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
|
Oedema peripheral
|
Oedema peripheral
|
very common, 20%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
19%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
very common, 0% - 89%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Shivering
|
very common
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
very common
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis atopic
|
Cutaneous hypersensitivity
|
very common
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oedema
|
Oedema
|
very rare — 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphopenia
|
Lymphopenia
|
5% - 51%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Asthenia
|
Asthenia
|
common, very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
0% - 32%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
common, very common
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
common, very common
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Vomiting
|
Vomiting
|
very common, 0% - 86%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
very common, 0% - 86%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
very common, 0% - 93%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very common, 0% - 87%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ulcer
|
Ulcer
|
rare, common
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
common
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Insomnia
|
Insomnia
|
common
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Difficulty sleeping
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing — 1% - 57%
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0% - 68%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 67%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Febrile neutropenia
|
Febrile neutropenia
|
common, 0% - 5%
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Constipation
|
Constipation
|
common, 0% - 39%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
very common, 0% - 28%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute dyspnea
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
0% - 23%
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
3%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Neuropathy
|
0% - 58%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
Myalgia
|
Myalgia
|
very common, 0% - 33%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
very common, 0% - 33%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
0% - 22%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 22%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
0% - 47%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
1% - 13%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Blood creatinine increased
|
Creatinine increased
|
0% - 31%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
0% - 17%
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
0% - 55%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Fatigue
|
Fatigue
|
0% - 32%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
common, 0% - 34%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
rare, 0% - 7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Transaminases increased
|
Transaminases increased
|
0% - 10%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Transaminitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Bronchospasm
|
Allergic bronchospasm
|
2%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Bronchospasm
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
uncommon
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Alopecia
|
Alopecia
|
common, 0% - 92%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia reversible
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
0% - 23%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
0% - 23%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
0% - 7%
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
1%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
0% - 26%
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
0% - 13%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
common, 0% - 66%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
1%
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Fluid retention
|
Generalised oedema
|
1%
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Sepsis
|
Sepsis
|
1%
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
1%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Somnolence
|
Somnolence
|
common, 0% - 30%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Cellulitis
|
Cellulitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Extravasation
|
Extravasation
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gangrene
|
Gangrene
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
postmarketing — 0.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Venoocclusive liver disease
|
Venoocclusive liver disease
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary fibrosis
|
Pulmonary fibrosis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal failure
|
Renal failure
|
postmarketing, rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Progressive renal failure
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory distress syndrome
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vasculitis
|
Vasculitis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Dermatitis bullous
|
Dermatitis bullous
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site reaction
|
Injection site reaction
|
postmarketing, 4%
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Interstitial lung disease
|
Interstitial pneumonia
|
postmarketing, uncommon
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Microangiopathic haemolytic anaemia
|
Microangiopathic haemolytic anaemia
|
postmarketing
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Tenderness
|
Tenderness
|
rare
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing, uncommon
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Skin exfoliation
|
Skin exfoliation
|
very rare — 0% - 5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Capillary leak syndrome
|
Capillary leak syndrome
|
postmarketing
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
Arrhythmia supraventricular
|
Arrhythmia supraventricular
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Nephropathy toxic
|
Nephropathy toxic
|
postmarketing
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Drug interaction
|
Drug interaction
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Liver function test abnormal
|
Raised liver function tests
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory failure
|
Respiratory failure
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Renal impairment
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Recall phenomenon
|
Radiation recall reaction (dermatologic)
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Colitis ischaemic
|
Colitis ischaemic
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytosis
|
Thrombocytosis
|
very rare
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Road traffic accident
|
Traffic accident
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia
|
very common, 0% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast cancer
|
Breast cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Chest pain
|
Chest pain
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cough
|
Cough
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
0% - 30%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
0% - 30%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eruption
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
common — 0% - 41%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Headache
|
Headache
|
very common, 0% - 7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Haematuria
|
Haematuria
|
postmarketing — 0% - 35%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Influenza
|
Influenza
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flu symptoms
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphoma
|
Lymphoma
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Azoospermia
|
Oligospermia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancytopenia
|
Pancytopenia
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Petechiae
|
Petechiae
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pneumonia
|
Pneumonia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Proteinuria
|
Proteinuria
|
postmarketing — 0% - 45%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
postmarketing — 0% - 45%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Peripheral sensory neuropathy
|
Peripheral sensory neuropathy
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urea increased
|
Blood urea increased
|
0% - 16%
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Injection site necrosis
|
Injection site necrosis
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Streptobacillary fever
|
Streptobacillary fever
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Septic arthritis streptobacillus
|
Streptobacillary fever
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Reticulocytosis
|
Reticulocytosis
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Tachypnoea
|
Tachypnoea
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuritis
|
Peripheral motor neuropathy
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Peripheral motor neuropathy
|
Peripheral motor neuropathy
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
Neurotoxicity
|
Neurotoxicity
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Poor quality sleep
|
Difficulty sleeping
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lung infiltration
|
Lung infiltration
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoxia
|
Hypoxia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypoxemia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disease progression
|
Disease progression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Traumatic lung injury
|
Traumatic lung injury
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactoid reaction
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyporeflexia
|
Tendon reflex decreased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Blood bilirubin normal
|
Bilirubin normal
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure chronic
|
Irreversible renal failure
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiotoxicity
|
Cardiotoxicity
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pulmonary toxicity
|
Pulmonary toxicity
|
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oral toxicity
|
Oral toxicity
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deafness
|
Hearing impaired
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Metastatic neoplasm
|
Metastatic disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|