|
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
|
|
Insomnia
|
Insomnia
|
common — 4% - 35%
|
1% - 20%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
Asthenia
|
common — 2% - 28.8%
|
1% - 10%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
Dry mouth
|
Dry mouth
|
common — 1% - 25.7%
|
1% - 23.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nervousness
|
Nervousness
|
common — 1% - 15.6%
|
1% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling jittery
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
Tension
|
Nervousness
|
common — 1% - 15.6%
|
1% - 9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
common — 1% - 18%
|
0% - 8.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dizziness
|
Dizziness
|
common — 2% - 15%
|
0% - 13.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope
|
infrequent, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
frequent, 6% - 40%
|
0% - 14%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
common — 4% - 27%
|
0% - 11%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Drowsiness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
common — 1% - 18%
|
1% - 8.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
common — 1% - 13.8%
|
0% - 9.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
9%
|
5%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Ejaculation disorder
|
Abnormal ejaculation
|
infrequent, 0% - 11%
|
0% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
Sweating
|
common, 1% - 7%
|
1% - 3%
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sweating increased
|
frequent, 6.9% - 11.2%
|
1.9% - 12.5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Hyperhidrosis
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia
|
common — 1% - 14.9%
|
0% - 6.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Appetite absent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
|
Pharyngitis
|
Pharyngitis
|
infrequent, 1% - 6.3%
|
1% - 5%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infection
|
Infection
|
infrequent, 11.3%
|
9.4%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Pain
|
Pain
|
infrequent, 4.4% - 10%
|
1.3% - 8%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Abdominal pain
|
Abdominal pain
|
common — 1% - 5.6%
|
0% - 8.1%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
common — 1% - 5.6%
|
0% - 8.1%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amnesia
|
Amnesia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anxiety
|
Anxiety
|
common — 1% - 9.4%
|
1% - 6.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
rare, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Headache
|
Headache
|
common — 2% - 35%
|
1% - 31%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypotension
|
Hypotension
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myoclonus
|
Myoclonus
|
rare, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
Syncope
|
infrequent, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Syncope
|
Syncope
|
infrequent, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
infrequent, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Tremor
|
Tremor
|
common — 0% - 10.8%
|
0% - 4.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
frequent, 2% - 6%
|
1% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight increased
|
Weight increased
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
postmarketing — 1% - 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokinesia
|
Hypokinesia
|
infrequent — 8.1%
|
3.6%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Injury
|
Accidental injury
|
infrequent — 3% - 5%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Injury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Mania
|
Manic psychosis
|
infrequent, frequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mania
|
rare
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
infrequent — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Discomfort
|
Malaise
|
infrequent — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Malaise
|
infrequent — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Ill-defined disorder
|
Malaise
|
infrequent — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
Hyperkinesia
|
infrequent — 6.7%
|
8.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
common — 1% - 15.7%
|
0% - 8.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia
|
Hyperkinesia
|
infrequent — 6.7%
|
8.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence
|
Flatulence
|
infrequent, 4%
|
3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amblyopia
|
Amblyopia
|
infrequent, 1% - 3%
|
1% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing, 1% - 3%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza
|
Influenza
|
infrequent, 3% - 5%
|
2% - 3.8%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Palpitations
|
Palpitations
|
common — 3%
|
1% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tooth disorder
|
Tooth disorder
|
rare, 1% - 3%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pollakiuria
|
Pollakiuria
|
infrequent, 2.2% - 5%
|
1.3% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Micturition urgency
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Apathy
|
Apathy
|
infrequent — 0% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flat affect
|
Apathy
|
infrequent — 0% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
Thinking abnormal
|
frequent, 1% - 6.9%
|
1% - 3.8%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mental disability
|
Thinking abnormal
|
frequent, 1% - 6.9%
|
1% - 3.8%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
rare, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
Cough increased
|
rare, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cough
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Libido decreased
|
Libido decreased
|
infrequent, 2% - 7.5%
|
1% - 4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido decreased
|
infrequent, 2% - 7.5%
|
1% - 4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysphagia
|
Dysphagia
|
postmarketing — 2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Depression
|
Depression
|
1% - 6.3%
|
0% - 4.4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
Dyspnoea
|
Dyspnoea
|
infrequent, 2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
infrequent — 1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertonia
|
Hypertonia
|
infrequent, 2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Viral infection
|
Viral infection
|
1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Yawning
|
Yawning
|
rare, 0% - 5%
|
0% - 1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
Chills
|
rare — 2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Anorgasmia
|
Anorgasmia
|
postmarketing — 0% - 5%
|
0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing — 2%
|
1% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sexual dysfunction
|
Sexual dysfunction
|
1% - 3%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
infrequent, 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Rhinitis
|
Rhinitis
|
infrequent, 1.3% - 5.6%
|
1.9% - 2.6%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
infrequent — 2% - 5%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Myalgia
|
infrequent — 2% - 5%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
