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
|
Nausea
|
Nausea
|
16% - 30%
|
10%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
18% - 19%
|
13%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
15% - 19%
|
13%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal dreams
|
Abnormal dreams
|
9% - 13%
|
5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
6% - 9%
|
3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
5% - 8%
|
3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
5% - 8%
|
4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
4% - 7%
|
3.9% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
uncommon, 4% - 7%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
Fatigue
|
4% - 7%
|
3.9% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
uncommon, 5% - 7%
|
5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
uncommon, 5% - 7%
|
5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
frequent
|
|
x
|
|
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
|
x
|
Back pain
|
Back pain
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Depression
|
Depression
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
frequent
|
|
x
|
x
|
x
|
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
|
Dyspepsia
|
Dyspepsia
|
5%
|
3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gingivitis
|
Gingivitis
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
frequent
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
frequent
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Cramp muscle
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine output increased
|
Polyuria
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
4% - 6%
|
4%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sensory disturbance
|
Sensory disturbance
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in attention
|
Disturbance in attention
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Emotional disorder
|
Emotional disorder
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash generalised
|
Rash generalised
|
uncommon, frequent
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza like illness
|
Influenza like illness
|
frequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hot flush
|
Hot flush
|
uncommon, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
Malaise
|
uncommon, 4% - 7%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
uncommon, 4% - 7%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Malaise
|
uncommon, 4% - 7%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
uncommon, 4% - 7%
|
6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Increased appetite
|
Increased appetite
|
3% - 4%
|
1.2% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disorder
|
2% - 5%
|
3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disturbance
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
1% - 5%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnolence
|
Somnolence
|
frequent, 2% - 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
1% - 3%
|
2%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Dermatitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
1% - 3%
|
2%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Nightmare
|
Nightmare
|
1% - 2%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
uncommon, 1% - 2%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
uncommon, 1% - 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
uncommon, 1% - 2%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
uncommon, 1%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lethargy
|
Lethargy
|
uncommon, 0% - 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
infrequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bronchitis
|
Bronchitis
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal chest pain
|
Chest wall pain
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal chest pain
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tongue coated
|
Tongue coated
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
infrequent
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cyst
|
Cyst
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Libido decreased
|
Libido decreased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysphagia
|
Dysphagia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Enterocolitis
|
Enterocolitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oesophagitis
|
Oesophagitis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gallbladder disorder
|
Gallbladder disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glycosuria
|
Glycosuria
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematemesis
|
Haematemesis
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematochezia
|
Haematochezia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysphonia
|
Hoarseness
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysphonia
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypotension
|
Hypotension
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Menorrhagia
|
Menorrhagia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fungal infection
|
Fungal infection
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mydriasis
|
Mydriasis
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myopia
|
Myopia
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinorrhoea
|
infrequent — 0% - 1%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Night sweats
|
Night sweats
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nocturia
|
Nocturia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoporosis
|
Osteoporosis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Upper-airway cough syndrome
|
Postnasal drip
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper-airway cough syndrome
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
uncommon, 0% - 1%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psoriasis
|
Psoriasis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Restless legs syndrome
|
Restless legs syndrome
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Salivary hypersecretion
|
Salivary hypersecretion
|
uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Snoring
|
Snoring
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aphthous stomatitis
|
Aphthous stomatitis
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Shock
|
Syncope
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
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
|
Tachycardia
|
Tachycardia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombosis
|
Thrombosis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thyroid disorder
|
Thyroid disorder
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Costochondritis
|
Costochondritis
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema
|
Erythema
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Varicose vein
|
Varicose vein
|
uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Vertigo
|
Vertigo
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Polydipsia
|
Polydipsia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
postmarketing — frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dissociation
|
Dissociation
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Mouth ulceration
|
infrequent
|
|
|
|
|
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
|
x
|
x
|
x
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye pain
|
Eye pain
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry skin
|
Dry skin
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypogeusia
|
Hypogeusia
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus congestion
|
Sinus congestion
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lacrimation increased
|
Lacrimation increased
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urethral syndrome
|
Urethral syndrome
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abnormal faeces
|
Abnormal faeces
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Joint stiffness
|
Joint stiffness
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal discharge
|
Vaginal discharge
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Disorientation
|
Disorientation
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysphoria
|
Dysphoria
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thinking abnormal
|
Thinking abnormal
