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
|
Abdominal pain
|
Abdominal cramps
|
14%
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Abdominal pain
|
postmarketing — 0.537% - 23.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Enlargement abdomen
|
2.7% - 13.9%
|
|
|
x
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Fullness abdominal
|
6.67%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Abdominal distension
|
postmarketing — 1.07% - 1.19%
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Headache
|
Headache
|
postmarketing — 1.05% - 26.5%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site haemorrhage
|
Injection site bruising
|
9.7%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Injection site haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Injection site bruising
|
Injection site bruising
|
9.7%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
x
|
Pelvic discomfort
|
Pelvic discomfort
|
8.26%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramp muscle
|
6.67%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Muscle spasms
|
postmarketing, 2.67%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Cramps of lower extremities
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Breast pain
|
Breast pain female
|
4.2% - 6.1%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Breast pain
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.7% - 11.9%
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Ovarian hyperstimulation syndrome
|
Ovarian hyperstimulation
|
3.5% - 7.23%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
|
Ovarian hyperstimulation syndrome
|
very rare — 3.65% - 11.4%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Cyst
|
Cyst
|
2.86% - 8.11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
2.5% - 7.23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Sinusitis
|
Sinusitis
|
2% - 6.02%
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Breast disorder
|
Breast disorder
|
postmarketing, common
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nervous system disorder
|
Nervous system disorder
|
postmarketing, common
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Varicocele
|
Varicocele
|
common
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Rhinitis
|
Rhinitis
|
0.8% - 7.23%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Pelvic pain
|
Pelvic pain female
|
1.7% - 7.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Pelvic pain
|
postmarketing, 1.24% - 6.67%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Dysmenorrhoea
|
Dysmenorrhoea
|
2.5% - 6.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Injection site reaction
|
Injection site reaction
|
postmarketing — 4% - 6.67%
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abortion spontaneous
|
Abortion spontaneous
|
0.679% - 11.3%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Foetal disorder
|
Foetal disorder
|
4.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gynaecomastia
|
Gynaecomastia
|
common, 3.33%
|
|
x
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Metrorrhagia
|
Metrorrhagia
|
postmarketing, 3.6% - 9.3%
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Back pain
|
Back pain
|
1.8% - 5.1%
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Low back pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Diarrhoea
|
Diarrhoea
|
postmarketing — 0% - 7.6%
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Loose stools
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Flatulence
|
Flatulence
|
0% - 8.8%
|
|
|
x
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Abdominal bloating
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Nausea
|
Nausea
|
postmarketing — 0% - 13.6%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ovarian cyst
|
Ovarian cyst
|
very common, 2.86% - 28.9%
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
Toothache
|
Toothache
|
3.61%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Migraine
|
Migraine
|
3.61%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Acne
|
Acne
|
common, 0% - 6.67%
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
Influenza like illness
|
Influenza-like symptoms
|
2.6% - 4.2%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Dermoid cyst
|
Dermoid cyst
|
3.33%
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Injection site inflammation
|
Injection site inflammation
|
2.41% - 4.22%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 0.537% - 23.2%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 0% - 8.11%
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ache
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Abdominal discomfort
|
postmarketing — 1.5% - 2.9%
|
|
x
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Upset stomach
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Weight increased
|
Weight increased
|
common, 0% - 3.6%
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Ovarian disorder
|
Ovarian disorder
|
1.7% - 8.11%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
postmarketing, 0% - 4.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing, 2.67% - 3.33%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Rash
|
Rash
|
postmarketing, 2.67% - 3.33%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Vaginal discharge
|
Vaginal discharge
|
postmarketing, 2.67%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Leukorrhea
|
1.7% - 3.4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Vaginal haemorrhage
|
Spotting vaginal
|
2.67%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Vaginal haemorrhage
|
postmarketing, 0% - 8.57%
|
|
|
|
x
|
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing — 0% - 2.7%
|
|
x
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperemesis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Mood swings
|
Mood swings
|
0% - 5.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Affect lability
|
Mood swings
|
0% - 5.1%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
Application site oedema
|
Application site oedema
|
2.53%
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Skin disorder
|
Unspecified disorder of skin and subcutaneous tissue
|
postmarketing, common
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cough
|
Cough
|
1.7% - 2.6%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
Cough increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cystitis
|
Cystitis
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Bladder pain
|
Cystitis
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Cystitis noninfective
|
Cystitis
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Dizziness
|
Dizziness
|
0% - 2.5%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
1.7% - 3.5%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
|
Body temperature increased
|
Body temperature increased
|
0% - 4.2%
|
|
|
|
x
|
x
|
x
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Reaction febrile
