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
|
Respiratory tract infection
|
Respiratory tract infection
|
16.1% - 24.7%
|
26.4%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Skin exfoliation
|
Localized exfoliation
|
very common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Headache
|
Headache
|
postmarketing — 5% - 50%
|
2.7% - 23.6%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometrial disorder
|
Endometrial disorder
|
1.8% - 15.1%
|
1.4% - 8.21%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Vulvovaginal mycotic infection
|
Vulvovaginal mycotic infection
|
8.29%
|
2.91%
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal moniliasis
|
postmarketing, 6.19% - 10.7%
|
2.78%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Vaginal mycosis
|
0.82% - 6.4%
|
3.2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal pruritus
|
Vulvovaginal pruritus
|
7.8%
|
1.94%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal itching
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Application site reaction
|
Application site reaction
|
postmarketing — 0.6% - 56.7%
|
0% - 58.6%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
|
Injury
|
Accidental injury
|
4.49% - 13.9%
|
4.6% - 11%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Breast tenderness
|
Breast tenderness
|
postmarketing — 2.46% - 17%
|
0% - 5.26%
|
x
|
|
|
|
|
x
|
x
|
x
|
|
x
|
|
|
|
|
x
|
x
|
x
|
|
|
x
|
Back pain
|
Back pain
|
postmarketing, 0% - 10.6%
|
1.3% - 6.38%
|
|
x
|
x
|
|
|
x
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Cervical polyp
|
Cervical polyp
|
6.25%
|
1.91%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasopharyngitis
|
Nasopharyngitis
|
1.32% - 19.6%
|
1.3% - 15.3%
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Genital candidiasis
|
Genital candidiasis
|
uncommon, 5.49% - 7%
|
2.13%
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
Breast pain
|
Breast pain female
|
3% - 9%
|
0%
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast pain
|
postmarketing — 1% - 34.8%
|
2.99% - 9.6%
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
1.6% - 17%
|
1.6% - 16.7%
|
|
x
|
x
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
x
|
Influenza
|
Influenza
|
0% - 13.3%
|
0% - 10.3%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Metrorrhagia
|
Metrorrhagia
|
postmarketing — 0% - 10.6%
|
0% - 4.46%
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Bleeding breakthrough
|
postmarketing
|
|
x
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Sinusitis
|
Sinusitis
|
1.77% - 13.1%
|
1.4% - 18.4%
|
|
x
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
Menstrual disorder
|
Menstrual disorder
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pain
|
Pain
|
postmarketing, 0% - 12.5%
|
4.46% - 12.6%
|
|
x
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Ache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal discomfort
|
Vaginal discomfort
|
5%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
Vaginal irritation
|
postmarketing, 0.885% - 1.79%
|
3.7%
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Vulvovaginal discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
Vulva discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weight fluctuation
|
Weight fluctuation
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Cervical discharge
|
Cervical discharge
|
common
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Sinus headache
|
Sinus headache
|
0% - 10.9%
|
5.1%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza like illness
|
Influenza like illness
|
0% - 7.77%
|
6.37%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Influenza-like symptoms
|
2% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Perineal pain
|
Perineal pain
|
1% - 8%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
3.45% - 7.87%
|
4.31% - 6.9%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
1% - 10.6%
|
1% - 1.15%
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Vaginal discharge
|
postmarketing, 1.47% - 3.52%
|
0.73% - 8.33%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Dyspepsia
|
Dyspepsia
|
0% - 9.23%
|
1.15% - 6.37%
|
|
|
|
|
|
|
x
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Pain in extremity
|
Pain in extremity
|
postmarketing, 0% - 7.69%
|
2.78% - 5.73%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Leg pain
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal pain
|
postmarketing — 0% - 16%
|
1.4% - 8.13%
|
x
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Abdominal cramps
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing — 0% - 16%
|
1.4% - 8.13%
|
x
|
x
|
x
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Rhinitis
|
Rhinitis
|
2% - 6%
|
1% - 6.8%
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Common cold
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
postmarketing — 1.2% - 16.7%
|
0% - 4.6%
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fungal infection
|
Fungal infection
|
0% - 10%
|
1.15%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Constipation
|
Constipation
|
postmarketing, 1.12% - 6.67%
|
2.55% - 4.6%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing, 0% - 12.4%
|
0% - 13.8%
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing, 0% - 12.4%
|
0% - 13.8%
|
|
x
|
|
|
|
x
|
x
|
x
|
|
|
x
|
|
x
|
x
|
x
|
|
|
x
|
x
|
x
|
Myalgia
|
postmarketing, 1.72% - 5.62%
|
2.87% - 4.6%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
Neck pain
|
Neck pain
|
0% - 6.38%
|
1.27%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Gastroenteritis
|
Gastroenteritis
|
0% - 4.44%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Infection
|
Infection
|
1.15% - 17.3%
|
2.3% - 7.46%
|
|
|
|
|
|
x
|
x
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
Flatulence
|
Flatulence
|
postmarketing, 1% - 7%
|
1% - 5.75%
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Abdominal bloating
|
postmarketing, common
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
postmarketing, 6.19% - 10.7%
|
2.78%
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Uterine pain
|
Uterine pain
|
1.77% - 4.46%
|
0.926%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Vulvovaginitis
|
Vulvovaginitis
|
0.893% - 5.31%
|
6.48%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sinus congestion
|
Sinus congestion
|
0% - 6.52%
|
4.46%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Depression
