|
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
|
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
common, 65% - 65.4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
|
|
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
common, 65% - 65.4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
common, 57%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
very common, 0% - 91.1%
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Renal impairment
|
Kidney function abnormal
|
23% - 57%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal impairment
|
postmarketing, very common
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Function kidney decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
very common, 0% - 47%
|
6.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tremor
|
Tremor
|
very common, 4.5% - 56%
|
1.9%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion
|
Pleural effusion
|
common, 30% - 36%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
Constipation
|
common, 13.6% - 43%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
Asthenia
|
0% - 52%
|
3.2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
1.79% - 15.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Bacterial infection
|
Bacterial infection
|
8.41% - 40.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
Cytomegalovirus infection
|
Cytomegalovirus infection
|
6.25% - 32%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
Pain
|
Pain
|
common, 0% - 63%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
Insomnia
|
very common, 0% - 68%
|
5.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
common, 1% - 59%
|
4.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
common, 1% - 59%
|
4.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
1% - 56%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypophosphataemia
|
Hypophosphataemia
|
common, 3% - 53%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
Influenza-like symptoms
|
22% - 34%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza like illness
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Procedural pain
|
Post procedural pain
|
27% - 29%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection
|
Respiratory tract infection
|
22% - 34.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
16.2% - 28.7%
|
16.6%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
very common, 2% - 72%
|
5.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loose stools
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Hyperkalaemia
|
Hyperkalaemia
|
very common, 9% - 45%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Incision site complication
|
Incision site complication
|
23% - 28%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
Headache
|
very common, 5% - 64%
|
8.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
Creatinine increased
|
19% - 45%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
16.3% - 23.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
common, 1% - 50%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
common, 0% - 25%
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
common, 0% - 25%
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
Myalgia
|
postmarketing, 0% - 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
postmarketing, 1% - 76%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diabetes mellitus
|
Diabetes mellitus
|
very common, 9% - 89.3%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Post transplant diabetes mellitus
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vomiting
|
Vomiting
|
common, 0% - 29%
|
1.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
9.3% - 47%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
common, 1% - 48%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
0% - 35%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fasting
|
Fasting
|
15.7% - 25.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
common, 14% - 24%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea
|
Dyspnoea
|
common, 4% - 29%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
common, 12% - 26%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
common, 6.95% - 92.6%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
common, 13% - 34%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Graft dysfunction
|
Graft dysfunction
|
13.6% - 24%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Primary graft dysfunction
|
postmarketing, common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
Back pain
|
common, 0% - 30%
|
2.5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bronchitis
|
Bronchitis
|
0% - 18%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Paraesthesia
|
Paraesthesia
|
0% - 40%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tingling skin
|
1% - 8%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urea increased
|
Blood urea increased
|
9% - 30%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atelectasis
|
Atelectasis
|
4% - 30%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumothorax
|
Atelectasis
|
4% - 30%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumothorax
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
13% - 19%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness
|
Dizziness
|
common, 4.5% - 19%
|
3.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
0% - 48%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
very common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Application site pruritus
|
Application site pruritus
|
very common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site pain
|
Application site burn
|
very common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site pain
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site burn
|
Application site burn
|
very common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure
|
Renal impairment
|
postmarketing, very common
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Renal failure
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
0% - 28%
|
3.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukopenia
|
Leukopenia
|
common, 10% - 48%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oliguria
|
Oliguria
|
common, 12% - 19%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Opportunistic infection
|
Opportunistic infection
|
15%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
Pruritus
|
Pruritus
|
common, 7% - 46%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
Cough increased
|
1% - 18%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pericardial effusion
|
Pericardial effusion
|
postmarketing — 14% - 15%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
Rash
|
common, 1% - 24%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Rash
|
Rash
|
common, 1% - 24%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin infection
|
Skin infection
|
5% - 16%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
Erythema
|
7% - 28%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
4% - 13%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ascites
|
Ascites
|
common, 7% - 27%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
Leukocytosis
|
common, 8% - 32%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
common, 5% - 34%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
3% - 12.2%
|
5.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
Fatigue
|
1.79% - 15.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
uncommon, 4% - 13%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Otitis media
|
Otitis media
|
2% - 11%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
