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
|
very rare — 0% - 45%
|
16.5% - 17%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
very rare — 0% - 36.8%
|
2.5% - 3%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
common, 9.09% - 31.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Dehydration
|
Dehydration
|
common, 0% - 21.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
Diarrhoea
|
Diarrhoea
|
very rare — 0% - 15.8%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
very rare — 0% - 20%
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
2.9% - 14.6%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
2.9% - 14.6%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
very rare — 0% - 26.3%
|
1%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
very rare — 0% - 32.1%
|
4%
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Body temperature increased
|
Body temperature increased
|
very rare — 4.92% - 35%
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Somnolence
|
Somnolence
|
very rare — 0% - 20%
|
2.5% - 3%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drowsiness
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cough
|
Cough
|
3.23% - 8.62%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
Cough increased
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
very rare — 0% - 10.5%
|
6.5% - 7%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
0% - 8.33%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0% - 8.33%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Neutropenia
|
Neutropenia
|
0% - 8.33%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
2.08% - 16.1%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
Decreased appetite
|
Anorexia
|
very rare — 0% - 10.3%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Decreased appetite
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
Asthenia
|
Fatigue
|
common, 0% - 20.5%
|
3%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
Asthenia
|
very rare — 0% - 38%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
common, 0% - 20.5%
|
3%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
|
Oedema peripheral
|
Oedema peripheral
|
common, 1% - 31.6%
|
1%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cancer pain
|
Cancer pain
|
1.72% - 15.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
0% - 10.5%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
Anxiety
|
Anxiety
|
very rare — 0% - 15%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing — 0% - 22%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
1% - 4%
|
1%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
x
|
Injury
|
Accidental injury
|
0% - 9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Malnutrition
|
Malnutrition
|
postmarketing, 4% - 5%
|
0%
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
Malaise
|
1% - 4%
|
0.5% - 1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
Malaise and fatigue
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Discomfort
|
Malaise
|
1% - 4%
|
0.5% - 1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
Feeling abnormal
|
Malaise
|
1% - 4%
|
0.5% - 1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
Confusional state
|
very rare — 0% - 15.8%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ill-defined disorder
|
Malaise
|
1% - 4%
|
0.5% - 1%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, 1% - 13%
|
1%
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
2% - 4%
|
2%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
Hyperhidrosis
|
0% - 14.3%
|
1%
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Sweating
|
0% - 4%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Sweating increased
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
1% - 3%
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
very rare — 0% - 13%
|
2%
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
2% - 4%
|
1.5% - 2%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Confusional state
|
Confusional state
|
very rare — 0% - 15.8%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
very rare — 1% - 3%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
0% - 6.45%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Depression
|
Depression
|
very rare — 0% - 10.5%
|
0%
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
Anxiety depression
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis
|
Rash
|
very rare — 0% - 8%
|
1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Dermatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Rash
|
Rash
|
very rare — 0% - 8%
|
1%
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
x
|
Paraesthesia
|
Paraesthesia
|
very rare — 1.8% - 2%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Muscle spasms
|
Muscle spasms
|
2% - 4.2%
|
1.5% - 2%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tremor
|
Tremor
|
very rare — 0% - 3%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
very rare — 0% - 5.71%
|
0%
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
0% - 4%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Feeling jittery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tension
|
Nervousness
|
0% - 4%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Visual impairment
|
Abnormal vision
|
0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Visual disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary retention
|
Urinary retention
|
very rare — 0% - 3%
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Stomatitis
|
Stomatitis
|
0% - 8.33%
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
very rare — 0% - 2%
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing, 1% - 3%
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing, 1% - 3%
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
0% - 4%
|
0.5% - 1%
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Stupor
|
Stupor
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Depressed level of consciousness
|
Stupor
|
0% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Application site reaction
|
Application site reaction
|
very rare — 1%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Thinking abnormal
|
Thinking abnormal
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Mental disability
|
Thinking abnormal
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Abnormal dreams
|
Abnormal dreams
|
0% - 1%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Respiratory depression
|
Respiratory depression
|
very rare — 1%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pulmonary function test decreased
|
Respiratory depression
|
very rare — 1%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
0% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
Amnesia
|
Amnesia
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare, postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Anaphylactoid reaction
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
|
Apnoea
|
Apnoea
|
very rare, postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing, 3% - 10%
|
7%
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
|
x
|
|
|
Neoplasm malignant
|
Neoplasm malignant
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dental caries
|
Dental caries
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Grand mal convulsion
|
Grand mal convulsion
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Tonic-clonic seizures
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing, 10% - 41%
|
17%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, 4%
|
1%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension
|
Hypertension
|
very rare — 0% - 1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Hypotension
|
Hypotension
|
very rare, postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotensive
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing, 1% - 3%
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing, 1%
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Drug withdrawal syndrome neonatal
|
Drug withdrawal syndrome neonatal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, 12% - 19%
