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
|
Application site pruritus
|
Application site pruritus
|
17% - 37%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Blister
|
Blister
|
uncommon — 3% - 12%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Dermatitis bullous
|
Blister
|
uncommon — 3% - 12%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Vesiculobullous rash
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Thermal burn
|
Burn
|
12%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Prostatomegaly
|
Prostatomegaly
|
postmarketing, 11.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Stomatitis
|
Mouth irritation
|
9.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Stomatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Buccal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Application site irritation
|
Application site irritation
|
0.5% - 8%
|
0%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Laboratory test abnormal
|
Laboratory test abnormal
|
postmarketing, 3% - 9.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Application site vesicles
|
Application site vesicles
|
postmarketing, 6%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Injection site pain
|
Injection site pain
|
postmarketing, 4.58% - 4.6%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dysgeusia
|
Taste bitter
|
4.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Dysgeusia
|
postmarketing, 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Bad taste
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Application site reaction
|
Application site reaction
|
postmarketing, 0.5% - 16.1%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
Dermatitis contact
|
Allergic contact dermatitis
|
common, 4%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Dermatitis contact
|
2.14% - 4%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
Haematocrit increased
|
Haematocrit increased
|
postmarketing, 0.7% - 7%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Application site erythema
|
Application site erythema
|
postmarketing, 1.2% - 7%
|
2%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 3% - 4%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
x
|
Prostatic disorder
|
Prostatic disorder
|
3% - 5%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Vomiting
|
Vomiting
|
postmarketing, 3% - 4%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Induration
|
Induration
|
common, 3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Acne
|
Acne
|
postmarketing — 0.5% - 8%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
x
|
Application site pain
|
Application site burn
|
postmarketing — 3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Application site burn
|
Application site burn
|
postmarketing — 3%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Prostatic specific antigen increased
|
Prostatic specific antigen increased
|
postmarketing, 1% - 11.1%
|
0%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Hypogonadism
|
Hypogonadism
|
2.6% - 2.61%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oestradiol increased
|
Oestradiol increased
|
2.6% - 2.61%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaemia
|
Anaemia
|
postmarketing, 2.47% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gastrointestinal haemorrhage
|
Gastrointestinal haemorrhage
|
postmarketing — 2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Gingival swelling
|
Gingival swelling
|
postmarketing, 2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Gingival oedema
|
Gingival oedema
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haemoglobin increased
|
Haemoglobin increased
|
postmarketing, 0.2% - 4.6%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
Pruritus
|
Pruritus
|
postmarketing — 1.85% - 39%
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Testicular disorder
|
Testicular disorder
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Dry skin
|
Dry skin
|
postmarketing, 1.85% - 1.9%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Application site induration
|
Application site induration
|
postmarketing, 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
Ejaculation disorder
|
Ejaculation disorder
|
1.31%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site erythema
|
Injection site erythema
|
1.31%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypertension
|
Hypertension worsened
|
0.2% - 1.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
postmarketing — 0% - 3%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
Red blood cell count increased
|
Red blood cell count increased
|
0.2% - 1.3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prostate cancer
|
Prostate carcinoma
|
postmarketing — 1.2% - 1.23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Prostate cancer
|
postmarketing, 1.31%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
Application site rash
|
Application site rash
|
postmarketing, 0.5% - 1.8%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Depression
|
Depression
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing, 0% - 3%
|
0%
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
Headache
|
Headache
|
postmarketing, 0% - 6%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
postmarketing, 1% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood swings
|
postmarketing, 0% - 3%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
|
x
|
|
x
|
Affect lability
|
Mood swings
|
postmarketing, 0% - 3%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
x
|
|
x
|
|
x
|
Affect lability
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing, 1%
|
0%
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Prostate induration
|
Prostate induration
|
postmarketing, 1.31%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Benign prostatic hyperplasia
|
Benign prostatic hyperplasia
|
postmarketing, 0% - 1.3%
|
1%
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Benign prostatic hypertrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pain
|
Pain
|
uncommon
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Stinging
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pelvic pain
|
Pelvic pain
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Urinary tract infection
|
Urinary tract infection
|
uncommon
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Vertigo
|
Vertigo
|
uncommon
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Peripheral vascular disorder
|
Peripheral vascular disorder
|
uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Lacrimation increased
|
Lacrimation increased
|
0% - 1%
|
0%
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Lacrimation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood pressure diastolic decreased
|
Blood pressure diastolic decreased
|
0% - 1%
|
0%
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Spontaneous penile erection
|
Spontaneous penile erection
|
0% - 1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Confusional state
|
Confusional state
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Feeling abnormal
|
Confusional state
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Urinary incontinence
|
Urinary incontinence
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Growth accelerated
|
Growth accelerated
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
Increased appetite
|
Increased appetite
|
postmarketing, uncommon
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
|
|
x
|
|
x
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Abdominal cramps
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
Aggression
|
Aggression
|
postmarketing, 1.31%
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Alopecia
|
Alopecia
|
postmarketing, 0% - 1%
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
Amnesia
|
Amnesia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactoid reaction
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anger
|
Anger
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Angina pectoris
|
Angina pectoris
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
Anxiety
|
postmarketing, uncommon
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Myalgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Asthenia
