MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
Dry mouth
|
Dry mouth
|
63% - 84%
|
16% - 17%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
46% - 54%
|
11% - 16%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
very common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
common — 41% - 54%
|
14%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
very common, 35% - 39%
|
9% - 18%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
very common, 35% - 39%
|
9% - 18%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
very common, 33% - 54%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common — 28% - 52%
|
34% - 41%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
very common, 22% - 47%
|
9% - 11%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
very common, 20%
|
3%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
very common
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sweating increased
|
9% - 29%
|
3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
very common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Libido disorder
|
Libido disorder
|
very common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Agitation
|
Unrest
|
very common
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Agitation
|
common, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
14%
|
5% - 9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
13% - 22%
|
2% - 10%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
13%
|
9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
13%
|
9%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
3%
|
5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common, 11% - 13%
|
9% - 16%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common, 11% - 13%
|
9% - 16%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
common, 12% - 22%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Increased appetite
|
Increased appetite
|
very common, 11%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
common, 11% - 25%
|
7% - 15%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
10% - 12%
|
10% - 14%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
common — 9% - 33%
|
11% - 14%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
4% - 9%
|
5%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disturbance
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Weight increased
|
Weight increased
|
very common, 2% - 18%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myoclonus
|
Myoclonus
|
very common, 2% - 13%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchospasm
|
Bronchospasm
|
2% - 7%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
4% - 7%
|
4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
common, 7% - 13%
|
5% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
7% - 8%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
7% - 12%
|
9% - 10%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 7%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
7%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Memory impairment
|
Memory impairment
|
common, 7% - 9%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
7% - 18%
|
2% - 4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
6%
|
6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
6%
|
2% - 3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
6%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ejaculation failure
|
Ejaculation failure
|
6% - 42%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggression
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Aggressive reaction
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delirium
|
Delirium
|
infrequent, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
5%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression aggravated
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Dermatitis atopic
|
Dermatitis atopic
|
common
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hallucination
|
Hallucination
|
infrequent, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nightmare
|
Nightmare
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Parkinson's disease
|
Parkinson's disease
|
common
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Parkinsonism
|
Parkinson's disease
|
common
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
common, 2% - 6%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
common
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Tooth disorder
|
Tooth disorder
|
5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
5%
|
3%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug withdrawal syndrome
|
Withdrawal symptom
|
common
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
common
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Thinking abnormal
|
Thinking abnormal
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebration impaired
|
common, 5%
|
2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
Cerebration impaired
|
common, 5%
|
2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Galactorrhoea
|
Galactorrhoea
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hypomania
|
Hypomania
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Mania
|
Mania
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Manic psychosis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
infrequent, common
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Transaminases increased
|
Transaminases increased
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Anxiety
|
Anxiety state
|
common
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Anxiety
|
common, 2% - 9%
|
4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phobia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal disorder
|
Abdominal disorder
|
common
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
2%
|
2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
common, 4% - 8%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
common, 4% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
common, 4% - 18%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
common, 4% - 18%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
common, 4% - 6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
4% - 6%
|
5% - 6%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
rare — 4% - 8%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
rare — 4% - 8%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
4%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
4%
|
5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
3% - 4%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
4%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
very common, 4% - 14%
|
2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
4% - 7%
|
1% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
common, 2% - 9%
|
2% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
common, 2% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
common, 2% - 5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
3%
|
5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
2% - 7%
|
3% - 5%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertonia
|
Hypertonia
|
common, 2% - 4%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychosomatic disease
|
Psychosomatic disease
|
3%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
very rare, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
very rare, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Speech disorder
|
Speech disorder
|
common, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Yawning
