MedDRA Preferred Term
|
Side effect
|
Data for drug
|
Placebo
|
Labels
|
|
1
|
2
|
3
|
4
|
5
|
6
|
7
|
8
|
9
|
Pruritus
|
Pruritus
|
postmarketing, 0.714% - 5.03%
|
0% - 2.11%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Breast pain
|
Breast pain
|
2.14% - 4.9%
|
0% - 4.17%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulvovaginal disorder
|
Vulvovaginal disorder
|
2.14% - 2.8%
|
0% - 2.94%
|
|
x
|
|
|
|
|
|
|
|
Vasodilation procedure
|
Vasodilation
|
1.43% - 2.1%
|
0% - 2.78%
|
|
x
|
|
|
|
|
|
|
|
Candida infection
|
Candida infection
|
0.714% - 1.4%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Vaginal haemorrhage
|
Vaginal haemorrhage
|
0.714% - 1.4%
|
0% - 1.47%
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Acne
|
Acne
|
0% - 1.43%
|
0%
|
|
x
|
|
|
|
|
|
|
|
Dysuria
|
Dysuria
|
0% - 1.4%
|
0%
|
x
|
x
|
|
|
|
|
|
|
|
Muscle spasms
|
Cramp muscle
|
0% - 1.4%
|
0%
|
x
|
x
|
|
|
|
|
|
|
|
Cramps of lower extremities
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pollakiuria
|
Micturition urgency
|
0% - 0.699%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Pollakiuria
|
0%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Micturition urgency
|
Micturition urgency
|
0% - 0.699%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Breast enlargement
|
Breast enlargement
|
0% - 0.699%
|
0% - 1.39%
|
x
|
x
|
|
|
|
|
|
|
|
Abdominal pain
|
Abdominal cramps
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Abdominal pain
|
postmarketing
|
9.72%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Gastrointestinal pain
|
Abdominal pain
|
postmarketing
|
9.72%
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Arthralgia
|
Arthralgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Musculoskeletal discomfort
|
Arthralgia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myalgia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Breast cancer
|
Breast cancer
|
postmarketing
|
|
|
x
|
|
|
|
|
x
|
|
|
Vulvovaginal candidiasis
|
Vaginal moniliasis
|
postmarketing, 0% - 1.4%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulvovaginal mycotic infection
|
Vaginal moniliasis
|
postmarketing, 0% - 1.4%
|
0%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cystitis
|
Cystitis
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
Bladder pain
|
Cystitis
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
Cystitis noninfective
|
Cystitis
|
postmarketing
|
|
x
|
x
|
|
|
|
|
|
|
|
Depression
|
Depression
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dizziness
|
Dizziness
|
postmarketing, 0% - 0.699%
|
0% - 4.17%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Syncope
|
|
|
x
|
|
|
|
|
|
|
|
|
Dysmenorrhoea
|
Dysmenorrhoea
|
postmarketing
|
2.78%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Oedema
|
Oedema
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometrial hyperplasia
|
Endometrial hyperplasia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Epilepsy
|
Epilepsy
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema multiforme
|
Erythema multiforme
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Erythema nodosum
|
Erythema nodosum
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dermatitis
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Rash
|
Rash
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Fibrocystic breast disease
|
Fibrocystic breast disease
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gallbladder disorder
|
Gallbladder disorder
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Gynaecomastia
|
Gynaecomastia
|
postmarketing
|
|
|
x
|
|
|
|
|
x
|
|
|
Headache
|
Headache
|
postmarketing, 2.14% - 3.5%
|
1.39% - 20.8%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Haemangioma
|
Haemangioma
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hirsutism
|
Hirsutism
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Hypersensitivity
|
Hypersensitivity
|
postmarketing
|
|
|
x
|
|
|
|
|
x
|
|
|
Irritability
|
Irritability
|
postmarketing
|
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice cholestatic
|
Jaundice cholestatic
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal discharge
|
Leukorrhea
|
postmarketing, 2.1% - 2.86%
|
1.39% - 7.35%
|
|
x
|
|
|
|
|
x
|
x
|
x
|
Chloasma
|
Chloasma
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Myocardial infarction
|
Myocardial infarction
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Acute coronary syndrome