rare, 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Urinary retention
|
Urinary retention
|
postmarketing — 1%
|
0%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Agoraphobia
|
Agoraphobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Alopecia
|
Alopecia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anaemia
|
Anaemia
|
rare, infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Angina pectoris
|
Angina pectoris
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anuria
|
Anuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthritis
|
Arthritis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Ataxia
|
Ataxia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back pain
|
Back pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
|
Bronchitis
|
Bronchitis
|
rare — 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bursitis
|
Bursitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Neck pain
|
Neck pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis
|
Cystitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bladder pain
|
Cystitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis noninfective
|
Cystitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dehydration
|
Dehydration
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delirium
|
Delirium
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Delusion
|
Delusion
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Diplopia
|
Diplopia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyskinesia
|
Dyskinesia
|
rare, infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urination impaired
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Ecchymosis
|
Ecchymosis
|
postmarketing — 2% - 4%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eczema
|
Eczema
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Epistaxis
|
Epistaxis
|
rare — 0% - 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eructation
|
Eructation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oesophagitis
|
Oesophagitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis
|
Rash
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rash
|
Rash
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
rare, infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Extrapyramidal symptoms
|
uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Furuncle
|
Furunculosis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis
|
Gastroenteritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing — infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gingivitis
|
Gingivitis
|
rare — 0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Glossitis
|
Glossitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hallucination
|
Hallucination
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure
|
Cardiac failure
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Haematuria
|
Haematuria
|
rare, infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hemiplegia
|
Hemiplegia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysphonia
|
Hoarseness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hostility
|
Hostility
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoaesthesia
|
Hypoaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Hypochondriasis
|
Hypochondriasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Hypothyroidism
|
Hypothyroidism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Conversion disorder
|
Hysteria
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
Leukocytosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Breast pain
|
Breast pain
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Melaena
|
Melaena
|
rare, infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menopause
|
Menopause
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Menorrhagia
|
Menorrhagia
|
postmarketing — 0% - 3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Hypotonia
|
Hypotonia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle relaxant therapy
|
Hypotonia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mydriasis
|
Mydriasis
|
rare, infrequent
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neurosis
|
Neurosis
|
infrequent, 1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Nocturia
|
Nocturia
|
rare, infrequent
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Otitis media
|
Otitis media
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pallor
|
Pallor
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyuria
|
Polyuria
|
rare — 1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diuresis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
rare — 1% - 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Premenstrual syndrome
|
Premenstrual syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Pruritus
|
Pruritus
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Psychotic disorder
|
Psychotic disorder
|
rare — frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperacusis
|
Hyperacusis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Scotoma
|
Scotoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Convulsion
|
Convulsion
|
rare, infrequent
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle spasms
|
Muscle spasms
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cramps of lower extremities
|
rare
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Stomatitis
|
Stomatitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mouth ulceration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Tenosynovitis
|
Tenosynovitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Tetany
|
Tetany
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Thirst
|
Thirst
|
infrequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Urinary tract infection
|
Urinary tract infection
|
rare — 2%
|
1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urticaria
|
Urticaria
|
rare, infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition urgency
|
Micturition urgency
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Stupor
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressed level of consciousness
|
Stupor
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
CNS depression NOS
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Mood swings
|
Mood swings
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Affect lability
|
Mood swings
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Photophobia
|
Photophobia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Musculoskeletal stiffness
|
Neck stiffness
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nuchal rigidity
|
Neck stiffness
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye pain
|
Eye pain
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paranoia
|
Paranoid reaction
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Skin discolouration
|
Skin discolouration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dry skin
|
Dry skin
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Accommodation disorder
|
Accommodation disorder
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tendinous contracture
|
Tendinous contracture
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Photosensitivity
|
rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Muscle twitching
|
Muscle twitching
|
infrequent, 0% - 2%
|
0%
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gait disturbance
