MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
13
|
Dizziness
|
Dizziness
|
3% - 38%
|
0.436% - 11%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
3.8% - 12%
|
0.251% - 6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
8.2%
|
4.6%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
Infection
|
Infection
|
7%
|
4% - 6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
5.3% - 11%
|
3.2% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
2% - 12.6%
|
0% - 6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
5.3% - 11%
|
3.2% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 4.2% - 12%
|
5% - 12%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
2% - 35.7%
|
0% - 11.5%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
frequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
frequent, 2%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
frequent, 4%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
frequent, 4%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
frequent
|
|
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
|
Depersonalisation
|
Depersonalisation
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diplopia
|
Diplopia
|
frequent, 2% - 9%
|
0% - 4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ecchymosis
|
Ecchymosis
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
rare, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
infrequent, frequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramps of lower extremities
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
4%
|
2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Generalised spasm
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cramp muscle
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Lung disorder
|
Lung disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Otitis media
|
Otitis media
|
frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
frequent, 2.2%
|
0.6% - 1.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus
|
Pruritus
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
frequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
frequent, 5%
|
4%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
infrequent, frequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
infrequent, frequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry mouth
|
Dry mouth
|
2% - 11%
|
0.251% - 3%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stupor
|
Stupor
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Depressed level of consciousness
|
Stupor
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
CNS depression NOS
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Generalised oedema
|
Generalised oedema
|
frequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
Generalised oedema
|
frequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
2%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
frequent, 1.4% - 5%
|
0% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
Disturbance in attention
|
1.4% - 5%
|
0% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cerebration impaired
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorgasmia
|
Anorgasmia
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vision blurred
|
Vision blurred
|
1% - 10%
|
1% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough increased
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cough
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Balance disorder
|
Balance disorder
|
5%
|
0%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Myasthenia
|
frequent, 1%
|
0% - 4.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscular weakness
|
4.9%
|
1.7%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ataxia
|
Ataxia
|
1% - 15%
|
0% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing, 0% - 10.7%
|
1.3% - 6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
3.3% - 5%
|
1.1% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
0% - 12%
|
0% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injury
|
Accidental injury
|
2% - 9%
|
2% - 5%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intentional injury
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle twitching
|
Muscle twitching
|
frequent, 4%
|
0% - 1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuropathy peripheral
|
Neuropathy
|
frequent, 2% - 9%
|
3%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuritis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
frequent, 3.8% - 10.7%
|
2.9%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
3.3%
|
2.3%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
Speech disorder
|
Speech disorder
|
1% - 5%
|
0% - 1.5%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Memory impairment
|
Memory impairment
|
1.5% - 3.3%
|
0% - 1.1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neck pain
|
Neck pain
|
infrequent, 2.7%
|
1.1% - 1.5%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Decubitus ulcer
|
Decubitus ulcer
|
2.7%
|
1.1%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
infrequent — 1% - 2.7%
|
0% - 3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
rare — 2% - 3%
|
1% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood creatine phosphokinase increased
|
Blood creatine phosphokinase increased
|
2.7%
|
0%
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
Creatine phosphokinase increased
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
frequent, 2.2%
|
1.1%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Joint swelling
|
Joint swelling
|
2.2%
|
0%
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
Abdominal distension
|
Abdominal distension
|
2%
|
1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enlargement abdomen
|
infrequent
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Amnesia
|
Amnesia
|
0% - 5%
|
0% - 3%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
frequent, 0% - 3%
|
0% - 3%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
1% - 4%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retrosternal pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
Confusional state
|
0% - 4%
|
0% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
0% - 4%
|
0% - 2%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
2%
|
0%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
2%
|
2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspnoea
|
Dyspnoea
|
frequent, 0% - 3%
|
1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
0% - 8.2%
|
0% - 1.1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
0% - 3%
|
1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
frequent, 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoalgesia
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
infrequent, 1% - 3%
|
1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycemic reaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza
|
Influenza
|
frequent, 2%
|
1% - 1.5%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
1.7% - 2%
|
0% - 0.1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myoclonus
|
Myoclonus
|
infrequent, 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
1% - 4%
|
0.3% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disorientation
|
Disorientation
|
2%
|
0%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
Thinking abnormal
|
0% - 8%
|
0% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
0% - 8%
|
