MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
10
|
11
|
12
|
Application site reaction
|
Application site reaction
|
24%
|
12%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Nausea
|
Nausea
|
10% - 11%
|
3% - 9%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Pain
|
Pain
|
8%
|
7%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Ache
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Generalized aching
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Dizziness
|
Dizziness
|
postmarketing, 7% - 11%
|
1% - 8%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Syncope
|
postmarketing — 7%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Lightheadedness
|
7%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Rhinitis
|
Rhinitis
|
7%
|
6%
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Shock
|
Syncope
|
postmarketing — 7%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Shock
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Syncope
|
Syncope
|
postmarketing — 7%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing — 7%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Skin disorder
|
Skin disorder
|
6%
|
2%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Amnesia
|
Amnesia
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Decreased appetite
|
Anorexia
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Decreased appetite
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Bronchitis
|
Bronchitis
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neck pain
|
Neck pain
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Chest pain
|
Chest pain
|
frequent, 2%
|
0%
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Precordial pain
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Constipation
|
Constipation
|
frequent, 4%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysgeusia
|
Dysgeusia
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Ecchymosis
|
Ecchymosis
|
frequent, 2%
|
0%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Flatulence
|
Flatulence
|
frequent, 2%
|
1%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Gastroenteritis
|
Gastroenteritis
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hypertension
|
Hypertension
|
frequent, 3%
|
2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Paraesthesia
|
Paraesthesia
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pruritus
|
Pruritus
|
frequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Stomatitis
|
Stomatitis
|
5%
|
4%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Sweating
|
postmarketing, frequent
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Sweating increased
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Tinnitus
|
Tinnitus
|
frequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
frequent, 3%
|
0%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Agitation
|
Agitation
|
postmarketing, frequent
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperkinesia
|
infrequent
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Oedema peripheral
|
Oedema peripheral
|
frequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ankle edema
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Myalgia
|
Myalgia
|
frequent, 3%
|
0%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Myalgia
|
frequent, 3%
|
0%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Arthralgia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Thinking abnormal
|
Thinking abnormal
|
postmarketing, frequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mental disability
|
Thinking abnormal
|
postmarketing, frequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cough
|
Cough increased
|
frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Abdominal pain
|
Abdominal pain
|
4%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
4%
|
2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Dyspepsia
|
Dyspepsia
|
4% - 5%
|
3%
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Heartburn
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Dermatitis
|
Rash
|
4%
|
1% - 2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
4%
|
1% - 2%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Confusional state
|
Confusional state
|
postmarketing — 3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Feeling abnormal
|
Confusional state
|
postmarketing — 3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Malaise
|
rare, 0%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hallucination
|
Hallucination
|
postmarketing, 3% - 4%
|
1% - 2%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Pharyngitis
|
Pharyngitis
|
3% - 4%
|
2%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
3%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing, 3% - 8%
|
1% - 6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
infrequent, frequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Depression
|
Depression
|
2%
|
1%
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Dyskinesia
|
Dyskinesia
|
postmarketing, 2% - 6%
|
3% - 5%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Movements involuntary
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Headache
|
Headache
|
postmarketing, 2% - 18%
|
1% - 17%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypokalaemia
|
Hypokalaemia
|
2%
|
0%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Tooth disorder
|
Tooth disorder
|
2%
|
1%
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Abnormal dreams
|
Vivid dreams
|
2%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Abnormal dreams
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Somnolence
|
Somnolence
|
postmarketing, 3%
|
2%
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Drowsiness
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Anxiety
|
Anxiety
|
postmarketing, 1%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Diarrhoea
|
Diarrhoea
|
1% - 9%
|
0% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain in extremity
|
Leg pain
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Lethargy
|
Lethargy
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Back pain
|
Low back pain
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Back pain
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Palpitations
|
Palpitations
|
1%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Weight decreased
|
Weight decreased
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Urinary retention
|
Urinary retention
|
1%
|
0%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Tension
|
Tension
|
1%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Nervousness
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 1% - 12%
|
1% - 7%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ejaculation disorder
|
Abnormal ejaculation
|
1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Erectile dysfunction
|
Erectile dysfunction
|
0.7%
|
0.4%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Amenorrhoea
|
Amenorrhoea
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Arthritis
|
Arthritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Asthma
|
Asthma
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Atrial fibrillation
|
Atrial fibrillation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Bacterial infection
|
Bacterial infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Benign neoplasm of skin
|
Benign neoplasm of skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Colitis
|
Colitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Conjunctivitis
|
Conjunctivitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Bladder pain
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dysphagia
|
Dysphagia
|
infrequent, 2%
|
1%
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dehydration
|
Dehydration
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dental caries
|
Dental caries