|
Asthenia
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
Fatigue
|
postmarketing — 1.96%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Asthma
|
Asthma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Mental disorder
|
Mental disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Cerebral infarction
|
Cerebral infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Transient ischaemic attack
|
Transient ischaemic attack
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Chest pain
|
Chest pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chest discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
Cough
|
Cough
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cyst
|
Cyst
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Sudden hearing loss
|
Sudden hearing loss
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Libido decreased
|
Libido decreased
|
postmarketing — 0% - 3%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Disturbance in sexual arousal
|
Libido decreased
|
postmarketing — 0% - 3%
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Libido increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Dermatitis atopic
|
Dermatitis atopic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Diabetes mellitus
|
Diabetes mellitus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dizziness
|
Dizziness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Dysuria
|
Dysuria
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
Urination impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Strangury
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Oedema
|
Oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Endocrine disorder
|
Endocrine disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Epididymitis
|
Epididymitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis
|
Rash
|
postmarketing — 2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing — 2%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Eye disorder
|
Eye disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Fatigue
|
Fatigue
|
postmarketing — 1.96%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Cardiac arrest
|
Cardiac arrest
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cardiac disorder
|
Cardiac disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Cardiac failure
|
Cardiac failure
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematuria
|
Haematuria
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
Hirsutism
|
Hirsutism
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
|
Hostility
|
Hostility
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Hypercholesterolaemia
|
Hypercholesterolaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Hyperhidrosis
|
Hyperhidrosis
|
postmarketing, 1.31%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sweating
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hyperlipidaemia
|
Hyperlipidaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
Hyperparathyroidism
|
Hyperparathyroidism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Hypertriglyceridaemia
|
Hypertriglyceridaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Blood triglycerides increased
|
Hypertriglyceridaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Blood triglycerides increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Hyperventilation
|
Hyperventilation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypoglycaemia
|
Hypoglycaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hypokalaemia
|
Hypokalaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Immune system disorder
|
Immune system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Incontinence
|
Incontinence
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Libido increased
|
Libido increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
Irritability
|
Irritability
|
postmarketing, 1.96%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Hepatic neoplasm
|
Hepatic neoplasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Chronic obstructive pulmonary disease
|
Chronic obstructive pulmonary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchial hyperreactivity
|
Chronic obstructive pulmonary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Systemic lupus erythematosus
|
Systemic lupus erythematosus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mediastinal disorder
|
Mediastinal disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Musculoskeletal pain
|
Musculoskeletal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nausea
|
Nausea
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Neoplasm
|
Neoplasm
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
Tension
|
Nervousness
|
postmarketing, 0% - 3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
Nocturia
|
Nocturia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Azoospermia
|
Oligospermia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Osteopenia
|
Osteopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Osteoporosis
|
Osteoporosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pain in extremity
|
Pain in extremity
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Paraesthesia
|
Paraesthesia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Paresthesia generalized
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Peliosis hepatis
|
Peliosis hepatis
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Personality disorder
|
Personality disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Polycythaemia
|
Polycythaemia
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
|
x
|
x
|
x
|
Polyp
|
Polyp
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Priapism
|
Priapism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
x
|
|
Prostatitis
|
Prostatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
Male orgasmic disorder
|
Male orgasmic disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Precocious puberty
|
Precocious puberty
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rhinitis
|
Rhinitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Seborrhoeic dermatitis
|
Seborrhoeic dermatitis
|
postmarketing
|
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Shock
|
Shock
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sleep apnoea syndrome
|
Sleep apnoea syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Snoring
|
Snoring
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Spermatocele
|
Spermatocele
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Testicular pain
|
Testicular pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Thrombocytopenia
|
Thrombocytopenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Embolism
|
Thromboembolism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Embolism venous
|
Thromboembolism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Venous thromboembolism
|
postmarketing
|
|
x
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
Thrombosis
|
Thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tinnitus
|
Tinnitus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erythema
|
Erythema
|
postmarketing — 8%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Pollakiuria
|
Pollakiuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Urinary tract disorder
|
Urinary tract disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Varicocele
|
Varicocele
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
x
|
x
|
|
|
x
|
x
|
x
|
Vasodilation procedure
|
Vasodilation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
Venous insufficiency
|
Venous insufficiency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Virilism
|
Virilism
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
|
|
Vitreous detachment
|
Vitreous detachment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Weight increased
|
Weight increased
|
postmarketing, 1.31%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Urinary retention
|
Urinary retention
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urogenital disorder
|
Urogenital disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Micturition urgency
|
Micturition urgency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Agitation
|
