MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
50.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
0.7% - 95%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
43.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
35.3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
23.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
White blood cell count decreased
|
White blood cell count decreased
|
2% - 43%
|
0% - 13%
|
|
|
|
|
x
|
x
|
x
|
Blood calcium decreased
|
Calcium low
|
0.5% - 37%
|
0% - 12%
|
|
|
|
|
|
x
|
|
Lymphocyte count decreased
|
Lymphocyte count decreased
|
2% - 51%
|
0% - 28%
|
|
|
|
|
x
|
x
|
|
Asthenia
|
Asthenia
|
very common, 0% - 19%
|
0% - 20%
|
|
|
|
x
|
x
|
x
|
|
Fatigue
|
common — 0% - 45%
|
0% - 27%
|
|
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
common — 0% - 50%
|
0% - 25%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common — 0% - 30%
|
0% - 15%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
very common, 0% - 85%
|
0% - 46%
|
|
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
very common, 25%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Fasting hyperglycaemia
|
0% - 14%
|
0% - 8%
|
|
|
|
|
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
common — 9.54% - 52.2%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
very common, 0% - 44.9%
|
0% - 8%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
1% - 92%
|
1% - 79%
|
|
|
|
|
x
|
x
|
|
Blood glucose increased
|
Glucose increased
|
1% - 57%
|
0% - 25%
|
|
|
|
|
x
|
x
|
|
Nausea
|
Nausea
|
common — 0% - 32%
|
0% - 33%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
common — 0% - 47.4%
|
0% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood potassium decreased
|
Potassium low
|
4% - 23%
|
0% - 5%
|
|
|
|
|
x
|
x
|
|
Tremor
|
Tremor
|
12%
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
common — 2.07% - 12.9%
|
|
|
x
|
|
x
|
x
|
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
common — 0% - 24.9%
|
0% - 0.5%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
common — 0% - 31%
|
0% - 18%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common — 0% - 36%
|
1% - 32%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common — 0% - 36%
|
1% - 32%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
common — 0% - 21%
|
0% - 13%
|
|
|
x
|
x
|
x
|
x
|
x
|
Blood phosphorus decreased
|
Phosphate low
|
0% - 40%
|
0% - 14%
|
|
|
|
|
x
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
9.96%
|
|
|
x
|
|
|
|
|
x
|
Pain
|
Pain
|
very common, 3.27% - 15.4%
|
|
x
|
x
|
|
|
|
|
x
|
Weight decreased
|
Weight decreased
|
common — 0% - 28%
|
0% - 11%
|
|
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
common — 0% - 29%
|
0% - 21%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
common — 0% - 78%
|
0% - 26%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
common — 1.24% - 9.39%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Hyponatraemia
|
Sodium decreased
|
1% - 16%
|
1% - 16%
|
|
|
|
|
|
x
|
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
very common, 0% - 21%
|
0% - 3%
|
|
x
|
|
|
|
x
|
x
|
Blood creatinine increased
|
Creatinine increased
|
0% - 50%
|
0% - 34%
|
|
|
|
|
x
|
x
|
|
Blood creatinine increased
|
common
|
|
|
|
|
x
|
x
|
|
x
|
Serum creatinine increased
|
|
|
|
|
x
|
|
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
0% - 74%
|
0% - 66%
|
|
|
|
