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
|
Injection site reaction
|
Injection site reaction
|
59%
|
24%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
Injection site haemorrhage
|
Injection site bruising
|
postmarketing, 16%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site haemorrhage
|
postmarketing, 6%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site bruising
|
Injection site bruising
|
postmarketing, 16%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paraesthesia
|
Tingling sensation
|
common, 1% - 14%
|
1% - 3%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
infrequent — 1% - 5%
|
0% - 2%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
common, 11% - 14%
|
7% - 11.3%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 11% - 14%
|
7% - 11.3%
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
common, 1% - 12%
|
0.9% - 4%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Syncope
|
infrequent — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Flushing
|
Flushing
|
1% - 7%
|
1% - 2%
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Sensation of pressure
|
Sensation of pressure
|
1% - 7%
|
1% - 2%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
x
|
Injection site pain
|
Injection site pain
|
postmarketing — 6%
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Injection site stinging
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neck pain
|
Neck pain
|
3% - 5%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
infrequent, frequent
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
Numbness
|
frequent, 2% - 5%
|
1% - 2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory loss
|
Numbness
|
frequent, 2% - 5%
|
1% - 2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
very rare — 1%
|
1%
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Burning sensation
|
Burning sensation
|
frequent, 0.4% - 7%
|
0% - 1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory disturbance
|
Sensory disturbance
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Abdominal discomfort
|
frequent, 3%
|
3%
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal discomfort
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Feeling hot
|
Sensation of heat
|
common
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Warmth
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
Chest discomfort
|
5%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
1% - 3%
|
1%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
Chest discomfort
|
5%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Chest tightness
|
3%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Chest pressure
|
2%
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
Musculoskeletal stiffness
|
Stiffness
|
infrequent, 3% - 5%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Muscle stiffness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
frequent
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phonophobia
|
Phonophobia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
common, 0.4% - 5%
|
1%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
common, 0.4% - 9.5%
|
1% - 5.1%
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
|
Dermatitis contact
|
Dermatitis contact
|
4%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergic contact dermatitis
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site pain
|
Application site pain
|
4%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instillation site pain
|
Application site pain
|
4%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Somnolence
|
Drowsiness
|
common, 3%
|
1% - 2%
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Muscle spasms
|
3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cramp muscle
|
rare — frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
0.8% - 3%
|
1% - 0.9%
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Oropharyngeal pain
|
Throat sore
|
0.8% - 3%
|
1% - 0.9%
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Fatigue
|
Fatigue
|
common, 0.4% - 9.5%
|
1% - 5.1%
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
|
Headache
|
Headache
|
1% - 2%
|
1%
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
|
Head pressure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
postmarketing — 1% - 8%
|
1% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Stinging
|
postmarketing, infrequent
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
rare — 0.6% - 2%
|
0.4% - 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
Malaise
|
2% - 9.5%
|
1% - 5.1%
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
Discomfort
|
Malaise
|
2% - 9.5%
|
1% - 5.1%
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
Discomfort
|
2% - 3.8%
|
0% - 2.4%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
2% - 9.5%
|
1% - 5.1%
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
Feeling strange
|
0% - 2%
|
0% - 1%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
2% - 9.5%
|
1% - 5.1%
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
Myalgia
|
Myalgia
|
frequent, 0.1% - 2%
|
0.3% - 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
frequent, 0.1% - 2%
|
0.3% - 1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pain in jaw
|
Pain in jaw
|
1% - 3%
|
1%
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
0.4% - 2.3%
|
0.7%
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Viral infection
|
Viral infection
|
0.1% - 1.1%
|
0.3%
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Feeling cold
|
Feeling cold
|
1%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Muscle atrophy
|
Muscle atrophy
|
0.4% - 1.4%
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
very rare — infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus arrhythmia
|
Sinus arrhythmia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
postmarketing — infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
rare — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysarthria
|
Dysarthria
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Taste bitter
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Facial pain
|
Facial pain
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
infrequent, 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Hypertensive episode
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
very rare — 1%
|
0%
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pallor
|
Pallor
|
rare — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Shivering
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disturbance
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
infrequent — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
infrequent — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
infrequent — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
very rare — 1%
|
0%
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
very rare — infrequent
|
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Monoplegia
|
Monoplegia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Temperature intolerance
|
Heat intolerance
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tenderness
|
Tenderness
|
infrequent, 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain of skin
|
Skin tenderness
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Fluid retention
|
Fluid retention
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Eruption
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Rash
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Lacrimation increased
|
