HRT Side Effects

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Answer the side-effect intent for hrt without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.

Part of women’s health & hormonal medicine side effects side effects.

What is HRT?

Hormone replacement therapy covers several products registered in South Africa, not one. They work in a similar way, and their approved leaflets do not list identical side effects.

The medicines covered here, and the leaflet used for each:

• estradiol — Kliogest, Novo Nordisk (Pty) Ltd (Film-coated tablets.)
• tibolone — TIBILIVE, Pharma Dynamics (Pty) Ltd (Tablet)
• estriol — GYNOFLOR, Adcock Ingram Limited (Vaginal Tablet)

Common side effects of HRT

Each medicine in this group has its own approved leaflet, and the effects below are the ones that leaflet lists. They are shown separately rather than combined, because the leaflets do not agree on what to list or how to word it.

Estradiol (Kliogest)

• Breast pain or breast tenderness
• Vaginal bleeding
• Vaginal candidiasis with fungus or vaginal inflammation
• Fluid retention (swelling of the legs, hands or feet)
• Abdominal pain, swelling or discomfort
• Depression or deterioration of present depression
• Nausea (feeling sick)
• Back pain
• Leg cramps
• Breast oedema or breast enlargement
• Uterine fibroids (benign tumour of the womb) or aggravation, occurrence or recurrence
• Peripheral oedema (swelling of arms or legs)

The leaflet lists 29 more. Read the full leaflet.

Tibolone (TIBILIVE)

• lower abdominal pain
• abnormal hair growth
• vaginal problems such as discharge, itching, irritation, vaginal bleeding or spotting, breast tenderness, pelvic pain, thickening of the lining of the womb or the lining of the cervix
• weight increase, abnormal pap-smear test results
• acne
• breast discomfort, fungal infection, vaginal thrush (yeast infection), nipple pain
• memory loss The following side effects have been reported but the frequency for them to occur is not known:
• fluid retention (swollen hands, ankles or feet)
• gastrointestinal upset, abdominal discomfort
• depression
• dizziness, headache, migraine
• visual disturbances, blurred vision

The leaflet lists 3 more. Read the full leaflet.

Estriol (GYNOFLOR)

• swelling of the hands, feet, ankles, face, lips and mouth or throat, which may cause difficulty in swallowing or breathing
• rash or itching
• fainting
• These are all very serious side effects. If you have them, you may have had a serious reaction to GYNOFLOR. You may need urgent medical attention or hospitalisation. Tell your doctor if you notice any of the following:
• vaginal inflammation (redness, pain and swelling)
• vaginal burning and/or itching (especially at the start of treatment)
• vaginal discharge

Serious side effects and warning signs

None of the leaflets reviewed set out a separate serious-effects list.

General warning signs that apply to any medicine

How long can side effects last?

How long a side effect lasts depends on the effect, the product, how long it has been used, and the person. Some effects ease within days as the body adjusts. Others continue for as long as the product is used. A few can persist after stopping, and some need review rather than waiting.

• Settling effects — mild effects that ease over the first days or weeks of use
• Ongoing effects — effects that continue while the product is being used and improve after stopping
• Persistent effects — effects that continue after stopping and need medical review
• Delayed effects — effects that appear after weeks or months rather than immediately

Which of these applies to a particular effect is a clinical question. If a side effect is not settling, is getting worse, or is affecting your daily life, that is worth a conversation with a pharmacist or doctor regardless of how long it has been going on.

Factors that may affect side effects

Cautions from each medicine’s approved leaflet.

Estradiol (Kliogest)

Do not use it at all if:

• If you have, have had or suspect you have breast cancer
• If you have a family history of breast cancer
• If you have, have had or suspect having any estrogen-dependent cancer, e.g. of the womb lining (endometrial cancer), ovarian cancer or any other hormone-dependent cancer
• If you have any abnormal vaginal bleeding
• If you have excessive thickening of the womb lining (endometrial hyperplasia)
• If you have endometriosis (a deposition of uterine mucosa outside the womb)

Use with care, and tell your doctor, if:

• Fibroids inside your womb
• A history of excessive growth of the womb lining (endometrial hyperplasia)
• Increased risk of getting an estrogen-sensitive cancer (such as having a mother, sister or grandmother who has had endometrial cancer)
• Diabetes mellitus (high blood sugar) (with or without the involvement of blood vessels)
• Gallstones
• A disease affecting the eardrum and hearing (otosclerosis)