1% - 8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug ineffective
|
Lack of drug effect
|
0% - 6%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm malignant
|
Neoplasm malignant
|
common
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
Skin cancer
|
Skin cancer
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin carcinoma
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cholestasis
|
Cholestasis
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Confusional state
|
Confusional state
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
postmarketing, common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Flatulence
|
Flatulence
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal bloating
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hallucination
|
Hallucination
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatitis
|
Hepatitis
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oral herpes
|
Herpes labialis
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes virus infection
|
Herpes virus infection
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypocalcaemia
|
Hypocalcaemia
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Inflammation
|
Inflammation
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
postmarketing, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Kaposi's varicelliform eruption
|
Kaposi's varicelliform eruption
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lung disorder
|
Lung disorder
|
common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle spasms
|
Cramp muscle
|
common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Generalised spasm
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nasal congestion
|
Nasal congestion
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing — common
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nightmare
|
Nightmare
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Pain in extremity
|
Pain in extremity
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Neuropathy
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngitis
|
Pharyngitis
|
common, 3% - 12%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion
|
Convulsion
|
postmarketing, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stomatitis
|
Stomatitis
|
common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
Tinnitus
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
Angiopathy
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Weight increased
|
Weight increased
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Burning sensation
|
Burning sensation
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin irritation
|
Skin irritation
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Metabolic acidosis
|
Metabolic acidosis
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Discomfort
|
Discomfort
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Malaise
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Altered state of consciousness
|
Consciousness abnormal
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Depressed mood
|
Depressed mood
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Application site irritation
|
Application site irritation
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instillation site pain
|
Application site pain
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site rash
|
Application site rash
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Affective disorder
|
Affective disorder
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Fluid overload
|
Fluid overload
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgraphia
|
Writing impaired
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephropathy toxic
|
Nephropathy toxic
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephrotoxicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Hyperhidrosis
|
Sweating increased
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Sweating
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood uric acid increased
|
Hyperuricaemia
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperuricaemia
|
Hyperuricaemia
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Application site erythema
|
Application site erythema
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes dermatitis
|
Herpes simplex dermatitis
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal ulcer perforation
|
Gastrointestinal ulcer perforation
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Application site warmth
|
Application site warmth
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety
|
Anxiety symptoms NOS
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Anxiety
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Application site paraesthesia
|
Application site paraesthesia
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
Abdominal bloating
|
common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Enlargement abdomen
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal tubular necrosis
|
Renal tubular necrosis
|
common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash pustular
|
Rash pustular
|
2% - 7%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vesiculobullous rash
|
0% - 4%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
postmarketing, 1% - 6%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Fungal skin infection
|
Fungal skin infection
|
0% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Folliculitis
|
Folliculitis
|
common, 0% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes simplex
|
Herpes simplex
|
common, 0% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
Rhinitis
|
2% - 6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acne
|
Acne
|
uncommon, 0% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
uncommon, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin
|
Haemorrhage
|
uncommon, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ulcer
|
Ulcer
|
rare, common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Skin disorder
|
1% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis contact
|
Dermatitis contact
|
1% - 4%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes zoster
|
Herpes zoster
|
0% - 5%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Varicella zoster
|
0% - 5%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alcohol intolerance
|
Alcohol intolerance
|
common, 0% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Encephalopathy
|
Encephalopathy
|
uncommon, 2.5%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
common, 0% - 1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cellulitis
|
Cellulitis
|
0% - 1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cyst
|
Cyst
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Depression
|
Depression
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
uncommon, 0% - 4%
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Ear pain
|
Ear pain
|
0% - 1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eczema
|
Eczema
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperaesthesia
|
Hyperaesthesia
|
common, 0% - 2%
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth abscess
|
Abscess periodontal
|
0% - 1%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm skin
|
Neoplasm skin
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sunburn
|
Sunburn
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Sunburn
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phototoxicity
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth disorder
|
Tooth disorder
