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
|
Pertussis
|
Pertussis
|
0.015% - 34%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne
|
Acne
|
0.06% - 21%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diarrhoea
|
Loose stools
|
1.2% - 19.1%
|
6.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
postmarketing, 4% - 52.8%
|
15.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
6.5%
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Application site pain
|
Application site pain
|
6.5%
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Instillation site pain
|
Application site pain
|
6.5%
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
1.9% - 32.2%
|
6.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
1.9% - 32.2%
|
6.6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 3.4% - 9.4%
|
2.2% - 3.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Rash
|
Rash
|
postmarketing, 3.4% - 9.4%
|
2.2% - 3.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
3% - 32.6%
|
11%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
5%
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Pain
|
Pain
|
4.4%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Stinging
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inflammation
|
Inflammation
|
3.1%
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
0% - 4.2%
|
1.1%
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing, 1% - 14%
|
1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 1% - 3.9%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
postmarketing, 1% - 9%
|
1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
postmarketing, 1% - 2.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
postmarketing, 1% - 2.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 0% - 2.5%
|
0%
|
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
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
postmarketing, 0% - 4.2%
|
1.1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, 0% - 4.2%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, 0% - 4.2%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Asthenia
|
Asthenia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
postmarketing, 2.1% - 3.9%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Candida infection
|
Candida infection
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Oral candidiasis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oral candidiasis
|
Oral candidiasis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
postmarketing, 0.4% - 1.1%
|
2.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
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
|
Fatigue
|
Fatigue
|
postmarketing, 2.1% - 3.9%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
postmarketing, 5% - 10.7%
|
4.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 0% - 5.5%
|
0%
|
|
|
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
|
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypotension
|
Hypotension
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
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
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing, 0% - 3.9%
|
3.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pyloric stenosis
|
Pyloric stenosis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
Shock
|
Syncope
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
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
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, 0.9% - 3.4%
|
4.4%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immunodeficiency
|
Immunocompromised
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic function abnormal
|
Hepatic function abnormal
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Tongue discolouration
|
Tongue discolouration
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
postmarketing
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic necrosis
|
Hepatic necrosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alkaline phosphatase serum increased
|
postmarketing
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
postmarketing
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing, 0% - 1.1%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing, 0% - 1.1%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
postmarketing, 0% - 1.1%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, 0% - 1.1%
|
0%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatotoxicity
|
Hepatotoxicity
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
Hyperkinesia
|
Hyperkinesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menorrhagia
|
Prolonged menses
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Menorrhagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyponatraemia
|
Sodium decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
|
Pseudomembranous colitis
|
Pseudomembranous colitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
Hearing impaired
|
postmarketing, 0.4% - 1.1%
|
2.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggressive reaction
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parosmia
|
Parosmia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Congenital anomaly
|
Congenital anomaly
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Developmental delay
|
Congenital anomaly
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Acquired immunodeficiency syndrome
|
Acquired immunodeficiency syndrome
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autoimmune disorder
|
Acquired immunodeficiency syndrome
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaemia
|
Anaemia
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Asthma
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Blister
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vesiculobullous rash
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Breast feeding
|
Breast feeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
Chest pain
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Dermatitis contact
|
Dermatitis contact
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fungal skin infection
|
Fungal skin infection
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Enteritis
|
Enteritis
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Extravasation
|
Extravasation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hostility
|
Hostility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Irritability
|
Irritability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Melaena
|
Melaena
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Nasal congestion
|
Nasal congestion
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephritis
|
Nephritis
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Nephrotic syndrome
|
Nephrotic syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Otitis media
|
Otitis media
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Genetic polymorphism
|
Genetic polymorphism
|
|
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|
|
|
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|
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|
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|
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|
|
|
|
|
|
Serum sickness
|
Serum sickness
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin infection
|
Skin infection
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stomatitis
|
Stomatitis
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Swelling
|
Swelling
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Vasculitis
|
Vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Viral infection
|
Viral infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry mouth
|
Dry mouth
|
0% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Application site reaction
|
Application site reaction
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Swelling face
|
Swelling face
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash pustular
|
Vesiculobullous rash
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin discolouration
|
Skin discolouration
|
0% - 2.1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal faeces
|
Abnormal faeces
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Abdominal pain upper
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Eye irritation
|
Eye irritation
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Punctate keratitis
|
Punctate keratitis
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dry eye
|
Dry eye
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mucosal inflammation
|
Mucosal inflammation
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal erosion
|
Corneal erosion
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Transaminases increased
|
Transaminases increased
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Cough
|
Cough increased
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Allergic rash
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood potassium decreased
|
Potassium low
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Insomnia
|
Insomnia
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infusion site reaction
|
Infusion site reaction
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Urethritis
|
Unspecified non-gonococcal urethritis (NGU)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis bacterial
|
Sinusitis bacterial
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug-induced liver injury
|
Drug-induced hepatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Pathogen resistance
|
Cross resistance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|