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
|
Hirsutism
|
Hirsutism
|
postmarketing, 1% - 45%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
postmarketing, 0% - 21.1%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
postmarketing, 15.9% - 18.4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
postmarketing, very common
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Tremor
|
Tremor
|
postmarketing — 0% - 55%
|
4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling hot
|
Sensation of heat
|
7.53% - 11.1%
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Oedema
|
Oedema
|
postmarketing — 1% - 31.1%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
postmarketing, 7.5% - 9.6%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Skin infection
|
Skin infection
|
7% - 10.1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Wound
|
Wound
|
7% - 10.1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
postmarketing, 0% - 9.2%
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 3.2% - 15.6%
|
4%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Stinging
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephropathy toxic
|
Nephropathy toxic
|
0% - 5.7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Nephrotoxicity
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Septicemia
|
4.8% - 5.3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Gingival hyperplasia
|
Gingival hyperplasia
|
postmarketing — 0% - 16%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection susceptibility increased
|
Infection susceptibility increased
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Fluid retention
|
Fluid retention
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Abscess
|
Abscess
|
postmarketing, 4.4% - 5.3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 1% - 23%
|
14%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing — 1% - 15.6%
|
5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
postmarketing — 3%
|
3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 1% - 13%
|
8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing — 3% - 8%
|
7%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Asthenia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing — 3% - 8%
|
7%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
postmarketing, 0% - 7%
|
3%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Systemic mycosis
|
Systemic mycosis
|
2.2% - 3.9%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing — 1% - 25%
|
9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
common, 0% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Cramps of lower extremities
|
postmarketing, 2% - 12%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Muscle spasms
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Acne
|
Acne
|
postmarketing, 1% - 8%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
Renal tubular necrosis
|
Nephrosis lower nephron
|
0% - 2.6%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing — 0% - 11.1%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Tingling sensation
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
postmarketing — 1% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Rigors
|
postmarketing, 1% - 4%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebellar ataxia
|
Cerebellar ataxia
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Coma
|
Coma
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Paresis
|
Paresis
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Encephalopathy
|
Encephalopathy
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Agitation
|
Agitation
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Blindness cortical
|
Blindness cortical
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Disorientation
|
Disorientation
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Visual impairment
|
Visual disturbance
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Abnormal vision
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Visual impairment
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Deafness
|
Hearing impaired
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing — 0% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing — 0% - 19%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphoma
|
Lymphoma
|
0% - 6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
0% - 6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing, 1% - 7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Lymphoproliferative disorder
|
Lymphoproliferative disorder
|
0% - 0.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
X-linked lymphoproliferative syndrome
|
Lymphoproliferative disorder
|
0% - 0.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing, 0% - 7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 2.7% - 15%
|
10%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Stomach ache
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 2.7% - 15%
|
10%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Pancreatitis acute
|
Pancreatitis acute
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Alopecia
|
Alopecia
|
postmarketing, 0% - 4%
|
4%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing — common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing, 2% - 5%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, 1.1% - 6%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, 1.1% - 6%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Rheumatoid arthritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Coagulopathy
|
Coagulopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing, 4.9% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
postmarketing, 1% - 3%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Bursitis
|
Bursitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Carcinoma
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Malignant solid tumour
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Cellulitis
|
Cellulitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing, 4% - 6%
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Cholestasis
|
Cholestasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Infection
|
Infection
|
postmarketing, 0% - 24.7%
|
10%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Constipation
|
Constipation
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
postmarketing, 3% - 5%
|
4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Libido increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
postmarketing, 1% - 6%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dermatitis
|
Dermatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rash
|
postmarketing — 7% - 12%
|
10%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Joint dislocation
|
Joint dislocation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 6% - 8%
|
3%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing, 2.2% - 12%
|
4%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Digestion impaired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 1% - 5%
|
2%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
postmarketing, 0% - 1%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ear disorder
|
Ear disorder
|
postmarketing, 0% - 5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Enanthema
|
Enanthema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 7% - 12%
|
10%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 0% - 4%
|
4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
postmarketing, 4% - 5%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Flushing
|
Flushing
|
postmarketing — 0% - 5%
|
2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Folliculitis
|
Folliculitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Multiple fractures
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Fracture
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 0% - 4%
|
0%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Digestion impaired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal symptom NOS
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Gingival bleeding
|
Gingival bleeding
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
postmarketing, 0% - 4%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Goitre
|
Goitre
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing, common
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
postmarketing — 0% - 53%
|
2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertrichosis
|
Hypertrichosis
|
postmarketing — 5.4% - 37.8%
|
3%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Serum triglycerides increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Salivary gland enlargement
|
Salivary gland enlargement
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Arthropathy
|
Arthropathy
|
postmarketing, 0% - 5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
postmarketing, 0% - 5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperkeratosis
|
Keratosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nephropathy
|
Nephropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Progressive multifocal leukoencephalopathy
|
Progressive multifocal leukoencephalopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
x
|
Vaginal discharge
|
Leukorrhea
|
postmarketing, 0% - 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
postmarketing, 1% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Myositis
|
Myositis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Nail disorder
|
Nail disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nightmare
|
Nightmare
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nocturia
|
Nocturia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Peptic ulcer
|
Peptic ulcer
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Neuropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
postmarketing, 3% - 5%
|
4%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Plaque psoriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Purpura
|
Purpura
|
postmarketing, 2% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
postmarketing, 2% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Pyelonephritis
|
Pyelonephritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
postmarketing, 0% - 5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
postmarketing, 0% - 1%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing, 5% - 7%
|
8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue disorder
|
Tongue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tonsillitis
|
Tonsillitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
postmarketing, 7.7% - 11.3%
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
postmarketing, 2% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Uterine haemorrhage
|
Uterine haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Vestibular disorder
|
Vestibular disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
postmarketing — common