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Vesiculobullous rash
|
0% - 4%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
0% - 7%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
Myalgia
|
postmarketing, 0% - 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash maculo-papular
|
Rash maculo-papular
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
1% - 2%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Procedural complication
|
Procedural complication
|
0% - 1%
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hemiplegia
|
Hemiplegia
|
0.8%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nystagmus
|
Nystagmus
|
0.8%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Delirium
|
Delirium
|
0.2% - 1.2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia
|
Amnesia
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anuria
|
Anuria
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Coagulopathy
|
Coagulopathy
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coma
|
Coma
|
postmarketing — 2.1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Dehydration
|
Dehydration
|
uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure
|
Cardiac failure
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
Hypoglycaemia
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoproteinaemia
|
Hypoproteinaemia
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infarction
|
Infarction
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteoarthritis
|
Arthropathy
|
uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysarthria
|
postmarketing, 0.4%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Palpitations
|
Palpitations
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Ileus paralytic
|
Ileus paralytic
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Paresis
|
Paresis
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Peritonitis
|
Peritonitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
Shock
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Uterine haemorrhage
|
Uterine haemorrhage
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Hyperphosphataemia
|
Hyperphosphataemia
|
uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cataract
|
Cataract
|
uncommon
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Chest discomfort
|
Chest pressure sensation of
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Chest tightness
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pancreatitis acute
|
Pancreatitis acute on chronic
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Ventricular hypertrophy
|
Ventricular hypertrophy
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Arrhythmia supraventricular
|
Arrhythmia supraventricular
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Haemorrhagic stroke
|
Haemorrhagic stroke
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebral haemorrhage
|
Haemorrhagic stroke
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amylase increased
|
Blood amylase increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Amylase increased
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood lactate dehydrogenase increased
|
Blood lactate dehydrogenase increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cardiomyopathy
|
Cardiomyopathy
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Temperature intolerance
|
Temperature intolerance
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paralysis
|
Paralysis
|
uncommon, 0.4%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Dysarthria
|
postmarketing, 0.4%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Paralysis flaccid
|
Paralysis flaccid
|
postmarketing, 0.4%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stupor
|
Stupor
|
0.2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depressed level of consciousness
|
Stupor
|
0.2%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Atrial flutter
|
Atrial flutter
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental disorder
|
Mental disorder
|
postmarketing, common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Basal cell carcinoma
|
Basal cell carcinoma
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carpal tunnel syndrome
|
Carpal tunnel syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebral infarction
|
Cerebral infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cholangitis
|
Cholangitis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Colitis
|
Colitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hearing impaired
|
very rare — uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphagia
|
Dysphagia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disseminated intravascular coagulation
|
Disseminated intravascular coagulation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enterocolitis
|
Enterocolitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic steatosis
|
Liver fatty
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic steatosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Flushing
|
Flushing
|
postmarketing, common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing, 2% - 7.48%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glycosuria
|
Glycosuria
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Graft versus host disease
|
Graft versus host disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Deafness neurosensory
|
Deafness neurosensory
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hemiparesis
|
Hemiparesis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
postmarketing, uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Venoocclusive liver disease
|
Venoocclusive liver disease
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hirsutism
|
Hirsutism
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary hypertension
|
Pulmonary hypertension
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Bullous impetigo
|
Bullous impetigo
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intestinal obstruction
|
Intestinal obstruction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Renal failure acute
|
Renal failure acute
|
postmarketing, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukaemia
|
Leukaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Progressive multifocal leukoencephalopathy
|
Progressive multifocal leukoencephalopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphoma
|
Lymphoma
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Lymphoproliferative disorder
|
Lymphoproliferative disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
X-linked lymphoproliferative syndrome
|
Lymphoproliferative disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Malignant melanoma
|
Malignant melanoma
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Multi-organ failure
|
Multi-organ failure
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertonia
|
Hypertonia
|
rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mutism
|
Mutism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Neutropenia
|
Neutropenia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic atrophy
|
Optic atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Osteomyelitis
|
Osteomyelitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancreatic pseudocyst
|
Pancreatic pseudocyst
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancytopenia
|
Pancytopenia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Quadriplegia
|
Quadriplegia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aplasia pure red cell
|
Aplasia pure red cell
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