Tibolone (TIBILIVE)

Do not use it at all if:

• if you are hypersensitive (allergic) to tibolone or any of the other ingredients of Tibolone 2,5 mg Dyna
• if you have or have ever had a blood clot in a vein (thrombosis), such as in the legs (deep venous thrombosis – DVT) or the lungs (pulmonary embolism)
• if you have a blood clotting disorder (such as protein C, protein S, or antithrombin deficiency), including an inherited disorder that makes your blood more likely to clot
• if you have or have ever had a liver disease and your liver function tests have not returned to normal
• if you have inherited genetic mutations: BRCA1 and BRCA2 genes, as you have a higher risk of developing cancer
• in the case of early menstrual periods (before the age of 12 years)

Use with care, and tell your doctor, if:

• yellowing of your skin or the whites of your eyes (jaundice). These may be signs of a liver disease
• a large rise in your blood pressure (symptoms may be headache, tiredness, dizziness)
• migraine-like headaches which happen for the first time
• if you become pregnant
• if you notice signs of a blood clot, such as:
• painful swelling and redness of the legs

Estriol (GYNOFLOR)

Do not use it at all if:

• if you are hypersensitive (allergic) to Lactobacillus acidophilus, estriol or any of the other ingredients of GYNOFLOR (listed in section 6)
• if you have breast cancer, suspect that you might have breast cancer or if you have a history of breast cancer
• if you have an oestrogen-dependent cancer like breast cancer, ovarian cancer and endometrial (uterine) cancer which rely on oestrogen to develop and grow
• if you have endometriosis, a condition where the layer of tissue that normally covers the inside of the womb, grows outside of it
• if you have an untreated thickening of the lining of the womb
• if you have vaginal bleeding of unknown cause

Use with care, and tell your doctor, if:

• if you suffer from heart disease
• if you suffer from liver disease
• if you suffer from kidney disease
• if you suffer from epilepsy
• if you have increased cholesterol levels in your blood
• if you suffer from high blood pressure

What to do if you experience side effects

If you think you are having a side effect, the response depends on how severe it is. Use the warning signs above first — if any of those apply, treat it as urgent.

If the symptom is severe or frightening

Get medical help immediately. Call 10177 for an ambulance, or 112 from a mobile phone, or go to the nearest emergency department. Take the product and its packaging with you if you can.

If the symptom is mild but bothering you

• Write down what the symptom is, when it started, and how it relates to when you take the product
• Check the leaflet that came with the product to see whether the symptom is listed
• Speak to your pharmacist — for many questions this is the fastest route to a useful answer
• Contact the prescriber if the symptom is affecting your daily life or is not settling

You can also report a suspected side effect in South Africa. Reporting does not replace getting medical advice, and you do not need to be certain the product was the cause.

When to seek urgent medical help

Some symptoms need medical attention straight away rather than an appointment in a few days. Do not wait to see whether they settle.

Get same-day medical advice if you have

• A high fever, or a rash together with feeling generally unwell
• Yellowing of the eyes or skin, or unusually dark urine
• Unusual bruising or bleeding that you cannot explain
• Severe or persistent vomiting or diarrhoea, especially if you cannot keep fluids down
• A sudden change in mood, or thoughts of harming yourself
• Any symptom that is rapidly getting worse

How to report a suspected side effect in South Africa

South Africa has an official system for reporting suspected side effects, run by the South African Health Products Regulatory Authority (SAHPRA). Reports from the public and from healthcare professionals are how safety signals get detected after a product is already in use.

Who can report

Anyone can report — you do not have to be a healthcare professional, and you do not need to prove that the product caused the problem. A suspicion is enough. Patients, caregivers and family members can all submit a report.

What to have ready

• The name of the product, its strength and form, and the batch number if you have it
• Why it was being used, and when it was started and stopped
• What the suspected reaction was, when it began, and how long it lasted
• Any other medicines, supplements or remedies being used at the same time
• Basic details about the person affected — age and sex are usually enough

How to report

SAHPRA accepts adverse reaction reports through its e-Services reporting system and through the Med Safety mobile app. Healthcare professionals can also report through the same routes. Current forms and access points are published on the SAHPRA site.

• SAHPRA Health Products Vigilance — the main vigilance and reporting hub
• SAHPRA e-Services — current adverse reaction reporting access

For a fuller walkthrough see how to report an adverse drug reaction.

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