Lacrimation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram change
|
Electrocardiogram change
|
infrequent, 0%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
|
Vertigo
|
Vertigo
|
1% - 12%
|
1% - 4%
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggression
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare, postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
very rare, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Prinzmetal angina
|
Prinzmetal angina
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
rare, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phobia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arteriosclerosis
|
Atherosclerosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cluster headache
|
Cluster headache
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Migraine
|
Cluster headache
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Migraine
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Colitis
|
Colitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
rare, 0.6% - 1.4%
|
0.6%
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Contusion
|
Contusion
|
postmarketing, rare
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cyanosis
|
Cyanosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Cyanosis peripheral
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depressive disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysthymic disorder
|
Depressive disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug abuse
|
Drug abuse
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing — 1%
|
0%
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Eczema
|
Eczema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometriosis
|
Endometriosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
VIIth nerve paralysis
|
Facial paralysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Conversion disorder
|
Globus hystericus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hysteria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrioventricular block
|
Block heart
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematemesis
|
Haematemesis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematoma
|
Haematoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes virus infection
|
Herpes NOS
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hiccups
|
Hiccups
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hunger
|
Hunger
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
very rare — frequent
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Inflammation
|
Inflammation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Keratitis
|
Keratitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
Melaena
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Meniere's disease
|
Meniere's disease
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Muscle rigidity
|
Muscle rigidity
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mydriasis
|
Mydriasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neurosis
|
Neurosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nodule
|
Nodule
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Panic disorder
|
Panic disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Peptic ulcer
|
Peptic ulcer
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Pituitary tumour
|
Pituitary tumour
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
postmarketing — infrequent
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Retinal artery occlusion
|
Retinal artery occlusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
very rare, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Salivary hypersecretion
|
Salivary hypersecretion
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin wrinkling
|
Skin wrinkling
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Subarachnoid haemorrhage
|
Subarachnoid haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Completed suicide
|
Suicide
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sunburn
|
Sunburn
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Sunburn
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing — infrequent
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tetany
|
Tetany
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toothache
|
Toothache
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Redness
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Redness of face
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethritis
|
Urethritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethritis noninfective
|
Urethritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Vasculitis
|
Vasculitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Vasodilation procedure
|
Vasodilation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Visual acuity reduced
|
Vision decreased
|
very rare, rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Vision decreased
|
very rare, rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual disturbance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Disorder sight
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Weight decreased
|
Weight decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Yawning
|
Yawning
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Polydipsia
|
Polydipsia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast discharge
|
Breast discharge
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytoclastic vasculitis
|
Allergic cutaneous angiitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Swelling face
|
Swelling face
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Intracranial pressure increased
|
Intracranial pressure increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
rare
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Optic ischaemic neuropathy
|
Optic ischaemic neuropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Intervertebral disc disorder
|
Intervertebral disc disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Colitis ischaemic
|
Colitis ischaemic
|
very rare, postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Aortic aneurysm
|
Abdominal aortic aneurysm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Diplegia
|
Diplegia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Decreased appetite
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Retching
|
Retching
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual cycle abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Speech disorder
|
Speech impairment NOS
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Memory impairment
|
Memory impairment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Motor dysfunction
|
Motor dysfunction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypervigilance
|
Hypervigilance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye irritation
|
Eye irritation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulse abnormal
|
Pulse abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Galactorrhoea
|
Galactorrhoea
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin exfoliation
|
Skin exfoliation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin scaly
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Localized exfoliation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Personality change
|
Personality change
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivary gland enlargement
|
Salivary gland swelling
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin tightness
|
Skin tightness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle fatigue