|
x
|
x
|
|
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
|
x
|
Hepatitis C
|
Hepatitis C
|
7.88%
|
|
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
common — 0.5% - 20%
|
0% - 7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood albumin decreased
|
Albumin low
|
1% - 13%
|
0% - 8%
|
|
|
|
|
|
x
|
|
Insomnia
|
Insomnia
|
uncommon — 0% - 26.9%
|
0% - 8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
common — 1.24% - 9.39%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Constipation
|
Constipation
|
common — 0% - 42.9%
|
0% - 13%
|
|
x
|
x
|
|
x
|
x
|
x
|
Cough
|
Cough
|
common — 0% - 25%
|
0% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
common, 0% - 15%
|
0% - 7%
|
|
x
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
common, 0% - 15%
|
0% - 7%
|
|
x
|
|
x
|
x
|
x
|
x
|
Myalgia
|
common, 1.66% - 7.17%
|
|
x
|
x
|
|
|
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
6%
|
|
|
|
|
|
|
x
|
|
Metrorrhagia
|
Metrorrhagia
|
6%
|
|
|
|
|
|
|
x
|
|
Menorrhagia
|
Menorrhagia
|
common, 6% - 10%
|
|
|
|
x
|
|
x
|
x
|
|
Decreased appetite
|
Decreased appetite
|
common — 0% - 30%
|
0% - 18%
|
|
|
x
|
x
|
x
|
x
|
x
|
Anorexia
|
|
|
|
|
|
|
|
x
|
x
|
Embolism
|
Thromboembolic event
|
very common, 1.24% - 12.2%
|
|
|
x
|
|
|
|
|
|
Alopecia
|
Alopecia
|
common
|
|
|
|
x
|
x
|
|
x
|
x
|
Anaemia
|
Anaemia
|
common — 0% - 61%
|
0% - 49%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cellulitis
|
Cellulitis
|
common, 29%
|
|
|
|
x
|
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
5%
|
|
|
|
|
|
|
x
|
x
|
Chest discomfort
|
|
|
|
|
|
|
|
|
x
|
Dysphagia
|
Dysphagia
|
common, 4%
|
|
|
|
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
common
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
common — 0% - 19%
|
0% - 5%
|
|
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
common
|
|
|
|
|
x
|
x
|
|
x
|
Epistaxis
|
Epistaxis
|
common — 0% - 22%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
common — 0% - 59%
|
0% - 19%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
common — 0% - 59%
|
0% - 19%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
common — 0% - 45%
|
0% - 27%
|
|
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
common
|
|
|
|
x
|
|
x
|
|
x
|
Gastritis
|
Gastritis
|
common
|
|
|
|
x
|
|
x
|
|
|
Gingivitis
|
Gingivitis
|
common
|
|
|
|
x
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
common, 3%
|
|
|
|
x
|
x
|
x
|
x
|
|
Haemoglobin
|
Haemorrhage
|
common, 3%
|
|
|
|
x
|
x
|
x
|
x
|
|
Haemorrhoids
|
Haemorrhoids
|
5%
|
|
|
|
|
|
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
common, 0% - 52%
|
0% - 15%
|
|
|
x
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
common, 0% - 52%
|
0% - 15%
|
|
|
x
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
|
|
|
|
|
|
|
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
common
|
|
|
|
|
x
|
|
|
x
|
Irritability
|
Irritability
|
common
|
|
|
|
x
|
|
x
|
|
|
Leukopenia
|
Leukopenia
|
common, 0% - 37%
|
0% - 21%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphopenia
|
Lymphopenia
|
common, 0% - 20%
|
0% - 8%
|
|
|
x
|
x
|
x
|
x
|
|
Nail disorder
|
Nail disorder
|
common, 0% - 22%
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
|
Nasopharyngitis
|
Nasopharyngitis
|
common, 0% - 25%
|
0% - 13%
|
|
|
x
|
|
x
|
x
|
x
|
Rhinorrhoea
|
3%
|
|
|
|
|
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
