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
|
Rhinitis
|
Rhinitis
|
9% - 23%
|
14.3% - 29.1%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
infrequent — 9% - 29.7%
|
6% - 13.5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
frequent — 1% - 33%
|
7% - 22%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
frequent, very common
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Asthenia
|
very common, 4.4% - 21.7%
|
1.9% - 11%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
frequent, very common
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Headache
|
Headache
|
very rare — 13% - 32.6%
|
9% - 26.9%
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
Somnolence
|
Somnolence
|
very common, 5% - 17.1%
|
2% - 7.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Decreased appetite
|
Anorexia
|
common, 4% - 17%
|
1% - 10.1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
very common, 2% - 13.3%
|
3% - 11.2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Tremor
|
Tremor
|
very common, 3% - 13.7%
|
1% - 3.9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
common, 4% - 12.1%
|
3% - 8.6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
8% - 10.1%
|
14.6% - 16.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
infrequent — 2% - 18.2%
|
4% - 13.5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
3% - 9%
|
7%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
frequent — 1% - 14.9%
|
3% - 15%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tension
|
Nervousness
|
frequent — 1% - 14.9%
|
3% - 15%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
3% - 11.1%
|
3% - 9%
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
common, 2% - 8.9%
|
0% - 3.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
7.6%
|
6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Dyspepsia
|
Dyspepsia
|
common, 6% - 11%
|
2% - 6.7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
3% - 12%
|
3% - 7%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Yawning
|
Yawning
|
common, 1% - 11.1%
|
0.5% - 0.8%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ejaculation disorder
|
Abnormal ejaculation
|
infrequent — 2% - 7%
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
Infection
|
Infection
|
0% - 7%
|
3% - 6.2%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
4.9% - 9.6%
|
5% - 11.2%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
4.9% - 9.6%
|
5% - 11.2%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
frequent — 1% - 16.3%
|
2% - 11.1%
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
3.4% - 8.3%
|
4.8% - 5.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Urinary tract infection
|
Urinary tract infection
|
frequent, 5.1%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Amnesia
|
Amnesia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
infrequent, frequent
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
infrequent, frequent
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
4.2% - 6.9%
|
3% - 6.7%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
common, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
frequent, 3.4% - 6.1%
|
5.6% - 7.8%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
common, 5.7%
|
1.1% - 5.9%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
infrequent — frequent
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
infrequent — frequent
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
common
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Hypertension
|
Hypertension
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
common — 3%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
common, 3%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
1% - 6%
|
2% - 6.9%
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
common — 2% - 6.2%
|
1% - 1.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
frequent
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
common
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Weight increased
|
Weight increased
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
uncommon, frequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
infrequent — 2.7%
|
7.8%
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
Affect lability
|
Mood swings
|
infrequent — 2.7%
|
7.8%
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
Muscle twitching
|
Muscle twitching
|
uncommon, common
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Increased appetite
|
Increased appetite
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
common, 2% - 6%
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
common, 2% - 6%
|
0% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Abnormal dreams
|
Abnormal dreams
|
common — 1% - 5%
|
1% - 3%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
common, frequent
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
common, 1% - 11%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
common, 1% - 11%
|
1% - 2%
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
common, 1% - 6.4%
|
2% - 4.9%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
common, 1% - 6.4%
|
2% - 4.9%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
1% - 8%
|
3% - 5%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Intentional injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
3.3% - 4.7%
|
5.4% - 9.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal discomfort
|
Myalgia
|
3.3% - 4.7%
|
5.4% - 9.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Back pain
|
Back pain
|
2.7% - 6.9%
|
5.6% - 8.6%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
3% - 7.2%
|
2% - 5.6%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
infrequent — 3%
|
2%
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
Weight decreased
|
Weight decreased
|
common, 2% - 3%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
common, 2% - 3%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
infrequent — 1% - 7%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Anaemia
|
Anaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bruxism
|
Bruxism
|
infrequent, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholelithiasis
|
Cholelithiasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cystitis
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depersonalisation
|
Depersonalisation
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis contact
|
Dermatitis contact
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
postmarketing, uncommon
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Buccoglossal syndrome
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urination impaired
|
uncommon
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ecchymosis
|
Ecchymosis
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
infrequent, common
|
|
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
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
infrequent, 2% - 3%
|
1% - 2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fibrocystic breast disease
|
Fibrocystic breast disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingival bleeding
|
Gingival bleeding
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hiccups
|
Hiccups
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperventilation
|
Hyperventilation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
very rare, infrequent
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Breast pain
|
Breast pain
|
infrequent, uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
Melaena
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopause
|
Menopause
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Menorrhagia
|
Menorrhagia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
Hypertonia
|
Hypertonia
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Mydriasis
|
Mydriasis
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myoclonus
|
Myoclonus
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neurosis
|
Neurosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Nocturia
|
Nocturia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ovarian disorder
|
Ovarian disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pelvic pain
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Personality disorder
|
Personality disorder
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diuresis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blacked-out (not amnesia)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tenosynovitis
|
Tenosynovitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Vascular headache
|
Vascular headache
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary retention
|
Urinary retention
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Buccoglossal syndrome
|
Buccoglossal syndrome
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depressed level of consciousness
|
CNS depression NOS
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Stupor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised oedema
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fluid retention
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperchlorhydria
|
