|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
|
Oedema peripheral
|
48% - 64%
|
42% - 48%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
very common, 23% - 49%
|
41% - 48%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertriglyceridaemia
|
postmarketing — 45% - 57%
|
23%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Hypercholesterolaemia
|
postmarketing, 23% - 46%
|
20% - 23%
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
Creatinine increased
|
postmarketing, 22% - 40%
|
33% - 38%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
28% - 38%
|
28% - 31%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
10% - 34%
|
20% - 31%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Local reaction
|
34%
|
34%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Body temperature increased
|
19% - 35%
|
23% - 35%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperlipidaemia
|
very common, 23% - 57%
|
20% - 23%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
25% - 39%
|
22% - 29%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal pain
|
very common, 22% - 36%
|
23% - 30%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
20% - 33%
|
21% - 25%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
22% - 40%
|
19% - 28%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
5.1% - 42%
|
14% - 27%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
very common, 21% - 37%
|
14% - 21%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
very common, 19.8% - 33%
|
21.5% - 26%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
very common, 13% - 31%
|
15% - 18%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
19% - 31%
|
16% - 21%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Dyspnoea
|
14% - 30%
|
23% - 30%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
17% - 34%
|
25% - 34%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Back pain
|
16% - 26%
|
17% - 20%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Tremor
|
18% - 31%
|
11% - 19%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Acne
|
very common, 11% - 31%
|
14% - 19%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pyelonephritis
|
postmarketing — 19.8% - 23.1%
|
21.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypophosphataemia
|
postmarketing, 15% - 23%
|
19%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
12% - 24%
|
16% - 19%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Oedema
|
15% - 24%
|
7% - 15%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkalaemia
|
12% - 27%
|
23% - 27%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pharyngitis
|
16% - 22%
|
22%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Weight increased
|
8% - 21%
|
13% - 15%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
7% - 30%
|
3% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Insomnia
|
8% - 22%
|
8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Haematuria
|
13%
|
9%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
13%
|
23%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cough increased
|
13%
|
17%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Leukopenia
|
postmarketing, 8% - 20%
|
2% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dizziness
|
11%
|
8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
postmarketing, 9% - 21%
|
6% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysuria
|
10%
|
6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Rash
|
common, 2% - 20%
|
5% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypotension
|
10%
|
6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Accidental injury
|
9%
|
10%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Enlargement abdomen
|
9%
|
10%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
8%
|
8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Abnormal vision
|
8%
|
6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Ecchymosis
|
7%
|
3%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Wound infection
|
5% - 8.3%
|
6.9%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sepsis
|
postmarketing, 3.7% - 6.7%
|
6.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia
|
6%
|
5%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Oliguria
|
6%
|
10%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Herpes simplex
|
postmarketing, 3.7% - 12.2%
|
6.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Paraesthesia
|
4%
|
6%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
postmarketing — 4%
|
4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Face oedema
|
4%
|
4%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Transplant rejection
|
3%
|
15%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hirsutism
|
3%
|
8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Lymphocele
|
postmarketing — 3%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Osteonecrosis
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Stomatitis
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cytomegalovirus infection
|
0.4% - 4.1%
|
0.8% - 5.4%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Impaired healing
|
postmarketing — 4%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
2%
|
8%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Herpes zoster
|
postmarketing, 1.8% - 2.2%
|
3.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Carcinoma
|
0.4% - 8.8%
|
3.1%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Melanoma skin
|
0.4% - 8.8%
|
3.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Neoplasm malignant
|
postmarketing, 0% - 7%
|
0% - 2.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphoproliferative disorder
|
postmarketing, 0.4% - 1.4%
|
0% - 3.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphoma
|
postmarketing — 0.4% - 1.4%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis
|
postmarketing — 1%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Post transplant lymphoproliferative disorder
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Amenorrhoea
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Ascites
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Azoospermia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Basal cell carcinoma
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Squamous cell carcinoma
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Infection
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis exfoliative
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Effusion
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Enterocolitis
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Focal segmental glomerulosclerosis
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Haemolytic uraemic syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
postmarketing, 13%
|
10%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Nephropathy
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Progressive multifocal leukoencephalopathy
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Lymphoedema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Menorrhagia
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menstrual disorder
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Mycobacterial infection
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nephrotic syndrome
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Neutropenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Ovarian cyst
|
postmarketing, common
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Pancytopenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pericardial effusion
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Pleural effusion
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
postmarketing, 1.2% - 10.3%
|
3.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Proteinuria
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Alveolar proteinosis
|
postmarketing, rare
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Pulmonary embolism
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Pulmonary fibrosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombotic thrombocytopenic purpura
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Tuberculosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Deep vein thrombosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Allergic cutaneous angiitis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Pulmonary haemorrhage
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Liver function test abnormal
|
postmarketing — 9%
|
7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatic necrosis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
rare
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Interstitial lung disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hepatotoxicity
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bronchiolitis obliterans with organizing pneumonia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Incisional hernia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Hepatobiliary disease