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
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Rosacea
|
Rosacea
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sepsis
|
Septicemia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sepsis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Speech disorder
|
Speech disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Status epilepticus
|
Status epilepticus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastric ulcer
|
Gastric ulcer
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thirst
|
Thirst
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Thrombosis
|
Thrombosis
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Torsade de pointes
|
Torsade de pointes
|
very rare — uncommon
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition disorder
|
Micturition disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Ventricular fibrillation
|
Ventricular fibrillation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Photophobia
|
Photophobia
|
postmarketing, common
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis haemorrhagic
|
Cystitis haemorrhagic
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration
|
Mouth ulceration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal perforation
|
Gastrointestinal perforation
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial ischaemia
|
Myocardial ischaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatocellular injury
|
Hepatocellular injury
|
postmarketing, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Liver injury
|
Hepatocellular injury
|
postmarketing, common
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic necrosis
|
Hepatic necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blindness cortical
|
Blindness cortical
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyarthritis
|
Polyarthritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Interstitial lung disease
|
Interstitial lung disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Application site oedema
|
Application site oedema
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lung infiltration
|
Lung infiltration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Activated partial thromboplastin time prolonged
|
Activated partial thromboplastin time prolonged
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ventricular dysfunction
|
Ventricular dysfunction
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Netherton's syndrome
|
Netherton's syndrome
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Bile duct stenosis
|
Bile duct stenosis
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis haemorrhagic
|
Pancreatitis haemorrhagic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis necrotising
|
Pancreatitis necrotising
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukoencephalopathy
|
Leukoencephalopathy
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nerve injury
|
Nerve compression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nerve compression
|
Nerve compression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic artery thrombosis
|
Hepatic artery thrombosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Post transplant lymphoproliferative disorder
|
Post transplant lymphoproliferative disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Electrocardiogram T wave abnormal
|
Electrocardiogram T wave abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blindness
|
Blindness
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory distress
|
Respiratory distress
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Impaired gastric emptying
|
Impaired gastric emptying
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervousness
|
Feeling jittery
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervousness
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling jittery
|
Feeling jittery
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menopausal symptoms
|
Hot flush
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hot flush
|
Hot flush
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mobility decreased
|
Mobility decreased
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Graft loss
|
Graft loss
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Subileus
|
Subileus
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Respiratory failure
|
Respiratory failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deep vein thrombosis
|
Venous thrombosis deep limb
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deep vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatosplenic T-cell lymphoma
|
Hepatosplenic T-cell lymphoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hearing impaired
|
Hearing impaired
|
very rare — uncommon
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyomavirus-associated nephropathy
|
Polyomavirus-associated nephropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Feeling hot
|
Feeling hot
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sensation of warmth
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Factor II deficiency
|
Hypoprothrombinaemia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Hypoprothrombinaemia
|
Hypoprothrombinaemia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cardiac hypertrophy
|
Myocardial hypertrophy
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephropathy
|
Nephropathy
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic failure
|
Hepatic failure
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Fat tissue increased
|
Fat tissue increased
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Echocardiogram abnormal
|
Echocardiogram abnormal
|
very rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Myasthenia
|
very rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abscess
|
Abscess
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acidosis
|
Acidosis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Albuminuria
|
Albuminuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alkalosis
|
Alkalosis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaphylactic shock
|
Anaphylactic shock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Anaphylactoid reaction
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Hypochromic anaemia
|
Hypochromic anaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aphasia
|
Aphasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Arthritis
|
Arthritis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bladder cancer
|
Bladder cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Blepharitis
|
Blepharitis
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
Oral candidiasis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin candida
|
Skin candida
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertrophic cardiomyopathy
|
Hypertrophic cardiomyopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neck pain
|
Neck pain
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Varicella
|
Varicella
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anogenital warts
|
Anogenital warts
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cushing's syndrome
|
Cushing's syndrome
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis
|
Cystitis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder pain
|
Cystitis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dental caries
|
Dental caries
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
0% - 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diabetic nephropathy
|
Diabetic nephropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Duodenitis