common, 0% - 46%
|
0% - 41%
|
|
|
x
|
x
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
common, 6%
|
|
|
|
x
|
|
x
|
x
|
|
Ovarian cyst
|
Ovarian cyst
|
common
|
|
|
|
x
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
5%
|
|
|
|
|
|
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
common
|
|
|
|
x
|
|
x
|
|
|
Pneumonia
|
Pneumonia
|
uncommon — 0.5% - 17%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infectious pneumonitis
|
|
|
|
|
|
|
|
x
|
x
|
Renal failure
|
Renal failure
|
common, 3%
|
|
|
|
x
|
x
|
x
|
x
|
|
Renal impairment
|
|
|
|
|
|
|
|
|
x
|
Pharyngitis streptococcal
|
Pharyngitis streptococcal
|
common, 0% - 10%
|
0% - 3%
|
|
|
x
|
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
common
|
|
|
|
x
|
|
x
|
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
common
|
|
|
|
x
|
x
|
x
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
common — 0% - 19%
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
common, 0% - 16%
|
0% - 6%
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
common, 0% - 11%
|
0% - 4%
|
|
|
|
x
|
x
|
x
|
|
Hypophosphataemia
|
Hypophosphataemia
|
common, 0% - 49%
|
0% - 15%
|
|
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
common
|
|
|
|
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
common
|
|
x
|
|
|
x
|
x
|
x
|
|
Dry skin
|
Dry skin
|
common, 0% - 13%
|
0% - 6%
|
|
|
x
|
x
|
x
|
x
|
|
Viral diarrhoea
|
Viral diarrhoea
|
common
|
|
|
|
x
|
|
x
|
|
|
Menstruation irregular
|
Menstruation irregular
|
uncommon — 6% - 10%
|
|
|
|
x
|
x
|
x
|
x
|
|
Oral pain
|
Oral pain
|
common
|
|
|
|
x
|
x
|
x
|
|
|
Myalgia
|
Myalgia
|
common, 1.66% - 7.17%
|
|
x
|
x
|
|
|
|
|
x
|
Dermatitis acneiform
|
Dermatitis acneiform
|
common, 3%
|
|
|
|
x
|
|
x
|
x
|
x
|
Tongue ulceration
|
Tongue ulceration
|
common
|
|
|
|
|
x
|
x
|
|
|
Lung infiltration
|
Lung infiltration
|
common
|
|
|
|
|
x
|
x
|
|
|
Skin exfoliation
|
Skin exfoliation
|
common
|
|
|
|
|
x
|
|
|
|
Menstruation delayed
|
Menstruation delayed
|
common
|
|
|
|
x
|
|
x
|
|
|
Mucosal inflammation
|
Mucosal inflammation
|
common
|
|
|
|
|
x
|
x
|
x
|
|
Alveolitis
|
Alveolitis
|
common
|
|
|
|
|
x
|
x
|
|
|
Acne
|
Acne
|
common, 0% - 22%
|
0% - 5%
|
|
x
|
x
|
|
x
|
x
|
|
Pulmonary alveolar haemorrhage
|
Pulmonary alveolar haemorrhage
|
common
|
|
|
|
|
x
|
x
|
|
|
Blood luteinising hormone increased
|
Blood luteinising hormone increased
|
common
|
|
|
|
x
|
|
x
|
|
|
Gonadotropic luteinizing hormone increased
|
|
|
x
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Blood lactate dehydrogenase increased
|
common
|
|
|
|
x
|
|
x
|
|
|
Pulmonary toxicity
|
Pulmonary toxicity
|
common
|
|
|
|
|
x
|
x
|
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
common, 8%
|
|
|
|
x
|
|
x
|
x
|
|
Pleural effusion
|
Pleural effusion
|
1.83% - 25.4%
|
|
x
|
x
|
|
|
|
x
|
x
|
Skin lesion
|
Skin lesion
|
common, 4%
|
|
|
|
|
x
|
|
x
|
|
Erythema
|
Erythema
|
uncommon — 4%
|
|
|
|
x
|
x
|
x
|
x
|
|
Eyelid oedema
|
Eyelid oedema
|
common, 4%
|
|
|
|
|
x
|
|
x
|
|
Onychoclasis
|
Onychoclasis
|
common, 4%
|
|
|
|
|
x
|
|
x
|
|
Oropharyngeal pain
|
Oropharyngeal pain
|
common, 0% - 11%
|
0% - 6%
|
x
|
x
|
|
|
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
0% - 14%
|
0% - 6%
|
|
|
|
|
|
x
|
x
|
Tachycardia
|
Tachycardia
|
common, 2.04% - 7.09%
|
|
|
x
|
|
|
|
x
|
x
|
Proteinuria
|
Proteinuria
|