0% - 2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Cerebration impaired
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
0% - 6%
|
0% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Coordination abnormal
|
Coordination abnormal
|
0% - 4%
|
0% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling drunk
|
Feeling drunk
|
2%
|
0%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
2%
|
2%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bronchitis
|
Bronchitis
|
1%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing — 1%
|
0%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
0% - 1%
|
0%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
0% - 1%
|
0%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
1% - 8%
|
0% - 4%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Face oedema
|
Face oedema
|
0% - 2%
|
0% - 1%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
0% - 4%
|
0% - 1%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Local swelling
|
Peripheral swelling
|
1%
|
0.3%
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Abnormal vision
|
0% - 4%
|
0% - 1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual disturbance
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Abscess
|
Abscess
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Albuminuria
|
Albuminuria
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amenorrhoea
|
Amenorrhoea
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypochromic anaemia
|
Hypochromic anaemia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aphasia
|
Aphasia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Word finding difficulty
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arteriosclerosis
|
Arteriosclerosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Benign neoplasm of skin
|
Benign neoplasm of skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blepharitis
|
Blepharitis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bundle branch block
|
Bundle branch block
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bursitis
|
Bursitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Candida infection
|
Candida infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oral candidiasis
|
Oral candidiasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm malignant
|
Carcinoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cellulitis
|
Cellulitis
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cheilitis
|
Cheilitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cholecystitis
|
Cholecystitis
|
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
|
Cystitis
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder pain
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis noninfective
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deafness
|
Deafness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysphagia
|
Dysphagia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dental caries
|
Dental caries
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fungal skin infection
|
Fungal skin infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysarthria
|
Dysarthria
|
infrequent, 1.7%
|
0.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
infrequent, 1.7%
|
0.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urination impaired
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear disorder
|
Ear disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eosinophilia
|
Eosinophilia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Oesophagitis
|
Oesophagitis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
VIIth nerve paralysis
|
Facial paralysis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Furuncle
|
Furunculosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glaucoma
|
Glaucoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glossitis
|
Glossitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gout
|
Gout
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hallucination
|
Hallucination
|
infrequent
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure
|
Cardiac failure
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hernia
|
Hernia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes simplex
|
Herpes simplex
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes zoster
|
Herpes zoster
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hirsutism
|
Hirsutism
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hostility
|
Hostility
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperpathia
|
Hyperpathia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Hyperpathia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyponatraemia
|
Hyponatraemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypotension
|
Hypotension
|
infrequent, 2.2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypothyroidism
|
Hypothyroidism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Libido increased
|
Libido increased
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthropathy
|
Arthropathy
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lacrimal disorder
|
Lacrimal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lacrimal structural disorder
|
Lacrimal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngitis
|
Laryngitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Leukocytosis
|
Leukocytosis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
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
|
Menstrual disorder
|
Menstrual disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Metrorrhagia
|
Metrorrhagia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyskinesia
|
Movement disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyskinesia
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Movement disorder
|
Movement disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypotonia
|
Hypotonia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle relaxant therapy
|
Hypotonia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nephritis
|
Nephritis
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuralgia
|
Neuralgia
|
infrequent
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Oliguria
|
Oliguria
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoporosis
|
Osteoporosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis externa
|
Otitis externa
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis
|
rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pelvic pain
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Polyuria
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Prostatic disorder
|
Prostatic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Psoriasis
|
Psoriasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Psychotic disorder
|
Psychotic disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pyuria
|
Pyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperacusis
|
Hyperacusis
|
rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anorectal disorder
|
Rectal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Refraction disorder
|
Refraction disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Retinal disorder
|
Retinal disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Convulsion
|
Convulsion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Skin disorder
|
Skin disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Skin ulcer
|
Skin ulcer
|
infrequent
|