|
Duodenitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
Dysgeusia
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear disorder
|
Ear disorder
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Furuncle
|
Furunculosis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glomerulonephritis
|
Glomerulonephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac valve disease
|
Cardiac valve disease
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hernia
|
Hernia
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hiccups
|
Hiccups
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hydronephrosis
|
Hydronephrosis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypercalcaemia
|
Hypercalcaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypotension
|
Hypotension
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypothyroidism
|
Hypothyroidism
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypotrichosis
|
Hypotrichosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Impetigo
|
Impetigo
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Congenital cystic kidney disease
|
Polycystic kidney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Laryngitis
|
Laryngitis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myoclonus
|
Myoclonus
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nail disorder
|
Nail disorder
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephrosclerosis
|
Nephrosclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Tension
|
Nervousness
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuralgia
|
Neuralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nocturia
|
Nocturia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteopenia
|
Osteopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Osteoporosis
|
Osteoporosis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear infection
|
Otitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Otitis externa
|
Otitis externa
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phlebitis
|
Phlebitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polycythaemia
|
Polycythaemia
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Proteinuria
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Protein urine present
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Emphysema
|
Emphysema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pyuria
|
Pyuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Kaposi's sarcoma
|
Kaposi's sarcoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aphthous stomatitis
|
Aphthous stomatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thrombophlebitis
|
Thrombophlebitis
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tinea versicolour
|
Tinea versicolour
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Unintended pregnancy
|
Unintended pregnancy
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal infection
|
Vaginal inflammation
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth
|
Dry mouth
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mycosis fungoides
|
Cutaneous T-cell lymphoma
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary retention
|
Urinary retention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
Chills
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mood swings
|
Mood swings
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Affect lability
|
Mood swings
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epstein-Barr virus infection
|
Epstein-Barr virus infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urge incontinence
|
Urge incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drug level increased
|
Drug level increased
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Conjunctival oedema
|
Conjunctival oedema
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generalised oedema
|
Generalised oedema
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fluid retention
|
Generalised oedema
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Impaired healing
|
Impaired healing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin hypertrophy
|
Skin hypertrophy
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye pain
|
Eye pain
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tendon disorder
|
Tendon disorder
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukoderma
|
Leukoderma
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Elevated mood
|
Elevated mood
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
Thinking abnormal
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental disability
|
Thinking abnormal
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neurotoxicity
|
Neurotoxicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
Respiratory depression
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pulmonary function test decreased
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Granulomatous liver disease
|
Hepatitis granulomatous
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood iron decreased
|
Serum iron decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Papillary thyroid cancer
|
Papillary thyroid cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Productive cough
|
Productive cough
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Haematocrit increased
|
Haematocrit increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight fluctuation
|
Weight fluctuation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Quadriparesis
|
Quadriparesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Monoparesis
|
Monoparesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pneumonia streptococcal
|
Pneumonia due to Streptococcus, group b
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoglobin abnormal
|
Haemoglobin abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophagitis
|
Gastrooesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder spasm
|
Bladder spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bradycardia
|
Bradycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram QRS complex abnormal
|
Electrocardiogram QRS complex abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Prothrombin level decreased
|
Prothrombin level decreased
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperlactacidaemia
|
Hyperlactacidaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypertensive nephropathy
|
Hypertensive nephropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Electrocardiogram ST segment abnormal
|
Electrocardiogram ST segment abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Psychomotor skills impaired
|
Psychomotor skills impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebral ischaemia
|
Cerebral ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Eczema herpeticum
|
Eczema herpeticum
|
common, 0% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ileus
|
Ileus
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiopulmonary failure
|
Cardiopulmonary failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast neoplasm
|
Breast neoplasm
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oesophagitis ulcerative
|
Oesophagitis ulcerative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis allergic
|
Rhinitis allergic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Thrombotic microangiopathy
|
Thrombotic microangiopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Visual impairment
|
Abnormal vision
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin papilloma
|
Warts
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
