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
|
Vertigo
|
Vertigo
|
0.926% - 33%
|
0.449% - 6.9%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing — 7.41% - 33%
|
2.69% - 12.4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Nausea
|
Nausea
|
postmarketing — 13% - 40%
|
5.54% - 21.4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Constipation
|
Constipation
|
common, 9.32% - 46%
|
3.89% - 13.6%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Constipation aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Headache
|
Headache
|
common, 2.83% - 32%
|
3.14% - 22.1%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Headache aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Somnolence
|
Somnolence
|
4.34% - 30.2%
|
1.72% - 13.8%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing — 3.24% - 17%
|
0.599% - 10.4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
uncommon, 1.4% - 13%
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dyspepsia aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dry mouth
|
Dry mouth
|
common, 1.13% - 13.1%
|
1.2% - 8.29%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Flushing
|
Flushing
|
uncommon, 7.69% - 15.8%
|
4.43%
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
uncommon, 3.03% - 11.9%
|
0.985% - 5.76%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Hyperhidrosis
|
Sweating
|
common, 4.2% - 9%
|
0.619% - 5.3%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
x
|
|
Sweating increased
|
postmarketing, 0.463% - 7.44%
|
0.246% - 0.749%
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Asthenia
|
Asthenia
|
rare — 0.744% - 12%
|
1.23% - 5.99%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fatigue
|
common, 1.7% - 4.2%
|
0.898%
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
uncommon, 2.33% - 10%
|
4.19%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Loose stools
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthralgia
|
Arthralgia
|
0.9% - 5.36%
|
4.61% - 5.11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Polyarthralgia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
0.9% - 5.36%
|
4.61% - 5.11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Myalgia
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 0.926% - 10.9%
|
1.2% - 3.2%
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Insomnia NEC
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain worsened
|
2.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fatigue
|
Fatigue
|
common, 1.7% - 4.2%
|
0.898%
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Decreased appetite
|
Anorexia
|
0.744% - 7.44%
|
0.155% - 5.3%
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Decreased appetite
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
postmarketing — 1.74% - 5.45%
|
2.22%
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
1.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Rhinorrhoea
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Chills
|
Rigors
|
0.5% - 3.47%
|
0.246%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Shivering
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Chills
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
1.4% - 4.19%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Angina pectoris
|
Angina pectoris
|
postmarketing — 1.86% - 1.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Angina unstable
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertension
|
Hypertension worsened
|
postmarketing — 1.86% - 1.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Hypertension
|
postmarketing — 2.3% - 2.33%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza like illness
|
Influenza like illness
|
postmarketing — 0.248% - 1.98%
|
0.493%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Abdominal pain
|
Abdominal pain
|
uncommon, 0.9% - 1.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
uncommon, 0.9% - 1.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Influenza
|
Influenza
|
0.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
0.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
postmarketing — 0.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
postmarketing — 0.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
postmarketing — 0.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
postmarketing — 3.72%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Dermatitis
|
Rash
|
uncommon
|
|
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
|
Rash
|
Rash
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Flatulence
|
Flatulence
|
uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tremor
|
Trembling
|
postmarketing, uncommon
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tremor
|
postmarketing — 0.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Weight decreased
|
Weight decreased
|
0.5%
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Menopausal symptoms
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Hot flush
|
Hot flush
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Exacerbation of hot flushes
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety NEC
|
0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
0.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
x
|
Angina unstable
|
Angina unstable
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Aortic aneurysm
|
Aortic aneurysm
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthritis
|
Rheumatoid arthritis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ataxia
|
Ataxia
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Back injury
|
Back injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bipolar disorder
|
Bipolar disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bipolar I disorder
|
Bipolar disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blister
|
Blister
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dermatitis bullous
|
Blister
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Concussion
|
Concussion
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast cancer
|
Breast cancer
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast cancer invasive NOS
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchitis
|
Bronchitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
Acute bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bursitis
|
Bursitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neck pain
|
Neck pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
Musculoskeletal chest pain
|
Chest wall pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cholelithiasis
|
Cholelithiasis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Infection
|
Infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Contusion
|
Contusion
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Cough
|
Cough
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Cough increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysphagia
|
Dysphagia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dehydration
|
Dehydration
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dermatitis atopic
|
Dermatitis atopic
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dermatitis contact
|
Dermatitis contact
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diverticulitis
|
Diverticulitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Dysarthria
|
Dysarthria
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Osteoarthritis
|
Dysarthria
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Arthropathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Osteoarthritis aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear pain
|
Ear pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eczema
|
Eczema
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Eczema exacerbated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Emotional disorder
|
Emotional disturbance NOS
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Epistaxis
|
Epistaxis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Erysipelas
|
Erysipelas
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye injury
|
Eye injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eyelid disorder
|
Eyelid disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Face injury
|
Face injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Faecalith
|
Faecalith
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Faecaloma
|
Faecalith
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Food poisoning
|
Food poisoning
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastroenteritis
|
Gastroenteritis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Gout
|
Gout
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Seasonal allergy
|
Seasonal allergy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinitis seasonal
|
Seasonal allergy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Head injury
|
Head injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiac murmur
