MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
Infestation
|
Infestation NOS
|
59.4%
|
59.5%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
11.1% - 69.2%
|
9.48% - 64.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
11.4% - 37.5%
|
11.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
17.9% - 39.3%
|
6.03% - 22.8%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
14.1% - 41%
|
14.7% - 38.4%
|
|
|
x
|
|
|
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
8.12% - 38.5%
|
3.45% - 41.8%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Mental state abnormal
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
4.17% - 37.5%
|
22.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
0% - 31.4%
|
31.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
0% - 31.4%
|
31.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
very common, 20.1% - 68.8%
|
8.62% - 59.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
0% - 23.5%
|
17.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
0% - 25.8%
|
0.431% - 8.57%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
1.96% - 79.4%
|
13.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
15%
|
11.6%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Asthenia
|
Fatigue
|
1.96% - 79.4%
|
15.5%
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Asthenia
|
2.9% - 23.9%
|
1.72% - 20.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
1.96% - 79.4%
|
15.5%
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Headache
|
Headache
|
0% - 22.5%
|
11.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deep vein thrombosis
|
Deep vein thrombosis
|
11.5% - 12.8%
|
1.72%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 2.94% - 42.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
11.5%
|
5.6%
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
7.26% - 15%
|
6.03% - 12.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral sensory neuropathy
|
Peripheral sensory neuropathy
|
10.3%
|
5.17%
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
0% - 11.3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
0.98% - 40.2%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myasthenia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Altered state of consciousness
|
Depressed level of consciousness
|
2.94% - 15.7%
|
|
|
|
|
|
|
|
|
|
|
x
|
Consciousness abnormal
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
Depressed level of consciousness
|
2.94% - 15.7%
|
|
|
|
|
|
|
|
|
|
|
x
|
Stupor
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Lymphopenia
|
Lymphopenia
|
postmarketing, 0% - 12.1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
0% - 14.5%
|
0.431% - 8.57%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Embolism
|
Embolism
|
1.96% - 22.5%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Thromboembolism
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thromboembolic event
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Thrombosis
|
Thrombosis
|
1.96% - 22.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
0% - 36.3%
|
|
|
|
|
|
|
|
|
|
x
|
|
Bone tenderness
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
6.84%
|
1.72%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
2.78% - 8.33%
|
5.71%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
1.96% - 28.4%
|
0.862%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
1.96% - 28.4%
|
0.862%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
0% - 8.33%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
0% - 56.9%
|
8.19%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing, 0.98% - 71.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
0% - 11.8%
|
5.71%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
0% - 64.7%
|
5.71%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
4.17% - 8.33%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
4.17% - 18.8%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
0% - 15.6%
|
6.47% - 11.4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tingling sensation
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
0% - 12.5%
|
8.57%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
1.96% - 15.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
0% - 11.8%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing, 0% - 59.4%
|
2.86% - 59.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Febrile neutropenia
|
Febrile neutropenia
|
postmarketing, 1.96% - 27.5%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
0% - 9.4%
|
2.86%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
0% - 5.6%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
Oral candidiasis
|
0% - 11.1%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Candida infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oral candidiasis
|
Oral candidiasis
|
0% - 11.1%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
0% - 54.9%
|
0% - 21.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal skin infection
|
Fungal skin infection
|
0% - 9.4%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
0% - 18.8%
|
17.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
0% - 19.6%
|
0% - 13.8%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
0% - 19.6%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Syncope
|
postmarketing, 3.42%
|
0.431%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
0% - 28.4%
|
2.86% - 11.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
3.1% - 8.33%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
0% - 11.4%
|
11.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
0% - 34.2%
|
0% - 24.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
0% - 5.6%
|
2.86%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
0% - 11.4%
|
11.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing, 0.98% - 42.7%
|
1.29% - 2.59%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
0% - 30.4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Skin necrosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
3.42%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy
|
0% - 53.9%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
2.78% - 4.17%
|
11.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
2.78% - 4.17%
|
11.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
0% - 8.33%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nail disorder
|
Nail disorder
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchopneumonia
|
Bronchopneumonia
|
2.99%
|
1.29%
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
0% - 25.5%
|
1.29% - 9.48%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
0% - 28.4%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 12.5%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
0% - 8.33%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
2.56%
|
0.862%
|
|
|
|
|
|
|
|
|
|
x
|
Arthralgia
|
Arthralgia
|
0% - 12.7%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 12.7%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