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Mouth ulceration
|
Ulcerative stomatitis
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
|
Uterine haemorrhage
|
Uterine haemorrhage
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
Viral infection
|
Viral infection
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
Malaise
|
Malaise
|
2.41%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Discomfort
|
Malaise
|
2.41%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Feeling abnormal
|
Malaise
|
2.41%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Ill-defined disorder
|
Malaise
|
2.41%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
Menopausal symptoms
|
Hot flush
|
postmarketing, 0% - 5.71%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Hot flush
|
Hot flush
|
postmarketing, 0% - 5.71%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Genital pain
|
Gynecological-related pain
|
2.41%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
Asthenia
|
Fatigue
|
2.26%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Fatigue
|
Fatigue
|
2.26%
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Injection site pain
|
Injection site pain
|
0.5% - 6.67%
|
|
|
x
|
x
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing, 0% - 2.7%
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Abdominal pain lower
|
Abdominal pain lower
|
1.49% - 2.86%
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ectopic pregnancy
|
Ectopic pregnancy
|
0.198% - 3.8%
|
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Menstrual disorder
|
Menstrual disorder
|
0.9% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Cervix disorder
|
Uterine cervical lesion
|
0.9% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Cervix disorder
|
0% - 2.86%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Genital candidiasis
|
Genital candidiasis
|
0.9% - 2.5%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Neck pain
|
Neck pain
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Dehydration
|
Dehydration
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Depression
|
Depression
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Dermatitis exfoliative
|
Dermatitis exfoliative
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Hypertension
|
Hypertension
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Injury
|
Accidental injury
|
0% - 2.7%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
Breast tenderness
|
Breast tenderness
|
postmarketing, 2%
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
Infection
|
Infection
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
Connective tissue disorder
|
Connective tissue disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Contusion
|
Contusion
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Gastrointestinal symptom NOS
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
very rare, postmarketing
|
|
x
|
x
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
Nasopharyngitis
|
Nasopharyngitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Multiple pregnancy
|
Multiple pregnancy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pruritus
|
Pruritus
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
postmarketing
|
|
x
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Angiopathy
|
Angiopathy
|
postmarketing
|
|
x
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Erythema
|
Redness
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
Erythema
|
|
|
x
|
|
x
|
x
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Anaphylactic shock
|
Anaphylactoid reaction
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Anaphylactic shock
|
very rare
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
|
Ovarian enlargement
|
Ovarian enlargement
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Infestation
|
Infestation NOS
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Asthma
|
Asthma
|
very rare, postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
Exacerbation of asthma
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embolism
|
Thromboembolism
|
very rare, postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Thromboembolic event
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
Embolism venous
|
Thromboembolism
|
very rare, postmarketing
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Immune system disorder
|
Immune system disorder
|
very rare
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
very rare
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Shock
|
Shock
|
very rare
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Congenital anomaly
|
Congenital anomaly
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Developmental delay
|
Congenital anomaly
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Multiple congenital abnormalities
|
Multiple congenital abnormalities
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Abscess
|
Abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Alopecia
|
Alopecia
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
Anorexia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Anxiety
|
Anxiety
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Arthralgia
|
Arthralgia
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal discomfort
|
Arthralgia
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Atelectasis
|
Atelectasis
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pneumothorax
|
Atelectasis
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Coagulopathy
|
Coagulopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bronchitis
|
Bronchitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Congestive cardiomyopathy
|
Congestive cardiomyopathy
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Chest pain
|
Chest pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
|
Conjunctivitis
|
Conjunctivitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Cryptorchism
|
Cryptorchism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Drug abuse
|
Drug abuse
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
Dyspnoea
|
Dyspnoea
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Dysuria
|
Dysuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eczema
|
Eczema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oedema
|
Oedema
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Congenital eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Eye disorder
|
Congenital eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Assisted fertilisation
|
Fertilization
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Haematoma
|
Haematoma
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Peritoneal haemorrhage
|
Peritoneal haemorrhage
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Haemoptysis
|
Haemoptysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Haemorrhage
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Haemoglobin