|
Unsteady gait
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Gait disturbance
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Increased appetite
|
Increased appetite
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
infrequent, 3%
|
2%
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Suicidal ideation
|
Suicidal tendency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Suicidal ideation
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal ulcer
|
Gastrointestinal ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Menstruation delayed
|
Menstruation delayed
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Major depression
|
Psychotic depression
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Peripheral coldness
|
Peripheral coldness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Phobia
|
Phobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Akathisia
|
Akathisia
|
infrequent
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Heart rate irregular
|
Pulse irregular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Bradycardia
|
Bradycardia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram ST segment
|
Electrocardiogram ST segment
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paralysis
|
Paralysis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sleep disorder
|
Sleep disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cardiomyopathy
|
Cardiomyopathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypersomnia
|
Hypersomnia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Myasthenia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Parosmia
|
Parosmia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ageusia
|
Ageusia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
|
Visual impairment
|
Abnormal vision
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Visual disturbance
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Deafness
|
Deafness
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Ear pain
|
Ear pain
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
Hyperventilation
|
Hyperventilation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthropathy
|
Arthropathy
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Osteoarthritis
|
Arthropathy
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Dysarthria
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Metrorrhagia
|
Metrorrhagia
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
Neuralgia
|
Neuralgia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Paraesthesia
|
Paraesthesia
|
postmarketing — 3%
|
2%
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Tingling sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Aggression
|
Aggression
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Amenorrhoea
|
Amenorrhoea
|
postmarketing, rare
|
|
|
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
|
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Anger
|
Anger
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Angioedema
|
Angioedema
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Apnoea
|
Apnoea
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Arrhythmia
|
Arrhythmia
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Atrioventricular block
|
Atrioventricular block
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Blepharitis
|
Blepharitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bruxism
|
Bruxism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Cholecystitis
|
Cholecystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cholelithiasis
|
Cholelithiasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Coma
|
Coma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ulcerative keratitis
|
Ulcerative keratitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Cyanosis
|
Cyanosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Sudden death
|
Sudden death
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Diabetes mellitus
|
Diabetes mellitus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysarthria
|
Dysarthria
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Slurred speech
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
rare
|
|
|
x
|
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
|
|
|
Fatigue
|
Fatigue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
Faecal incontinence
|
Faecal incontinence
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
postmarketing — infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Glossodynia
|
Glossodynia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Goitre
|
Goitre
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Breath odour
|
Breath odour
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Haematemesis
|
Haematemesis
|
rare
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haemoptysis
|
Haemoptysis
|
rare
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Hepatitis
|
Hepatitis
|
postmarketing, rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hernia
|
Hernia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Herpes simplex
|
Herpes simplex
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Herpes zoster
|
Herpes zoster
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Hiccups
|
Hiccups
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperaesthesia
|
Hyperaesthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypomenorrhoea
|
Hypomenorrhoea
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Irritability
|
Irritability
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Jaundice
|
Jaundice
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
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
|
x
|
x
|
|
|
Lacrimal disorder
|
Lacrimal disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Lacrimal structural disorder
|
Lacrimal disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Laryngospasm
|
Laryngospasm
|
postmarketing, rare
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laryngitis
|
Laryngitis
|
rare, 0% - 3%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Leukopenia
|
Leukopenia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal discharge
|
Leukorrhea
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Menstrual disorder
|
Menstrual disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myopathy
|
Myopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Mutism
|
Mutism
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Obesity
|
Obesity
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Oliguria
|
Oliguria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pelvic pain
|
Pelvic pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
|
Pericarditis
|
Pericarditis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Phlebitis
|
Phlebitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Porphyrin metabolism disorder
|
Porphyrin metabolism disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Priapism
|
Priapism
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Prostatic disorder
|
Prostatic disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Psoriasis
|
Psoriasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Pulmonary infarction
|
Pulmonary infarction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Purpura
|
Purpura
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vascular purpura
|
Purpura