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disability
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye irritation
|
Eye irritation
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral ischaemia
|
Peripheral ischaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine abnormality
|
Urine abnormality
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine analysis abnormal
|
Urine abnormality
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urine analysis abnormal
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Chest discomfort
|
Chest discomfort
|
infrequent, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Semen analysis abnormal
|
Semen abnormal
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Semen analysis abnormal
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scleral discolouration
|
Scleral discolouration
|
uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingival pain
|
Gingival pain
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Change of bowel habit
|
Change of bowel habit
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vision blurred
|
Vision blurred
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Platelet count decreased
|
Platelet count decreased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nephrolithiasis
|
Nephrolithiasis
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradycardia
|
Bradycardia
|
infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Electrocardiogram T wave amplitude decreased
|
Electrocardiogram T wave amplitude decreased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Electrocardiogram ST segment depression
|
Electrocardiogram ST segment depression
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coordination abnormal
|
Coordination abnormal
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Visual impairment
|
Visual disturbance
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Throat irritation
|
Throat irritation
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acne
|
Acne
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
C-reactive protein increased
|
C-reactive protein increased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
infrequent, uncommon
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Circadian rhythm sleep disorder
|
Circadian rhythm sleep disorder
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Respiratory tract congestion
|
Respiratory tract congestion
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle enzyme increased
|
Muscle enzyme increased
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
infrequent — 0% - 1%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Parosmia
|
Parosmia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood calcium decreased
|
Blood calcium decreased
|
infrequent, uncommon
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pancreatitis acute
|
Pancreatitis acute
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggression
|
postmarketing, infrequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Anxiety
|
Anxiety
|
postmarketing, frequent
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deafness
|
Deafness
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Delusion
|
Delusion
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Drug hypersensitivity
|
Drug hypersensitivity
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysarthria
|
Dysarthria
|
rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Dysarthria
|
rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
VIIth nerve paralysis
|
Facial paralysis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vitreous floaters
|
Vitreous floaters
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac flutter
|
Cardiac flutter
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hostility
|
Hostility
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkalaemia
|
Hyperkalaemia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Renal failure acute
|
Renal failure acute
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukocytosis
|
Leukocytosis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Meniere's disease
|
Meniere's disease
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Multiple sclerosis
|
Multiple sclerosis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myositis
|
Myositis
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nystagmus
|
Nystagmus
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Panic reaction
|
Panic reaction
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
Pleurisy
|
Pleurisy
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychotic disorder
|
Psychotic disorder
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cor pulmonale
|
Cor pulmonale
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Scotoma
|
Scotoma
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Convulsion
|
Convulsion
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Splenomegaly
|
Splenomegaly
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Gastric ulcer
|
Gastric ulcer
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Completed suicide
|
Suicide
|
postmarketing, rare
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Completed suicide
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Suicide attempt
|
Suicide attempt
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary retention
|
Urinary retention
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photophobia
|
Photophobia
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Drug withdrawal syndrome
|
Withdrawal symptom
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Night blindness
|
Acquired night blindness
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blindness transient
|
Blindness transient
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cataract subcapsular
|
Cataract subcapsular
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mania
|
Mania
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Depressed mood
|
Depressed mood
|
postmarketing
|
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Suicidal ideation
|
Suicidal ideation
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Homicidal ideation
|
Homicidal ideation
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Sexual dysfunction
|
Sexual dysfunction
|
rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bradyphrenia
|
Bradyphrenia
|
rare — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Balance disorder
|
Balance disorder
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Psychomotor skills impaired
|
Psychomotor skills impaired
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ocular vascular disorder
|
Ocular vascular disorder
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental retardation
|
Mental disability
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paranoia
|
Paranoia
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Coronary artery disease
|
Coronary artery disease
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal distension
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Anger
|
Anger
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast disorder
|
Breast disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Frustration
|
Frustration
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac disorder
|
Cardiac disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Somnambulism
|
Somnambulism
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Toothache
|
Toothache
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
1.2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal behaviour
|
Abnormal behaviour
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrapyramidal disorder
|
Extrapyramidal symptoms
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Tenderness
|
Tenderness
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal discomfort
|
Upset stomach
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Initial insomnia
|
Initial insomnia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Middle insomnia
|
Middle insomnia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Terminal insomnia
|
Terminal insomnia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upper respiratory tract inflammation
|
Upper respiratory tract inflammation
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis allergic
|
Rhinitis allergic
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|