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
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
6%
|
7.3%
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
3% - 9%
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Cough
|
Cough
|
0% - 10%
|
0%
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 4% - 12.3%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing, 0% - 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing, 2.9% - 4%
|
0%
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
postmarketing, 0% - 15%
|
1.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 1.7% - 11%
|
3.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 1% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 1% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatinine increased
|
Serum creatinine increased
|
2% - 26%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Chest pain
|
Chest pain
|
0% - 3%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
1% - 3%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Sputum increased
|
Sputum increased
|
1% - 3%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Increased bronchial secretion
|
Sputum increased
|
1% - 3%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing, 0% - 7%
|
2.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing, 0% - 7%
|
2.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
1% - 4%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
postmarketing, 0% - 3%
|
2.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 0% - 3%
|
2.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
0% - 3%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, 0% - 29%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
0% - 4%
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
1% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing, 0% - 3%
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
1% - 3%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Pneumocystis jirovecii infection
|
Pneumocystis carinii infection
|
0% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Discomfort
|
Discomfort
|
1.7%
|
2.6%
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hypomagnesaemia
|
Hypomagnesaemia
|
0% - 5%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Bacteriuria
|
Bacteriuria
|
1.4%
|
1.6%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
1.4%
|
1.6%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
1.2%
|
2.1%
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Headache
|
Headache
|
postmarketing, 0% - 6%
|
1.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
1%
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
postmarketing, 1%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Libido decreased
|
Libido decreased
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido decreased
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Depression
|
Depression
|
0% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 0% - 4%
|
0%
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 0% - 5%
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
0% - 3%
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Jaundice
|
Jaundice
|
postmarketing, 0% - 2%
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Pain
|
Pain
|
0% - 4%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
0% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
0% - 3%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
1%
|
0.5%
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Vasculitis
|
Vasculitis
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Sinus bradycardia
|
Sinus bradycardia
|
1%
|
0%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urea increased
|
Blood urea increased
|
0% - 7%
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Renal impairment
|
Kidney function abnormal
|
0% - 12%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
0% - 2%
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
0% - 2%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Malaise
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
postmarketing, 1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
postmarketing, 1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating increased
|
0% - 6%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
1%
|
0.5%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Somnolence
|
Somnolence
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing, 1% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
0% - 3%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Rigors
|
0% - 34%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Fluid overload
|
Fluid overload
|
0% - 3%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Congenital anomaly
|
Congenital anomaly
|
postmarketing
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Developmental delay
|
Congenital anomaly
|
postmarketing
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing, 0% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Heartburn
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, 0% - 8%
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
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
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
postmarketing, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
postmarketing, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Inner ear disorder
|
Labyrinthine disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Leukopenia
|
Leukopenia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver disorder
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic impairment
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatocellular injury
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatocellular injury
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Foetor hepaticus
|
Liver disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
postmarketing
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, 1.6%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy peripheral
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy
|
postmarketing
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Left ventricular failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Serum sickness
|
Serum sickness
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Onychomycosis
|
Onychomycosis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing, 1.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic insufficiency
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute hepatic failure
|
Acute hepatic failure
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing, 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic enzyme abnormal
|
Hepatic enzyme abnormal
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Visual disturbance
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Drug interaction
|
Drug interaction
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Blood creatine phosphokinase increased
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Acute generalised exanthematous pustulosis
|
Acute generalised exanthematous pustulosis
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Hearing impaired
|
postmarketing, 3.3%
|
3.1%
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
postmarketing, 3.3%
|
3.1%
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Adrenal insufficiency
|
Adrenal insufficiency
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Anxiety
|
Anxiety
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Infection
|
Infection
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Dehydration
|
Dehydration
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Encephalocele
|
Encephalocele
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Flatulence
|
Flatulence
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Gynaecomastia
|
Gynaecomastia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Left ventricular failure
|
Left ventricular failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Lung disorder
|
Lung disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Chronic obstructive pulmonary disease
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchial hyperreactivity
|
Chronic obstructive pulmonary disease
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Ulcerative stomatitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Tremor
|
Tremor
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Hypophosphataemia
|
Hypophosphataemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Application site reaction
|
Application site reaction
|
0% - 4%
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Generalised oedema
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Fluid retention
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Injection site inflammation
|
Injection site inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Liver injury
|
Hepatocellular injury
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Abdominal pain upper
|
Epigastric pain
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Teratogenicity
|
Teratogenicity
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Abdominal discomfort
|
Upset stomach
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Vein disorder
|
Vein disorder
|
0% - 3%
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain
|
Breast pain male
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Implant site reaction
|
Implantation complication
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Lung infiltration
|
Lung infiltration
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal pain
|
Throat sore
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mucosal inflammation
|
Mucosal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Urine analysis abnormal
|
Urine analysis abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Insomnia
|
Insomnia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dysphonia
|
Dysphonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|