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
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
|
x
|
x
|
Injury
|
Trauma
|
postmarketing, 0% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Synovial cyst
|
Synovial cyst
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cataract
|
Cataract
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
postmarketing, 2% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Renal abscess
|
Renal abscess
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Creatinine increased
|
postmarketing, 15.7% - 19.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Serum creatinine increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Swelling face
|
Swelling face
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
postmarketing — 0% - 6%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatocellular injury
|
Hepatocellular injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Liver injury
|
Hepatocellular injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Liver injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Eye pain
|
Eye pain
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tendon disorder
|
Tendon disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Polyneuropathy
|
Polyneuropathy
|
rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Pustular psoriasis
|
Pustular psoriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breath sounds abnormal
|
Abnormal chest sounds NOS
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Traumatic liver injury
|
Liver injury
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Microangiopathic haemolytic anaemia
|
Microangiopathic haemolytic anaemia
|
rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
postmarketing, 2% - 12%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Contraction skeletal muscle
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Disturbance in attention
|
Cerebration impaired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mental disability
|
Cerebration impaired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urine abnormality
|
Urine abnormality
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urine analysis abnormal
|
Urine abnormality
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Bullous eruption
|
postmarketing, 0% - 1%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pharyngeal oedema
|
Pharyngeal oedema
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Swollen tongue
|
Swollen tongue
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interstitial lung disease
|
Lung fibrosis interstitial
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing, 0% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Eye swelling
|
Eye swelling
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Azotaemia
|
Uraemic syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Atrophy
|
Atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Influenza like illness
|
Influenza-like symptoms
|
postmarketing, 1% - 9.9%
|
2%
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Musculoskeletal stiffness
|
Stiffness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Heart sounds abnormal
|
Heart sounds abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
postmarketing, common
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
postmarketing, common
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythrodermic psoriasis
|
Erythrodermic psoriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure
|
Progressive renal failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Renal failure
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Graft loss
|
Graft loss
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
Renal graft loss
|
Renal graft loss
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Insomnia
|
Insomnia
|
postmarketing — 1% - 4%
|
2%
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Autonomic neuropathy
|
Unspecified disorder of autonomic nervous system
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pigmentation disorder
|
Abnormal pigmentation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Fibroadenoma of breast
|
Fibroadenosis of breast
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Polyomavirus-associated nephropathy
|
Polyomavirus-associated nephropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
Gout
|
Gout attack
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Thrombotic microangiopathy
|
Thrombotic microangiopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Somnolence
|
Somnolence
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Optic neuritis
|
Papilloedema
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Papilloedema
|
Papilloedema
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Benign intracranial hypertension
|
Benign intracranial hypertension
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Skin cancer
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Skin cancer
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x
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x
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x
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Cyst
|
Cyst
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x
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x
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x
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x
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|
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Gingival disorder
|
Gingival disorder
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x
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Gingival hypertrophy
|
Gingival hypertrophy
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x
|
x
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Hiccups
|
Hiccups
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|
|
|
|
|
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x
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x
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x
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x
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x
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x
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|
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x
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|
|
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x
|
x
|
x
|
x
|
Hodgkin's disease
|
Hodgkin's disease
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|
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x
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x
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x
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Hodgkin's disease lymphocyte depletion type stage unspecified
|
Hodgkin's disease
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x
|
x
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x
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Hodgkin's disease lymphocyte predominance type stage unspecified
|
Hodgkin's disease
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x
|
x
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x
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Hypotrichosis
|
Hypotrichosis
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x
|
x
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x
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Mediastinal disorder
|
Mediastinal disorder
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x
|
x
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Night sweats
|
Night sweats
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x
|
x
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x
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x
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x
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x
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|
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x
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x
|
x
|
x
|
x
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Obstruction
|
Obstruction
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x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
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x
|
x
|
x
|
x
|
Polyp
|
Polyp
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x
|
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x
|
x
|
x
|
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Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
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|
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x
|
x
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Thrombosis
|
Thrombosis
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|
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x
|
x
|
x
|
x
|
x
|
x
|
|
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x
|
|
|
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x
|
x
|
x
|
x
|
Upper gastrointestinal haemorrhage
|
Upper gastrointestinal haemorrhage
|
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|
|
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x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
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|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
Burning sensation
|
Burning sensation
|
|
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|
|
x
|
x
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
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Hypocholesterolaemia
|
Hypocholesterolaemia
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Lacrimation increased
|
Lacrimation increased
|
|
|
x
|
x
|
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|
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|
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Abdominal pain upper
|
Stomach ache
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperamylasaemia
|
Hyperamylasaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Renal impairment
|
Function kidney decreased
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Hallucination, visual
|
Hallucination, visual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Altered state of consciousness
|
Consciousness abnormal
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Anaphylactic shock
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
Vision blurred
|
Vision blurred
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensation of foreign body
|
Sensation of foreign body
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Toxicity to various agents
|
Cyclosporine toxicity
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Transplant failure
|
Transplant failure
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctival hyperaemia
|
Conjunctival hyperaemia
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|