|
Yawning
|
common, 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
3%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
3%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
common, 2% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
common, 2% - 3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pupils unequal
|
Pupils unequal
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharospasm
|
Blepharospasm
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depersonalisation
|
Depersonalisation
|
common, 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
2% - 4%
|
7%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breath odour
|
Breath odour
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngitis
|
Laryngitis
|
2%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mydriasis
|
Mydriasis
|
common, 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Panic reaction
|
Panic reaction
|
1% - 2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paresis
|
Paresis
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
2% - 6%
|
4% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Ulcerative stomatitis
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
Syncope
|
2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
2% - 4%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vestibular disorder
|
Vestibular disorder
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary retention
|
Urinary retention
|
very rare, 2% - 7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chills
|
Chills
|
2%
|
1%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
2%
|
2%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscular weakness
|
Muscular weakness
|
common, 1% - 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
2%
|
5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin odour abnormal
|
Skin odour abnormal
|
2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acne
|
Acne
|
2%
|
2% - 5%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Local swelling
|
Local swelling
|
2%
|
4%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast enlargement
|
Breast enlargement
|
common, 2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
common, 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ataxia
|
Ataxia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bruxism
|
Bruxism
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cellulitis
|
Cellulitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Coma
|
Coma
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dental caries
|
Dental caries
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Duodenitis
|
Duodenitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometriosis
|
Endometriosis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epididymitis
|
Epididymitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrapyramidal symptoms
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gout
|
Gout
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhoids
|
Haemorrhoids
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hostility
|
Hostility
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperventilation
|
Hyperventilation
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Generalised spasm
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nocturia
|
Nocturia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oliguria
|
Oliguria
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ovarian cyst
|
Ovarian cyst
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pallor
|
Pallor
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peptic ulcer
|
Peptic ulcer
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Prostatic disorder
|
Prostatic disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus genital
|
Pruritus genital
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperacusis
|
Hyperacusis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Scleritis
|
Scleritis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnambulism
|
Somnambulism
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric ulcer
|
Gastric ulcer
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urethral disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Urinary incontinence
|
Urinary incontinence
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uterine haemorrhage
|
Uterine haemorrhage
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Encephalopathy
|
Encephalopathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
Rash pustular
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electroencephalogram abnormal
|
Electroencephalogram abnormal
|
very rare, infrequent
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin discolouration
|
Skin discolouration
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory disturbance
|
Sensory disturbance
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Accommodation disorder
|
Accommodation disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypnagogic hallucination
|
Hypnagogic hallucination
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue ulceration
|
Tongue ulceration
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection susceptibility increased
|
Infection susceptibility increased
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Perineal pain
|
Perineal pain
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phobia
|
Phobia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensation of foreign body
|
Sensation of foreign body
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicidal ideation
|
Suicidal ideation
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Coordination abnormal
|
Coordination abnormal
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haematochezia
|
Blood in stool
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
Paranoia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parosmia
|
Parosmia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphonia
|
Dysphonia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ageusia
|
Ageusia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aneurysm
|
Aneurysm
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aphasia
|
Aphasia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apraxia
|
Apraxia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial flutter
|
Atrial flutter
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blepharitis
|
Blepharitis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bundle branch block
|
Bundle branch block
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Waxy flexibility
|
Catalepsy
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cervical dysplasia
|
Cervical dysplasia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cheilitis
|
Cheilitis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Conjunctival haemorrhage
|
Conjunctival haemorrhage
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Contusion
|
Contusion
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cyanosis
|
Cyanosis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometrial hyperplasia
|
Endometrial hyperplasia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Enteritis
|
Enteritis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Exophthalmos
|
Exophthalmos
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Folliculitis
|
Folliculitis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingival bleeding
|
Gingival bleeding
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angle closure glaucoma
|
Angle closure glaucoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Glycosuria
