MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
Asthenia
|
Fatigue
|
postmarketing, 2.9% - 18.5%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Asthenia
|
postmarketing, 0% - 7.1%
|
16.7%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Fatigue
|
Fatigue
|
postmarketing, 2.9% - 18.5%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
3.9% - 7.4%
|
3.3%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 4.1% - 14.8%
|
15.6% - 23.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 2.7% - 17.3%
|
5.5% - 15%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 5.2%
|
1.7% - 1.8%
|
|
|
|
|
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 5.2%
|
1.7% - 1.8%
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
3.2% - 3.7%
|
3.3%
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
Myalgia
|
3.2% - 3.7%
|
3.3%
|
|
|
|
|
|
|
|
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 1.2% - 8.2%
|
0% - 3.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 1.9% - 8%
|
0% - 0.9%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Lethargy
|
Lethargy
|
2.7% - 4.1%
|
0.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
1.9% - 3.7%
|
1.7%
|
|
|
|
|
|
|
|
|
x
|
x
|
Chest pain
|
Chest pain
|
1.4% - 7.1%
|
0.9% - 5%
|
|
|
|
|
|
|
|
|
x
|
|
Depression
|
Depression
|
0.8% - 4%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
0.8% - 4%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
Tension
|
Nervousness
|
0.8% - 4%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
Bradycardia
|
Bradycardia
|
postmarketing, 0% - 12%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing, 1.9% - 2.5%
|
0%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing, 1.3% - 2.7%
|
0.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing, 1.2% - 5.8%
|
0%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Abnormal dreams
|
Bizarre dreams
|
1% - 2.7%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
Oedema
|
Oedema
|
0% - 1.8%
|
0% - 1.8%
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Peripheral coldness
|
Peripheral coldness
|
0% - 1.9%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
Rhinitis
|
Rhinitis
|
postmarketing, 0% - 4%
|
0.9%
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
|
|
|
Arrhythmia
|
Arrhythmia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Asthenopia
|
Asthenopia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Asthma
|
Asthma
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Atrioventricular block
|
Atrioventricular block
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Block heart
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Blepharitis
|
Blepharitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Blepharospasm
|
Blepharospasm
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
|
|
|
Confusional state
|
Confusional state
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Conjunctival disorder
|
Conjunctival disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dermatitis
|
Dermatitis
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
|
|
|
Rash
|
postmarketing, 0% - 1.2%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
|
|
|
Endophthalmitis
|
Endophthalmitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Panophthalmitis
|
Endophthalmitis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Hallucination
|
Hallucination
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
postmarketing
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Influenza
|
Influenza
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Intermittent claudication
|
Intermittent claudication
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Eye pruritus
|
Eye pruritus
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Keratitis
|
Keratitis
|
postmarketing
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Nightmare
|
Nightmare
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Psychotic disorder
|
Psychotic disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Refraction disorder
|
Refraction disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Sinusitis
|
Sinusitis
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disturbance
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Shock
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
|
|
|
Hyperthyroidism
|
Thyrotoxicosis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Vomiting
|
Vomiting
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Cataract
|
Cataract
|
postmarketing
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Periorbital oedema
|
Periorbital oedema
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Conjunctival oedema
|
Conjunctival oedema
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Eye pain
|
Eye pain
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Lacrimation increased
|
Lacrimation increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Lacrimation
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Visual acuity reduced
|
Visual acuity reduced
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Eye irritation
|
Eye irritation
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Erythema of eyelid
|
Erythema of eyelid
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Punctate keratitis
|
Punctate keratitis
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Dry eye
|
Dry eye
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Eye discharge
|
Eye discharge
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Abnormal sensation in eye
|
Abnormal sensation in eye
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Foreign body sensation in eyes
|
Foreign body sensation in eyes
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Eyelid margin crusting
|
Eyelid margin crusting
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Ocular discomfort
|
Ocular discomfort
|
postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Nasopharyngitis
|
Rhinorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Visual impairment
|
Visual impairment
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Acidosis
|
Acidosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Short-term memory loss
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pupils unequal
|
Pupils unequal
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Ataxia
|
Ataxia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Catatonia
|
Catatonia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Neck pain
|
Neck pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Constipation
|
Constipation
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Deafness
|
Deafness
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ear pain
|
Ear pain
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 0% - 1.2%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Flushing
|
Flushing
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Gout
|
Gout
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypertrichosis
|
Hypertrichosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Inflammation
|
Inflammation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Iritis
|
Iritis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Laryngospasm
|
Laryngospasm
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cramp muscle
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypertonia
|
Hypertonia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Myasthenia gravis
|
Myasthenia gravis
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypoaesthesia
|
Numbness
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sensory loss
|
Numbness
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oliguria
|
Oliguria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Otitis media
|
Otitis media
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ache
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Peyronie's disease
|
Peyronie's disease
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pharyngitis
|
Pharyngitis
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Pneumonia
|
Pneumonia
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Prostatitis
|
Prostatitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Protein urine present
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Purpura
|
Purpura
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vascular purpura
|
Purpura
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivation
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Scotoma
|
Scotoma
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Speech disorder
|
Speech disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tendonitis
|
Tendonitis
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Tremor
|
Tremor
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Erythema
|
Erythema
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
0% - 2.6%
|
5.5%
|
|
|
|
|
|
|
|
|
x
|
x
|
Micturition disorder
|
Micturition disorder
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Vertigo
|
Vertigo
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Stupor
|
Stupor
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Depressed level of consciousness
|
Stupor
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Stomatitis
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Breast abscess
|
Breast abscess
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Kidney function abnormal
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Arterial thrombosis
|
Arterial thrombosis
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vitreous disorder
|
Vitreous disorder
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Vascular anomaly
|
Vascular anomaly
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Colitis ischaemic
|
Colitis ischaemic
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Discomfort
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Emotional distress
|
Distress
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Muscle twitching
|
Muscle twitching
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Disturbance in attention
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing, 0% - 1.2%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Oropharyngeal pain
|
Throat sore
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Purpura non-thrombocytopenic
|
Purpura non-thrombocytopenic
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cardiac failure acute
|
Cardiac failure acute
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Systemic lupus erythematosus
|
Lupus erythematosus
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Sensation of foreign body
|
Sensation of foreign body
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Chills
|
Rigors
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Respiratory distress
|
Respiratory distress
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Musculoskeletal chest pain
|
Musculoskeletal chest pain
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Renal pain
|
Renal pain
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Hypoaesthesia eye
|
Corneal sensitivity decreased
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
|
Respiratory failure
|
Respiratory failure
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Fibroadenoma of breast
|
Fibroadenosis of breast
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Ageusia
|
Ageusia
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|