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Depersonalisation
|
Depersonalisation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dermatitis contact
|
Dermatitis contact
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Fungal skin infection
|
Fungal skin infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
infrequent, 3%
|
0%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urination impaired
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Strangury
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Ear pain
|
Ear pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Eructation
|
Eructation
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Body temperature increased
|
Body temperature increased
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Flank pain
|
Flank pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Gastritis
|
Gastritis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Glossitis
|
Glossitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Haematuria
|
Haematuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hernia
|
Hernia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Herpes simplex
|
Herpes simplex
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Herpes zoster
|
Herpes zoster
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hostility
|
Hostility
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperaesthesia
|
Hyperaesthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperglycaemia
|
Hyperglycaemia
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Hyponatraemia
|
Hyponatraemia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Libido increased
|
Libido increased
|
postmarketing, infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Disturbance in sexual arousal
|
Libido increased
|
postmarketing, infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Libido decreased
|
0% - 0.7%
|
0% - 0.2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Arthropathy
|
Arthropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Osteoarthritis
|
Arthropathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nephrolithiasis
|
Calculus of kidney
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Laryngospasm
|
Laryngospasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Muscle spasms
|
Cramps of lower extremities
|
infrequent, 3%
|
1%
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Generalised spasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Cramp muscle
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Breast pain
|
Breast pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Melaena
|
Melaena
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Menorrhagia
|
Menorrhagia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypertonia
|
Hypertonia
|
postmarketing, infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Myoclonus
|
Myoclonus
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Neoplasm
|
Neoplasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Neurosis
|
Neurosis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Otitis media
|
Otitis media
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pelvic pain
|
Pelvic pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tooth abscess
|
Abscess periodontal
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Pneumonia
|
Pneumonia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Polyuria
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urine output increased
|
Polyuria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Salivary hypersecretion
|
Salivary hypersecretion
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Suicide attempt
|
Suicide attempt
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tachycardia
|
Tachycardia
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tenosynovitis
|
Tenosynovitis
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Thirst
|
Thirst
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tongue disorder
|
Tongue disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Tremor
|
Tremor
|
postmarketing — 3%
|
1%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Unintended pregnancy
|
Unintended pregnancy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urticaria
|
Urticaria
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vaginal infection
|
Vaginal inflammation
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vertigo
|
Vertigo
|
postmarketing, infrequent
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Viral infection
|
Viral infection
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Chills
|
Chills
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Micturition urgency
|
Micturition urgency
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Affect lability
|
Mood swings
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Migraine
|
Migraine
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal stiffness
|
Neck stiffness
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Nuchal rigidity
|
Neck stiffness
|
infrequent
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Alcohol intolerance
|
Alcohol intolerance
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Generalised oedema
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Fluid retention
|
Generalised oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Tongue oedema
|
Tongue oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Skin hypertrophy
|
Skin hypertrophy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Injury
|
Intentional injury
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Accidental injury
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Injury
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mania
|
Manic psychosis
|
postmarketing, infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Eye pain
|
Eye pain
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Paranoia
|
Paranoid reaction
|
postmarketing, infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Paraesthesia oral
|
Circumoral paresthesia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Rash pustular
|
Vesiculobullous rash
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dermatitis bullous
|
Vesiculobullous rash
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dry skin
|
Dry skin
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Photosensitivity reaction
|
Photosensitivity reaction
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Photosensitivity
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Muscle twitching
|
Muscle twitching
|
infrequent
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Increased appetite
|
Increased appetite
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Euphoric mood
|
Euphoric mood
|
infrequent
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Dry eye
|
Dry eye
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Rash maculo-papular
|
Rash maculo-papular
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperkinesia
|
Hyperkinesia
|
infrequent
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Lymphadenopathy
|
Lymphadenopathy
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Face oedema
|
Face oedema
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Muscular weakness
|
Myasthenia
|
infrequent
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Muscular weakness
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Breast neoplasm
|
Breast neoplasm
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Parosmia
|
Parosmia
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
infrequent
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Libido decreased
|
Libido decreased
|
0% - 0.7%
|
0% - 0.2%
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Anorgasmia
|
Anorgasmia
|
0.2%
|
0%
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ataxia
|
Ataxia
|
postmarketing — 3%
|
1%
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Candida infection