|
Depression
|
postmarketing — 0% - 10.6%
|
0% - 9.2%
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Candida infection
|
Candida infection
|
1% - 5%
|
2%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Arthritis
|
Arthritis
|
postmarketing, 2% - 5.29%
|
7.18%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Arthritis aggravated
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone pain
|
Bone pain
|
2% - 4%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urinary tract infection
|
Urinary tract infection
|
0.885% - 7%
|
1.85% - 2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Pneumonia
|
Pneumonia
|
0.575% - 4.49%
|
4.6%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Reproductive tract disorder
|
Reproductive tract disorder
|
2.65% - 2.68%
|
8.33%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pharyngitis
|
Pharyngitis
|
0.5% - 7%
|
1.15% - 3%
|
|
x
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing — 0% - 6.74%
|
1.32% - 6.49%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hyperaesthesia
|
Nipple pain
|
postmarketing, 0.735% - 6.76%
|
0%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Hyperaesthesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nipple pain
|
Nipple pain
|
postmarketing, 0.735% - 6.76%
|
0%
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Oedema peripheral
|
Oedema peripheral
|
0% - 4.44%
|
0% - 4.6%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Leg edema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Breast neoplasm
|
Breast neoplasm
|
1.12% - 5.56%
|
6.9%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Abnormal withdrawal bleeding
|
Abnormal withdrawal bleeding
|
postmarketing, common
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Family stress
|
Family stress
|
2% - 3%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Asthenia
|
Asthenia
|
postmarketing, 0% - 7.87%
|
4.1% - 4.6%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Fatigue
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Cough
|
Cough increased
|
1.12% - 4.44%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Cough
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Conjunctivitis
|
Conjunctivitis
|
0% - 3.33%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Asthma
|
Asthma
|
1.12% - 3.37%
|
1.15%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Exacerbation of asthma
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Pruritus genital
|
Pruritus genital
|
postmarketing, 4% - 6%
|
0%
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Vaginal inflammation
|
Vaginal inflammation
|
postmarketing, 0% - 8.9%
|
4.1% - 6.9%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
postmarketing, 0% - 8.9%
|
4.1% - 6.9%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
|
x
|
x
|
x
|
Vaginal ulceration
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Insomnia
|
Insomnia
|
postmarketing, 0% - 6.38%
|
5.73% - 8.05%
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Myalgia
|
Myalgia
|
postmarketing, 1.72% - 5.62%
|
2.87% - 4.6%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
Cyst
|
Cyst
|
0% - 6.67%
|
3.45%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
|
|
x
|
|
Pruritus
|
Pruritus
|
postmarketing — 0.5% - 7.8%
|
0% - 6%
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Otitis media
|
Otitis media
|
0% - 3.37%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
Vasodilation procedure
|
Vasodilation
|
0% - 6.74%
|
14.9%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Anxiety
|
Anxiety NEC
|
0% - 6.38%
|
2.55%
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Anxiety
|
postmarketing, 0% - 10%
|
0% - 3.45%
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
x
|
|
|
|
x
|
x
|
|
Weight increased
|
Weight increased
|
postmarketing, 0% - 8.51%
|
0% - 4.6%
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
|
x
|
|
x
|
x
|
Chest pain
|
Chest pain
|
postmarketing, 1.12% - 4.49%
|
4.6%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
Chest discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing, 0.575% - 4.49%
|
2.3%
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Libido increased
|
Libido increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Disturbance in sexual arousal
|
Libido increased
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Muscle spasms
|
Cramp muscle
|
uncommon
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Cramps of lower extremities
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Muscle spasms
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast enlargement
|
Breast enlargement
|
postmarketing — 1.12% - 6.74%
|
3.45%
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
Oedema
|
Oedema
|
postmarketing — 0.5% - 13%
|
6%
|
x
|
x
|
|
|
x
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Abdominal distension
|
Abdominal distension
|
postmarketing — 2.68% - 7.08%
|
2.78%
|
|
|
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
|
x
|
Enlargement abdomen
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Abdominal bloating
|
postmarketing, common
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Alopecia
|
Alopecia
|
postmarketing, uncommon
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Amenorrhoea
|
Amenorrhoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactic shock
|
Anaphylactic shock
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
|
x
|
|
x
|
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Angioedema
|
Angioedema
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
|
x
|
|
x
|
|
Aphasia
|
Aphasia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Speech loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast cancer
|
Breast cancer
|
postmarketing
|
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Breast cancer invasive NOS
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast disorder
|
Breast disorder
|
postmarketing
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
Breast swelling
|
Breast swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Transient ischaemic attack
|
Transient ischaemic attack
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Cholecystitis
|
Cholecystitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Cholelithiasis
|
Cholelithiasis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Chorea
|
Chorea
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Contusion
