|
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
|
|
Headache
|
Headache
|
24% - 26.9%
|
17% - 26.7%
|
x
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Autonomic neuropathy
|
Unspecified disorder of autonomic nervous system
|
6% - 20%
|
5% - 14%
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Ejaculation disorder
|
Ejaculation disorder
|
1.3% - 14%
|
0% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal ejaculation
|
6.1%
|
1%
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Insomnia
|
Insomnia
|
1% - 18.8%
|
1% - 18.9%
|
x
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Diarrhoea
|
Diarrhoea
|
4.4% - 14%
|
4.4% - 6%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy peripheral
|
Neuropathy peripheral
|
rare, 8%
|
6%
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neuropathy
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Tremor
|
Tremor
|
postmarketing — 8% - 8.8%
|
0.8% - 6%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dry mouth
|
Dry mouth
|
1% - 20%
|
1% - 14%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
2% - 18%
|
1% - 10.3%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amenorrhoea
|
Amenorrhoea
|
infrequent — frequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amnesia
|
Amnesia
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Confusional state
|
Confusional state
|
postmarketing — 1.4%
|
0.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state
|
postmarketing — 1.4%
|
0.6%
|
|
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
|
|
Feeling abnormal
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cough
|
Cough
|
infrequent — 1.7%
|
0.8% - 1.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysgeusia
|
Dysgeusia
|
infrequent — frequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Taste metallic
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
infrequent — 1%
|
1.2%
|
|
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
|
x
|
|
Rash
|
Rash
|
infrequent — 1%
|
1.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
Fatigue
|
0.8% - 16.7%
|
2% - 5.3%
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Asthenia
|
postmarketing — 1% - 11.5%
|
1% - 11.7%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fatigue
|
Fatigue
|
0.8% - 16.7%
|
2% - 5.3%
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flatulence
|
Flatulence
|
frequent, 1.7% - 2%
|
0.8% - 1.2%
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal bloating
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypotension
|
Hypotension
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orthostatic hypotension
|
Orthostatic hypotension
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Orgasm abnormal
|
Orgasm abnormal
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain
|
Pain
|
infrequent — 1.3%
|
1.3%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Palpitations
|
Palpitations
|
frequent, 7.1%
|
0.8% - 7.4%
|
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Paraesthesia
|
Paraesthesia
|
frequent, 1.4% - 2%
|
0.7% - 1.2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
|
Diuresis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
uncommon — frequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pruritus
|
Pruritus
|
infrequent — 1%
|
0.8%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rhinitis
|
Rhinitis
|
3% - 5%
|
2.9% - 4.8%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent — frequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Suicide attempt
|
Suicide attempt
|
postmarketing — 1.3%
|
1.2%
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
4.9% - 5%
|
4% - 5.1%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Weight increased
|
Weight increased
|
common, frequent
|
1.1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
postmarketing — 1.5%
|
0.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Injury
|
Trauma
|
frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Accidental injury
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Inflicted injury
|
|
1.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Apathy
|
Apathy
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flat affect
|
Apathy
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Flat affect
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
common, frequent
|
0.9%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Migraine aggravated
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Accommodation disorder
|
Accommodation disorder
|
infrequent — frequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
Increased appetite
|
uncommon — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in attention
|
Cerebration impaired
|
uncommon, frequent
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in attention
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disability
|
Cerebration impaired
|
uncommon, frequent
|
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Depression
|
Depression aggravated
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
Influenza-like symptoms
|
infrequent — 1% - 5%
|
1% - 4%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Influenza like illness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperhidrosis
|
Sweating increased
|
3% - 11.3%
|
1% - 9%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hyperhidrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sleep disorder
|
Sleep disorder
|
uncommon, frequent
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
4% - 4.2%
|
0.7% - 2%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Decreased appetite
|
frequent, 1% - 3%
|
0.5% - 1%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Anxiety
|
Anxiety
|
postmarketing, 2.9% - 5.3%
|
2.5% - 4.3%
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
Anxiety attack
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anxiety aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dizziness
|
Dizziness
|
2% - 10.3%
|
1% - 10.1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lightheadedness
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Syncope
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
2% - 21.4%
|
0% - 14%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido decreased
|
Libido decreased
|
2% - 7%
|
0.3% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido decreased
|
2% - 7%
|
0.3% - 2%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Ejaculation delayed
|
Ejaculation delayed
|
uncommon, 3.6% - 10.4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pharyngitis
|
Pharyngitis
|
infrequent, 3.2%
|
2.5%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Constipation
|
Constipation
|
1% - 8.4%
|
1% - 8.2%
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
uncommon — 3%
|
2%
|
|
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
infrequent — 1% - 6%
|
1% - 4%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Heartburn
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lethargy
|
Lethargy
|
uncommon — 1% - 3%
|
1%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Musculoskeletal pain
|
Shoulder pain
|
frequent, 3%
|
1%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
1% - 3%
|
1% - 2.9%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vomiting
|
Vomiting
|
frequent, 0% - 4%
|
0% - 3%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Anorgasmia
|
Anorgasmia
|
1.8% - 6%
|
0.2% - 1%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
0.8% - 3%
|
1% - 2%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Erectile dysfunction
|
Erectile dysfunction
|
2% - 3.8%
|
0% - 0.6%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pain in extremity
|
Pain in extremity
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Leg pain
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Ejaculation failure
|