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Anaphylactoid reaction
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Cholesterol serum elevated
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Skin carcinoma
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Renal graft loss
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
Venous thromboembolism
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abscess
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Acidosis
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Albuminuria
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Anorexia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Anxiety
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Asthma
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Atelectasis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Atrial fibrillation
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Bacterial infection
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Benign neoplasm of skin
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bone disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Breast disorder
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Obliterative bronchiolitis
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Skin cancer
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Cellulitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Confusional state
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Connective tissue disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Cushing's syndrome
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Cyst
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Deafness
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Dehydration
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Fungal skin infection
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Diabetes mellitus
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Ear pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Eructation
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Flatulence
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Gastritis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Gastrointestinal disorder
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Gingival hyperplasia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Glycosuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Gout
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Hallucination
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac disorder
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Cardiomegaly
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Haemoptysis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hernia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hiccups
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hydronephrosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hyperbilirubinaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypercalcaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypocalcaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypoproteinaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Orthostatic hypotension
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Immune system disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Arthropathy
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Mediastinal disorder
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Malignant melanoma
|
postmarketing — 0% - 1.4%
|
0% - 1.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Metrorrhagia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypertonia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypotonia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Nail disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Neoplasm
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nocturia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Osteoporosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Otitis media
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Palpitations
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Parathyroid disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pelvic pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Peritonitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Polycythaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Polyp
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Polyuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Pruritus
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Pyuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Rectal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Sinusitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin ulcer
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Sweating
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Testicular disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Tetany
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Thrombophlebitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Thrombosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Uremia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Angiopathy
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Viral infection
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Weight decreased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Wound
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Urinary retention
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hepatic failure
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Agitation
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Mood swings
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Hyperphosphataemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Cataract
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Epstein-Barr virus infection
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hormone level abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Arterial anomaly
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood urea increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Cataract specified
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Creatine phosphokinase increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Scrotal oedema
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Skin hypertrophy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Kidney function abnormal
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Lactic dehydrogenase activity increased
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hepatocellular injury
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Circumoral paresthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Decreased tolerance
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Malnutrition
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Fatal outcomes
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Myalgia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bladder pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Blood creatinine increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Urine abnormality
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Infection susceptibility increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Erectile dysfunction
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Organising pneumonia
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Hepatic artery thrombosis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Chronic allograft nephropathy
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Laboratory test abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Neuropathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Fluid overload
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Renal pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Nephropathy toxic
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperuricaemia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Hyperlactacidaemia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Serum triglycerides increased
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Infestation NOS
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Blood and lymphatic system disorders
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenic purpura
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
Carcinogenicity
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Graft loss
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Cyclosporine toxicity
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Ileus
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pneumocystis jirovecii pneumonia
|
0% - 0.4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal tubular necrosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Acute allograft rejection
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Somnolence
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