Hyperchlorhydria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric pH decreased
|
Hyperchlorhydria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Galactorrhoea
|
Lactation female
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Galactorrhoea
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mania
|
Manic psychosis
|
infrequent, uncommon
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Mania
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Bone pain
|
Bone pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
Paranoid reaction
|
infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
Vesiculobullous rash
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Vesiculobullous rash
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abortion
|
Abortion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
uncommon
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorgasmia
|
Anorgasmia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Akathisia
|
Akathisia
|
infrequent, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Balance disorder
|
Balance disorder
|
infrequent, uncommon
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne
|
Acne
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast enlargement
|
Breast enlargement
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Acute abdomen
|
Acute abdomen
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Hypochromic anaemia
|
Hypochromic anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Apnoea
|
Apnoea
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atelectasis
|
Atelectasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumothorax
|
Atelectasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumothorax
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebral artery embolism
|
Cerebral artery embolism
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholecystitis
|
Cholecystitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chondrodystrophy
|
Chondrodystrophy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Coma
|
Coma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
rare, infrequent
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetic ketoacidosis
|
Diabetic ketoacidosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Duodenal ulcer
|
Duodenal ulcer
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysarthria
|
Dysarthria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Enteritis
|
Enteritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Erythema nodosum
|
Erythema nodosum
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Exophthalmos
|
Exophthalmos
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Faecal incontinence
|
Faecal incontinence
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Furuncle
|
Furunculosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glaucoma
|
Glaucoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glycosuria
|
Glycosuria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing, 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
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood disorder
|
Blood disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hirsutism
|
Hirsutism
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary hypertension
|
Pulmonary hypertension
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salivary gland enlargement
|
Salivary gland enlargement
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypomenorrhoea
|
Hypomenorrhoea
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Body temperature decreased
|
Body temperature decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothermia
|
Body temperature decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Iritis
|
Iritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Arthropathy
|
Arthropathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngeal oedema
|
Laryngeal oedema
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphoedema
|
Lymphoedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphocytosis
|
Lymphocytosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Myositis
|
Myositis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
Neuritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
very rare, rare
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Malignant syndrome NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oliguria
|
Oliguria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteomyelitis
|
Osteomyelitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoporosis
|
Osteoporosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pallor
|
Pallor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancreatitis
|
Pancreatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Peptic ulcer
|
Peptic ulcer
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Petechiae
|
Petechiae
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Priapism
|
Priapism
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
x
|
x
|
Psoriasis
|
Psoriasis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Emphysema
|
Emphysema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Purpuric rash
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hyperacusis
|
Hyperacusis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Scleritis
|
Scleritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Scotoma
|
Scotoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Serum sickness
|
Serum sickness
|
rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Stridor
|
Stridor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, rare
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Uterine leiomyoma
|
Uterine leiomyoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
Uterine fibroids enlarged
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Uterine haemorrhage
|
Uterine haemorrhage
|
rare
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
x
|
x
|
Vasculitis
|
Vasculitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular fibrillation
|
Ventricular fibrillation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vasospasm
|
Vasospasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Stupor
|
Stupor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Peroneal nerve palsy
|
Footdrop
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast engorgement
|
Breast engorgement
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cataract
|
Cataract
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Alcohol intolerance
|
Alcohol intolerance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood urea increased
|
Blood urea increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough decreased
|
Cough decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea haemorrhagic
|
Diarrhoea haemorrhagic
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue disorder
|
Tongue oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue oedema
|
Tongue oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electroencephalogram abnormal
|
Electroencephalogram abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Necrolysis epidermal
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
Large intestinal haemorrhage
|
Hemorrhage of colon
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic steatosis
|
Liver fatty deposition
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Biliary colic
|
Biliary colic
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia oral
|
Circumoral paresthesia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyporeflexia
|
Hyporeflexia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperreflexia
|
Hyperreflexia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophageal ulcer
|
Oesophageal ulcer
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Iron deficiency anaemia
|
Iron deficiency anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophageal pain
|
Oesophageal pain
|
rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Antisocial personality disorder
|
Antisocial behaviour
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Antisocial behaviour
|
Antisocial behaviour
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asocial behaviour
|
Antisocial behaviour
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Protrusion tongue
|
Protrusion tongue
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Aggression
|
Violent
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Aggression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric ulcer haemorrhage
|
Gastric ulcer haemorrhage
|
rare
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paralysis
|
Paralysis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytosis
|
Thrombocytosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
postmarketing
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Cerebral ischaemia
|
Cerebral ischaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscular weakness
|
Myasthenia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Parosmia
|
Parosmia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilic pneumonia
|
Eosinophilic pneumonia
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ageusia
|
Ageusia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoxia
|