|
3%
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
Pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chronic pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Acute pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
very rare — 0% - 2%
|
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Chills
|
Shivering
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Chills
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Tachycardia
|
Tachycardia
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Ulcer
|
Ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Loss of consciousness
|
Loss of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
postmarketing, 3.23% - 10.3%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
|
x
|
Tooth loss
|
Tooth loss
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
Drug withdrawal syndrome
|
Withdrawal symptom
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Drug withdrawal syndrome
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
Respiratory rate decreased
|
Respiratory rate decreased
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Anorgasmia
|
Anorgasmia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clonic convulsion
|
Clonic convulsion
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Drug dependence
|
Dependence psychological
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Drug dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dependence
|
Dependence physiological
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
|
Vision blurred
|
Vision blurred
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
|
x
|
|
Bradycardia
|
Bradycardia
|
very rare, postmarketing
|
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
|
Respiratory distress
|
Respiratory distress
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Altered state of consciousness
|
Depressed level of consciousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Feeling of body temperature change
|
Feeling of body temperature change
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
Ileus
|
Ileus
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
|
|
x
|
|
|
x
|
|
Therapy naive
|
Opioid naive
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Hypoxia
|
Hypoventilation
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Hypoxia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory failure
|
Hypoventilation
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Respiratory insufficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Respiratory failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoventilation
|
Hypoventilation
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Euphoric mood
|
Euphoric mood
|
very rare, postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
Abdominal distension
|
Abdominal distension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
Enlargement abdomen
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Acidosis
|
Acidosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Alopecia
|
Alopecia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Angina pectoris
|
Angina pectoris
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anosmia
|
Anosmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anuria
|
Anuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Aphasia
|
Aphasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ascites
|
Ascites
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
Asthma
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Bacterial infection
|
Bacterial infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Biliary tract disorder
|
Biliary tract disorder
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
Cachexia
|
Cachexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Candida infection
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Oral candidiasis
|
Oral candidiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Cellulitis
|
Cellulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Neck pain
|
Neck pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cheilitis
|
Cheilitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lip ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
Chest discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Musculoskeletal chest pain
|
Chest wall pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cognitive disorder
|
Cognitive disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Coma
|
Coma
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Infection
|
Infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Contusion
|
Contusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Cyanosis
|
Cyanosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
Cyst
|
Cyst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decubitus ulcer
|
Decubitus ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Delirium
|
Delirium
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Depersonalisation
|
Depersonalisation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Dermatitis atopic
|
Dermatitis atopic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Dermatitis contact
|
Dermatitis contact
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Drug abuse
|
Drug abuse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Drug hypersensitivity
|
Drug hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Dysarthria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Osteoarthritis
|
Dysarthria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
0% - 14.3%
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Urination impaired
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear disorder
|
Ear disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
Eructation
|
Eructation
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophageal stenosis
|
Oesophageal stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
VIIth nerve paralysis
|
Facial paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Faecal incontinence
|
Faecal incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Faecalith
|
Faecalith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Faecaloma
|
Faecalith
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Flank pain
|
Flank pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Flushing
|
Flushing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
Gastritis
|
Gastritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gingival bleeding
|
Gingival bleeding
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glossodynia
|
Glossodynia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Glossitis
|
Glossitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Granuloma
|
Granuloma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Head injury
|
Head injury
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematemesis
|
Haematemesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Subdural haematoma
|
Subdural haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hemiplegia
|
Hemiplegia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemoptysis
|
Haemoptysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatorenal syndrome
|
Hepatorenal syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hiccups
|
Hiccups
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Hostility
|
Hostility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hydronephrosis
|
Hydronephrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypercalcaemia
|
Hypercalcaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
Hyperventilation
|
Hyperventilation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypogonadism
|
Hypogonadism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Hypoproteinaemia
|
Hypoproteinaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Inflammation
|
Inflammation
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Intestinal perforation
|
Intestinal perforation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Irritability
|
Irritability
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lacrimal disorder
|
Lacrimal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lacrimal structural disorder
