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
|
Neoplasm malignant
|
Neoplasm malignant
|
79% - 91.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
0.5% - 80.3%
|
0% - 27%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Lethargy
|
Lethargy
|
11.7% - 74.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
0.3% - 40.9%
|
0% - 14.8%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Edema of lower extremities
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Fatigue
|
very common, 0% - 74.9%
|
1.2% - 40.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
common, 0% - 74.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
very common, 0% - 74.9%
|
1.2% - 40.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoproteinaemia
|
Hypoproteinaemia
|
0% - 31.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
7.6% - 49.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neutrophil count decreased
|
Neutrophil count decreased
|
3.3% - 33.3%
|
0.9% - 6.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
very common, 0% - 57.2%
|
1.4% - 22.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
very common, 0% - 57.2%
|
1.4% - 22.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Dermatitis
|
very common, 1.5% - 38.9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
very common, 0% - 53%
|
0% - 12.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
very common, 0.464% - 70%
|
1.4% - 29.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loose stools
|
0% - 12%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
Eczema
|
Eczema
|
very common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash
|
Rash
|
very common, 0% - 53%
|
0% - 12.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
very common, 0% - 43.3%
|
0% - 20.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
very common, 0% - 49%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
very common, 0.4% - 74%
|
1.2% - 27.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Muscle spasms
|
very common, 0% - 49%
|
0% - 3.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cramp muscle
|
very common, 0% - 62%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
very common, 0.5% - 58%
|
0.6% - 13.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Periorbital oedema
|
Periorbital oedema
|
very common, 0.5% - 74.2%
|
0% - 14.5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
very common, 1.6% - 15.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
White blood cell count decreased
|
White blood cell count decreased
|
0.6% - 47%
|
0.3% - 4.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Pain
|
Pain
|
0.7% - 45.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Depression
|
Depression
|
uncommon, 0% - 35.8%
|
0.6% - 6.4%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoalbuminaemia
|
Hypoalbuminaemia
|
0% - 21.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Skin toxicity
|
Skin toxicity
|
5.7% - 20.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthralgia
|
Arthralgia
|
very common, 0% - 40%
|
0.3% - 14.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
very common, 0% - 40%
|
0.3% - 14.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
very common, 0% - 38.8%
|
0.3% - 11.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
very common, 0% - 27%
|
0% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Heartburn
|
0.5% - 11.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Digestion impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Oedema
|
Oedema
|
very common, 0% - 86.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema aggravated
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Myalgia
|
Myalgia
|
very common, 0% - 38.8%
|
0.3% - 11.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Platelet count decreased
|
Platelet count decreased
|
0% - 14.1%
|
0% - 3.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Ascites
|
Ascites
|
uncommon, 3% - 15%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
common, 0% - 42.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pleural effusion
|
Pleural effusion
|
uncommon, 0% - 15%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
3.1% - 16.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Lightheadedness
|
2.8% - 11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
common, 0% - 24.4%
|
0.3% - 10.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngeal mucositis
|
4.3% - 10%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pharyngitis
|
uncommon, 0% - 15%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
common, 0.5% - 21%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
uncommon, 0.155% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fluid retention
|
Fluid retention
|
very common, 0% - 81%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised oedema
|
common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
0% - 26%
|
0% - 8.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
2.8% - 12.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sweating increased
|
uncommon, 0.2% - 14.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
common, 0% - 19.2%
|
0.3% - 6.4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
common, 0% - 22.3%
|
0% - 6.7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
common, 0% - 35.8%
|
0% - 8.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
uncommon, 0% - 10.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
common, 0% - 7.6%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
common, 0% - 16%
|
0.3% - 17.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
common, 0% - 27%
|
0% - 11.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
common, 0% - 13%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
common, 0% - 34%
|
0% - 9.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing — 0% - 53%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing — 0% - 53%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Night sweats
|
Night sweats
|
common, 0.2% - 17%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
common, 0% - 12.1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
common, 0% - 25.8%
|
0% - 7.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
very common, 0% - 32%
|
0% - 11.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
common, 0% - 10.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
common, 3% - 11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rigors
|
common, 0% - 34%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Mouth ulceration
|
uncommon, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
uncommon, 0.6% - 16.3%
|
0% - 1.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
uncommon, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
common, 0% - 6.7%
|
0% - 5.2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Joint swelling
|
Joint swelling
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimation increased
|
Lacrimation increased
|
common, 0% - 18%
|
0% - 3.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eyelid oedema
|
Eyelid oedema
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