|
Cardiac murmur
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematoma
|
Haematoma
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hiccups
|
Hiccups
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hordeolum
|
Hordeolum
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypercalcaemia
|
Hypercalcaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ca++ increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing — 0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypothyroidism
|
Hypothyroidism
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerumen impaction
|
Cerumen impaction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Inflammation
|
Inflammation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Inflammation localised
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Irritability
|
Irritability
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Arthropathy
|
Arthropathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Labyrinthitis
|
Labyrinthitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngitis
|
Laryngitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Fungal infection
|
Fungal infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ingrowing nail
|
Ingrowing nail
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal congestion
|
Nasal congestion
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Nasal oedema
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neck injury
|
Neck injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuralgia
|
Neuralgia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Night sweats
|
Night sweats
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Nocturia
|
Nocturia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Osteopenia
|
Osteopenia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Osteoporosis
|
Osteoporosis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis externa
|
Otitis externa
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis media
|
Otitis media
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Otitis media serous
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pallor
|
Pallor
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Piloerection
|
Piloerection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Cutis anserina
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Prostatitis
|
Prostatitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Prurigo
|
Prurigo
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rales
|
Rales
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rectal prolapse
|
Rectal prolapse
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Rhonchi
|
Rhonchi
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rosacea
|
Rosacea
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus headache
|
Sinus headache
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinusitis
|
Sinusitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
Skin ulcer
|
Skin ulcer
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Soft tissue injury
|
Soft tissue injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Sinus tachycardia
|
Sinus tachycardia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendonitis
|
Tendonitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendon injury
|
Tendon injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Thyroid neoplasm
|
Thyroid neoplasm
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tracheitis
|
Tracheitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erythema
|
Erythema
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pollakiuria
|
Pollakiuria
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
|
x
|
Micturition urgency
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Uterine leiomyoma
|
Uterine leiomyoma
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral infection
|
Viral infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
Wound infection
|
Wound infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laceration
|
Laceration
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Helicobacter infection
|
Helicobacter infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle strain
|
Muscle strain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Micturition urgency
|
Micturition urgency
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Burning sensation
|
Burning sensation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Apathy
|
Apathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Flat affect
|
Apathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
Photopsia
|
Photopsia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Plantar fasciitis
|
Plantar fasciitis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal stiffness
|
Neck stiffness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Musculoskeletal stiffness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nuchal rigidity
|
Neck stiffness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Blood urea increased
|
Blood urea increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Urea increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bone pain
|
Bone pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye pain
|
Eye pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Dry skin
|
Dry skin
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Sinus congestion
|
Sinus congestion
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Joint swelling
|
Joint swelling
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Urinary hesitation
|
Urinary hesitation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Lacrimation increased
|
Lacrimation increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral diarrhoea
|
Viral diarrhoea
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Acute myocardial infarction
|
Acute myocardial infarction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Temporomandibular joint syndrome
|
Arthralgia of temporomandibular joint
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemoglobin decreased
|
Haemoglobin decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Joint stiffness
|
Joint stiffness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Vaginal discharge
|
Vaginal discharge
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Malaise
|
Malaise
|
postmarketing, uncommon
|
|
|
|
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
|
Feeling abnormal
|
Malaise
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
postmarketing — uncommon
|
|
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
|
Myalgia
|
Myalgia
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Joint crepitation
|
Joint crepitation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chest discomfort
|
Chest tightness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vascular insufficiency
|
Vascular insufficiency
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cold sweat
|
Cold sweat
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Sticky skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Gastrointestinal tract irritation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain lower
|
Abdominal pain lower
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Abdominal tenderness
|
Abdominal tenderness
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Retching
|
Retching
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Menometrorrhagia
|
Menometrorrhagia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Disturbance in attention
|
Disturbance in attention
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Cerebration impaired
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Abnormal behaviour
|
Abnormal behaviour
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Euphoric mood
|
Euphoric mood
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dry throat
|
Dry throat
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Faeces discoloured
|
Faeces discoloured
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Small intestinal obstruction
|
Small intestinal obstruction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood creatinine increased
|
Blood creatinine increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Productive cough
|
Productive cough
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Groin pain
|
Groin pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematocrit increased
|
Haematocrit increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vaginal cyst
|
Vaginal cyst
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Wound haemorrhage
|
Wound haemorrhage
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Mammogram abnormal
|
Mammogram abnormal
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Back disorder
|
Back disorder
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing — 0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing, uncommon