|
Myocardial infarction
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nausea
|
Nausea
|
postmarketing
|
8.33%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Nervousness
|
Nervousness
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Tension
|
Nervousness
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pain
|
Pain
|
postmarketing, 0.714% - 1.4%
|
0% - 8.33%
|
|
x
|
|
|
|
|
x
|
|
|
Pancreatitis
|
Pancreatitis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pelvic pain
|
Pelvic pain
|
postmarketing, 2.8% - 2.86%
|
0% - 2.78%
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Porphyrin metabolism disorder
|
Porphyrin metabolism disorder
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Pruritus genital
|
Pruritus genital
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
Precocious puberty
|
Precocious puberty
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
Pulmonary embolism
|
Pulmonary embolism
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Cerebrovascular accident
|
Cerebrovascular accident
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis
|
Thrombophlebitis
|
postmarketing
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Urticaria
|
Urticaria
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uterine leiomyoma
|
Uterine leiomyoma
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Uterine haemorrhage
|
Uterine haemorrhage
|
postmarketing
|
|
|
x
|
|
|
|
|
x
|
|
|
Vaginal inflammation
|
Vaginal inflammation
|
postmarketing, 1.4% - 2.14%
|
1.39% - 4.41%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vaginal infection
|
Vaginal inflammation
|
postmarketing, 1.4% - 2.14%
|
1.39% - 4.41%
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vomiting
|
Vomiting
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Deep vein thrombosis
|
Deep vein thrombosis
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
Migraine
|
Migraine
|
postmarketing, 0%
|
0% - 1.47%
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Colitis ischaemic
|
Colitis ischaemic
|
postmarketing
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Tenderness
|
Tenderness
|
postmarketing
|
|
x
|
x
|
x
|
|
x
|
x
|
x
|
x
|
x
|
Thrombophlebitis superficial
|
Superficial phlebothrombosis
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Galactorrhoea
|
Galactorrhoea
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Glucose tolerance impaired
|
Glucose tolerance impaired
|
postmarketing
|
|
|
x
|
x
|
|
|
|
x
|
x
|
x
|
Meningioma benign
|
Meningioma benign
|
postmarketing
|
|
|
|
x
|
|
|
|
x
|
x
|
x
|
Asthma
|
Exacerbation of asthma
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Endometrial cancer
|
Endometrial cancer
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Blood pressure increased
|
Blood pressure increased
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Dementia
|
Dementia
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Vulvovaginal discomfort
|
Vulvovaginal discomfort
|
postmarketing
|
|
|
x
|
|
|
|
|
|
|
|
Retinal vascular thrombosis
|
Retinal vascular thrombosis
|
postmarketing
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Ovarian cancer
|
Ovarian cancer
|
postmarketing
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Abdominal distension
|
Abdominal bloating
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
Abdominal bloating
|
postmarketing
|
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
x
|
Flatulence
|
|
2.78%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Mood swings
|
Mood alteration NOS
|
postmarketing
|
|
|
x
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Anaphylactic shock
|
Anaphylactic shock
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Angioedema
|
Angioedema
|
|
|
|
|
|
x
|
x
|
x
|
|
x
|
x
|
Asthenia
|
Asthenia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Fatigue
|
|
|
x
|
|
|
|
|
|
|
|
|
Back pain
|
Back pain
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Coagulopathy
|
Clotting
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast swelling
|
Breast swelling
|
|
|
x
|
|
|
|
|
|
|
|
|
Bronchitis
|
Bronchitis
|
|
4.17%
|
|
|
|
x
|
x
|
x
|
|
|
|
Neoplasm malignant
|
Neoplasm malignant
|
|
|
x
|
x
|
|
|
|
|
|
|
|
Cardiovascular disorder
|
Cardiovascular disorder
|
|
|
|
x
|
|
|
|
|
|
|
|
Uterine cervical erosion
|
Uterine cervical erosion
|
|
|
x
|
|
|
|
|
|
|
|
|
Chorea
|
Chorea
