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
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
56%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reflux esophagitis
|
44%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing — 6.6% - 15%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Headache
|
Headache
|
common, 1.9% - 10.9%
|
6.3%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain
|
Abdominal pain
|
common, 1% - 5.8%
|
3.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
common, 1% - 5.8%
|
3.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
5%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Duodenal ulcer haemorrhage
|
Duodenal ulcer haemorrhage
|
4.27%
|
4.11%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nausea
|
Nausea
|
common, 2% - 6.4%
|
3.1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 2% - 28%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 3.2%
|
4.7%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
very rare, 3%
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
common, 2.3% - 10.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tongue discolouration
|
Tongue discolouration
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Regurgitation
|
Regurgitation
|
1% - 1.9%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Injection site reaction
|
Injection site reaction
|
1.7% - 4.27%
|
0.514%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Constipation
|
Constipation
|
common, 0% - 2.5%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Constipation aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
uncommon, 1.07% - 2.8%
|
0% - 0.771%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Asthenia
|
Asthenia
|
1.3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
postmarketing, 1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Back pain
|
Back pain
|
0.5% - 1.1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cough
|
Cough
|
1.07% - 1.5%
|
0% - 0.257%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glossitis
|
Glossitis
|
1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pharyngitis
|
Pharyngitis
|
1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
1% - 6%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachypnoea
|
Tachypnoea
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Epigastric pain
|
1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis
|
Rash
|
postmarketing — 0% - 1.5%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
postmarketing, uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 0% - 1.5%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eruption
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Visual acuity reduced
|
Visual acuity reduced
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Visual disturbance
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
rare
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatic enzyme increased
|
Elevated liver enzyme levels
|
uncommon
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis
|
Sweating increased
|
rare, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggression
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agranulocytosis
|
Agranulocytosis
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angioedema
|
Angioedema
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
Anorexia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anxiety
|
Anxiety
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Carcinoid tumour
|
Carcinoid tumour
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Retrosternal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Malaise
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Diplopia
|
Diplopia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lacrimation decreased
|
Dry eye syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Fatigue
|
Fatigue
|
postmarketing, 1%
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 3.47%
|
2.83%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Multiple fractures
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fracture
|
Fracture
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Glycosuria
|
Glycosuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
x
|
x
|
x
|
Haematuria
|
Haematuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic encephalopathy
|
Hepatic encephalopathy
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatitis
|
Hepatitis
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, rare
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypokalaemia
|
Hypokalaemia
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Jaundice
|
Jaundice
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Leg pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Leukocytosis
|
Leukocytosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Liver disorder
|
Liver disorder
|
postmarketing, rare
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Hepatocellular injury
|
Liver disorder
|
postmarketing, rare
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Foetor hepaticus
|
Liver disorder
|
postmarketing, rare
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramp muscle
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tubulointerstitial nephritis
|
Nephritis interstitial
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Neutropenia
|
Neutropenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic atrophy
|
Optic atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic neuritis
|
Optic neuritis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain
|
Pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pancreatitis
|
Pancreatitis
|
very rare, postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pancytopenia
|
Pancytopenia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Paraesthesia
|
Paraesthesia
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Petechiae
|
Petechiae
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Polyp
|
Polyp
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Proteinuria
|
Proteinuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Protein urine present
|
Proteinuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
postmarketing — 1.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vascular purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pyuria
|
Pyuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
Shock
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Sleep disorder
|
Sleep disturbance
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sleep disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Testicular pain
|
Testicular pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Urticaria
|
Urticaria
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vertigo
|
Vertigo
|
postmarketing — 1.1% - 2.8%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
very rare, postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing — 2% - 3.9%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrinoma
|
Zollinger-Ellison syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
Microcytic anaemia
|
Microcytic anaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Encephalopathy
|
Encephalopathy
|
rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Hepatic failure
|
Hepatic failure
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Apathy
|
Apathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flat affect
|
Apathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Leg edema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypomagnesaemia
|
Hypomagnesaemia
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscular weakness
|
Muscular weakness
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hepatic necrosis
|
Hepatic necrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry skin
|
Dry skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing, uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eye irritation
|
Eye irritation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Faeces discoloured
|
Faeces discoloured
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oesophageal candidiasis
|
Oesophageal candidiasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain of skin
|
Pain of skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal candidiasis
|
Gastrointestinal candidiasis
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis microscopic
|
Colitis microscopic
|
postmarketing
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Painful respiration
|
Painful respiration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bradycardia
|
Bradycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Optic ischaemic neuropathy
|
Anterior ischemic optic neuropathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing — common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastric polyps
|
Fundic gland polyp
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mucosal atrophy
|
Mucosal atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
postmarketing — 1.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Gastritis
|
Gastritis
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Necrosis
|
Necrosis
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Nephrotic syndrome
|
Nephrosis
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Leukocytoclastic vasculitis
|
Allergic cutaneous angiitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Erectile dysfunction
|
Erectile dysfunction
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Renal failure
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Renal impairment
|
Renal impairment
|
very rare
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Albuminuria
|
Albuminuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypochromic anaemia
|
Hypochromic anaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Barrett's oesophagus
|
Barrett's oesophagus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cyst
|
Cyst
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Duodenitis
|
Duodenitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophageal disorder
|
Oesophageal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophageal stenosis
|
Oesophageal stenosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Varices oesophageal
|
Varices oesophageal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fibromyalgia
|
Fibromyalgia
|
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x
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Flushing
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Flushing
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Gastroenteritis
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Gastroenteritis
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Gastrointestinal haemorrhage
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Gastrointestinal haemorrhage
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x
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Goitre
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Goitre
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Hernia
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Hernia
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x
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Hiccups
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Hiccups
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x
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Hyperbilirubinaemia
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Hyperbilirubinaemia
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Hypertension
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Hypertension
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x
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Hypoaesthesia
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Hypoaesthesia
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x
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Irritability
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Irritability
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Arthropathy