Ejaculation failure
|
0% - 7.3%
|
0% - 0.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
1% - 3.2%
|
1% - 2.6%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Abdominal cramps
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
1% - 3.2%
|
1% - 2.6%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthralgia
|
Arthralgia
|
infrequent — 1.8% - 2%
|
0.8% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Musculoskeletal discomfort
|
Arthralgia
|
infrequent — 1.8% - 2%
|
0.8% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
infrequent — 1.9% - 2%
|
1% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back distress
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
2%
|
2.3% - 3.4%
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Back distress
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Body temperature increased
|
Body temperature increased
|
uncommon — 1% - 2.3%
|
0.4% - 1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Menstrual disorder
|
Menstrual disorder
|
infrequent — 2% - 4%
|
1% - 2.2%
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Toothache
|
Toothache
|
infrequent — 2%
|
0%
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Yawning
|
Yawning
|
0.7% - 5.3%
|
0% - 1%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myalgia
|
Myalgia
|
infrequent — 1.9% - 2%
|
1% - 1.2%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Agitation
|
Agitation
|
postmarketing — 1% - 3%
|
0.3% - 1.2%
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Excitability
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperkinesia
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Restlessness aggravated
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal distension
|
Abdominal distension
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal bloating
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abscess
|
Abscess
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
|
Anaemia
|
Anaemia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angina pectoris
|
Angina pectoris
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Animal bite
|
Animal bite
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Arthritis
|
Arthritis
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ataxia
|
Ataxia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Blepharospasm
|
Blepharospasm
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Bronchitis
|
Bronchitis
|
infrequent — frequent
|
1.7%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute bronchitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bruxism
|
Bruxism
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vulvovaginal mycotic infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Carpal tunnel syndrome
|
Carpal tunnel syndrome
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Neck pain
|
Neck pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Colitis ulcerative
|
Colitis ulcerative
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Proctocolitis
|
Colitis ulcerative
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Infection
|
Infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Contusion
|
Contusion
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Crohn's disease
|
Crohn's disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cystitis
|
Cystitis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Bladder pain
|
Cystitis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cystitis noninfective
|
Cystitis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Deafness
|
Deafness
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysphagia
|
Dysphagia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Delusion
|
Delusion
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Depersonalisation
|
Depersonalisation
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Dermatitis contact
|
Dermatitis contact
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fungal skin infection
|
Fungal skin infection
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Joint dislocation
|
Joint dislocation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug abuse
|
Drug abuse
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear disorder
|
Ear disorder
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ear pain
|
Ear pain
|
infrequent — frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Eczema
|
Eczema
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Enteritis
|
Enteritis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Epistaxis
|
Epistaxis
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eructation
|
Eructation
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oesophagitis
|
Oesophagitis
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Excoriation
|
Excoriation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrapyramidal disorder
|
Extrapyramidal disorder
|
postmarketing, infrequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye haemorrhage
|
Eye haemorrhage
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Eye infection
|
Eye infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Femoral neck fracture
|
Femoral neck fracture
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Fibromyalgia
|
Fibromyalgia
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Flushing
|
Flushing
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Folliculitis
|
Folliculitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Food poisoning
|
Food poisoning
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Furuncle
|
Furunculosis
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Furuncle
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retching
|
Gagging
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastroenteritis
|
Gastroenteritis
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Gingivitis
|
Gingivitis
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Gout
|
Gout
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hallucination
|
Hallucination
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Cardiac failure
|
Cardiac failure
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Haemorrhoids
|
Haemorrhoids
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hernia
|
Hernia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Herpes simplex
|
Herpes simplex
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Herpes zoster
|
Herpes zoster
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypertension
|
Hypertension
|
infrequent — frequent
|
1.3%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypertension worsened
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Libido increased
|
Libido increased
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Irritable bowel syndrome
|
Irritable bowel syndrome
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Functional gastrointestinal disorder
|
Irritable bowel syndrome
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Irritability
|
Irritability
|
uncommon, frequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Eye pruritus
|
Eye pruritus
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropathy
|
Arthropathy
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Osteoarthritis
|
Arthropathy
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dysarthria
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramps of lower extremities
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Muscle spasms
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cramp muscle
|
postmarketing — frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Leukocytosis
|
Leukocytosis
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Leukopenia
|
Leukopenia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lipoma
|
Lipoma
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain
|