|
Candida infection
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Coma
|
Coma
|
postmarketing
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
Delirium
|
Delirium
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Delirium toxic
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Eczema
|
Eczema
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Epistaxis
|
Epistaxis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Flushing
|
Flushing
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal neoplasm
|
Gastrointestinal neoplasm
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Breath odour
|
Breath odour
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Heat stroke
|
Heat stroke
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hyperbilirubinaemia
|
Hyperbilirubinaemia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Impulse-control disorder
|
Impulse-control disorder
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Renal failure chronic
|
Renal failure chronic
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Laryngitis
|
Laryngitis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Leukocytosis
|
Leukocytosis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Mydriasis
|
Mydriasis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Myocardial infarction
|
Myocardial infarction
|
rare
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
rare
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Neuroleptic malignant syndrome
|
Neuroleptic malignant syndrome
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Nightmare
|
Nightmare
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Osteoporosis
|
Osteoporosis
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Otitis externa
|
Otitis externa
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Petechiae
|
Petechiae
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Psychotic disorder
|
Psychotic disorder
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Scotoma
|
Scotoma
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Convulsion
|
Convulsion
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Sleep disorder
|
Sleep disturbance
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Sleep disorder
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Yawning
|
Yawning
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Skin odour abnormal
|
Body odor
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Rectal haemorrhage
|
Rectal haemorrhage
|
rare
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Hypoglycaemia
|
Hypoglycemic reaction
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Hypoglycaemia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Compulsions
|
Compulsions
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Infection parasitic
|
Infection parasitic
|
rare
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Aggression
|
Aggressive reaction
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Albuminuria
|
Albuminuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Alopecia
|
Alopecia
|
infrequent, 0%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Amblyopia
|
Amblyopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia
|
Anaemia
|
infrequent, 0%
|
1%
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Angina pectoris
|
Angina pectoris
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Angina pectoris aggravated
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Aphasia
|
Aphasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Apraxia
|
Apraxia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Arrhythmia
|
Arrhythmia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Asthenia
|
Asthenia
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
Fatigue
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Atrial flutter
|
Atrial flutter
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blepharospasm
|
Blepharospasm
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Bruxism
|
Bruxism
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Bursitis
|
Bursitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cellulitis
|
Cellulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Cheilitis
|
Cheilitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cholecystitis
|
Cholecystitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cholelithiasis
|
Cholelithiasis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chorea
|
Chorea
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Infection
|
Infection
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Cyanosis
|
Cyanosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deafness
|
Deafness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Delusion
|
Delusion
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Diabetes mellitus
|
Diabetes mellitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diplopia
|
Diplopia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Eosinophilia
|
Eosinophilia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Epididymitis
|
Epididymitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophagitis
|
Oesophagitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye haemorrhage
|
Eye haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Fatigue
|
Fatigue
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glaucoma
|
Glaucoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gout
|
Gout
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiac arrest
|
Cardiac arrest
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiomegaly
|
Cardiomegaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiac failure congestive
|
Cardiac failure congestive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood disorder
|
Blood disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Haematoma
|
Haematoma
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Subdural haematoma
|
Subdural haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatitis
|
Hepatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hiccups
|
Hiccups
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Hyperkalaemia
|
Hyperkalaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperlipidaemia
|
Hyperlipidaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoproteinaemia
|
Hypoproteinaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypotension
|
Hypotension
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Orthostatic hypotension
|
Orthostatic hypotension
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Illusion
|
Illusion
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Intestinal obstruction
|
Intestinal obstruction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Irritability
|
Irritability
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Myeloid leukaemia
|
Myeloid leukaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acute leukaemia
|
Myeloid leukaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Malignant melanoma
|
Malignant melanoma
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Melanoma skin
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypotonia
|
Hypotonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Muscle relaxant therapy
|
Hypotonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myopathy
|
Myopathy
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Neuralgia
|
Neuralgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuritis
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuropathy peripheral
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neuropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoaesthesia
|
Numbness
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Sensory loss
|
Numbness
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Nocturia
|
Nocturia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Ovarian disorder
|
Ovarian disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pallor