0% - 16.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
0% - 23.5%
|
8.19%
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Anxiety depression
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing, 1.96% - 48%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
0% - 22.5%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Vomiting
|
Vomiting
|
0% - 11.8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, 2.56%
|
0.431%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
0% - 18.6%
|
9.05%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
postmarketing, 0% - 19.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, 0% - 22.5%
|
1.29%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
0% - 21.6%
|
1.72%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
0% - 16.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, 4.7%
|
3.45%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Cholestasis
|
Cholestasis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Diplopia
|
Diplopia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Enuresis
|
Enuresis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Grand mal convulsion
|
Grand mal convulsion
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema nodosum
|
Erythema nodosum
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hodgkin's disease
|
Hodgkin's disease
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hodgkin's disease lymphocyte depletion type stage unspecified
|
Hodgkin's disease
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hodgkin's disease lymphocyte predominance type stage unspecified
|
Hodgkin's disease
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercalcaemia
|
Hypercalcaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal perforation
|
Intestinal perforation
|
postmarketing
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inner ear disorder
|
Labyrinthine disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Erythroleukaemia
|
Erythroleukaemia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chronic myeloid leukaemia
|
Chronic myeloid leukaemia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver disorder
|
Liver disorder
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Hepatocellular injury
|
Liver disorder
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Foetor hepaticus
|
Liver disorder
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Lymphoedema
|
Lymphoedema
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Metrorrhagia
|
Metrorrhagia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myxoedema
|
Myxoedema
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oliguria
|
Oliguria
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parkinson's disease
|
Parkinson's disease
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Parkinsonism
|
Parkinson's disease
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Petechiae
|
Petechiae
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pleural effusion
|
Pleural effusion
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal failure
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Septic shock
|
Septic shock
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Sick sinus syndrome
|
Sick sinus syndrome
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Status epilepticus
|
Status epilepticus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastric ulcer
|
Gastric ulcer
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
postmarketing, 3.42%
|
0.431%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing, 3.42%
|
0.431%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing, 3.42%
|
0.431%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tumour lysis syndrome
|
Tumour lysis syndrome
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stupor
|
Stupor
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Peroneal nerve palsy
|
Footdrop
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal perforation
|
Gastrointestinal perforation
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
Raised liver function tests
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Interstitial lung disease
|
Interstitial lung disease
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Hangover
|
Hangover
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Galactorrhoea
|
Galactorrhoea
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Sepsis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrolyte imbalance
|
Electrolyte imbalance
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysaesthesia
|
Dysaesthesia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
postmarketing
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Mental status changes
|
Mental status changes
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
White blood cell count decreased
|
White blood cell count low
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Multiple congenital abnormalities
|
Multiple congenital abnormalities
|
0% - 9.4%
|
0%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Acquired immunodeficiency syndrome
|
Acquired immunodeficiency syndrome
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Autoimmune disorder
|
Acquired immunodeficiency syndrome
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amyloidosis
|
Amyloidosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypochromic anaemia
|
Hypochromic anaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia macrocytic
|
Anaemia macrocytic
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia megaloblastic
|
Anaemia megaloblastic
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apnoea
|
Apnoea
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ascites
|
Ascites
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrioventricular block
|
Atrioventricular block
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Benign neoplasm of skin
|
Benign neoplasm of skin
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Disorder periosteal
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Complex regional pain syndrome
|
Causalgia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cellulitis
|
Cellulitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neck pain
|
Neck pain
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholangitis
|
Cholangitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis
|
Colitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
0% - 18.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cyanosis
|
Cyanosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Demyelination
|
Demyelination
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
0% - 8.33%
|
5.71%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingival disorder
|
Gingival disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
0% - 11.1%
|
2.86%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatomegaly
|