Breast pain
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Melaena
|
Melaena
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Metrorrhagia
|
Metrorrhagia
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypertonia
|
Hypertonia
|
infrequent, uncommon
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myopathy
|
Myopathy
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Fungal infection
|
Fungal infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myocarditis
|
Myocarditis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nasal congestion
|
Nasal congestion
|
uncommon, frequent
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nasopharyngitis
|
Nasopharyngitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neuralgia
|
Neuralgia
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neurosis
|
Neurosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Nightmare
|
Nightmare
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Nocturia
|
Nocturia
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Obsessive-compulsive disorder
|
Obsessive-compulsive disorder
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Otitis externa
|
Otitis externa
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Otitis media
|
Otitis media
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ovarian cyst
|
Ovarian cyst
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Panic reaction
|
Panic reaction
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Pelvic pain
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Penis disorder
|
Penis disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pneumonia
|
Pneumonia
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Premenstrual syndrome
|
Premenstrual syndrome
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Premenstrual tension
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Prostatic disorder
|
Prostatic disorder
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Psoriasis
|
Psoriasis
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Psoriasis flare-up
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Paranoia
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Purpura
|
Purpura
|
postmarketing — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Idiopathic thrombocytopenic purpura
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular purpura
|
Purpura
|
postmarketing — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiratory tract infection
|
Respiratory tract infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Salpingitis
|
Salpingitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sciatica
|
Sciatica
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ischial neuralgia
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Pharyngitis streptococcal
|
Pharyngitis streptococcal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus headache
|
Sinus headache
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin disorder
|
Skin disorder
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin infection
|
Skin infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Snoring
|
Snoring
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Speech disorder
|
Speech disorder
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Stomatitis
|
Stomatitis
|
postmarketing — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Sunburn
|
Sunburn
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
Sunburn
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Photosensitivity reaction
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Shock
|
Syncope
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shock
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
Syncope
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Syncope vasovagal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss of consciousness
|
Syncope
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of consciousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tendonitis
|
Tendonitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tenosynovitis
|
Tenosynovitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Testicular disorder
|
Testicular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Testicular pain
|
Testicular pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tetany
|
Tetany
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Thirst
|
Thirst
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Costochondritis
|
Costochondritis
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Onychomycosis
|
Onychomycosis
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tinnitus
|
Tinnitus
|
infrequent — 1%
|
0.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Tonsillitis
|
Tonsillitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tracheitis
|
Tracheitis
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tuberculosis
|
Tuberculosis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Unintended pregnancy
|
Unintended pregnancy
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Pollakiuria
|
Pollakiuria
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urinary incontinence
|
Urinary incontinence
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
infrequent — frequent
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Micturition disorder
|
Micturition disorder
|
uncommon, 2.3%
|
1.9%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
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
|
|
Uterine leiomyoma
|
Uterine leiomyoma
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vaginal infection
|
Vaginal inflammation
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vaginal infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Varicose vein
|
Varicose vein
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vertigo
|
Vertigo
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Viral infection
|
Viral infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Skin papilloma
|
Common wart
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Skin papilloma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Xerophthalmia
|
Xerophthalmia
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Urinary retention
|
Urinary retention
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chills
|
Chills
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rigors
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Shivering
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Micturition urgency
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Burning sensation
|
Burning sensation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
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
|
x
|
x
|
x
|
x
|
|
Photopsia
|
Photopsia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash pustular
|
Rash pustular
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypokinesia
|
Hypokinesia
|
infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Panic attack
|
Panic attack
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Acute sinusitis
|
Acute sinusitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tracheobronchitis
|
Acute bronchitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Plantar fasciitis
|
Plantar fasciitis
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alcohol intolerance
|
Alcohol intolerance
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Myocardial ischaemia
|
Myocardial ischaemia
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Mania
|
Manic psychosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Mania
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscular weakness
|
Muscular weakness
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone pain
|
Bone pain
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
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