|
Contusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Libido decreased
|
Libido decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Diarrhoea
|
Diarrhoea
|
postmarketing, 1.12% - 5.37%
|
0% - 2.3%
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing — 0.575% - 7.78%
|
0% - 2.87%
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Dysgeusia
|
Dysgeusia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyspnoea
|
Dyspnoea
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eczema
|
Eczema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endometrial hyperplasia
|
Endometrial hyperplasia
|
postmarketing, 0% - 0.704%
|
0%
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Epilepsy
|
Epilepsy
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
|
Erythema nodosum
|
Erythema nodosum
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Dermatitis
|
Rash
|
postmarketing — 2.87% - 8.89%
|
5.5% - 5.75%
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Dermatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Rash
|
Rash
|
postmarketing — 2.87% - 8.89%
|
5.5% - 5.75%
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Facial rash
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Eruption
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Fatigue
|
Fatigue
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
x
|
Body temperature increased
|
Body temperature increased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Fibrocystic breast disease
|
Fibrocystic breast disease
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Flushing
|
Flushing
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gallbladder disorder
|
Gallbladder disorder
|
postmarketing
|
|
|
x
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemangioma
|
Haemangioma
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
Hemiparesis
|
Hemiparesis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Haemorrhage
|
Haemorrhage
|
postmarketing
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoglobin
|
Haemorrhage
|
postmarketing
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hirsutism
|
Hirsutism
|
postmarketing — 0.575% - 4.49%
|
0%
|
|
|
|
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Hyperhidrosis
|
Hyperhidrosis
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Sweating increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypoaesthesia
|
Hypoaesthesia
|
postmarketing, 0% - 3.37%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypocalcaemia
|
Hypocalcaemia
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Inflammation
|
Inflammation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intestinal obstruction
|
Intestinal obstruction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Irritability
|
Irritability
|
postmarketing
|
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Arthropathy
|
Arthropathy
|
postmarketing, 0% - 4.49%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Osteoarthritis
|
Arthropathy
|
postmarketing, 0% - 4.49%
|
2.3%
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
Osteoarthritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Lethargy
|
Lethargy
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast mass
|
Breast mass
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Chloasma
|
Chloasma
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Meningioma
|
Meningioma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menorrhagia
|
Menorrhagia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Myoclonus
|
Myoclonus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nervousness
|
Nervousness
|
postmarketing, 2.4%
|
1.4%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Tension
|
Nervousness
|
postmarketing, 2.4%
|
1.4%
|
|
|
|
|
|
x
|
|
x
|
x
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
|
Night sweats
|
Night sweats
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Ovarian cyst
|
Ovarian cyst
|
postmarketing
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Palpitations
|
Palpitations
|
postmarketing, 0.6%
|
1.4%
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Paraesthesia
|
Paraesthesia
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Pelvic pain
|
Pelvic pain
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Phlebitis
|
Phlebitis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Porphyrin metabolism disorder
|
Porphyrin metabolism disorder
|
postmarketing
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Prurigo
|
Prurigo
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Anal pruritus
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Anorectal discomfort
|
Anal pruritus
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Dermatitis hemorrhagic
|
postmarketing
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Vascular purpura
|
Purpura
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Retinal vein occlusion
|
Retinal vein occlusion
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pigmentation disorder
|
Pigmentation skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
Sunburn
|
Sunburn
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Photosensitivity reaction
|
Sunburn
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Swelling
|
Swelling
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Shock
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Syncope
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Loss of consciousness
|
Syncope
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
Tachycardia
|
Tachycardia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Thrombophlebitis
|
Thrombophlebitis
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
x
|
|
|
x
|
x
|
|
Thrombosis
|
Thrombosis
|
postmarketing
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
Tremor
|
Tremor
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ulcer
|
Ulcer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Erythema
|
Erythema
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
Redness
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Urethral disorder
|
Urethral disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pollakiuria
|
Pollakiuria
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
|
x
|
|
|
x
|
|
x
|
|
x
|
|
x
|
x
|
|
x
|
|
x
|
|
x
|
x
|
Uterine leiomyoma
|
Uterine leiomyoma
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Uterine haemorrhage
