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
|
Nausea
|
Nausea
|
9% - 30%
|
7% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
very common, 9% - 20%
|
8% - 15%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
3% - 18%
|
3% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
2% - 15%
|
3% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
6% - 17%
|
5% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Asthenia
|
Fatigue
|
2% - 16%
|
5% - 8%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Asthenia
|
frequent, 2% - 8%
|
1%
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
2% - 16%
|
5% - 8%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Insomnia
|
Insomnia
|
5% - 16%
|
5% - 10%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
5% - 21%
|
3% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
7% - 13%
|
5% - 8%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loose stools
|
2% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
Decreased appetite
|
Decreased appetite
|
1% - 14%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorexia
|
3% - 5%
|
1%
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
2% - 10%
|
1% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sweating increased
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
Abdominal pain
|
Abdominal pain
|
common — 2% - 6%
|
4% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common — 2% - 6%
|
4% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neck pain
|
Neck pain
|
common
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
4% - 9%
|
4% - 5%
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
common, frequent
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
infrequent, common
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
common, frequent
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Tension
|
infrequent, common
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Nightmare
|
Nightmare
|
uncommon, frequent
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Myalgia
|
Myalgia
|
common, 1% - 4%
|
1%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
common, 1% - 4%
|
1%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Increased appetite
|
Increased appetite
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Abdominal discomfort
|
Upset stomach
|
common
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Abdominal discomfort
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Initial insomnia
|
Initial insomnia
|
frequent
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Middle insomnia
|
Middle insomnia
|
frequent
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
Feeling jittery
|
infrequent, common
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
frequent, 1% - 6%
|
0% - 2%
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
frequent, 1% - 6%
|
0% - 2%
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
4% - 5%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
Muscle spasms
|
postmarketing — 2% - 4%
|
2% - 3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
3% - 7%
|
3% - 6%
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Vomiting
|
Vomiting
|
3% - 6%
|
2% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
infrequent — 1% - 6%
|
1% - 3%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
0% - 5%
|
0% - 1%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
common — 3%
|
2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Back pain
|
Back pain
|
2% - 5%
|
3%
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
x
|
Low back pain
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Cough
|
Cough
|
2% - 6%
|
2% - 4%
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Seasonal allergy
|
Seasonal allergy
|
3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Rhinitis seasonal
|
Seasonal allergy
|
3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Influenza
|
Influenza
|
2% - 3%
|
2%
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
postmarketing — 3% - 5%
|
3% - 4%
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
0% - 5%
|
0% - 1%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
3%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Migraine
|
Migraine
|
3%
|
3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ejaculation delayed
|
Ejaculation delayed
|
frequent, 2% - 3%
|
1%
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing — 2% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
1% - 6%
|
1% - 3%
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 4%
|
4%
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
common — 2% - 5%
|
1% - 3%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
1% - 3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
Orgasm abnormal
|
Orgasm abnormal
|
postmarketing — 2% - 4%
|
0% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
postmarketing — 2%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing — 1% - 4%
|
2% - 4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Penis disorder
|
Penis disorder
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Weight decreased
|
Weight decreased
|
postmarketing — 2%
|
1%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
Yawning
|
Yawning
|
postmarketing — 2%
|
1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Viral diarrhoea
|
Viral diarrhoea
|
2%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ejaculation disorder
|
Ejaculation disorder
|
uncommon — 2% - 4%
|
0% - 1%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
uncommon, 2%
|
1%
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Oropharyngeal pain
|
Oropharyngeal pain
|
postmarketing — 2%
|
2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
x
|
|
Pollakiuria
|
Pollakiuria
|
postmarketing — 1% - 5%
|
2%
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
Micturition urgency
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Alopecia
|
Alopecia
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Anaemia
|
Anaemia
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Ataxia
|
Ataxia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Atrial fibrillation
|
Atrial fibrillation
|
infrequent
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
Colitis
|
Colitis
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Diverticulitis
|
Diverticulitis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Oedema
|
Oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Flushing
|
Flushing
|
postmarketing — 2% - 3%
|
1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Cardiac failure
|
Cardiac failure
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Nephropathy
|
Nephropathy
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Leukopenia
|
Leukopenia
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Macular degeneration
|
Macular degeneration
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Mydriasis
|
Mydriasis
|
uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Oliguria
|
Oliguria
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Phlebitis
|
Phlebitis
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Prurigo
|
Prurigo
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Retinal detachment
|
Retinal detachment
