|
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
|
|
Bone pain
|
Bone pain
|
common, 59.4% - 70%
|
69.1% - 75.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
Cough
|
21.2% - 26.3%
|
18.8% - 22.5%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
Headache
|
common, 0% - 27.2%
|
19.7% - 23.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
Asthenia
|
16.1% - 25.6%
|
15.4% - 19.2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
very common, 0% - 40.3%
|
28.3% - 35.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Metastasis
|
Metastasis
|
1% - 31.3%
|
3% - 24.4%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agranulocytosis
|
Agranulocytosis
|
16.8% - 20.5%
|
15.5% - 20.5%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing, 0% - 32.3%
|
20.2% - 28.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
|
|
x
|
|
|
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 0% - 38.5%
|
30.5% - 38%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
15.6% - 20.2%
|
9.1% - 17.6%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
14.6% - 16.1%
|
10.4% - 16.6%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flushing
|
Flushing
|
very common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue
|
Fatigue
|
very common, 0% - 40.3%
|
28.3% - 35.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
Influenza-like symptoms
|
postmarketing — 0% - 11.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
common, 10.7% - 15.3%
|
7% - 12.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
common, 10.7% - 15.3%
|
7% - 12.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
postmarketing — 0% - 26.4%
|
15% - 22.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion
|
Pleural effusion
|
2.9% - 15%
|
4.3% - 9.1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
Pain
|
common, 0% - 15%
|
11.8% - 18.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Generalized aching
|
common
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
Malaise
|
very common, 0% - 5.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Discomfort
|
Malaise
|
very common, 0% - 5.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Malaise
|
very common, 0% - 5.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ill-defined disorder
|
Malaise
|
very common, 0% - 5.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
postmarketing — 0% - 47.8%
|
32.6% - 41.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
common, 0% - 31.1%
|
17.1% - 24.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
Constipation
|
common, 0% - 36%
|
30.9% - 38.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
Rash
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash
|
Rash
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastritis
|
Gastritis
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphopenia
|
Lymphopenia
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
common, 0% - 63.5%
|
37.4% - 59.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia
|
Paraesthesia
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phlebitis
|
Phlebitis
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Swelling
|
Swelling
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tetany
|
Tetany
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombophlebitis
|
Thrombophlebitis
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Induration
|
Induration
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erythema
|
Redness
|
common
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
Serum creatinine increased
|
common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
common, 0% - 18%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
common, 0% - 46.3%
|
19.8% - 39.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
common, 3% - 12%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypophosphataemia
|
Hypophosphataemia
|
very common, 0% - 18%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infusion site reaction
|
Infusion site reaction
|
common, 0% - 18%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
common, 0% - 24.3%
|
14% - 18.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
common, 0% - 24.3%
|
14% - 18.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
common, 0% - 29.4%
|
26.2% - 30.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing — 0% - 12%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
common, 0% - 16.6%
|
13.1% - 17.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
postmarketing — 0% - 26.4%
|
15% - 22.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
Insomnia
|
common, 0% - 25.1%
|
17.2% - 19.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bronchospasm
|
Bronchospasm
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
uncommon, 0% - 22.6%
|
12.4% - 17.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Iridocyclitis
|
Iridocyclitis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Iritis
|
Iritis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute
|
Renal failure acute
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lethargy
|
Lethargy
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramp muscle
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Uveitis
|
Uveitis
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
Agitation
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactoid reaction
|
uncommon
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
uncommon
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urea increased
|
Serum urea increased
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Osteonecrosis of jaw
|
Osteonecrosis of jaw
|
uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dyspnoea
|
Dyspnoea
|
very rare — 0% - 35.1%
|
18.7% - 24.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Femur fracture
|
Femur fracture
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Focal segmental glomerulosclerosis
|
Focal segmental glomerulosclerosis
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypercalcaemia
|
Hypercalcaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypotension
|
Hypotension
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Inflammation
|
Inflammation
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Oral disorder
|
Oral disorder
|
postmarketing
|
|
x
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plasma cell myeloma
|
Plasma cell myeloma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Plasmacytoma
|
Plasma cell myeloma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephrotic syndrome
|
Nephrotic syndrome
|
postmarketing, rare
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Obesity
|
Obesity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Osteonecrosis
|
Osteonecrosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tubulointerstitial nephritis
|
Tubulointerstitial nephritis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Interstitial lung disease
|
Interstitial pneumonia
|
rare
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Interstitial lung disease
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Drug administration error
|
Drug maladministration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Electrolyte imbalance
|
Electrolyte imbalance
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast cancer
|
Advanced breast cancer
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Episcleritis
|
Episcleritis
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes simplex
|
Herpes simplex
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Herpes zoster
|
Herpes zoster
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia
|
Hyperkalaemia
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypernatraemia
|
Hypernatraemia
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephropathy
|
Nephropathy
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Left ventricular failure
|
Left ventricular failure
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Left ventricular failure
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute lymphocytic leukaemia
|
Acute lymphocytic leukaemia
|
very rare
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scleritis
|
Scleritis
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Xanthopsia
|
Xanthopsia
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hallucination, visual
|
Hallucination, visual
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety
|
Anxiety
|
0% - 18%
|
9.1% - 16.8%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
Atrial fibrillation
|
common, 0% - 6%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial flutter
|
Atrial flutter
|
0% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coagulopathy
|
Coagulopathy
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
very rare — 0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epilepsy
|
Epilepsy
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
0% - 6%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac failure
|
Cardiac failure
|
0% - 1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
common, 0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypothyroidism
|
Hypothyroidism
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye pruritus
|
Eye pruritus
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteoarthritis
|
Arthropathy
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia
|
Leukopenia
|
very rare, 0% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tension
|
Nervousness
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neutropenia
|
Neutropenia
|
0% - 1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteomyelitis
|
Osteomyelitis
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Periodontal disease
|
Periodontal disease
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rales
|
Rales
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure
|
Renal failure
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion
|
Convulsion
|
uncommon, 0% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stomatitis
|
Stomatitis
|
0% - 3%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
Syncope
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
Syncope
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
0% - 6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
0% - 32.3%
|
20.2% - 28.3%
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Azotaemia
|
Uremia
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Injury
|
Trauma
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurological symptom
|
Neurological symptom
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cholecystitis infective
|
Gangrenous cholecystitis
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
Rigors
|
very common, 0% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine abnormal
|
Serum creatinine abnormal
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Fluid overload
|
Fluid overload
|
very rare, 0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephropathy toxic
|
Nephropathy toxic
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
Sweating increased
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Soft tissue inflammation
|
Soft tissue inflammation
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Local reaction
|
Local reaction
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinorrhoea
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
common, 0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