Agitation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Hyperkinesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
Mouth ulceration
|
Mouth ulceration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Migraine
|
Migraine
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
Injection site abscess
|
Injection site abscess
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gamma-glutamyltransferase increased
|
Gamma-glutamyltransferase increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hair colour changes
|
Hair discoloration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
High density lipoprotein decreased
|
High density lipoprotein decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Injection site reaction
|
Injection site reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Coronary artery occlusion
|
Coronary artery occlusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rash pustular
|
Vesiculobullous rash
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Urinary hesitation
|
Urinary hesitation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Renal colic
|
Renal colic
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Testicular atrophy
|
Testicular atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Enlarged clitoris
|
Enlarged clitoris
|
postmarketing
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Androgenetic alopecia
|
Androgenetic alopecia
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Malnutrition
|
Malnutrition
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
x
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
Abdominal pain upper
|
Abdominal pain upper
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tenderness
|
Tenderness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intraocular pressure increased
|
Intraocular pressure increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pharyngeal oedema
|
Pharyngeal oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lip swelling
|
Lip swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prostate infection
|
Prostate infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood testosterone decreased
|
Testosterone low
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Blood testosterone decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Serum testosterone decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Cerebrovascular insufficiency
|
Cerebrovascular insufficiency
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Erectile dysfunction
|
Erectile dysfunction
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
x
|
Hepatobiliary disease
|
Hepatobiliary disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
Fluid retention
|
Fluid retention
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Wernicke-Korsakoff syndrome
|
Korsakoff's psychosis (non-alcoholic)
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast induration
|
Breast induration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Glucose tolerance impaired
|
Glucose tolerance impaired
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
Prostatic dysplasia
|
Prostatic intraepithelial neoplasia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Prostatic dysplasia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood bilirubin increased
|
Blood bilirubin increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Bilirubin total increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Atrophy
|
Atrophy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cognitive disorder
|
Cognitive impairment
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nephrolithiasis
|
Nephrolithiasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Transaminases increased
|
Transaminases increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Urine flow decreased
|
Poor urinary stream
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Respiratory distress
|
Respiratory distress
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Musculoskeletal chest pain
|
Musculoskeletal chest pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pulmonary microemboli
|
Pulmonary microemboli
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site irritation
|
Injection site irritation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza like illness
|
Influenza like illness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Injection site haematoma
|
Injection site haematoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Surgery
|
Surgical intervention
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
|
|
x
|
|
|
Renal pain
|
Renal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood glucose increased
|
Blood glucose increased
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Menopausal symptoms
|
Hot flush
|
postmarketing, 0% - 1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Hot flush
|
Hot flush
|
postmarketing, 0% - 1%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Erythropoiesis abnormal
|
Erythropoiesis abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Abdominal symptom
|
Abdominal symptom
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
Administration site reaction
|
Administration site reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sleep disorder
|
Sleep disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood testosterone increased
|
Blood testosterone increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Blood prolactin increased
|
Blood prolactin increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
postmarketing, 0% - 1.96%
|
0%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Injection site discomfort
|
Injection site discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Free prostate-specific antigen increased
|
Free prostate-specific antigen increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Prostate examination abnormal
|
Prostate examination abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Rash papular
|
Rash papular
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Dysphonia
|
Dysphonia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Procedural pain
|
Procedural pain
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coronary artery disease
|
Coronary artery disease
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Pulmonary oil microembolism
|
Pulmonary oil microembolism
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Leukocytoclastic vasculitis
|
Leukocytoclastic vasculitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Amenorrhoea
|
Amenorrhoea
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Appetite disorder
|
Appetite disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Arthritis
|
Arthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Coagulopathy
|
Clotting
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast cyst
|
Breast cyst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm malignant
|
Carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Contusion
|
Contusion
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
Diplopia
|
Diplopia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Folliculitis
|
Folliculitis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Gingival recession
|
Gingival recession
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gingivitis
|
Gingivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haemarthrosis
|
Haemarthrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Haemorrhage
|
Haemorrhage
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Hyperaesthesia
|
Hyperaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Nipple pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Inflammation
|
Inflammation
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice cholestatic
|
Jaundice cholestatic
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Leukoplakia
|
Leukoplakia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Nasal oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Nasopharyngitis
|
Nasopharyngitis
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Penis disorder
|
Penis disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Pneumonia
|
Pneumonia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Neoplasm prostate
|
Neoplasm prostate
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pruritus genital