|
Uterine haemorrhage
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vomiting
|
Vomiting
|
postmarketing, uncommon
|
|
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulval disorder
|
Vulval disorder
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Weight decreased
|
Weight decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Dry mouth
|
Dry mouth
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood swings
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Mood alteration NOS
|
postmarketing
|
|
|
|
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Affect lability
|
Mood swings
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast engorgement
|
Breast engorgement
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Breast discharge
|
Breast discharge
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
postmarketing — 0% - 6.74%
|
2.3%
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
x
|
Migraine aggravated
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Oedema genital
|
Oedema genital
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Ventricular extrasystoles
|
Ventricular extrasystoles
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Myocardial ischaemia
|
Myocardial ischaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Liver function test abnormal
|
Liver function test abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Raised liver function tests
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Skin discolouration
|
Skin discolouration
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry skin
|
Dry skin
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uterine enlargement
|
Uterine enlargement
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Uterine cancer
|
Uterine cancer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Endophthalmitis
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ocular hyperaemia
|
Ocular hyperaemia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menstruation irregular
|
Menstruation irregular
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Malnutrition
|
Malnutrition
|
postmarketing, 12%
|
10.5%
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
x
|
Contact lens intolerance
|
Contact lens intolerance
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
Malaise
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discomfort
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Discomfort
|
postmarketing
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling abnormal
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Feeling abnormal
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ill-defined disorder
|
Malaise
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Decreased appetite
|
Decreased appetite
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tenderness
|
Tenderness
|
postmarketing
|
|
|
|
|
x
|
x
|
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
|
x
|
x
|
|
Dry throat
|
Dry throat
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye irritation
|
Eye irritation
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
Upset stomach
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal discomfort
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
Thrombophlebitis superficial
|
Superficial phlebothrombosis
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Superficial thrombophlebitis of leg
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Galactorrhoea
|
Galactorrhoea
|
postmarketing
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Chest discomfort
|
Chest discomfort
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Menopausal symptoms
|
Menopausal symptoms
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Hot flush
|
postmarketing, 0% - 6.38%
|
3.82%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Vulvovaginal pain
|
Vaginal pain
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Heart rate irregular
|
Heart rate irregular
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Pulse irregular
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatitis acute
|
Hepatitis acute
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Fluid retention
|
Fluid retention
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Ectropion of cervix
|
Ectropion of cervix
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Glucose tolerance impaired
|
Glucose tolerance impaired
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Papule
|
Papule
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Malignant mesenchymoma
|
Malignant mesenchymoma
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Anaphylactoid reaction
|
Anaphylactoid reaction
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Blindness
|
Blindness
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Endometrial cancer
|
Endometrial cancer
|
postmarketing
|
|
x
|
|
x
|
x
|
|
|
x
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
|
x
|
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
|
x
|
|
x
|
x
|
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
|
x
|
x
|
Dementia
|
Dementia
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
x
|
|
|
|
|
Application site rash
|
Application site rash
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug effect decreased
|
Drug effect decreased
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Pre-existing disease
|
Pre-existing disease
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Face oedema
|
Face oedema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Visual impairment
|
Visual disturbance
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Abnormal vision
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Disorder sight
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bradyphrenia
|
Bradyphrenia
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal ulceration
|
Vaginal ulceration
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Vaginitis ulcerative
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gait disturbance
|
Gait disturbance
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hot flush
|
Hot flush
|
postmarketing, 0% - 6.38%
|
3.82%
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Toxic shock syndrome
|
Toxic shock syndrome
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Generalised erythema
|
Generalised erythema
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Drug ineffective