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Change of bowel habit
|
Change of bowel habit
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Dry eye
|
Dry eye
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Benign breast neoplasm
|
Benign breast neoplasm
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle injury
|
Muscle injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Red blood cell count decreased
|
Red blood cell count decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Red blood cell count increased
|
Red blood cell count increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ligament sprain
|
Joint sprain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Ligament injury
|
Ligament injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Wrist fracture
|
Wrist fracture
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hand fracture
|
Hand fracture
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal oedema
|
Nasal oedema
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus generalised
|
Pruritus generalised
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tooth abscess
|
Tooth abscess
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Poor peripheral circulation
|
Poor peripheral circulation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus genital
|
Genital itching female
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
High density lipoprotein decreased
|
Low density lipoprotein increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Low density lipoprotein increased
|
Low density lipoprotein increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haemoglobin increased
|
Haemoglobin increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Renal pain
|
Renal pain
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Gait disturbance
|
Gait disturbance
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
|
x
|
x
|
Abscess limb
|
Abscess limb
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood glucose abnormal
|
Blood glucose abnormal
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood glucose increased
|
Blood glucose increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Blood cholesterol increased
|
Blood cholesterol increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis
|
Bladder infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Ear infection
|
Ear infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Throat irritation
|
Throat irritation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
C-reactive protein increased
|
C-reactive protein increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Limb injury
|
Limb injury
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tinea pedis
|
Foot infection fungal NOS
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematocrit decreased
|
Haematocrit decreased
|
postmarketing — 0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Scleral haemorrhage
|
Scleral haemorrhage
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
White blood cell count increased
|
White blood cell count increased
|
postmarketing — 0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear congestion
|
Ear congestion
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Blood alkaline phosphatase increased
|
Blood alkaline phosphatase increased
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Amylase increased
|
Blood amylase increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Amylase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood lactate dehydrogenase increased
|
Blood lactate dehydrogenase increased
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lactic dehydrogenase activity increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neutrophil count decreased
|
Neutrophil count decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lymphocyte count increased
|
Lymphocyte count increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood potassium abnormal
|
Blood potassium abnormal
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Potassium abnormal NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Alanine aminotransferase decreased
|
Alanine aminotransferase decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Aspartate aminotransferase decreased
|
Aspartate aminotransferase decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Pancreatitis
|
Pancreatitis aggravated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Pancreatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
Lip blister
|
Lip blister
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Protein total decreased
|
Protein total decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkeratosis
|
Hyperkeratosis
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tooth infection
|
Tooth infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Respiratory tract infection viral
|
Respiratory tract infection viral
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Postoperative wound complication
|
Postoperative wound complication
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Red cell distribution width increased
|
Red cell distribution width increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Ear discomfort
|
Ear discomfort
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mean platelet volume decreased
|
Mean platelet volume decreased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinorrhoea
|
Rhinorrhoea
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Gastrointestinal infection
|
Gastrointestinal infection
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Excoriation
|
Abrasion NOS
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mental retardation
|
Mental disability
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Mental disability
|
Mental disability
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Cerebration impaired
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Haematochezia
|
Blood in stool
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Renal failure
|
Renal impairment
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Renal impairment
|
Renal impairment
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Exostosis
|
Bone spur
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinitis allergic
|
Rhinitis allergic
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastrointestinal tract irritation
|
Gastrointestinal tract irritation
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Coma
|
Coma
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing — uncommon
|
|
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
|
|
|
|
x
|
Cyst
|
Cyst
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deafness
|
Deafness
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Drug abuse
|
Drug abuse
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing — uncommon
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Strangury
|
rare
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing, uncommon
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing, uncommon
|
|
|
|
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
|
|
Hepatitis
|
Hepatitis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing — 1.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Hypotension
|
Hypotension
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Miosis
|
Miosis
|
postmarketing
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
Dyskinesia
|
Movement disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Movement disorder
|
Movement disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Mydriasis
|
Mydriasis
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Tension
|
Nervousness
|
postmarketing
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
postmarketing, rare
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Palpitations
|
Palpitations
|
postmarketing, uncommon
|
|
|
|
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
|
Paraesthesia NEC
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polyp
|
Polyp
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
|
|
|
|
|
|
Pulmonary oedema
|
Pulmonary oedema
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
Shock
|
Shock
|
postmarketing — uncommon
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sleep disorder
|
Sleep disturbance
|
postmarketing, rare
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
Speech disorder
|
Speech disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
Speech impairment NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
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
|
x
|
|
|
|
|
|
x
|
x
|
Stomatitis
|
Stomatitis
|
postmarketing
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
Syncope
|
Syncope
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing, uncommon
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Urticaria
|
Urticaria
|
postmarketing, uncommon
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|