|
Lacrimal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngospasm
|
Laryngospasm
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Lethargy
|
Lethargy
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Leukopenia
|
Leukopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Lung disorder
|
Lung disorder
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
Lymphoedema
|
Lymphoedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Breast pain
|
Breast pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Miosis
|
Miosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
Motion sickness
|
Motion sickness
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypotonia
|
Hypotonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Muscle relaxant therapy
|
Hypotonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Muscle rigidity
|
Muscle rigidity
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle atrophy
|
Muscle atrophy
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Myopathy
|
Myopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myoclonus
|
Myoclonus
|
0% - 4%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Nasopharyngitis
|
Nasopharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Night sweats
|
Night sweats
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nocturia
|
Nocturia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oliguria
|
Oliguria
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pallor
|
Pallor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancytopenia
|
Pancytopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pelvic pain
|
Pelvic pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tooth abscess
|
Abscess periodontal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tooth abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Peritonitis
|
Peritonitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumothorax
|
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper-airway cough syndrome
|
Postnasal drip
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Pregnancy
|
Pregnancy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Proteinuria
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Protein urine present
|
Proteinuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pyelonephritis
|
Pyelonephritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Proctalgia
|
Proctalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Renal failure
|
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
|
|
|
x
|
|
x
|
Shock
|
Shock
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Musculoskeletal pain
|
Shoulder pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin lesion
|
Skin lesion
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Skin ulcer
|
Skin ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sneezing
|
Sneezing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Speech disorder
|
Speech disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Aphthous stomatitis
|
Aphthous stomatitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Withdrawal syndrome
|
Withdrawal syndrome
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
|
Swelling
|
Swelling
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Synovitis
|
Synovitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Tongue disorder
|
Tongue disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Tooth disorder
|
Tooth disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Attention deficit/hyperactivity disorder
|
Attention deficit disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Attention deficit/hyperactivity disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Micturition urgency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary tract infection
|
Urinary tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
Micturition disorder
|
Micturition disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vaginal inflammation
|
Vaginal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal infection
|
Vaginal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vasodilation procedure
|
Vasodilation
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Viral infection
|
Viral infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Wound
|
Wound
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Micturition urgency
|
Micturition urgency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Burning sensation
|
Burning sensation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Mood swings
|
Mood swings
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Affect lability
|
Mood swings
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Affect lability
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Photopsia
|
Photopsia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Oculogyric crisis
|
Oculogyric crisis
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peroneal nerve palsy
|
Footdrop
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokinesia
|
Hypokinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mouth ulceration
|
Mouth ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
Deep vein thrombosis
|
Deep vein thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nuchal rigidity
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bleeding time prolonged
|
Bleeding time prolonged
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deafness permanent
|
Deafness permanent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Partial permanent deafness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deafness transitory
|
Partial transitory deafness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Swelling face
|
Swelling face
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Generalised oedema
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fluid retention
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Scrotal oedema
|
Scrotal oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Large intestinal haemorrhage
|
Hemorrhage of colon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Intracranial pressure increased
|
Intracranial pressure increased
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Lactic dehydrogenase activity increased
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Liver tenderness
|
Liver tenderness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mucous membrane disorder
|
Mucous membrane disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscular weakness
|
Muscular weakness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Myasthenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Accidental overdose
|
Accidental overdose
|
0% - 14.3%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site pain
|
Injection site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Paranoia
|
Paranoid reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Paranoia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Rash pustular
|
Vesiculobullous rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pustule
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Dermatitis bullous
|
Vesiculobullous rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendon disorder
|
Tendon disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Joint swelling
|
Joint swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Urinary hesitation
|
Urinary hesitation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Endophthalmitis
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory arrest
|
Respiratory arrest
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Sick sinus syndrome
|
Bradycardia-tachycardia syndrome
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
Dyspnoea exertional
|
Dyspnoea exertional
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Nasal dryness
|
Nasal dryness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Cold sweat
|
Cold sweat
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Retching
|
Retching
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Bladder pain
|
Bladder pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in attention