|
Muscle fatigue
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Walking disability
|
Walking disability
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Walking disability
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Induration
|
Induration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Phobia
|
Phobia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysaesthesia
|
Dysaesthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
very rare — 1%
|
0%
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blindness
|
Blindness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Unspecified visual loss
|
very rare, postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hemiplegia
|
Hemiplegia transient
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Paralysis
|
Paralysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling of body temperature change
|
Feeling hot and cold
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dissociation
|
Detachment psychological
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dystonia
|
Dystonic reaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
Blood thyroid stimulating hormone increased
|
Thyrotropin high
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Gastrointestinal pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Serotonin syndrome
|
Serotonin syndrome
|
postmarketing
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Radiculopathy
|
Radiculopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Poisoning
|
Intoxication
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Eye oedema
|
Eye oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Raised liver function tests
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
Cardiomyopathy
|
Cardiomyopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cerebral ischaemia
|
Cerebral ischaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oral pruritus
|
Oral pruritus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphasia
|
Dysphasia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Respiratory disorder
|
Respiration abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiration abnormal
|
Respiration abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lipohypertrophy
|
Lipohypertrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Lipoatrophy
|
Lipoatrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Dysphonia
|
Voice disturbance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinal vein thrombosis
|
Retinal vein thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Temporal arteritis
|
Temporal arteritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage subcutaneous
|
Subcutaneous bleeding
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
x
|
Arteriospasm coronary
|
Arteriospasm coronary
|
very rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Diplopia
|
Diplopia
|
very rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
very rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
Nystagmus
|
Nystagmus
|
very rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Scotoma
|
Scotoma
|
very rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Photopsia
|
Photopsia
|
very rare
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Cutaneous hypersensitivity
|
very rare
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Blister
|
Blister
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Blister
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast cancer
|
Breast cancer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Breast feeding
|
Breast feeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast swelling
|
Breast swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cyst
|
Cyst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Epilepsy
|
Epilepsy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hypertensive crisis
|
Hypertensive crisis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Infarction
|
Infarction
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Ischaemia
|
Ischaemia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Eye pruritus
|
Eye pruritus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Dyskinesia
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Movement disorder
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Otitis externa
|
Otitis externa
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pregnancy
|
Pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retinal vascular occlusion
|
Retinal vascular occlusion
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Venous thrombosis
|
Venous thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Ventricular fibrillation
|
Ventricular fibrillation
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Urogenital disorder
|
Urogenital disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vasospasm
|
Vasospasm
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
Akinesia
|
Akinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Lower respiratory tract infection
|
Lower respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin breakdown
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin irritation
|
Skin irritation
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abortion
|
Abortion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sick sinus syndrome
|
Bradycardia-tachycardia syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Choreoathetosis
|
Choreoathetoid movements
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Cerebellar infarction
|
Cerebellar infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Heart rate irregular
|
Heart rate irregular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glossodynia
|
Burning tongue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Parkinsonism
|
Parkinsonism
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Musculoskeletal deformity
|
Musculoskeletal deformity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Atrophy
|
Atrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Akathisia
|
Akathisia
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Hypoaesthesia oral
|
Numbness of tongue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Application site irritation
|
Application site irritation
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle tightness
|
Neck tightness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle tightness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Mass
|
Mass
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Application site pruritus
|
Application site pruritus
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphocyte count decreased
|
Lymphocyte count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Application site warmth
|
Application site warmth
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site haematoma
|
Application site haematoma
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site paraesthesia
|
Application site paraesthesia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site discolouration
|
Application site discolouration
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site discomfort
|
Application site discomfort
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hearing impaired
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Medication overuse headache
|
Medication overuse headache
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Rhinitis allergic
|
Rhinitis allergic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Nasal inflammation
|
Nasal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|