Like all medicines, tibolone may cause side effects. But it's common to have no side effects or only minor ones.
Side effects often improve as your body gets used to the medicine.
Common side effects
These common side effects of tibolone happen in more than 1 in 100 women. There are things you can do to help manage common side effects.
Breast pain or tenderness
This usually improves after a few weeks as your body gets used to the medicine. Contact your GP if it bothers you or does not go away.
If you notice a lump or changes in your breasts when taking tibolone, contact your GP for advice.
Unexpected vaginal bleeding or spotting
Unless you've had a hysterectomy to remove your womb, vaginal bleeding or spotting is common for the first 3 to 6 months after starting HRT. It usually settles down after this.
Talk to your GP if:
- you get heavy bleeding or unexpected bleeding after you've been taking HRT for 6 months
- you've had a hysterectomy and you get any vaginal bleeding
Weight gain
Tibolone can sometimes cause weight gain. But it's also common to put on weight around the time of menopause and as you get older - so it might not be your medicine that's causing it.
You can keep healthy by:
Stomach pain or pelvic pain
Try to rest and relax. It can help to eat and drink slowly and have smaller and more frequent meals. Putting a heat pad or covered hot water bottle on your stomach may also help.
If you're in a lot of pain, talk to your pharmacist or GP.
Unusual hair growth
If this bothers you, ask your GP if another type of HRT might be more suitable.
A pharmacist can also advise on products to remove unwanted hair.
Vaginal discharge, vaginal itching or thrush
Do not use perfumed soaps or washes around your vagina. If you have thrush, ask a pharmacist to recommend a medicine, or talk to your GP.
These symptoms should get better after a month or two. Talk to your GP if they do not improve or they get worse. You may need to change to a different type of HRT.
Talk to a pharmacist or GP if the advice on how to cope does not help and a side effect is still bothering you.
Serious side effects
Serious side effects from tibolone are rare.
Urgent advice: Call your GP or GP out of hours for advice now if:
- the whites of your eyes or your skin turn yellow, although this may be less obvious on brown or black skin - this could be a sign of liver problems
- you have a sudden migraine-type headache or severe headache
- you have pain, redness or swelling in one of your legs, usually in your calf - this could be a sign of deep vein thrombosis (DVT)
- you have a headache, tiredness or dizziness which may be a sign of a big rise in your blood pressure
Non-urgent advice: Contact your GP if you have:
- a lump or changes in your breasts or nipples - this could be a sign of breast cancer
- any changes in vaginal bleeding after you have been taking tibolone for more than a few months - this could be a sign of womb cancer
It's important to attend your breast screening appointments while you're taking tibolone.
Emergency action required: Call 112 or 999 or go to the nearest emergency department (ED) now if:
- you have pain in your chest and breathlessness - this could be a sign of a blood clot in your lungs (pulmonary embolism) or heart problems
- you have difficulty speaking or moving your arm or leg, or your face has dropped on 1 side - this could be a sign of a stroke
Do not drive to the ED. Ask someone to drive you or call 999 and ask for an ambulance.
Bring all the medicines you take with you.
Serious allergic reaction
In rare cases, it's possible to have a serious allergic reaction (anaphylaxis) to tibolone.
Urgent advice: Call 112 or 999 now if:
- your lips, mouth, throat or tongue suddenly become swollen
- you're breathing very fast or struggling to breathe (you may become very wheezy or feel like you're choking or gasping for air)
- your throat feels tight or you're struggling to swallow
- your skin, tongue or lips turn blue, grey or pale (if you have black or brown skin, this may be easier to see on the palms of your hands or soles of your feet)
- you suddenly become very confused, drowsy or dizzy
- someone faints and cannot be woken up
You or the person who's unwell may also have a rash that's swollen, raised, itchy, blistered or peeling.
These can be signs of a serious allergic reaction and may need immediate treatment in hospital.
Do not drive yourself to the emergency department.
The person you speak to at 999 will give you advice about what to do.
Other side effects
These are not all the side effects of tibolone. For a full list see the leaflet inside your medicines packet.
Non-urgent advice: Find your patient information leaflet
Your patient information leaflet is the leaflet that comes with your medicine. You can find a digital version of the leaflet online.
Report side effects
You can report any suspected side effects to the Health Products Regulatory Authority (HPRA): report an issue - hpra.ie