uncommon — 0.83% - 9.12%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Protein urine present
|
Proteinuria
|
uncommon — 0.83% - 9.12%
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Gastroenteritis
|
Gastroenteritis
|
1% - 10%
|
0% - 3%
|
|
|
|
|
|
x
|
x
|
Chills
|
Chills
|
4%
|
|
|
|
|
|
|
x
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
4%
|
|
|
|
|
|
|
x
|
|
Dizziness
|
Dizziness
|
0% - 12%
|
0% - 7%
|
|
|
|
|
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
Blood potassium increased
|
Potassium increased
|
0% - 7%
|
0.5% - 10%
|
|
|
|
|
|
x
|
|
Hepatic enzyme abnormal
|
Hepatic enzyme abnormal
|
1.87% - 9.96%
|
|
x
|
x
|
|
|
|
|
|
Lymphocele
|
Lymphocele
|
0% - 7.66%
|
|
x
|
x
|
|
|
|
|
x
|
Incisional hernia
|
Incisional hernia
|
common, 1.1% - 6.94%
|
|
x
|
x
|
|
|
|
|
x
|
Malaise
|
Malaise
|
0.5% - 45%
|
0.5% - 27%
|
|
|
|
|
|
x
|
x
|
Discomfort
|
Malaise
|
0.5% - 45%
|
0.5% - 27%
|
|
|
|
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
0.5% - 45%
|
0.5% - 27%
|
|
|
|
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
0.5% - 45%
|
0.5% - 27%
|
|
|
|
|
|
x
|
x
|
Pain in jaw
|
Pain in jaw
|
3%
|
|
|
|
|
|
|
x
|
|
Platelet count decreased
|
Platelet count decreased
|
0% - 45%
|
0% - 11%
|
|
|
|
|
x
|
x
|
|
Rhinorrhoea
|
Rhinorrhoea
|
3%
|
|
|
|
|
|
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
rare — common
|
|
|
|
x
|
x
|
x
|
x
|
|
Amenorrhea secondary
|
|
|
|
|
|
x
|
x
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
common, 1.22% - 5.38%
|
|
x
|
x
|
|
|
|
|
x
|
Thrombosis
|
Thrombosis
|
common, 1.1% - 2.19%
|
|
|
x
|
|
|
|
x
|
x
|
Dyspnoea exertional
|
Dyspnoea exertional
|
0.5% - 20%
|
0% - 7%
|
|
|
|
|
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
uncommon, 2%
|
|
|
|
|
x
|
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing — 1.22% - 5.02%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Back pain
|
Back pain
|
0% - 15%
|
0% - 11%
|
|
|
|
|
|
x
|
x
|
Oedema
|
Oedema
|
0.5% - 39%
|
0% - 12%
|
x
|
|
|
|
|
x
|
x
|
Respiratory tract infection
|
Respiratory tract infection
|
1% - 31%
|
0% - 23%
|
|
|
|
|
|
x
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
1% - 10%
|
0% - 14%
|
|
|
|
|
|
x
|
x
|
Interstitial lung disease
|
Interstitial lung disease
|
common, 0.408% - 2.51%
|
|
x
|
x
|
|
x
|
x
|
|
x
|
Pancytopenia
|
Pancytopenia
|
uncommon — 0% - 3.67%
|
|
x
|
x
|
|
x
|
x
|
|
x
|
Renal failure acute
|
Acute respiratory failure
|
0.7%
|
|
|
|
|
|
|
x
|
|
Renal failure acute
|
uncommon, 0.4%
|
|
|
|
|
x
|
x
|
x
|
x
|
Acute respiratory failure
|
Acute respiratory failure
|
0.7%
|
|
|
|
|
|
|
x
|
|
Pericardial effusion
|
Pericardial effusion
|
0.365% - 39.8%
|
|
x
|
x
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing — 0% - 1.43%
|
|
x
|
x
|
|
|
|
|
x
|
Aggression
|
Aggression
|
uncommon, 0% - 21%
|
0% - 3%
|
|
|
x
|
|
x
|
x
|
|
Flushing
|
Flushing
|
uncommon
|
|
|
|
|
x
|
|
|
|
Glossodynia
|
Glossodynia
|
uncommon
|
|
|
|
|
x
|
x
|
|
|
Glossitis
|
Glossitis
|
uncommon
|
|
|
|
x
|
x
|
x
|
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
uncommon, 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
uncommon
|
|
|
|
|
x
|
x
|
|
|
Herpes zoster
|
Herpes zoster
|
uncommon
|
|
|
|
x
|
x
|
x
|
|
|
Hypersensitivity
|
Hypersensitivity
|
uncommon, 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
uncommon, 0% - 2.07%
|
|
x
|
x
|
|
|
|
|
|
Opportunistic infection
|
Opportunistic infection