common, 0% - 11.1%
|
0% - 2.3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
common, 0.3% - 6.8%
|
0% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Febrile neutropenia
|
Febrile neutropenia
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
common, 0% - 19%
|
0% - 7.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing — 0% - 100%
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Anaemia
|
Anaemia
|
postmarketing — 0% - 42%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
0% - 15.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypokalaemia
|
Hypokalaemia
|
uncommon, 0.2% - 33.7%
|
0.6% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
0% - 11%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal pain
|
Throat sore
|
0% - 11%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in extremity
|
Pain in extremity
|
0.3% - 7.4%
|
0% - 7.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Leukopenia
|
Leukopenia
|
0.3% - 19.6%
|
0% - 2.6%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
0.3% - 6.2%
|
0% - 6.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Weight decreased
|
Weight decreased
|
infrequent — 0% - 17.3%
|
0% - 5.2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
common, 0% - 15%
|
0% - 2.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
uncommon — 0% - 21.2%
|
0% - 3.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
0.3% - 5.6%
|
0% - 1.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Hypoxia
|
Hypoxia
|
0.309% - 8.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
uncommon, 0.2% - 11.4%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 37.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Mucosal inflammation
|
Mucosal inflammation
|
0% - 10.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
0% - 34.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
infrequent — 0% - 7.1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
uncommon, 0.4% - 11%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing — 0% - 53.3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
uncommon, 0.2% - 8%
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Petechiae
|
Petechiae
|
uncommon, 0% - 10%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tumour haemorrhage
|
Tumour haemorrhage
|
postmarketing — 1% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ecchymosis
|
Ecchymosis
|
uncommon, 0% - 11%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
infrequent — 0% - 12%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
uncommon, 0% - 30.5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
uncommon, 0% - 13.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cellulitis
|
Cellulitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cheilitis
|
Cheilitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
infrequent, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Contusion
|
Contusion
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Oesophagitis
|
Oesophagitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
infrequent, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Folliculitis
|
Folliculitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
infrequent, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematemesis
|
Haematemesis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematoma
|
Haematoma
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Subdural haematoma
|
Subdural haematoma
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypercalcaemia
|
Hypercalcaemia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
uncommon, 0.6% - 9.8%
|
1.7% - 11.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent — 0.927% - 10.9%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotrichosis
|
Hypotrichosis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute respiratory failure
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphopenia
|
Lymphopenia
|
uncommon, 0.7% - 10.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
Melaena
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menorrhagia
|
Menorrhagia
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nail disorder
|
Nail disorder
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
uncommon, 0% - 5.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
rare, uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
infrequent, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone marrow depression
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cytopenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myelosuppression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
infrequent — 0% - 5.9%
|
0% - 6.4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Restless legs syndrome
|
Restless legs syndrome
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sciatica
|
Sciatica
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pigmentation disorder
|
Pigmentation skin
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Gastric ulcer
|
Gastric ulcer
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
Rash pustular
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Blood creatine phosphokinase increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Scrotal oedema
|
Scrotal oedema
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Blood lactate dehydrogenase increased
|
uncommon, 0% - 60.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstruation irregular
|
Menstruation irregular
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukoderma
|
Leukoderma
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal stiffness
|
Muscle stiffness
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
uncommon, 11.7% - 74.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
uncommon, 11.7% - 74.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
uncommon, 11.7% - 74.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon, 11.7% - 74.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Memory impairment
|
Memory impairment
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye irritation
|
Eye irritation
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Blood creatinine increased
|
uncommon — 0% - 44.4%
|
0.3% - 5.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Creatinine increased
|
0% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Dermatitis bullous
|
Bullous eruption
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Nipple pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nipple pain
|
Nipple pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Sepsis
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral coldness
|
Peripheral coldness
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry eye
|
Dry eye
|
infrequent, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased tendency to bruise
|
Increased tendency to bruise
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orbital oedema
|
Orbital oedema
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Onychoclasis
|
Onychoclasis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Scleral haemorrhage
|
Scleral haemorrhage
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytosis
|
Thrombocytosis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
uncommon, 0% - 16.7%
|
0% - 7.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phosphatase alkaline increased
|
0% - 5.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
uncommon, 0% - 18.1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Hearing impaired
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast enlargement
|
Breast enlargement
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
infrequent, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
uncommon, 0% - 1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing — 0% - 97.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
0% - 13.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Skin disorder
|
Skin disorder
|
0% - 4.35%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinal haemorrhage
|
Retinal haemorrhage
|
rare, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Macular oedema
|
Macular oedema
|
rare, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare — rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blast cell crisis
|
Blast cell crisis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Brain oedema
|
Edema cerebral
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac tamponade
|
Cardiac tamponade
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleuritic pain
|
Pleuritic pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis
|
Colitis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cyst
|
Cyst
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug eruption
|
Drug eruption
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Diverticulitis
|
Diverticulitis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Embolism
|
Embolism
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Digestion impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Glaucoma
|
Glaucoma
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Pulmonary hypertension
|
Pulmonary hypertension
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyponatraemia
|
Hyponatraemia
|
rare, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Inflammatory bowel disease
|
Inflammatory bowel disease
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chronic myeloid leukaemia
|
Chronic phase chronic myeloid leukemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Lichen planus
|
Lichen planus
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Necrosis
|
Necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
Necrosis ischaemic
|
Necrosis ischaemic
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteonecrosis
|
Necrosis ischaemic
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteonecrosis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Neoplasm
|
Neoplasm
|
postmarketing, 5% - 20.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Optic neuritis
|
Optic neuritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Papilloedema
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Papilloedema
|
Papilloedema
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pericardial effusion
|
Pericardial effusion
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pericarditis
|
Pericarditis
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyp
|
Polyp
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary fibrosis
|
Pulmonary fibrosis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tumour lysis syndrome
|
Tumour lysis syndrome
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vitreous haemorrhage
|
Vitreous haemorrhage
|
postmarketing, rare
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute febrile neutrophilic dermatosis
|
Acute febrile neutrophilic dermatosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing — 4% - 17.3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cataract
|
Cataract
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
Leukocytoclastic vasculitis
|
Allergic cutaneous angiitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Gastrointestinal perforation
|
Gastrointestinal perforation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Growth retardation
|
Growth retardation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary haemorrhage
|
Pulmonary haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intracranial pressure increased
|
Intracranial pressure increased
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Muscular weakness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic necrosis
|
Hepatic necrosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Interstitial lung disease
|
Interstitial pneumonia
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Interstitial lung disease
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash vesicular
|
Rash vesicular
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nail discolouration
|
Nail discolouration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute respiratory failure
|
Acute respiratory failure
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tumour necrosis
|
Tumour necrosis
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhagic ovarian cyst
|
Haemorrhagic ovarian cyst
|
very rare — rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amylase increased
|
Blood amylase increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute generalised exanthematous pustulosis
|
Acute generalised exanthematous pustulosis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ileus
|
Ileus
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lichenoid keratosis
|
Lichenoid keratosis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder cancer
|
Bladder cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Mastocytosis
|
Mastocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Musculoskeletal disorder
|
Musculoskeletal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Rhinitis
|
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Ulcer
|
Ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute hepatic failure
|
Acute hepatic failure
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
Dyspnoea exertional
|
Dyspnoea exertional
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
x
|
x
|
Gastrointestinal obstruction
|
Gastrointestinal obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Gastrointestinal stromal tumour
|
Gastrointestinal stromal tumour
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chronic eosinophilic leukaemia
|
Chronic eosinophilic leukaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Prostate cancer
|
Prostate cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Haematological malignancy
|
Haematological malignancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Skin cancer
|
Skin carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Renal cancer
|
Renal cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Eye oedema
|
Eye oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Post procedural haemorrhage
|
Post procedural haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Haematochezia
|
Blood in stool
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|