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Henoch-Schonlein purpura
|
Henoch-Schonlein purpura
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Retinal detachment
|
Retinal detachment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
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
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Withdrawal syndrome
|
Withdrawal syndrome
|
rare
|
|
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
|
|
Torticollis
|
Torticollis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Trismus
|
Trismus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
Vaginal infection
|
Vaginal inflammation
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
Vasculitis
|
Vasculitis
|
postmarketing
|
|
|
|
|
|
|
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
|
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Central nervous system neoplasm
|
Central nervous system neoplasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Self injurious behaviour
|
Self injurious behaviour
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Intentional self-injury
|
Self injurious behaviour
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Akinesia
|
Akinesia
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Haematospermia
|
Haematospermia
|
rare
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
Mouth ulceration
|
Mouth ulceration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Alcohol intolerance
|
Alcohol intolerance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Gastrointestinal carcinoma
|
Gastrointestinal carcinoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Tongue discolouration
|
Tongue discolouration
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Tongue disorder
|
Tongue oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Tongue oedema
|
Tongue oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Galactorrhoea
|
Lactation female
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
Galactorrhoea
|
rare
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Biliary colic
|
Biliary colic
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone pain
|
Bone pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Hyporeflexia
|
Hyporeflexia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Schizophreniform disorder
|
Schizophrenic reaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Crying
|
Syndrome screaming
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Screaming
|
Syndrome screaming
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
Interstitial lung disease
|
Interstitial lung disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Hangover
|
Hangover
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Proctalgia
|
Rectal tenesmus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Rectal tenesmus
|
Rectal tenesmus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Anorectal discomfort
|
Rectal tenesmus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Obsessive rumination
|
Obsessive rumination
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Obsessive thoughts
|
Obsessive rumination
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Somnolence neonatal
|
Somnolence neonatal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Dermatitis bullous
|
Bullous eruption
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Parkinsonism
|
Parkinsonism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Extrasystoles
|
Extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Abdominal distension
|
Enlargement abdomen
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuropathy
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Homicidal ideation
|
Homicidal ideation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Feeling drunk
|
Feeling drunk
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Face oedema
|
Face oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Feeling jittery
|
Feeling jittery
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
Renal pain
|
Renal pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Dermatitis atopic
|
Cutaneous hypersensitivity
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Blood glucose increased
|
Blood glucose increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Cardio-respiratory arrest
|
Cardio-respiratory arrest
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Obstructive airways disorder
|
Obstructive airways disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Serotonin syndrome
|
Serotonin syndrome
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Acne
|
Acne
|
rare, 0% - 2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
White blood cell count decreased
|
White blood cell count decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Ileus
|
Ileus
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Renal impairment
|
Renal impairment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Embolism
|
Embolus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Activation syndrome
|
Activation syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
Coronary artery disease
|
Coronary artery disease
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dental caries
|
Dental caries
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
Electric shock
|
Electric shock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enuresis
|
Enuresis
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Multiple fractures
|
Fracture
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Fracture
|
Fracture
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes virus infection
|
Herpes NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug withdrawal syndrome neonatal
|
Drug withdrawal syndrome neonatal
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Malignant syndrome NOS
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ligament sprain
|
Sprain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
|
Unintended pregnancy
|
Unintended pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Micturition disorder
|
Micturition disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depressive symptom
|
Depressive symptom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug withdrawal syndrome
|
Withdrawal symptom
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Drug withdrawal syndrome
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site reaction
|
Application site reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
Malnutrition
|
Malnutrition
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Ejaculation delayed
|
Ejaculation delayed
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
Abdominal discomfort
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Self-injurious ideation
|
Self-injurious ideation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
Administration site reaction
|
Administration site reaction
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Heart alternation
|
Heart alternation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Female sexual dysfunction
|
Female sexual dysfunction
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Obsessive-compulsive personality disorder
|
Compulsive personality disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Suicidal behaviour
|
Suicidal behaviour
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