|
uncommon
|
|
|
|
|
x
|
x
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
uncommon
|
|
|
|
x
|
|
|
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
uncommon, 1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Rash macular
|
Rash macular
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Rash erythematous
|
Rash erythematous
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Gingival pain
|
Gingival pain
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Sepsis
|
Sepsis
|
uncommon
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Cheilitis
|
Lip ulceration
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Lip pain
|
Lip ulceration
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Lip ulceration
|
Lip ulceration
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Bronchitis viral
|
Bronchitis viral
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Non-cardiac chest pain
|
Non-cardiac chest pain
|
uncommon
|
|
|
|
|
x
|
x
|
|
|
Rash generalised
|
Rash generalised
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Blood follicle stimulating hormone increased
|
Blood follicle stimulating hormone increased
|
uncommon
|
|
|
|
x
|
|
x
|
|
|
Ageusia
|
Ageusia
|
uncommon
|
|
|
|
|
x
|
x
|
|
|
Renal tubular necrosis
|
Renal tubular necrosis
|
0% - 5.47%
|
|
x
|
x
|
|
|
|
|
|
Migraine
|
Migraine
|
0% - 30%
|
0% - 15%
|
|
|
|
|
|
x
|
x
|
Impaired healing
|
Impaired healing
|
rare — 1%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Productive cough
|
Productive cough
|
0% - 25%
|
0% - 13%
|
|
|
|
|
|
x
|
|
Hepatitis
|
Hepatitis
|
uncommon, 0.358% - 2.07%
|
|
x
|
x
|
|
|
|
|
|
Coagulopathy
|
Coagulopathy
|
uncommon, 0% - 0.733%
|
|
x
|
x
|
|
|
|
|
|
Wound complication
|
Wound complication
|
uncommon, 0% - 0.373%
|
|
x
|
x
|
|
|
|
|
|
Aplasia pure red cell
|
Aplasia pure red cell
|
rare, uncommon
|
|
|
|
|
x
|
x
|
|
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
rare, uncommon
|
|
|
|
|
x
|
x
|
|
|
Pancreatitis acute
|
Pancreatitis acute
|
postmarketing
|
|
|
|
|
|
|
x
|
|
Cholecystitis
|
Cholecystitis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
Cholelithiasis
|
Cholelithiasis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
Infertility male
|
Infertility male
|
postmarketing
|
|
|
|
|
|
|
|
x
|
Cervicobrachial syndrome
|
Reflex sympathetic dystrophy
|
postmarketing
|
|
|
|
|
|
|
x
|
|
Complex regional pain syndrome
|
Reflex sympathetic dystrophy
|
postmarketing
|
|
|
|
|
|
|
x
|
|
Abdominal distension
|
Abdominal distension
|
|
|
|
|
|
|
|
|
x
|
Acidosis
|
Acidosis
|
|
|
|
|
|
|
|
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
|
x
|
Ascites
|
Ascites
|
|
|
|
|
|
|
|
|
x
|
Aspergillus infection
|
Aspergillosis
|
|
|
|
|
|
x
|
x
|
|
|
Atelectasis
|
Atelectasis
|
|
|
|
|
|
|
|
|
x
|
Pneumothorax
|
Atelectasis
|
|
|
|
|
|
|
|
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
|
|
|
|
|
|
|
|
x
|
Bacteraemia
|
Bacteraemia
|
|
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast cancer
|
Breast cancer
|
|
|
|
|
|
|
x
|
|
|
Breast disorder
|
Breast disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
x
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
x
|
Candida infection
|
Candida infection
|
|
|
|
|
|
x
|
x
|
|
x
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
x
|
Basal cell carcinoma
|
Basal cell carcinoma
|
|
|
|
|
|
|
|
|
x
|
Squamous cell carcinoma