|
x
|
x
|
|
Paranoia
|
Paranoid reaction
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Paranoia
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Blood alkaline phosphatase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperreflexia
|
Hyperreflexia
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Skin discolouration
|
Skin discolouration
|
infrequent, uncommon
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Dry skin
|
Dry skin
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sinus congestion
|
Sinus congestion
|
uncommon, frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary hesitation
|
Urinary hesitation
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Otosalpingitis
|
Otosalpingitis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Menstruation irregular
|
Menstruation irregular
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ankle fracture
|
Ankle fracture
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joint stiffness
|
Joint stiffness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaw stiffness
|
infrequent, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lichenoid keratosis
|
Eruption lichenoid
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Atrophic vulvovaginitis
|
Vaginitis atrophic
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Road traffic accident
|
Road traffic accident
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle twitching
|
Muscle twitching
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Chest discomfort
|
Chest tightness
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Chest discomfort
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Abdominal discomfort
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Emotional disorder
|
Emotional disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tension
|
Tension
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
postmarketing — 4%
|
0.7% - 3.7%
|
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Thinking abnormal
|
Thinking abnormal
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hallucination, auditory
|
Hallucination, auditory
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Memory impairment
|
Memory impairment
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Forgetfulness
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Painful erection
|
Painful erection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash erythematous
|
Rash erythematous
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Dizziness postural
|
Dizziness postural
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Euphoric mood
|
Euphoric mood
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Nervousness
|
Nervous tremulousness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling jittery
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nervousness
|
postmarketing — 4%
|
0.7% - 3.7%
|
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Eye irritation
|
Eye irritation
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Glucose tolerance impaired
|
Glucose tolerance abnormal
|
infrequent, uncommon
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Gravitational oedema
|
Gravitational oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Peripheral ischaemia
|
Peripheral ischaemia
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Vein disorder
|
Vein disorder
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy cervical
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Urine abnormality
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urine analysis abnormal
|
Urine abnormality
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Galactorrhoea
|
Galactorrhoea
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Chest pain
|
Chest discomfort
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
postmarketing — 1.2%
|
0.6%
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Oedema peripheral
|
Leg edema
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Oedema peripheral
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypersensitivity
|
Allergy aggravated
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypersensitivity
|
postmarketing — frequent
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Radiculopathy
|
Nerve root lesion
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Crying
|
Crying abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pain in jaw
|
Pain in jaw
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Periodontal destruction
|
Periodontal destruction
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Gastric polyps
|
Gastric polyps
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Throat tightness
|
Throat tightness
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Menopausal symptoms
|
Menopausal symptoms
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hot flush
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Frequent bowel movements
|
Frequent bowel movements
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vulvovaginal dryness
|
Vaginal dryness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pelvic inflammatory disease
|
Pelvic inflammatory disease
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Major depression
|
Psychotic depression
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Melancholia
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Major depression
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mouth injury
|
Mouth injury
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peripheral coldness
|
Peripheral coldness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change of bowel habit
|
Change of bowel habit
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Balance disorder
|
Dysequilibrium
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Balance disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry eye
|
Dry eye
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
House dust allergy
|
House dust allergy
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Viral upper respiratory tract infection
|
Viral upper respiratory tract infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Extrasystoles
|
Extrasystoles
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Genital candidiasis
|
Genital candidiasis
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vision blurred
|
Vision blurred
|
infrequent — frequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Depressed mood
|
Depressed mood
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysaesthesia
|
Dysaesthesia
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Initial insomnia
|
Initial insomnia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Middle insomnia
|
Middle insomnia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Joint injury
|
Joint injury
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash maculo-papular
|
Rash maculo-papular
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Increased tendency to bruise
|
Increased tendency to bruise
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperkinesia
|
Hyperkinesia
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Respiration abnormal
|
Respiratory sighs
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bradycardia
|
Bradycardia
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ligament sprain
|
Joint sprain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure increased
|
Blood pressure increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth abscess
|
Tooth abscess
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Food craving
|
Carbohydrate craving
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Paralysis
|
Paralysis
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Terminal insomnia
|