Hypoventilation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Respiratory failure
|
Hypoventilation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoventilation
|
Hypoventilation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactoid reaction
|
very rare, rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
very rare, rare
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Serotonin syndrome
|
Serotonin syndrome
|
very rare
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Alveolitis allergic
|
Alveolitis allergic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Haemolytic anaemia
|
Haemolytic anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Blister
|
Blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast feeding
|
Breast feeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Bundle branch block
|
Bundle branch block
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Cachexia
|
Cachexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Neck pain
|
Neck pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Fungal skin infection
|
Fungal skin infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Diverticulitis
|
Diverticulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Enterocolitis
|
Enterocolitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epididymitis
|
Epididymitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Foetal alcohol syndrome
|
Foetal alcohol syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Goitre
|
Goitre
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Haematochezia
|
Haematochezia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematoma
|
Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatomegaly
|
Hepatomegaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hydrocephalus
|
Hydrocephalus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperplasia
|
Hyperplasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyperthyroidism
|
Hyperthyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hyponatraemia
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Conversion disorder
|
Hysteria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Irritability
|
Irritability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Nephrolithiasis
|
Calculus of kidney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Nephropathy
|
Nephropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lethargy
|
Lethargy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Systemic lupus erythematosus
|
Systemic lupus erythematosus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Non-Hodgkin's lymphoma
|
Lymphoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movement disorder
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Necrosis
|
Necrosis
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensory loss
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Azoospermia
|
Oligospermia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Optic neuritis
|
Optic neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mouth haemorrhage
|
Mouth haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orchitis
|
Orchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Orchitis noninfective
|
Orchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Osteonecrosis
|
Osteonecrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Polymenorrhoea
|
Polymenorrhoea
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Pregnancy
|
Pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pulmonary fibrosis
|
Pulmonary fibrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pyelonephritis
|
Pyelonephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pyuria
|
Pyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Renal failure
|
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Retinal haemorrhage
|
Retinal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Salpingitis
|
Salpingitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Withdrawal syndrome
|
Withdrawal syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Completed suicide
|
Suicide
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Attention deficit/hyperactivity disorder
|
Attention deficit disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urethritis
|
Urethritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Urethritis noninfective
|
Urethritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hepatic failure
|
Hepatic failure
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Oculogyric crisis
|
Oculogyric crisis
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depressive symptom
|
Depressive symptom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Panic attack
|
Panic attack
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Nuchal rigidity
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Bleeding time prolonged
|
Bleeding time prolonged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Corneal lesion
|
Corneal lesion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Tongue discolouration
|
Tongue discolouration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Muscle haemorrhage
|
Muscle haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Skin hypertrophy
|
Skin hypertrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hepatocellular injury
|
Hepatocellular injury
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver injury
|
Hepatocellular injury
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver tenderness
|
Liver tenderness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Eye pain
|
Eye pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Urethral pain
|
Urethral pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Uterine spasm
|
Uterine spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Accommodation disorder
|
Accommodation disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Oesophageal varices haemorrhage
|
Oesophageal varices haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Enlarged clitoris
|
Enlarged clitoris
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hangover
|
Hangover
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Immobile
|
Immobile
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Teratogenicity
|
Teratogenicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menometrorrhagia
|
Menometrorrhagia
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Disturbance in attention
|
Disturbance in attention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Memory impairment
|
Memory impairment
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clonic convulsion
|
Clonic convulsion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in jaw
|
Pain in jaw
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Drug tolerance
|
Tolerance development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Hypomania
|
Hypomania
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Drug dependence
|
Dependence psychological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Drug seeking behavior
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Dependence
|
Dependence physiological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Ulcer haemorrhage
|
Ulcer haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal distension
|
Enlargement abdomen
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Suicidal ideation
|
Suicidal ideation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toe walking
|
Toe walking
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Calculus urinary
|
Urolithiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Respiratory distress
|
Respiratory distress
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Grand mal convulsion
|
Tonic-clonic seizures
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Blood pressure increased
|
Blood pressure increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Self-injurious ideation
|
Self-injurious ideation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Central nervous system stimulation
|
Excitation cerebral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Physical assault
|
Battery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling jittery
|
Feeling jittery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cough
|
Cough increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Genital haemorrhage
|
Genital haemorrhage
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Carcinogenicity
|
Carcinogenicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiotoxicity
|
Cardiotoxicity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urogenital haemorrhage
|
Urogenital haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cervix haemorrhage uterine
|
Cervix haemorrhage uterine
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Female sexual dysfunction
|
Female sexual dysfunction
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Dyspareunia
|
Dyspareunia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Langerhans' cell histiocytosis
|
Histiocytosis X of lung
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Overdose
|
Acute overdose
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Body height decreased
|
Body height decreased
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|