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
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, 1.9% - 50%
|
0% - 28%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing, 1.2% - 46%
|
0% - 30%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
x
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
1.7% - 44%
|
0.5% - 24%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
Decreased appetite
|
Decreased appetite
|
common — 0.7% - 30%
|
0% - 9%
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Anorexia
|
postmarketing, 0% - 7%
|
0% - 4.23%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Appetite absent
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
|
Headache
|
Headache
|
postmarketing — 0.6% - 39%
|
11% - 19%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Malnutrition
|
Malnutrition
|
16% - 34%
|
5% - 11%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
very common, 4% - 20%
|
3.6% - 4%
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
1.2% - 16%
|
0.3% - 8%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
common, 2% - 9%
|
0.9% - 4%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 9.66% - 14.3%
|
2.35% - 4.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
3.11% - 7.45%
|
3.8%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
Anxiety
|
Anxiety
|
postmarketing — 0.7% - 11%
|
0% - 2.9%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperhidrosis
|
Hyperhidrosis
|
common, 5.1% - 5.7%
|
0.9% - 1.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
Toothache
|
Toothache
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sleep disorder
|
Sleep disorder
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing — 0% - 17%
|
0% - 7.8%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood pressure fluctuation
|
Change in blood pressure
|
common
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Lethargy
|
Lethargy
|
4.97%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Asthenia
|
Fatigue
|
4.7%
|
4.2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Asthenia
|
1.2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
Fatigue
|
Fatigue
|
4.7%
|
4.2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Initial insomnia
|
Initial insomnia
|
2% - 5.7%
|
0% - 2.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Infestation
|
Infestation NOS
|
2.2% - 5.8%
|
0.9% - 1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
1.2% - 7%
|
0.9% - 2%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
|
Nervousness
|
Feeling jittery
|
common, 1.4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Nervousness
|
postmarketing — 0.7% - 3.1%
|
0.5% - 0.6%
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Feeling jittery
|
Feeling jittery
|
common, 1.4%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
postmarketing — 3.1% - 4.5%
|
0.6% - 0.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
common, 2.2% - 4%
|
0% - 0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
x
|
|
Nasopharyngitis
|
Nasopharyngitis
|
2.48% - 6.83%
|
2.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
common, 1.7% - 10.2%
|
0% - 4.71%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
common, 2.7% - 3.4%
|
0.5% - 0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
2.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Infection
|
Infection
|
postmarketing, 2.2% - 5.8%
|
0.9% - 1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing — 2.2%
|
0.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
2.2%
|
1.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.7% - 2.2%
|
0.9% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Excoriation
|
Excoriation
|
postmarketing, 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Motion sickness
|
Motion sickness
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Application site reaction
|
Application site reaction
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Eye pain
|
Eye pain
|
2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Cough
|
Cough
|
common, 1.2% - 1.9%
|
0.3% - 1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cough increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dizziness
|
Dizziness
|
postmarketing — 0% - 7.4%
|
0% - 5.5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Muscle tightness
|
Muscle tightness
|
1.3% - 1.9%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Thirst
|
Thirst
|
1.8%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Bruxism
|
Bruxism
|
postmarketing, 1.5% - 1.7%
|
0.5% - 0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
1.7%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Libido decreased
|
Libido decreased
|
1.3% - 1.7%
|
0.5% - 0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
1.3% - 1.7%
|
0.5% - 0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Vertigo
|
Vertigo
|
1.7% - 2%
|
0% - 0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Vision blurred
|
Vision blurred
|
postmarketing — 1.3% - 1.7%
|
0.5% - 1%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Constipation
|
Constipation
|
1.4% - 1.5%
|
0.6% - 0.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Irritability
|
Irritability
|
postmarketing — 0% - 11%
|
0% - 6.94%
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
Affect lability
|
Affect lability
|
0% - 9%
|
0% - 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Mood swings
|
0% - 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
Oropharyngeal pain
|
Oropharyngeal pain
|
1.2% - 1.7%
|
0.9% - 1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Sinusitis
|
Sinusitis
|
1.3%
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Panic attack
|
Panic attack
|
1.3%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
1.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
Menopausal symptoms
|
Hot flush
|
1.3%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hot flush
|
Hot flush
|
1.3%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Confusional state
|
Confusional state
|
1% - 1.2%
|
0.3% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Feeling abnormal
|
Confusional state
|
1% - 1.2%
|
0.3% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dyspnoea
|
Dyspnoea
|
1.2%
|
0.6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 1.2% - 1.7%
|
0.9% - 1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Paraesthesia
|
Paraesthesia
|
postmarketing, 1.2%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Tension headache
|
Tension headache
|
1% - 1.2%
|
0.3% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Tension
|
Tension
|
1.2% - 1.3%
|
0.3% - 0.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
Nervousness
|
postmarketing — 0.7% - 3.1%
|
0.5% - 0.6%
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Muscle spasms
|
Muscle spasms
|
1%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cramp muscle
|
very rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
1%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
1%
|
0.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Somnolence
|
Somnolence
|
1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Drowsiness
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Depression
|
Depression
|
0% - 3%
|
0% - 0.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 0.7% - 7.14%
|
0% - 5.88%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stomach ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 0.7% - 7.14%
|
0% - 5.88%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Aggression