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Arthropathy
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Osteoarthritis
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Arthropathy
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x
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Laryngeal oedema
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Laryngeal oedema
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x
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Melaena
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Melaena
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x
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Menstrual disorder
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Menstrual disorder
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Oral disorder
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Oral disorder
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x
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Hypertonia
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Hypertonia
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x
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Fungal infection
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Fungal infection
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x
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Nodule
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Nodule
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x
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Otitis media
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Otitis media
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x
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Pharyngeal disorder
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Pharyngeal disorder
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x
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Polymyalgia rheumatica
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Polymyalgia rheumatica
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x
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Polyuria
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Polyuria
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x
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Urine output increased
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Polyuria
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x
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Anal pruritus
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Anal pruritus
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x
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Pruritus genital
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Anal pruritus
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x
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Anorectal discomfort
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Anal pruritus
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x
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Anorectal disorder
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Rectal disorder
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x
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Scotoma
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Scotoma
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x
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Sinusitis
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Sinusitis
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x
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Mouth ulceration
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Ulcerative stomatitis
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x
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Thirst
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Thirst
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x
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Tongue disorder
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Tongue disorder
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x
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Tongue oedema
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x
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Vaginal inflammation
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Vaginal inflammation
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x
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Vaginal infection
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Vaginal inflammation
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x
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Vitamin B12 deficiency
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Vitamin B12 deficiency
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x
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Weight decreased
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Weight decreased
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x
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Hepatic function abnormal
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Hepatic function abnormal
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x
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Migraine
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Migraine
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x
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Migraine aggravated
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x
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Blood creatinine increased
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Creatinine increased
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x
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Generalised oedema
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Generalised oedema
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x
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Fluid retention
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Generalised oedema
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x
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Tongue oedema
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Tongue oedema
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x
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Injury
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Accidental injury
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x
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x
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x
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x
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x
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x
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x
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Blood alkaline phosphatase increased
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Phosphatase alkaline increased
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x
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Oesophageal ulcer
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Oesophageal ulcer
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x
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Increased appetite
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Increased appetite
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x
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Rash erythematous
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Rash erythematous
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x
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Lymphadenopathy
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Lymphadenopathy cervical
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x
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Urine abnormality
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Urine abnormality
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x
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Urine analysis abnormal
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Urine abnormality
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x
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Depression
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Depression aggravated
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x
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Arthritis
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Arthritis aggravated
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x
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Dysplasia
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Dysplasia
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x
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Genital candidiasis
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Genital candidiasis
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x
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Abdominal distension
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Enlargement abdomen
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x
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Dysaesthesia
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Dysaesthesia
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x
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x
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Rash maculo-papular
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Rash maculo-papular
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x
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Chills
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Rigors
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x
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Face oedema
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Face oedema
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x
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Asthma
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Asthma aggravated
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x
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Menopausal symptoms
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Hot flush
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x
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Hot flush
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Hot flush
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x
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Blood uric acid increased
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Hyperuricaemia
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x
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Hyperuricaemia
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Hyperuricaemia
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x
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Blood gastrin increased
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Serum gastrin increased
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x
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Mucosal discolouration
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Mucosal discolouration
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x
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Epidermal necrosis
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Epidermal necrosis
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x
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Parosmia
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Parosmia
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x
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Ageusia
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Ageusia
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x
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