|
Squamous cell carcinoma
|
|
|
|
|
|
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cytomegalovirus infection
|
Cytomegalovirus infection
|
|
|
|
|
|
|
|
|
x
|
Sudden death
|
Sudden death
|
|
|
|
|
|
|
|
x
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
|
|
|
x
|
|
|
|
|
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
x
|
Endocrine disorder
|
Endocrine disorder
|
|
|
x
|
x
|
|
|
|
|
x
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
x
|
|
x
|
x
|
Fibrosis
|
Fibrosis
|
|
|
x
|
|
|
|
|
|
|
Folliculitis
|
Folliculitis
|
|
|
|
|
|
|
|
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
x
|
Gingival hypertrophy
|
Gingival hypertrophy
|
|
|
|
|
|
|
|
|
x
|
Glioblastoma
|
Glioblastoma
|
|
|
|
|
|
|
|
|
x
|
Glomerulonephritis
|
Glomerulonephritis
|
|
|
|
|
|
|
|
|
x
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
x
|
Hallucination
|
Hallucination
|
|
|
|
|
|
|
|
|
x
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
|
|
|
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Cardiac failure
|
Cardiac failure
|
|
|
|
|
x
|
|
|
|
|
Haematemesis
|
Haematemesis
|
|
|
|
|
|
|
|
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
|
x
|
|
Haematoma
|
Haematoma
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
x
|
Hemiparesis
|
Hemiparesis
|
|
|
|
|
|
|
|
|
x
|
Haemolytic uraemic syndrome
|
Haemolytic uraemic syndrome
|
|
|
x
|
|
|
|
|
|
x
|
Hepatitis B
|
Hepatitis B
|
|
|
|
|
|
x
|
x
|
|
|
Hepatitis B reactivation
|
|
|
|
|
x
|
x
|
x
|
|
|
Chronic hepatitis
|
Chronic hepatitis
|
|
|
|
|
|
|
|
|
x
|
Herpes virus infection
|
Herpes virus infection
|
|
|
|
|
|
|
|
|
x
|
Hirsutism
|
Hirsutism
|
|
|
|
|
|
|
|
|
x
|
Histiocytosis
|
Histiocytosis
|
|
|
|
|
|
|
|
|
x
|
Hydronephrosis
|
Hydronephrosis
|
|
|
|
|
|
|
|
|
x
|
Hypercalcaemia
|
Hypercalcaemia
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
|
|
|
|
|
|
|
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
x
|
Hyperparathyroidism
|
Hyperparathyroidism
|
|
|
|
|
|
|
|
|
x
|
Hypertensive crisis
|
Hypertensive crisis
|
|
|
|
|
|
|
|
|
x
|
Hypertrichosis
|
Hypertrichosis
|
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
|
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
x
|
x
|
Hypotension
|
Hypotension
|
|
|
|
|
|
|
|
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
x
|
x
|
x
|
|
|
Inflammation
|
Inflammation
|
|
|
x
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
x
|
Seborrhoeic keratosis
|
Seborrhoeic keratosis
|
|
|
|
|
|
|
|
|
x
|
Lethargy
|
Lethargy
|
|
|
|
|
|
|
|
|
x
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
|
x
|
Cirrhosis alcoholic
|
Cirrhosis alcoholic
|
|
|
|
|
|
|
|
|
x
|
Liver disorder
|
Liver disorder
|
|
|
x
|
|
|
|
|
|
|
Hepatocellular injury
|
Liver disorder
|
|
|
x
|
|
|
|
|
|
|
Foetor hepaticus
|
Liver disorder
|
|
|
x
|
|
|
|
|
|
|
Lymphoma
|
Lymphoma
|
|
|
x
|
x
|
|
|
|
|
x
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
x
|
x
|
|
|
|
|
x
|
Lymphoproliferative disorder
|
Lymphoproliferative disorder
|
|
|
x
|
x
|
|
|
|
|
x
|
X-linked lymphoproliferative syndrome
|
Lymphoproliferative disorder
|
|
|
x
|
x
|
|
|
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
|
|
|
|
|
|
x
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
|
|
|
|
|
|
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
|
|
|
|
|
|
|
x
|
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
|
|
|
x
|
|
|
|
