
|
|
|
|
|
|
x
|