Terminal insomnia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling jittery
|
Feeling jittery
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Intervertebral disc disorder
|
Lumbar disc lesion
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Alcohol problem
|
Alcohol problem
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Surgery
|
Surgical intervention
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Traumatic haematoma
|
Traumatic haematoma
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sexual dysfunction
|
Sexual dysfunction
|
infrequent
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Lip dry
|
Lip dry
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laceration
|
Skin laceration
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait disturbance
|
Gait disturbance
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Blood glucose increased
|
Blood glucose increased
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hot flush
|
Hot flush
|
infrequent — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ear infection
|
Ear infection
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Thermal burn
|
Thermal burn
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acne
|
Acne
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Genital infection
|
Genital infection
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemorrhagic disorder
|
Hemorrhage abnormal
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Limb injury
|
Limb injury
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infection parasitic
|
Infection parasitic
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Arthropod bite
|
Arthropod bite
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lung infection
|
Lung infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth infection
|
Tooth infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle tightness
|
Muscle tightness
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hypersomnia
|
Hypersomnia
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sluggishness
|
Sluggishness
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Orchitis noninfective
|
Orchitis noninfective
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal infection
|
Gastrointestinal infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epigastric discomfort
|
Epigastric discomfort
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Aggression
|
Aggressive reaction
|
infrequent, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Aggression
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Breast neoplasm
|
Breast neoplasm
|
infrequent, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dysphonia
|
Dysphonia
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Procedural pain
|
Procedural pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vasodilatation
|
Vein distended
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Breast enlargement
|
Breast enlargement
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loss of libido
|
Loss of libido
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Visual impairment
|
Visual impairment
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal vision
|
infrequent — 4.7%
|
5.1%
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Visual disturbance
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Disorder sight
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis atopic
|
Dermatitis atopic
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tension headache
|
Tension headache
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin mass
|
Skin nodule
|
rare, infrequent
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abortion spontaneous
|
Abortion spontaneous
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Agranulocytosis
|
Agranulocytosis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemolytic anaemia
|
Haemolytic anaemia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hypochromic anaemia
|
Hypochromic anaemia
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Anger
|
Anger
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Appendicitis
|
Appendicitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Rheumatoid arthritis
|
Rheumatoid arthritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Asthenopia
|
Asthenopia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Asthma
|
Asthma
|
postmarketing — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Sports injury
|
Sports injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Atrial fibrillation
|
Atrial fibrillation
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Back injury
|
Back injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bacterial infection
|
Bacterial infection
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Mental disorder
|
Mental disorder
|
postmarketing — 18%
|
10%
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Coagulopathy
|
Coagulopathy
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Bone disorder
|
Bone disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Marrow hyperplasia
|
Marrow hyperplasia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Concussion
|
Concussion
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
rare
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Bundle branch block
|
Bundle branch block
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Bursitis
|
Bursitis
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Candida infection
|
Candida infection
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Carbuncle
|
Carbuncle
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cellulitis
|
Cellulitis
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Transient ischaemic attack
|
Transient ischaemic attack
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Musculoskeletal chest pain
|
Chest wall pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Varicella
|
Varicella
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Choking
|
Choking
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cholecystitis
|
Cholecystitis
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Cholelithiasis
|
Cholelithiasis
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Colitis
|
Colitis
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Large intestine polyp
|
Colonic polyp
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sudden death
|
Sudden death
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dehydration
|
Dehydration
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Delirium
|
Delirium
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dental caries
|
Dental caries
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing, uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Diplopia
|
Diplopia
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Diverticulitis
|
Diverticulitis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Duodenal ulcer
|
Duodenal ulcer
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Dysarthria
|
Dysarthria
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyskinesia
|
Dyskinesia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ecchymosis
|
Ecchymosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electric shock
|
Electric shock
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Embolism
|
Embolism
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Eosinophilia
|
Eosinophilia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Toxic epidermal necrolysis
|
Toxic epidermal necrolysis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Necrolysis epidermal
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Grand mal convulsion
|
Grand mal convulsion
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tonic-clonic seizures
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erysipelas
|
Erysipelas