1.5%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Hyperhidrosis
|
Sweating
|
infrequent
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
Syncope
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
Syncope
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Tachycardia
|
Tachycardia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Tenosynovitis
|
Tenosynovitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
rare, infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue disorder
|
Tongue disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tooth disorder
|
Tooth disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Varicose vein
|
Varicose vein
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Angiopathy
|
Angiopathy
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Vestibular disorder
|
Vestibular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral infection
|
Viral infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Weight decreased
|
Weight decreased
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Urinary retention
|
Urinary retention
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
rare, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus bradycardia
|
Sinus bradycardia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokinesia
|
Hypokinesia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ulcerative stomatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal stiffness
|
Neck stiffness
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle stiffness
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Nuchal rigidity
|
Neck stiffness
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amylase increased
|
Amylase increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Congenital arterial malformation
|
Arterial anomaly
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood urea increased
|
Blood urea increased
|
infrequent
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
NPN increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cataract
|
Cataract specified
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cataract
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Corneal lesion
|
Corneal lesion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine increased
|
Creatinine increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine increased
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
Drug level increased
|
Drug level increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tongue oedema
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ventricular bigeminy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Impaired healing
|
Impaired healing
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin hypertrophy
|
Skin hypertrophy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Kidney function abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bone pain
|
Bone pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Paraesthesia oral
|
Circumoral paresthesia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rash pustular
|
Vesiculobullous rash
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash pustular
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis bullous
|
Vesiculobullous rash
|
infrequent
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyporeflexia
|
Hyporeflexia
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
infrequent
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry skin
|
Dry skin
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tendon disorder
|
Tendon disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendon rupture
|
Tendon rupture
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Accommodation disorder
|
Accommodation disorder
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinal vascular disorder
|
Retinal vascular disorder
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vitreous disorder
|
Vitreous disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendinous contracture
|
Tendinous contracture
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abnormal faeces
|
Abnormal faeces
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal dreams
|
Abnormal dreams
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sputum increased
|
Sputum increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Increased bronchial secretion
|
Sputum increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urine abnormality
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine analysis abnormal
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retinal oedema
|
Retinal oedema
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sepsis
|
Sepsis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry eye
|
Dry eye
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laboratory test abnormal
|
Laboratory test abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin cancer
|
Skin carcinoma
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood uric acid increased
|
Hyperuricaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperuricaemia
|
Hyperuricaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebral ischaemia
|
Cerebral ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast neoplasm
|
Breast neoplasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coronary artery disease
|
Coronary artery disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ageusia
|
Ageusia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ejaculation disorder
|
Abnormal ejaculation
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acidosis
|
Acidosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lactic acidosis
|
Lactic acidosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Adenoma benign
|
Adenoma benign
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Adrenal insufficiency
|
Adrenal insufficiency
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia macrocytic
|
Anaemia macrocytic
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia megaloblastic
|
Anaemia megaloblastic
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pupils unequal
|
Pupils unequal
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aortic valve stenosis
|
Aortic valve stenosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Apnoea
|
Apnoea
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arachnoiditis
|
Arachnoiditis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ascites
|
Ascites
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atelectasis
|
Atelectasis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumothorax
|
Atelectasis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrial flutter
|
Atrial flutter
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Atrioventricular block
|
Atrioventricular block
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Block heart
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bacterial infection
|
Bacterial infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Balanitis
|
Balanitis
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Calculus bladder
|
Calculus bladder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder neoplasm
|
Bladder neoplasm
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coagulopathy
|
Coagulopathy
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bone neoplasm
|
Bone neoplasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast disorder |