Hepatomegaly
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hernia
|
Hernia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hostility
|
Hostility
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Numbness
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Hypoalgesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoproteinaemia
|
Hypoproteinaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ichthyosis
|
Ichthyosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ichthyosis acquired
|
Ichthyosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimal disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimal structural disorder
|
Lacrimal disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cramp muscle
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Leukaemia
|
Leukaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute myeloid leukaemia
|
Acute myeloid leukaemia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Acute leukaemia
|
Acute myeloid leukaemia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lung disorder
|
Lung disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Meningitis
|
Meningitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopause
|
Menopause
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Hypertonia
|
Hypertonia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myelodysplastic syndrome
|
Myelodysplastic syndrome
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
0% - 9.4%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
0% - 9.4%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
Neuritis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory loss
|
Numbness
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Orchitis
|
Orchitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orchitis noninfective
|
Orchitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pericarditis
|
Pericarditis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Periodontitis
|
Periodontitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peritonitis
|
Peritonitis
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Proteinuria
|
Proteinuria
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Emphysema
|
Emphysema
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pyuria
|
Pyuria
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rales
|
Rales
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinitis
|
Retinitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
0% - 12.5%
|
11.4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Embolism venous
|
Thromboembolism
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toothache
|
Toothache
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
0% - 26.5%
|
0% - 12.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vasodilation procedure
|
Vasodilation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Venous thrombosis
|
Venous thrombosis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
0% - 8.33%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Microcytic anaemia
|
Microcytic anaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus bradycardia
|
Sinus bradycardia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Burning sensation
|
Burning sensation
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Agitation
|
Agitation
|
0% - 25.5%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood alteration NOS
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Affect lability
|
Mood swings
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal stiffness
|
Neck stiffness
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nuchal rigidity
|
Neck stiffness
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hormone level abnormal
|
Hormone level abnormal
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Creatinine increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Serum creatinine increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue discolouration
|
Tongue discolouration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin necrosis
|
Skin necrosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia oral
|
Circumoral paresthesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
Vesiculobullous rash
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Vesiculobullous rash
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyporeflexia
|
Hyporeflexia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
0% - 20.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arterial thrombosis
|
Arterial thrombosis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Polyneuropathy
|
Polyneuropathy
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disability
|
Disability
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
0% - 8.33%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
0% - 8.33%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
0% - 8.33%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Teratogenicity
|
Teratogenicity
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine decreased
|
Creatinine low
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Pain in arm
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Spleen palpable
|
Spleen palpable
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disease progression
|
Disease progression
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parotid gland enlargement
|
Parotid gland enlargement
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Hypovitaminosis
|
Avitaminosis
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Enlargement abdomen
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hyperkinesia
|
Hyperkinesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dementia
|
Dementia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic skin eruption
|
Toxic skin eruption
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
0% - 4.2%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Visual disturbance
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Lipase increased
|
Lipase increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acne
|
Acne
|
0% - 11.1%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diverticular perforation
|
Diverticular perforation
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Cerebral ischaemia
|
Cerebral ischaemia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
0% - 47.1%
|
5.71%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood phosphorus decreased
|
Phosphorus low
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchopneumopathy
|
Bronchopneumopathy
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Pneumocystis jirovecii pneumonia
|
Pneumocystis jirovecii pneumonia
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Posterior reversible encephalopathy syndrome
|
Posterior reversible encephalopathy syndrome
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Embolism arterial
|
Arterial thromboembolism
|
|
|
|
|
|
|
|
|
|
|
|
x
|