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Congenital eye disorder
|
Congenital eye disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Congenital eye disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye injury
|
Eye injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foetal death
|
Foetal death
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anal fissure
|
Anal fissure
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
postmarketing — frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing — 18% - 21%
|
8% - 14%
|
x
|
|
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
|
x
|
x
|
|
x
|
|
Gingival bleeding
|
Gingival bleeding
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Glaucoma
|
Glaucoma
|
postmarketing
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Angle closure glaucoma
|
Angle closure glaucoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Glossitis
|
Glossitis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Goitre
|
Goitre
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Gynaecomastia
|
Gynaecomastia
|
rare
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Seasonal allergy
|
Seasonal allergy
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Rhinitis seasonal
|
Seasonal allergy
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Cardiac arrest
|
Cardiac arrest
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, rare
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Haematemesis
|
Haematemesis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematochezia
|
Haematochezia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematoma
|
Haematoma
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Haematuria
|
Haematuria
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
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
|
|
|
Hiccups
|
Hiccups
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hostility
|
Hostility
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hunger
|
Hunger
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperaesthesia
|
Hyperaesthesia
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperphagia
|
Hyperphagia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperprolactinaemia
|
Hyperprolactinaemia
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pulmonary hypertension
|
Pulmonary hypertension
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertensive crisis
|
Hypertensive crisis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertrichosis
|
Hypertrichosis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hyponatraemia
|
Hyponatraemia
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Hypothyroidism
|
Hypothyroidism
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Conversion disorder
|
Hysteria
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ileitis
|
Ileitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerumen impaction
|
Cerumen impaction
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Impetigo
|
Impetigo
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inappropriate antidiuretic hormone secretion
|
Inappropriate antidiuretic hormone secretion
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Iritis
|
Iritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Keratitis
|
Keratitis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Keratoconus
|
Keratoconus
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nephrolithiasis
|
Calculus of kidney
|
rare — uncommon
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Renal failure acute
|
Renal failure acute
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Laryngitis
|
Laryngitis
|
rare — uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Lymphadenitis
|
Lymphadenitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphatic disorder
|
Lymphatic disorder
|
rare
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Lymphocytosis
|
Lymphocytosis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Lymphopenia
|
Lymphopenia
|
rare
|
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Mastitis
|
Mastitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Melanosis
|
Melanosis
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Meniere's disease
|
Meniere's disease
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menorrhagia
|
Menorrhagia
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Prolonged menses
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Motion sickness
|
Motion sickness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mydriasis
|
Mydriasis
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Myoclonus
|
Myoclonus
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Myopia
|
Myopia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ingrowing nail
|
Ingrowing nail
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasal polyps
|
Nasal polyps
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neck injury
|
Neck injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
Night blindness
|
Night blindness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nystagmus
|
Nystagmus
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Obesity
|
Obesity
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Oliguria
|
Oliguria
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Osteoporosis
|
Osteoporosis
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Pallor
|
Pallor
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Personality disorder
|
Personality disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Phlebitis
|
Phlebitis
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pregnancy
|
Pregnancy
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Supraventricular extrasystoles
|
Supraventricular extrasystoles
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Priapism
|
Priapism
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Anal pruritus
|
Anal pruritus
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pruritus genital
|
Anal pruritus
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Anorectal discomfort
|
Anal pruritus
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing, rare
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Pyelonephritis
|
Pyelonephritis
|
rare, uncommon
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Radius fracture
|
Radius fracture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Restless legs syndrome
|
Restless legs syndrome
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Retinal detachment
|
Retinal detachment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhabdomyolysis
|
Rhabdomyolysis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Rib fracture
|
Rib fracture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Salmonellosis
|
Salmonellosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scotoma
|
Scotoma
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Convulsion
|
Convulsion
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Staphylococcal infection
|
Staphylococcal infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastric ulcer
|
Gastric ulcer
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Streptococcal infection
|
Streptococcal infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Withdrawal syndrome
|
Withdrawal syndrome
|
postmarketing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Completed suicide
|
Suicide
|
postmarketing, rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Completed suicide
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Thrombosis
|
Thrombosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Tongue disorder
|
Tongue disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth disorder
|
Tooth disorder
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tooth erosion
|
Tooth erosion