|
Haemorrhage
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Genital herpes
|
Genital herpes
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Joint dislocation
|
Hip dislocation
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Benign hydatidiform mole
|
Hydatidiform mole
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hydrocephalus
|
Hydrocephalus
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Hypotension
|
Hypotension
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Influenza
|
Influenza
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Arthropathy
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Osteoarthritis
|
Arthropathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Nephrolithiasis
|
Calculus of kidney
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Premature labour
|
Premature labour
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
Leukopenia
|
Leukopenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Systemic lupus erythematosus
|
Systemic lupus erythematosus
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Melaena
|
Melaena
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Menorrhagia
|
Menorrhagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Neoplasm
|
Neoplasm
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
x
|
Nervousness
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Tension
|
Nervousness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Neutropenia
|
Neutropenia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Otitis media
|
Otitis media
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Palpitations
|
Palpitations
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Paraesthesia
|
Paraesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Pilonidal cyst
|
Pilonidal cyst
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Pregnancy
|
Pregnancy
|
|
|
|
x
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Pruritus genital
|
Pruritus genital
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Acute respiratory distress syndrome
|
Acute respiratory distress syndrome
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Spermatocele
|
Spermatocele
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Hyperhidrosis
|
Sweating
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Syncope
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Syncope vasovagal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Loss of consciousness
|
Syncope
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tachycardia
|
Tachycardia
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
Thirst
|
Thirst
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Thrombosis
|
Thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Tooth disorder
|
Tooth disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Urticaria
|
Urticaria
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Uterine disorder
|
Uterine disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vulvovaginal pruritus
|
Vaginal itching
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Vaginal inflammation
|
Vaginal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Varicose vein
|
Varicose vein
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Presyncope
|
Syncope vasovagal
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Vulvovaginitis
|
Vulvovaginitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Chills
|
Chills
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Adnexal torsion
|
Torsion of ovary
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Adnexal torsion
|
|
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Blood urea increased
|
Blood urea increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Swelling face
|
Swelling face
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Complication of pregnancy
|
Pregnancy disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Aspartate aminotransferase increased
|
Aspartate aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Dry skin
|
Dry skin
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Uterine enlargement
|
Uterine enlargement
|
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uterine spasm
|
Uterine spasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Trisomy 18
|
Trisomy 18
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
General symptom
|
General symptom
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abnormal faeces
|
Abnormal faeces
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Upper limb fracture
|
Upper limb fracture
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Emotional distress
|
Distress
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Tachypnoea
|
Tachypnoea
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Tenderness
|
Tenderness
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hyperaesthesia
|
Nipple pain
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nipple pain
|
Nipple pain
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Oropharyngeal discomfort
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Oropharyngeal pain
|
Throat sore
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Sepsis
|
Sepsis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Secondary hypogonadism
|
Secondary hypogonadism
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blood bilirubin increased
|
Blood bilirubin increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Induration
|
Induration
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anovulatory cycle
|
Anovulatory cycle
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dependence
|
Dependence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
Adnexa uteri pain
|
Ovarian pain
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Injection site irritation
|
Injection site irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Injection site induration
|
Injection site induration
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Face oedema
|
Face oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Throat irritation
|
Throat irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Genital infection
|
Genital infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Exomphalos
|
Omphalocele
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Blood lactate dehydrogenase increased
|
Blood lactate dehydrogenase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Local reaction
|
Local reaction
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
x
|
Red blood cells semen positive
|
Red blood cells semen positive
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Insomnia
|
Insomnia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
Ovarian neoplasm
|
Ovarian neoplasm
|
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Meningocele
|
Meningocele
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Puerperal pyrexia
|
Puerperal pyrexia
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|