|
Pruritus genital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Renal failure
|
Renal failure
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rosacea
|
Rosacea
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Serum sickness
|
Serum sickness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinusitis
|
Sinusitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Ulcer
|
Ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Oral disorder
|
Oral lesion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Blood creatinine increased
|
Creatinine increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Blood creatinine increased
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Generalised oedema
|
Generalised oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Epiphyses premature fusion
|
Epiphyses premature fusion
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x
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Renal impairment
|
Kidney function abnormal
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x
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Prothrombin level increased
|
Prothrombin level increased
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x
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x
|
x
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Hypogeusia
|
Hypogeusia
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x
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Skin irritation
|
Skin irritation
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x
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|
Menstruation irregular
|
Menstruation irregular
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x
|
x
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Depression suicidal
|
Depression suicidal
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x
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x
|
x
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Chest discomfort
|
Chest tightness
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x
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Chest discomfort
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x
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Hair growth abnormal
|
Hair growth abnormal
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Disturbance in attention
|
Disturbance in attention
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x
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Clitoral engorgement
|
Clitoral engorgement
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x
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Abnormal dreams
|
Abnormal dreams
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x
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Dermatitis acneiform
|
Dermatitis acneiform
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Application site oedema
|
Application site oedema
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x
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Ocular hyperaemia
|
Eye redness
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x
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Throat tightness
|
Throat tightness
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x
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Gingival pain
|
Gingival pain
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x
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Irritation gum
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x
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Nipple pain
|
Nipple pain
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Activated partial thromboplastin time prolonged
|
Activated partial thromboplastin time prolonged
|
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x
|
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x
|
x
|
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Vulvovaginal burning sensation
|
Vaginal burning sensation
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x
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Strangury
|
Strangury
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|
x
|
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|
Breast tenderness
|
Breast tenderness
|
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|
x
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Soft tissue disorder
|
Soft tissue disorder
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Cheilitis
|
Lip ulceration
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Lip pain
|
Lip ulceration
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Lip ulceration
|
Lip ulceration
|
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|
Blood pressure systolic increased
|
Blood pressure systolic increased
|
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|
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|
|
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|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Haemoglobin abnormal
|
Haemoglobin abnormal
|
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|
Nipple disorder
|
Nipple disorder
|
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|
Hyperkinesia
|
Hyperkinesia
|
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|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
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|
Blood urea normal
|
Blood urea normal
|
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|
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|
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|
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|
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|
Nasal oedema
|
Nasal oedema
|
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|
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|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Penile pain
|
Penile pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Prostatic adenoma
|
Prostatic adenoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Paraesthesia oral
|
Paraesthesia oral
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Affective disorder
|
Affective disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dissociation
|
Detachment psychological
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lipids abnormal
|
Lipids abnormal
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Balance disorder
|
Balance disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Blood cholesterol increased
|
Cholesterol serum elevated
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
International normalised ratio increased
|
International normalised ratio increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Buccal mucosal roughening
|
Buccal mucosal roughening
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Lipids increased
|
Raised serum lipid levels
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Application site warmth
|
Application site warmth
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site dryness
|
Application site dryness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal clotting factor
|
Abnormal clotting factor
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Gingival erythema
|
Redness gum
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Gingival blister
|
Gingival blister
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Impatience
|
Impatience
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal hypomotility
|
Gastrointestinal hypomotility
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Epidermal necrosis
|
Epidermal necrosis
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Sensitisation
|
Sensitisation
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Parosmia
|
Parosmia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Application site exfoliation
|
Application site exfoliation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Breast enlargement
|
Breast enlargement
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Hepatic cancer
|
Hepatocellular carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatocellular carcinoma
|
Hepatocellular carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|