Adverse reactions : תופעות לוואי

4.8 Undesirable effects
The serious undesirable effects linked to the use of an HRT are also described in the section “Special warnings and special precautions for use” (q.v.).


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The following lists the undesirable effects by organ system and frequency, observed under HRT preparations. A connection with Progyluton cannot be corroborated, nor can it be ruled out.
The frequency brackets are defined as follows: common ≥1/100 and <1/10; uncommon ≥1/1,000 and <1/100; rare ≥1/10,000 and <1/1,000); unknown ( cannot be estimated from the available data)
Benign, malignant and unspecific growths (including cysts and polyps) Uncommon: mammary carcinoma.
Unknown: endometrial carcinoma.
Diseases of the immune system
Uncommon: hypersensitivity reactions.
Metabolic and nutritional disorders
Common: weight gain.
Unknown: weight loss.
Psychiatric diseases
Common: mood swings, depression.
Uncommon: changes in libido*, nervousness.
Rare: anxiety.
* Both decreased and increased libido have been reported.
Diseases of the nervous system
Common: headache.
Uncommon: sleep disorders, dizziness, migraine.
Eye diseases
Uncommon: visual impairments.
Heart disease
Uncommon: palpitations, increased blood pressure, arterial thromboembolic events (e.g.
myocardial infarction, apoplexy).
Vascular disease
Uncommon: venous thromboembolic events (e.g., deep vein thrombosis, pulmonary embolism)
Diseases of the gastrointestinal tract
Common: flatulence, stomach pain, nausea, dyspepsia.
Uncommon: vomiting.
Liver and gallbladder disorders
Uncommon: abnormal liver function tests.
Very rare: cholestatic jaundice.


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Unknown: cholelithiasis (and other gallbladder diseases).
Diseases of the skin and subcutaneous tissue
Common: skin rash, pruritus.
Uncommon: acne, hirsutism, alopecia, urticaria.
Unknown: chloasma, erythema nodosum, erythema multiforme, vascular purpura.
Skeletomuscular, connective tissue and bone diseases
Common: back pain.
Uncommon: muscle cramps.
Diseases of the sex organs and of the mammary glands
Very common: feeling of tightness in the breasts, breast pain, bleeding anomalies (menorrhagia, metrorrhagia, spotting, etc.)
Common: abdominal pain, vaginal discharge, increased size of uterine myomas, enlargement of the breasts.
Rare: dysmenorrhea, premenstrual syndrome.
Unknown: endometrial hyperplasia.
General diseases
Common: peripheral edema, asthenia.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product.
Any suspected adverse events should be reported to the Ministry of Health according to the National Regulation by using an online form https://sideeffects.health.gov.il/