|
Glycosuria
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Goitre
|
Goitre
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrioventricular block
|
Block heart
|
rare
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hemiparesis
|
Hemiparesis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemoptysis
|
Haemoptysis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hiccups
|
Hiccups
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperaesthesia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperthyroidism
|
Hyperthyroidism
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertrichosis
|
Hypertrichosis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivary gland enlargement
|
Salivary gland enlargement
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Illusion
|
Illusion
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Keratitis
|
Keratitis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Inner ear disorder
|
Labyrinthine disorder
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Laryngospasm
|
Laryngospasm
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukaemoid reaction
|
Leukaemoid reaction
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chloasma
|
Chloasma
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopathy
|
Myopathy
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mutism
|
Mutism
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myositis
|
Myositis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Night blindness
|
Night blindness
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
IIIrd nerve paralysis
|
IIIrd nerve paralysis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyarteritis nodosa
|
Polyarteritis nodosa
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Piloerection
|
Piloerection
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Premature ejaculation
|
Premature ejaculation
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pyelonephritis
|
Pyelonephritis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pyuria
|
Pyuria
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinal disorder
|
Retinal disorder
|
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
|
Skin ulcer
|
Skin ulcer
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric dilatation
|
Gastric dilatation
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomach dilation procedure
|
Gastric dilatation
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Withdrawal syndrome
|
Withdrawal syndrome
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Completed suicide
|
Suicide
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Torticollis
|
Torticollis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular tachycardia
|
Ventricular tachycardia
|
rare
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulval disorder
|
Vulval disorder
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Choreoathetosis
|
Choreoathetosis
|
rare
|
|
|
|
|
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
|
Depressed level of consciousness
|
Stupor
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oculogyric crisis
|
Oculogyric crisis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast engorgement
|
Breast engorgement
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anticholinergic syndrome
|
Anticholinergic syndrome
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin hypertrophy
|
Skin hypertrophy
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Bone marrow depression
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Hyperreflexia
|
Hyperreflexia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Schizophreniform disorder
|
Schizophrenic reaction
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pseudolymphoma
|
Pseudolymphoma
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Faeces discoloured
|
Faeces discoloured
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gravitational oedema
|
Gravitational oedema
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uterine inflammation
|
Uterine inflammation
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pharyngeal oedema
|
Pharyngeal oedema
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fat intolerance
|
Fat intolerance
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cholinergic syndrome
|
Cholinergic syndrome
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Toxicity to various agents
|
Cholinergic syndrome
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Systemic lupus erythematosus
|
Lupus erythematosus
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
very rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Chromatopsia
|
Chromatopsia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fibroadenoma of breast
|
Fibroadenosis of breast
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Exostosis
|
Exostosis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal cyst
|
Renal cyst
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
rare
|
|
|
|
|
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
|
Agranulocytosis
|
Agranulocytosis
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Alopecia
|
Alopecia
|
very rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alveolitis allergic
|
Alveolitis allergic
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Oedema
|
Oedema
|
very rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Glaucoma
|
Glaucoma
|
very rare, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
very rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Leukopenia
|
Leukopenia
|
very rare
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
very rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Ileus paralytic
|
Ileus paralytic
|
very rare, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
very rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hepatic necrosis
|
Hepatic necrosis
|
very rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Conduction disorder
|
Conduction disorder
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hepatitis acute
|
Hepatitis acute
|
very rare
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactoid reaction
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Hyperpyrexia
|
Hyperpyrexia
|
very rare
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Parotid gland enlargement
|
Parotid swelling
|
very rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Testicular swelling
|
Testicular swelling
|
very rare
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Sudden death
|
Sudden death
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Multiple fractures
|
Fracture
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Fracture
|
Fracture
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Torsade de pointes
|
Torsade de pointes
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Ventricular fibrillation
|
Ventricular fibrillation
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Depressive symptom
|
Depressive symptom
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Akathisia
|
Akathisia
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Electrocardiogram QRS complex
|
QRS complex
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Serotonin syndrome
|
Serotonin syndrome
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Blood prolactin increased
|
Blood prolactin increased
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT corrected interval prolonged
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cardiomyopathy
|
Cardiomyopathy
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|