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
|
|
|
|
|
|
|
|
x
|
Nephrosclerosis
|
Nephrosclerosis
|
|
|
|
|
|
|
|
|
x
|
Neuralgia
|
Neuralgia
|
|
|
|
|
|
|
|
|
x
|
Night sweats
|
Night sweats
|
|
|
|
|
|
|
|
|
x
|
Osteomyelitis
|
Osteomyelitis
|
|
|
|
|
|
|
|
|
x
|
Osteonecrosis
|
Osteonecrosis
|
|
|
|
|
|
|
|
|
x
|
Osteopenia
|
Osteopenia
|
|
|
|
|
|
|
|
|
x
|
Osteoporosis
|
Osteoporosis
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
x
|
Peritonitis
|
Peritonitis
|
|
|
|
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
x
|
Alveolar proteinosis
|
Alveolar proteinosis
|
|
|
x
|
x
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
x
|
Thrombotic thrombocytopenic purpura
|
Thrombotic thrombocytopenic purpura
|
common, 0% - 1.46%
|
|
x
|
x
|
|
|
|
|
x
|
Pyelonephritis
|
Pyelonephritis
|
common, 0% - 2.19%
|
|
x
|
x
|
|
|
|
|
x
|
Pyuria
|
Pyuria
|
|
|
|
|
|
|
|
|
x
|
Rhinitis
|
Rhinitis
|
0% - 25%
|
0% - 13%
|
|
|
|
|
|
x
|
|
Kaposi's sarcoma
|
Kaposi's sarcoma
|
|
|
|
|
|
|
|
|
x
|
Convulsion
|
Convulsion
|
|
|
|
|
|
|
|
x
|
|
Neoplasm skin
|
Neoplasm skin
|
|
|
|
x
|
|
|
|
|
|
Muscle spasms
|
Muscle spasms
|
0% - 10%
|
0% - 4%
|
|
|
|
|
|
x
|
x
|
Spondylitis
|
Spondylitis
|
|
|
|
|
|
|
|
|
x
|
Spondyloarthropathy
|
Spondylitis
|
|
|
|
|
|
|
|
|
x
|
Shock
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
Tinea pedis
|
Tinea pedis
|
|
|
|
|
|
|
|
|
x
|
Onychomycosis
|
Onychomycosis
|
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
0% - 11%
|
0% - 5%
|
x
|
|
x
|
|
x
|
x
|
x
|
Urethritis
|
Urethritis
|
|
|
|
|
|
|
|
|
x
|
Urethritis noninfective
|
Urethritis
|
|
|
|
|
|
|
|
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
x
|
Micturition urgency
|
|
|
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
|
|
x
|
x
|
|
|
|
|
x
|
Vitamin B12 deficiency
|
Vitamin B12 deficiency
|
|
|
|
|
|
|
|
|
x
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
|
|
x
|
Wound infection
|
Wound infection
|
|
|
x
|
x
|
|
|
|
|
x
|
Wound
|
Wound
|
|
|
|
|
|
|
|
|
x
|
Xeroderma
|
Xeroderma
|
0% - 13%
|
0% - 6%
|
|
|
|
|
|
x
|
|
Urinary retention
|
Urinary retention
|
|
|
|
|
|
|
|
|
x
|
Hepatic failure
|
Hepatic failure
|
|
|
|
|
|
|
|
x
|
|
Micturition urgency
|
Micturition urgency
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
x
|
x
|
Cataract
|
Cataract
|
|
|
|
|
|
|
|
|
x
|
Benign neoplasm
|
Benign neoplasm
|
|
|
|
|
|
|
|
|
x
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
x
|
|
|
|
|
|
|
Blood urea increased
|
Blood urea increased
|
|
|
|
|
|
|
|
|
x
|
Generalised oedema
|
Generalised oedema
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
Generalised oedema
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
|
|
|
|
|
|
|
|
x
|
Scrotal oedema
|
Scrotal oedema
|
|
|
|
|
|
|
|
|
x
|
Hypogonadism male
|
Hypogonadism male
|
uncommon, 0% - 0.733%
|
|
x
|
x
|
|
|
|
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
x
|
Muscular weakness
|
Muscular weakness
|
|
|
|
|
|
|
|
|
x
|
Sinus congestion
|
Sinus congestion
|
|
|
|
|
|
|
|
|
x
|
Joint swelling
|
Joint swelling
|
|
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythropenia
|
Erythropenia
|
|
|
|
x
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
x
|
Chest discomfort
|
Chest discomfort
|
|
|
|
|
|
|
|
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
x
|
Renal vein thrombosis
|
Renal vein thrombosis
|
|
|
|
|
|
|
|
|
x
|
Iron deficiency