|
Aggression
|
postmarketing, 1.2% - 1.7%
|
0.5% - 0.6%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Anaemia
|
Anaemia
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Aplastic anaemia
|
Aplastic anaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Angina pectoris
|
Angina pectoris
|
postmarketing, rare
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angioedema
|
Angioedema
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Arrhythmia
|
Arrhythmia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Arthralgia
|
Arthralgia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Bone disorder
|
Bone disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Cerebral arteritis
|
Cerebral arteritis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Chest pain exertional
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Contusion
|
Contusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
Sudden death
|
Sudden death
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Dermatitis
|
Dermatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
Rash
|
postmarketing — 1.3% - 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Diplopia
|
Diplopia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Dyskinesia
|
Dyskinesia
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Grand mal convulsion
|
Grand mal convulsion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Erythema multiforme
|
Erythema multiforme
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Rash
|
Rash
|
postmarketing — 1.3% - 2%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Eruption
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing, 1.7%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Hallucination
|
Hallucination
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing, 4.8%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Coma hepatic
|
Coma hepatic
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Hypersensitivity
|
Hypersensitivity
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Inflammation
|
Inflammation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Leukopenia
|
Leukopenia
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Mydriasis
|
Mydriasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Obsessive-compulsive disorder
|
Obsessive-compulsive disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Pancytopenia
|
Pancytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Priapism
|
Priapism
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Psychotic disorder
|
Psychotic disorder
|
very rare, postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
x
|
|
Convulsion
|
Convulsion
|
very rare, postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Stevens-Johnson syndrome
|
Stevens-Johnson syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Completed suicide
|
Suicide
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Completed suicide
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Suicide attempt
|
Suicide attempt
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing — 0.69% - 6%
|
0% - 1.9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
very rare, postmarketing
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Tourette's disorder
|
Tourette's disorder
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Ulcer
|
Ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Erythema
|
Erythema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing, common
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Weight increased
|
Weight increased
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Weight decreased
|
Weight decreased
|
postmarketing — 5.52% - 9.18%
|
0% - 3.6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Sudden cardiac death
|
Sudden cardiac death
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
very rare, postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Migraine
|
Migraine
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Growth retardation
|
Growth retardation
|
rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Blood alkaline phosphatase increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Accommodation disorder
|
Accommodation disorder
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
Dermatitis contact
|
Allergic contact dermatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Skin hyperpigmentation
|
Skin hyperpigmentation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Leukoderma
|
Leukoderma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, 1.7%
|
1.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Scab
|
Scab
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Drug eruption
|
Fixed drug eruption
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Myalgia
|
Myalgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Muscle twitching
|
Muscle twitching
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Disorientation
|
Disorientation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Abnormal behaviour
|
Abnormal behaviour
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Hallucination, auditory
|
Hallucination, auditory
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Hallucination, visual
|
Hallucination, visual
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Discomfort
|
Discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Chest discomfort
|
Chest discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Therapeutic response decreased
|
Therapeutic response decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Hepatic enzyme increased
|
Hepatic enzyme increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Skin exfoliation
|
Skin exfoliation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Peripheral coldness
|
Peripheral coldness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Induration
|
Induration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Papule
|
Papule
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Mania
|
Mania
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Extrasystoles
|
Extrasystoles
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Depressed mood
|
Depressed mood
|
very rare — 3.9% - 4.4%
|
1.4% - 2.6%
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Feeling sad
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling hot
|
Warmth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Platelet count decreased
|
Platelet count decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Hyperpyrexia
|
Hyperpyrexia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
Suicidal ideation
|
Suicidal ideation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Hyperkinesia
|
Hyperkinesia
|
very rare, postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
x
|
|
|
|
|
x
|
|
Bradycardia
|
Bradycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing, 1% - 2.5%
|
1.9%
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
|
x
|
|
x
|
Drug effect decreased
|
Drug effect decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Visual impairment
|
Visual disturbance
|
postmarketing, rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
|
Visual impairment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Abnormal vision
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Auricular swelling
|
Auricular swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Reversible ischaemic neurological deficit
|
Reversible ischaemic neurological deficit