|
Pallor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Peptic ulcer
|
Peptic ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Personality disorder
|
Personality disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pleural effusion
|
Pleural effusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pneumothorax
|
Pneumothorax
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pulmonary oedema
|
Pulmonary oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Retinal artery occlusion
|
Retinal artery occlusion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Retinal detachment
|
Retinal detachment
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Congenital skin disorder
|
Congenital skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin ulcer
|
Skin ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Superinfection
|
Superinfection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Supraventricular tachycardia
|
Supraventricular tachycardia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Trismus
|
Trismus
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ulcer
|
Ulcer
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
Erythema
|
Erythema
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Micturition disorder
|
Micturition disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Vasodilation procedure
|
Vasodilation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Weight increased
|
Weight increased
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Urogenital disorder
|
Urogenital disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Central nervous system neoplasm
|
Central nervous system neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Encephalopathy
|
Encephalopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sinus bradycardia
|
Sinus bradycardia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
Atrioventricular block first degree
|
Atrioventricular block first degree
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Akinesia
|
Akinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Apathy
|
Apathy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Flat affect
|
Apathy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Fall
|
Fall
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Hyperphosphataemia
|
Hyperphosphataemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokinesia
|
Hypokinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cataract
|
Cataract specified
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Red blood cell sedimentation rate increased
|
Red blood cell sedimentation rate increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial ischaemia
|
Myocardial ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Opisthotonus
|
Opisthotonus
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Bone pain
|
Bone pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Platelet disorder
|
Abnormal platelets
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyporeflexia
|
Hyporeflexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin discolouration
|
Skin discolouration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tendon rupture
|
Tendon rupture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oesophageal ulcer
|
Oesophageal ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urinary hesitation
|
Urinary hesitation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Accommodation disorder
|
Accommodation disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Malnutrition
|
Malnutrition
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Prostatic specific antigen increased
|
Prostatic specific antigen increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pseudolymphoma
|
Pseudolymphoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Malaise
|
Malaise
|
rare, 0%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Discomfort
|
Malaise
|
rare, 0%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Ill-defined disorder
|
Malaise
|
rare, 0%
|
1%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Parkinsonian gait
|
Festinating gait
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Disorientation
|
Disorientation
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Bradykinesia
|
Bradykinesia
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Hallucination, visual
|
Hallucination, visual
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Memory impairment
|
Memory impairment
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Respiratory depression
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pulmonary function test decreased
|
Respiratory depression
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Joint swelling
|
Ankle edema
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Grimacing
|
Grimacing
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Personality change
|
Personality change
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Strangury
|
Strangury
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Ventricular extrasystoles
|
Ventricular bigeminy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Extrasystoles
|
Ventricular bigeminy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Vision blurred
|
Vision blurred
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Hypovitaminosis
|
Avitaminosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cold sweat
|
Sticky skin
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Sticky skin
|
Sticky skin
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Epigastric discomfort
|
Gastric irritation
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Hyperpyrexia
|
Hyperpyrexia
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
Heart rate irregular
|
Pulse irregular
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Mean arterial pressure
|
Mean arterial pressure
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Bradycardia
|
Bradycardia
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Energy increased
|
Energy increased
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
Blindness
|
Blindness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dementia
|
Dementia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coordination abnormal
|
Coordination abnormal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sexual dysfunction
|
Sexual dysfunction
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Throat irritation
|
Burning in throat
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Gait disturbance
|
Gait disturbance
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Prostate cancer
|
Prostate carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast cancer
|
Carcinoma breast
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lung neoplasm malignant
|
Carcinoma of lung
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tardive dyskinesia
|
Tardive dyskinesia
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Skin cancer
|
Skin carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Electrocardiogram change
|
Electrocardiogram change
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Oral discomfort
|
Lip burning sensation of
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Cardiomyopathy
|
Cardiomyopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebral ischaemia
|
Cerebral ischaemia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Female sexual dysfunction
|
Female sexual dysfunction
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Blood pressure fluctuation
|
Change in blood pressure
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Benign prostatic hyperplasia
|
Prostatic hypertrophy
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
Ageusia
|
Ageusia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Visual impairment
|
Abnormal vision
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|