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torsade de pointes
|
Torsade de pointes
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Tracheal disorder
|
Tracheal disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ulna fracture
|
Ulna fracture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing, rare
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Presyncope
|
Syncope vasovagal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular tachycardia
|
Ventricular tachycardia
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vitreous detachment
|
Vitreous detachment
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Idiopathic thrombocytopenic purpura
|
Idiopathic thrombocytopenic purpura
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Idiopathic thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Post-traumatic neck syndrome
|
Whiplash injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wound infection
|
Wound infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Choreoathetosis
|
Choreoathetosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Hepatic failure
|
Hepatic failure
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ventricular arrhythmia
|
Ventricular arrhythmia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Stupor
|
Stupor
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Depressed level of consciousness
|
Stupor
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Photophobia
|
Photophobia
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Cataract
|
Cataract
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Muscle rupture
|
Muscle rupture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast discharge
|
Breast discharge
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatitis cholestatic
|
Hepatitis cholestatic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug level decreased
|
Drug level decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Drug level increased
|
Drug level increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypermagnesaemia
|
Hypermagnesaemia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic necrosis
|
Hepatic necrosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Prothrombin level increased
|
Prothrombin level increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Electrocardiogram QT prolonged
|
Electrocardiogram QT prolonged
|
postmarketing
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
rare, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hypogeusia
|
Hypogeusia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tendon disorder
|
Tendon disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Uterine spasm
|
Uterine spasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensory disturbance
|
Sensory disturbance
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Skin irritation
|
Skin irritation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facial bones fracture
|
Facial bones fracture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin decreased
|
Haemoglobin decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
postmarketing, rare
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tympanic membrane perforation
|
Tympanic membrane perforation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Muscle stiffness
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Musculoskeletal stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oral pain
|
Oral pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal discharge
|
Vaginal discharge
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Discomfort
|
Malaise
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Ill-defined disorder
|
Malaise
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Cold sweat
|
Cold sweat
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menometrorrhagia
|
Menometrorrhagia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disorientation
|
Disorientation
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Derealisation
|
Derealisation
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dermatitis acneiform
|
Dermatitis acneiform
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin odour abnormal
|
Skin odour abnormal
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Head discomfort
|
Head discomfort
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Suicidal ideation
|
Suicidal tendency
|
postmarketing, infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Suicidal ideation
|
postmarketing, infrequent
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
Skin warm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Erythema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin warm
|
Skin warm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tongue discolouration
|
Black hairy tongue
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood uric acid increased
|
Blood uric acid increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sputum increased
|
Sputum increased
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Increased bronchial secretion
|
Sputum increased
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Breast cancer female
|
Breast cancer female
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lacrimal disorder
|
Lacrimation abnormal NOS
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing — uncommon
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Early satiety
|
Early satiety
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genital pain
|
Genital pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingival pain
|
Gingival pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hand dermatitis
|
Hand dermatitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pregnancy test positive
|
Pregnancy test positive
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermal cyst
|
Dermal cyst
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypomania
|
Hypomania
|
postmarketing — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Intervertebral disc protrusion
|
Intervertebral disc protrusion
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Parkinsonism
|
Parkinsonism
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth injury
|
Tooth injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sepsis
|
Sepsis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Breast tenderness
|
Breast tenderness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Reflux gastritis
|
Reflux gastritis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
postmarketing — uncommon
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Generalised anxiety disorder
|
Generalised anxiety disorder
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye swelling
|
Eye swelling
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foot fracture
|
Foot fracture
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis viral
|
Bronchitis viral
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facial spasm
|
Facial spasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Acute psychosis
|
Acute psychosis
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatitis fulminant
|
Hepatitis fulminant
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
postmarketing — infrequent
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benign breast neoplasm
|
Benign breast neoplasm
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Akathisia
|
Akathisia
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Finger deformity
|
Finger deformity
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Psychomotor retardation
|
Psychomotor retardation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Disinhibition
|
Disinhibition
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Facial paresis
|
Facial paresis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