|
Drug ineffective
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Retinal vascular thrombosis
|
Retinal vascular thrombosis
|
postmarketing
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Medical device complication
|
Medical device complication
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Ovarian cancer
|
Ovarian cancer
|
postmarketing
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
x
|
|
|
|
x
|
|
Blood pressure fluctuation
|
Change in blood pressure
|
postmarketing
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginismus
|
Vaginismus
|
postmarketing
|
|
|
|
x
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Congenital anomaly
|
Congenital anomaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Developmental delay
|
Congenital anomaly
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Amnesia
|
Amnesia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bacterial infection
|
Bacterial infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mental disorder
|
Mental disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
Blepharitis
|
Blepharitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Coagulopathy
|
Clotting
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bone disorder
|
Bone disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Bronchospasm
|
Bronchospasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Neoplasm malignant
|
Neoplasm malignant
|
|
|
|
|
|
x
|
|
|
|
x
|
x
|
|
x
|
|
|
|
|
|
x
|
x
|
|
x
|
Basal cell carcinoma
|
Basal cell carcinoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
Carpal tunnel syndrome
|
Carpal tunnel syndrome
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Cerebrovascular disorder
|
Cerebrovascular disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Uterine cervical erosion
|
Uterine cervical erosion
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Confusional state
|
Confusional state
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Connective tissue disorder
|
Connective tissue disorder
|
|
|
|
|
|
|
|
x
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
|
x
|
Coronary artery thrombosis
|
Coronary artery thrombosis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Cystitis
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Bladder infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Bladder pain
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Cystitis noninfective
|
Cystitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Dysphagia
|
Dysphagia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dermatitis contact
|
Dermatitis contact
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Allergic contact dermatitis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Diverticulitis
|
Diverticulitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
postmarketing, 0% - 6.52%
|
0%
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
x
|
x
|
|
x
|
|
x
|
x
|
|
x
|
Ear disorder
|
Ear disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear pain
|
Ear pain
|
0% - 2.91%
|
0%
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Embolism
|
Embolism
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Thromboembolism
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Emotional disorder
|
Emotional disturbance NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Endocrine disorder
|
Endocrine disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Endometriosis
|
Endometriosis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
|
|
Epistaxis
|
Epistaxis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye disorder
|
Eye disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eye infection
|
Eye infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Foetal disorder
|
Foetal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastritis
|
Gastritis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Gastrooesophageal reflux disease
|
Gastrooesophageal reflux disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gastrointestinal disorder
|
Gastrointestinal disorder
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
Gastrointestinal symptom NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Goitre
|
Goitre
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cardiac disorder
|
Cardiac disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Haematoma
|
Haematoma
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haematuria
|
Haematuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemoptysis
|
Haemoptysis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Haemorrhoids
|
Haemorrhoids
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Hepatitis
|
Hepatitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hereditary angioedema
|
Hereditary angioedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Herpes simplex
|
Herpes simplex
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Herpes zoster
|
Herpes zoster
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hypercalcaemia
|
Hypercalcaemia
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
x
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hypernatraemia
|
Hypernatraemia
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Hypertension
|
Hypertension
|
0% - 6.74%
|
1.27% - 3.45%
|
|
|
|
|
|
|
x
|
|
|
|
x
|
|
|
|
|
x
|
|
|
x
|
x
|
Immune system disorder
|
Immune system disorder
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
Incontinence
|
Incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Jaundice
|
Jaundice
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Laryngitis
|
Laryngitis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic neoplasm
|
Hepatic neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Mediastinal disorder
|
Mediastinal disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
x
|
|
|
|
|
x
|
Hypertonia
|
Hypertonia
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Nail disorder
|
Nail disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nasal congestion
|
Nasal congestion
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Neoplasm
|
Neoplasm
|
|
|
|
x
|
|
|
x
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
x
|
|
|
Nervous system disorder
|
Nervous system disorder
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
Neuritis
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuritis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Sensory loss