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Infection
|
Infection
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Coronary artery thrombosis
|
Coronary artery thrombosis
|
|
|
x
|
|
|
|
|
|
|
|
|
Diarrhoea
|
Diarrhoea
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspepsia
|
Dyspepsia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Dyspnoea
|
Dyspnoea
|
|
|
x
|
|
|
|
|
|
|
|
|
Endometriosis
|
Endometriosis
|
|
|
x
|
|
|
|
|
|
|
|
|
Epistaxis
|
Epistaxis
|
|
|
x
|
|
|
|
|
|
|
|
|
Fatigue
|
Fatigue
|
|
|
x
|
|
|
|
|
|
|
|
|
Hyperglycaemia
|
Hyperglycaemia
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypernatraemia
|
Hypernatraemia
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypocalcaemia
|
Hypocalcaemia
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Influenza
|
Influenza
|
|
4.17%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Jaundice
|
Jaundice
|
|
|
x
|
|
|
|
|
|
|
|
|
Pain in extremity
|
Leg pain
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatic neoplasm
|
Hepatic neoplasm
|
|
|
x
|
|
|
|
|
|
|
|
|
Menorrhagia
|
Menorrhagia
|
|
|
x
|
|
|
|
|
|
|
|
|
Metrorrhagia
|
Metrorrhagia
|
0%
|
0% - 2.94%
|
x
|
x
|
|
x
|
x
|
x
|
|
|
|
Bleeding breakthrough
|
|
|
x
|
|
|
x
|
x
|
x
|
|
|
|
Musculoskeletal pain
|
Musculoskeletal pain
|
|
|
x
|
|
|
|
|
|
|
|
|
Neuritis
|
Neuritis
|
|
|
x
|
|
|
|
|
|
|
|
|
Neuropathy peripheral
|
Neuritis
|
|
|
x
|
|
|
|
|
|
|
|
|
Hypoaesthesia
|
Numbness
|
|
|
x
|
|
|
|
|
|
|
|
|
Sensory loss
|
Numbness
|
|
|
x
|
|
|
|
|
|
|
|
|
Optic neuritis
|
Optic neuritis
|
|
|
x
|
|
|
|
|
|
|
|
|
Palpitations
|
Palpitations
|
|
|
x
|
|
|
|
|
|
|
|
|
Paraesthesia
|
Paraesthesia
|
|
0%
|
|
|
|
x
|
x
|
x
|
|
|
|
Pharyngitis
|
Pharyngitis
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Phlebitis
|
Phlebitis
|
|
|
|
|
x
|
|
|
|
|
|
|
Rhinitis
|
Rhinitis
|
|
5.56%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Sinusitis
|
Sinusitis
|
|
2.78%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Swelling
|
Swelling
|
|
|
x
|
|
|
|
|
|
|
|
|
Shock
|
Syncope
|
|
|
x
|
|
|
|
|
|
|
|
|
Syncope
|
Syncope
|
|
|
x
|
|
|
|
|
|
|
|
|
Loss of consciousness
|
Syncope
|
|
|
x
|
|
|
|
|
|
|
|
|
Embolism
|
Thromboembolism
|
|
|
x
|
|
|
|
|
|
|
|
|
Embolism venous
|
Thromboembolism
|
|
|
x
|
|
|
|
|
|
|
|
|
Thrombosis
|
Thrombosis
|
|
|
x
|
|
|
|
|
|
|
|
|
Erythema
|
Erythema
|
0%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Upper respiratory tract infection
|
Upper respiratory tract infection
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Urinary tract infection
|
Urinary tract infection
|
0%
|
0% - 1.39%
|
|
x
|
|
|
|
|
|
|
|
Vulvovaginal pruritus
|
Vaginal itching
|
|
|
x
|
|
|
|
|
|
|
|
|
Varicose vein
|
Varicose vein
|
|
|
x
|
|
|
|
|
|
|
|
|
Hepatic function abnormal
|
Hepatic function abnormal
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast discharge
|
Breast discharge
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|
Injection site swelling
|
Injection site swelling
|
|
|
|
|
x
|
|
|
|
|
|
|
Glucose tolerance decreased
|
Glucose tolerance decreased
|
|
|
x
|
|
|
|
|
|
|
|
|
Injury
|
Accidental injury
|
|
6.94%
|
|
|
|
x
|
x
|
x
|
x
|
x
|
x
|
Injection site pain
|
Injection site pain
|
|
|
|
|
x
|
|
|
|
|
|
|
Skin irritation
|
Skin irritation
|
|
|
x
|
|
|
|
|
|
|
|
|
Myalgia
|
Myalgia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abdominal discomfort
|
Abdominal discomfort
|
|
|
x
|
|
|
|
|
|
|
|
|
Abdominal pain upper
|
Abdominal pain upper
|
|
|
x
|
|
|
|
|
|
|
|
|
Abdominal pain lower
|
Abdominal pain lower
|
|
|
x
|
|
|
|
|
|
|
|
|
Purpura
|
Dermatitis hemorrhagic
|
|
|
x
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Breast tenderness
|
Breast tenderness
|
|
|
x
|
|
|
x
|
|
|
|
|
|
Fluid retention
|
Fluid retention
|
|
|
x
|
|
|
|
|
|
|
|
|
Ectropion of cervix
|
Ectropion of cervix
|
|
|
|
|
x
|
x
|
x
|
x
|
|
x
|
x
|
Increased tendency to bruise
|
Increased tendency to bruise
|
|
|
x
|
|
|
|
|
|
|
|
|
Pre-existing disease
|
Pre-existing disease
|
|
|
|
|
x
|
|
|
|
|
x
|
x
|
Visual impairment
|
Visual disturbance
|
|
|
x
|
|
|
|
|
|
|
|
|
Cough
|
Cough increased
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Mass
|
Mass
|
|
|
x
|
|
|
|
|
|
|
|
|
Breast discomfort
|
Breast discomfort
|
|
|
x
|
|
|
|
|
|
|
|
|
Insomnia
|
Insomnia
|
|
|
|
|
|
|
|
|
x
|
x
|
x
|
Abnormal withdrawal bleeding
|
Abnormal withdrawal bleeding
|
|
|
|
|
|
x
|
x
|
x
|
|
|
|