VIIth nerve paralysis
|
Facial paresis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Facial paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ligament injury
|
Ligament injury
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromatopsia
|
Chromatopsia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pyelonephritis acute
|
Pyelonephritis acute
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Electrocardiogram PR shortened
|
Electrocardiogram PR shortened
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coordination abnormal
|
Coordination abnormal
|
rare, infrequent
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Electrocardiogram abnormal
|
Electrocardiogram abnormal
|
rare — uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Self-injurious ideation
|
Self-injurious ideation
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chromaturia
|
Chromaturia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep talking
|
Sleep talking
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Bladder dilatation
|
Bladder dilatation
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sensation of blood flow
|
Sensation of blood flow
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bladder discomfort
|
Bladder discomfort
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypohidrosis
|
Sweating decreased
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Prothrombin level decreased
|
Prothrombin level decreased
|
postmarketing
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Renal pain
|
Renal pain
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Stress at work
|
Stress at work
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sacroiliitis
|
Sacroiliitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Family stress
|
Family stress
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prothrombin time shortened
|
Prothrombin time shortened
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Sensation of heaviness
|
Sensation of heaviness
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genitourinary chlamydia infection
|
Genitourinary chlamydia infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood cholesterol increased
|
Blood cholesterol increased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tardive dyskinesia
|
Tardive dyskinesia
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Serotonin syndrome
|
Serotonin syndrome
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Emotional distress
|
Emotional distress
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingival infection
|
Gingival infection
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergic sinusitis
|
Allergic sinusitis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergic oedema
|
Allergic oedema
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis perennial
|
Rhinitis perennial
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthropod sting
|
Arthropod sting
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International normalised ratio increased
|
International normalised ratio increased
|
postmarketing
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Local swelling
|
Local swelling
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Performance status decreased
|
Performance status decreased
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood urine present
|
Blood urine present
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Latent tetany
|
Latent tetany
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aphasia
|
Dysphasia
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Exostosis
|
Exostosis
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Post-traumatic pain
|
Post-traumatic pain
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coronary artery disease
|
Coronary artery disease
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ageusia
|
Ageusia
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Feeling hot
|
Feeling hot
|
rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Catatonia
|
Catatonic reaction
|
rare
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Aneurysm
|
Aneurysm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arteriosclerosis
|
Arteriosclerosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Collagen disorder
|
Collagen disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Coma
|
Coma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle contracture
|
Muscle contracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cyanosis
|
Cyanosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cyst
|
Cyst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Petit mal epilepsy
|
Petit mal epilepsy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gilbert's syndrome
|
Gilbert's syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperthyroidism
|
Hyperthyroidism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperventilation
|
Hyperventilation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypocalcaemia
|
Hypocalcaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Movement disorder
|
Movement disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Muscle rigidity
|
Muscle rigidity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Night sweats
|
Night sweats
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Upper-airway cough syndrome
|
Postnasal drip
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Scoliosis
|
Scoliosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus tachycardia
|
Sinus tachycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thyroiditis
|
Thyroiditis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Torticollis
|
Torticollis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Trismus
|
Trismus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Wheezing
|
Wheezing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus bradycardia
|
Sinus bradycardia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis bullous
|
Dermatitis bullous
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neurotransmitter level altered
|
Neurotransmitter level altered
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nodal rhythm
|
Nodal rhythm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blunted affect
|
Blunted affect
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hallucination, visual
|
Hallucination, visual
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Clonic convulsion
|
Clonic convulsion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug tolerance
|
Tolerance development
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Autonomic nervous system imbalance
|
Autonomic nervous system imbalance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pericardial disease
|
Pericardial disease
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Fluid retention
|
Fluid retention
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug dependence
|
Dependence psychological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug seeking behavior
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dependence
|
Dependence physiological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epidermal naevus
|
Epidermal naevus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasal septum deviation
|
Nasal septum deviation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Throat irritation
|
Throat irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental status changes
|
Mental status changes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Female sexual dysfunction
|
Female sexual dysfunction
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
Rhinorrhoea
|
Rhinorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure fluctuation
|
Change in blood pressure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