|
Iron deficiency
|
|
|
|
|
|
|
|
|
x
|
Activated partial thromboplastin time prolonged
|
Activated partial thromboplastin time prolonged
|
|
|
|
|
|
|
x
|
|
|
Blood testosterone decreased
|
Testosterone low
|
uncommon, 0% - 0.733%
|
|
x
|
x
|
|
|
|
|
|
Dyslipidaemia
|
Dyslipidaemia
|
|
|
|
|
|
|
|
|
x
|
Disease progression
|
Disease progression
|
|
|
|
|
|
|
|
x
|
|
Wound dehiscence
|
Wound dehiscence
|
|
|
|
|
|
|
|
|
x
|
Seroma
|
Seroma
|
|
|
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
x
|
x
|
|
x
|
|
|
x
|
Glomerulonephropathy
|
Glomerulonephropathy
|
|
|
|
|
|
|
|
|
x
|
Metastatic malignant melanoma
|
Metastatic melanoma
|
|
|
|
|
|
|
|
|
x
|
Azotaemia
|
Uraemic syndrome
|
common, 0% - 1.46%
|
|
|
x
|
|
|
|
|
|
Lymphorrhoea
|
Lymphorrhoea
|
|
|
|
|
|
|
|
|
x
|
Renal artery thrombosis
|
Renal artery thrombosis
|
|
|
|
|
|
|
|
|
x
|
Oral herpes
|
Oral herpes
|
|
|
|
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
|
|
|
|
|
x
|
Hepatic cancer
|
Hepatic cancer
|
|
|
|
|
|
|
|
|
x
|
Hepatocellular carcinoma
|
|
|
|
|
|
|
|
|
x
|
Skin papilloma
|
Skin papilloma
|
|
|
|
|
|
|
|
|
x
|
Hepatic artery thrombosis
|
Hepatic artery thrombosis
|
|
|
|
|
|
|
|
|
x
|
Renal haemorrhage
|
Renal haemorrhage
|
|
|
|
|
x
|
|
|
|
|
Bladder pain
|
Bladder spasm
|
|
|
|
|
|
|
|
|
x
|
Bladder spasm
|
Bladder spasm
|
|
|
|
|
|
|
|
|
x
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
|
x
|
Perirenal haematoma
|
Perirenal haematoma
|
|
|
|
|
|
|
|
|
x
|
Pruritus generalised
|
Pruritus generalised
|
0% - 21%
|
0% - 13%
|
|
|
|
|
|
x
|
|
Respiratory distress
|
Respiratory distress
|
|
|
|
|
|
|
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
x
|
Blood cholesterol increased
|
Blood cholesterol increased
|
|
|
|
|
|
|
|
|
x
|
Nephropathy toxic
|
Nephrotoxicity
|
|
|
|
|
|
|
|
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
x
|
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
x
|
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
x
|
Chronic hepatic failure
|
End stage liver disease
|
|
|
|
|
|
|
|
|
x
|
Lymphangioleiomyomatosis
|
Lymphangioleiomyomatosis
|
|
|
|
|
x
|
|
|
x
|
|
Thrombocytosis
|
Thrombocytosis
|
|
|
|
|
|
|
|
|
x
|
Lipids increased
|
Lipids increased
|
|
|
|
|
|
|
|
|
x
|
Graft loss
|
Graft loss
|
|
|
|
|
|
|
|
|
x
|
Graft thrombosis
|
Graft thrombosis
|
|
|
x
|
|
|
|
|
|
x
|
Colorectal cancer metastatic
|
Colorectal cancer metastatic
|
|
|
|
|
|
|
|
|
x
|
BK virus infection
|
BK virus infection
|
|
|
|
|
|
|
|
|
x
|
Incision site pain
|
Incision site pain
|
|
|
|
|
|
|
|
|
x
|
Perinephric collection
|
Perinephric collection
|
|
|
|
|
|
|
|
|
x
|
Ileus
|
Ileus
|
|
|
|
|
|
|
|
|
x
|
Epigastric discomfort
|
Epigastric discomfort
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Renal impairment
|
|
|
|
|
|
|
|
|
x
|
Procedural pain
|
Procedural pain
|
|
|
|
|
|
|
|
|
x
|
Embolism venous
|
Venous thromboembolism
|
|
|
x
|
|
|
|
|
|
x
|
Localised intraabdominal fluid collection
|
Localised intraabdominal fluid collection
|
|
|
|
|
|
|
|
|
x
|
Hepatocellular carcinoma
|
Hepatocellular carcinoma
|
|
|
|
|
|
|
|
|
x
|
Thrombotic microangiopathy
|
Thrombotic microangiopathy
|
common, 0% - 1.46%
|
|
|
x
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
|
x
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
|
|
x
|
|
|
|
|
|
|
Infection reactivation
|
Infection reactivation
|
|
|
|
|
x
|
x
|
|
|
|