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, infrequent
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Urinary retention
|
Urinary retention
|
postmarketing — uncommon
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
Bundle branch block right
|
Bundle branch block right
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Photopsia
|
Photopsia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Oedema peripheral
|
Oedema peripheral
|
infrequent
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Sjogren's syndrome
|
Syndrome sicca
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Liver function test abnormal
|
Liver function test abnormal
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscular weakness
|
Muscular weakness
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
postmarketing, uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
postmarketing, uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary hesitation
|
Urinary hesitation
|
infrequent — frequent
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
Abdominal pain lower
|
Abdominal pain lower
|
infrequent
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Pressure of speech
|
Pressure of speech
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Abnormal dreams
|
Abnormal dreams
|
postmarketing — 2% - 3%
|
1%
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Blood creatinine increased
|
Blood creatinine increased
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Blood pressure systolic increased
|
Blood pressure systolic increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood pressure diastolic increased
|
Blood pressure diastolic increased
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ejaculation failure
|
Ejaculation failure
|
uncommon
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Epigastric discomfort
|
Gastric irritation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza like illness
|
Influenza like illness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Impaired gastric emptying
|
Impaired gastric emptying
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Face oedema
|
Face oedema
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Urine flow decreased
|
Urine flow decreased
|
rare, infrequent
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
Maculopathy
|
Maculopathy
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
White blood cell count increased
|
White blood cell count increased
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Oropharyngeal swelling
|
Oropharyngeal swelling
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Oesophageal stenosis
|
Oesophageal stenosis acquired
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Oesophageal stenosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Hypersomnia
|
Hypersomnia
|
infrequent, frequent
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sluggishness
|
Sluggishness
|
rare, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Musculoskeletal stiffness
|
Musculoskeletal stiffness
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haematochezia
|
Blood in stool
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haematochezia
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
Coronary artery disease
|
Coronary artery disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Hepatic steatosis
|
Hepatic steatosis
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Loss of libido
|
Loss of libido
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
postmarketing, infrequent
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Aggression
|
Aggression
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Anger
|
Anger
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Angioedema
|
Angioedema
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bruxism
|
Bruxism
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis contact
|
Dermatitis contact
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Diplopia
|
Diplopia
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Dysarthria
|
Dysarthria
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Osteoarthritis
|
Dysarthria
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Osteoarthritis
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing — 3%
|
1%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
postmarketing — frequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Ecchymosis
|
Ecchymosis
|
postmarketing — infrequent
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Eructation
|
Eructation
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Stevens-Johnson syndrome
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing — 4%
|
2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 4%
|
2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Extrapyramidal symptoms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
postmarketing, 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
postmarketing — frequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
postmarketing — frequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 14% - 30%
|
9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing — uncommon
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Glaucoma
|
Glaucoma
|
very rare — infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Angle closure glaucoma
|
Angle closure glaucoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
Breath odour
|
Breath odour
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, 2%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood disorder
|
Blood disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemorrhage
|
Haemorrhage
|
very rare, postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Haemoglobin
|
Haemorrhage
|
very rare, postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Hypertensive crisis
|
Hypertensive crisis
|
very rare — infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing — frequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia facial
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
very rare — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
Irritability
|
Irritability
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngitis
|
Laryngitis
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
postmarketing — frequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing, 2%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Melaena
|
Melaena
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Menstrual disorder
|
Menstrual disorder
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myoclonus
|
Myoclonus
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Night sweats
|
Night sweats
|
postmarketing — frequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nocturia
|
Nocturia
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Urine output increased
|
Polyuria
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
postmarketing — 3%
|
2%
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Restless legs syndrome
|
Restless legs syndrome
|
very rare, postmarketing
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Convulsion
|
Convulsion
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