|
Numbness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Optic neuritis
|
Optic neuritis
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Polyp
|
Polyp
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
|
Polyuria
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Urine output increased
|
Polyuria
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tension headache
|
Tension headache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Skin disorder
|
Skin disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Unspecified disorder of skin and subcutaneous tissue
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
x
|
|
|
|
x
|
Skin ulcer
|
Skin ulcer
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Embolism venous
|
Thromboembolism
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Embolism venous
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tinnitus
|
Tinnitus
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Tooth disorder
|
Tooth disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Toothache
|
Toothache
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
x
|
Urinary incontinence
|
Urinary incontinence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Urinary tract disorder
|
Urinary tract disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vaginal disorder
|
Vaginal disorder
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Varicose vein
|
Varicose vein
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Angiopathy
|
Angiopathy
|
|
|
|
|
|
|
|
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Vertigo
|
Vertigo
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Viral infection
|
Viral infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Muscle strain
|
Muscle strain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Agitation
|
Agitation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Musculoskeletal stiffness
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Nuchal rigidity
|
Neck stiffness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Glucose tolerance decreased
|
Glucose tolerance decreased
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
|
Skin hypertrophy
|
Skin hypertrophy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Blood alkaline phosphatase increased
|
Phosphatase alkaline increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Alanine aminotransferase increased
|
Alanine aminotransferase increased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Withdrawal bleed
|
Withdrawal bleed
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Benign vaginal neoplasm
|
Benign vaginal neoplasm
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Eyelid oedema
|
Eyelid oedema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Porphyria non-acute
|
Porphyria cutanea tarda
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Increased appetite
|
Increased appetite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Abdominal pain lower
|
Abdominal pain lower
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dysarthria
|
Slurred speech
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash erythematous
|
Rash erythematous
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Muscle contractions involuntary
|
Muscle contractions involuntary
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Vascular pain
|
Vein pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast oedema
|
Breast oedema
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Pain of skin
|
Skin tenderness
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Breast malformation
|
Breast malformation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hepatobiliary disease
|
Hepatobiliary disease
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dry eye
|
Dry eye
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Increased tendency to bruise
|
Increased tendency to bruise
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Chills
|
Rigors
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Dyskinesia
|
Jerky movement NOS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ligament sprain
|
Joint sprain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Pruritus generalised
|
Pruritus generalised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Lymphadenopathy
|
Lymphadenopathy
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Rash generalised
|
Rash generalised
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Tooth abscess
|
Tooth abscess
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site irritation
|
Application site irritation
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Carbohydrate tolerance decreased
|
Carbohydrate tolerance decreased
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Toxicity to various agents
|
Toxic reaction (NOS)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
Pelvic venous thrombosis
|
Pelvic venous thrombosis
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Mass
|
Mass
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Drug interaction
|
Drug interaction
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Ear infection
|
Ear infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Acne
|
Acne
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Infestation
|
Infestation NOS
|
|
|
|
|
|
|
|
x
|
x
|
|
|
x
|
|
|
|
|
|
|
|
|
|
x
|
Blood oestrogen increased
|
Blood oestrogen increased
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
|
|
|
|
Arthropod bite
|
Arthropod bite
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Application site erythema
|
Application site erythema
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Laryngeal pain
|
Pharyngolaryngeal pain
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Local swelling
|
Peripheral swelling
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Breast discomfort
|
Breast discomfort
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
Pleural infection
|
Pleural infection
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
Deafness
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Hearing impaired
|
Hearing impaired
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Somnolence
|
Somnolence
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
x
|
|
|
|
|
|
|
Loss of libido
|
Loss of libido
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|