|
Disturbance in attention
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Cerebration impaired
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Dysphoria
|
Dysphoria
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hallucination, visual
|
Hallucination, visual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Memory impairment
|
Memory impairment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Motor dysfunction
|
Motor dysfunction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Extrapyramidal disorder
|
Extrapyramidal symptoms
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Visual acuity reduced
|
Visual acuity reduced
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
Abdominal discomfort
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Tongue ulceration
|
Tongue ulceration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sputum increased
|
Sputum increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Increased bronchial secretion
|
Sputum increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Increased bronchial secretion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Chest discomfort
|
Chest discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nasal septum perforation
|
Nasal septum perforation
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Throat tightness
|
Throat tightness
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Breath sounds abnormal
|
Respiratory sounds decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingival pain
|
Gingival pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypoalbuminaemia
|
Hypoalbuminaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Pain of skin
|
Pain of skin
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Sepsis
|
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Spinal compression fracture
|
Spinal compression fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nail ridging
|
Nail longitudinal striations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Onychoclasis
|
Nail longitudinal striations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nasal ulcer
|
Nasal ulcer
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral disorder
|
Oral soft tissue disorder NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lip pain
|
Lip ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lip ulceration
|
Lip ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
Dry eye
|
Dry eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
Papule
|
Papule
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
Oral herpes
|
Oral herpes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Akathisia
|
Akathisia
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza like illness
|
Influenza-like symptoms
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza like illness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Gingival ulceration
|
Gingival ulceration
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dysaesthesia
|
Dysaesthesia
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral discomfort
|
Oral discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rash maculo-papular
|
Rash maculo-papular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chapped lips
|
Chapped lips
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Light anaesthesia
|
Light anaesthesia
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus generalised
|
Pruritus generalised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Non-cardiac chest pain
|
Non-cardiac chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Abnormal sensation in eye
|
Abnormal sensation in eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Application site irritation
|
Application site irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Application site pain
|
Application site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Instillation site pain
|
Application site pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site ulcer
|
Application site ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site rash
|
Application site rash
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Paraesthesia oral
|
Paraesthesia oral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypoaesthesia oral
|
Hypoaesthesia oral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Impaired gastric emptying
|
Impaired gastric emptying
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Feeling jittery
|
Feeling jittery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin reaction
|
Localised skin reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Lip dry
|
Lip dry
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Renal pain
|
Renal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Balance disorder
|
Balance disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood glucose increased
|
Blood glucose increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Menopausal symptoms
|
Hot flush
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hot flush
|
Hot flush
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Cardio-respiratory arrest
|
Cardio-respiratory arrest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
Throat irritation
|
Throat irritation
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upper airway obstruction
|
Upper airway obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Haematocrit decreased
|
Haematocrit decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Sleep disorder
|
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
Oral mucosal discolouration
|
Oral mucosal discolouration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tongue blistering
|
Tongue blistering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Oral mucosal blistering
|
Oral mucosal blistering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypoaesthesia eye
|
Hypoaesthesia eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Nasal discomfort
|
Nasal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
Hyperlactacidaemia
|
Lactate increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Cerebral ischaemia
|
Cerebral ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site eczema
|
Application site eczema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Subileus
|
Subileus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Nasal mucosal disorder
|
Nasal mucosal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sluggishness
|
Sluggishness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rhinalgia
|
Rhinalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ear discomfort
|
Ear discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Liver disorder
|
Hepatic impairment
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Upper respiratory tract congestion
|
Upper respiratory tract congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Oral pustule
|
Oral pustule
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rhinorrhoea
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
Cardiovascular insufficiency
|
Cardiovascular insufficiency
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Circulatory depression
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Paranoia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Breast neoplasm
|
Breast neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site hypersensitivity
|
Application site hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
Parosmia
|
Parosmia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Dysphonia
|
Dysphonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Renal impairment
|
Renal impairment
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Intentional drug misuse
|
Intentional drug misuse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Intranasal hypoaesthesia
|
Intranasal hypoaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Oropharyngeal pain
|
Oropharyngeal pain
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Ageusia
|
Ageusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Feeling hot
|
Feeling hot
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|