postmarketing — infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Suicide attempt
|
Suicide attempt
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Testicular pain
|
Testicular pain
|
postmarketing, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
Thirst
|
Thirst
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Trismus
|
Trismus
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
|
Urticaria
|
Urticaria
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing, 2% - 3%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
postmarketing — 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
postmarketing — frequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Rigors
|
postmarketing — frequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Apathy
|
Apathy
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Affect lability
|
Mood swings
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing, 7% - 9%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, 6%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
postmarketing — frequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Cold sweat
|
Cold sweat
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disorientation
|
Disorientation
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
Disturbance in attention
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Anorgasmia
|
Anorgasmia
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Galactorrhoea
|
Galactorrhoea
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Pharyngeal oedema
|
Pharyngeal oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Throat tightness
|
Throat tightness
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Menopausal symptoms
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hot flush
|
postmarketing — 2% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyslipidaemia
|
Dyslipidaemia
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
Peripheral coldness
|
Peripheral coldness
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Urine odour abnormal
|
Urine odour abnormal
|
postmarketing — infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
very rare — uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dry eye
|
Dry eye
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Mania
|
Mania
|
very rare — infrequent
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
Increased tendency to bruise
|
Increased tendency to bruise
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Arrhythmia supraventricular
|
Arrhythmia supraventricular
|
very rare, postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Visual impairment
|
Visual disturbance
|
postmarketing, infrequent
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Visual impairment
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Sexual dysfunction
|
Sexual dysfunction
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
postmarketing, rare
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Blood cholesterol increased
|
Blood cholesterol increased
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
postmarketing — 2% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
postmarketing — 3%
|
2%
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disturbance
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Completed suicide
|
Completed suicide
|
postmarketing — infrequent
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Muscle tightness
|
Muscle tightness
|
postmarketing — frequent
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Poor quality sleep
|
Poor quality sleep
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Feeling hot
|
Feeling hot
|
postmarketing — uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Jaundice
|
Jaundice
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Shock
|
Syncope
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Loss of consciousness
|
Syncope
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Diabetes mellitus
|
Diabetic
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes mellitus
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Serotonin syndrome
|
Serotonin syndrome
|
very rare, postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Contusion
|
Contusion
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electric shock
|
Electric shock
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Pain in extremity
|
Pain in extremity
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pharyngitis
|
Pharyngitis
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Rhabdomyolysis
|
Rhabdomyolysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Essential hypertension
|
Essential hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic failure
|
Hepatic failure
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Drug withdrawal syndrome
|
Withdrawal symptom
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
Creatine phosphokinase increased
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood creatine phosphokinase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Secondary hypertension
|
Secondary hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver injury
|
Liver injury
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute liver injury
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Traumatic liver injury
|
Liver injury
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Systolic hypertension
|
Systolic hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac fibrillation
|
Cardiac fibrillation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Abdominal tenderness
|
Abdominal tenderness
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Diastolic hypertension
|
Diastolic hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatotoxicity
|
Hepatotoxicity
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glycosylated haemoglobin increased
|
Glycosylated haemoglobin increased
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure diastolic decreased
|
Blood pressure diastolic decreased
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Akathisia
|
Akathisia
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Suicidal ideation
|
Suicidal ideation
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Paraesthesia oral
|
Paraesthesia oral
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Terminal insomnia
|
Terminal insomnia
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Orthostatic hypertension
|
Orthostatic hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhagic disorder
|
Hemorrhage abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood potassium increased
|
Blood potassium increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Blood glucose increased
|
Fasting blood glucose increased
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal failure
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal impairment
|
Renal impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Suicidal behaviour
|
Suicidal behaviour
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Genital hypoaesthesia
|
Genital hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Labile hypertension
|
Labile hypertension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|