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
White blood cell count abnormal
|
White blood cell count abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Drug interaction
|
Drug interaction
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
|
Thrombocytopenic purpura
|
Thrombocytopenic purpura
|
very rare, postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vasculitis necrotising
|
Vasculitis necrotising
|
postmarketing
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
Suicidal behaviour
|
Suicidal behaviour
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
Logorrhoea
|
Logorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Vasculitis
|
Vasculitis
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Hallucination, tactile
|
Hallucination, tactile
|
very rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Choreoathetosis
|
Choreoathetoid movements
|
very rare
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Cerebral haemorrhage
|
Cerebral haemorrhage
|
very rare
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Albuminuria
|
Albuminuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anger
|
Anger
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Asthma
|
Asthma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Neck pain
|
Neck pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coma
|
Coma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dehydration
|
Dehydration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Delirium
|
Delirium
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Dental caries
|
Dental caries
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Depersonalisation
|
Depersonalisation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Ear disorder
|
Ear disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Ear pain
|
Ear pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ecchymosis
|
Ecchymosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Flushing
|
Flushing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Gastritis
|
Gastritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastroenteritis
|
Gastroenteritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
Gynaecomastia
|
Gynaecomastia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cardiac murmur
|
Cardiac murmur
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hernia
|
Hernia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Herpes virus infection
|
Herpes NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hiccups
|
Hiccups
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hostility
|
Hostility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fungal infection
|
Fungal infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nail disorder
|
Nail disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasal congestion
|
Nasal congestion
|
0% - 5%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Nasal polyps
|
Nasal polyps
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Neoplasm
|
Neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Neurosis
|
Neurosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Obstruction
|
Obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Otitis media
|
Otitis media
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Pain in extremity
|
Pain in extremity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Personality disorder
|
Personality disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Petechiae
|
Petechiae
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing — 0% - 3%
|
0%
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
Psoriasis
|
Psoriasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anorectal disorder
|
Rectal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Serum sickness
|
Serum sickness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Speech disorder
|
Speech disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Stereotypy
|
Stereotypy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Shock
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Attention deficit/hyperactivity disorder
|
Attention deficit disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Chills
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin odour abnormal
|
Body odor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Apathy
|
Apathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Flat affect
|
Apathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Mood swings
|
Mood swings
|
0% - 3%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
Rash pustular
|
Rash pustular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benign neoplasm
|
Benign neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Corneal lesion
|
Corneal lesion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Injury
|
Accidental injury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Adverse reaction
|
Reaction aggravation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperreflexia
|
Hyperreflexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Skin irritation
|
Skin irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Photosensitivity reaction
|
Photosensitivity reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Photosensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash macular
|
Rash macular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Malaise
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Ill-defined disorder
|
Malaise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Weight gain poor
|
Weight gain poor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Thinking abnormal
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Mental disability
|
Thinking abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Abnormal dreams
|
Abnormal dreams
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypervigilance
|
Hypervigilance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Euphoric mood
|
Euphoric mood
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Gastrointestinal obstruction
|
Gastrointestinal obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Lip swelling
|
Lip swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hypomania
|
Hypomania
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Dry eye
|
Dry eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Cardiac death
|
Cardiac death
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Akathisia
|
Akathisia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Crying
|
Tearfulness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Tearfulness
|
Tearfulness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Ligament sprain
|
Joint sprain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Paralysis
|
Paralysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Poisoning
|
Intoxication
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Tic
|
Motor tic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Vocal tic
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Local reaction
|
Local reaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Libido disorder
|
Libido disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Sympathomimetic effect
|
Sympathomimetic effect
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Sensitisation
|
Sensitisation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Drug dependence
|
Drug dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
Overdose
|
Acute overdose
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|