Vagifem Side Effects

Home › Medicine Side Effects › Vagifem

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

What is Vagifem?

Vagifem contains the active ingredient Estradiol hemihydrate.

• Active ingredient — Estradiol hemihydrate
• Registration number — 47/21.8.1/0166
• Registration holder — Novo Nordisk (Pty) Ltd

It is approved for:

• Vagifem® 10 μg vaginal tablet is used to relieve menopausal symptoms in the vagina such as dryness or irritation
• It is inserted into your vagina

Common side effects of Vagifem

Not everyone gets side effects. The effects below are those listed in the South African approved leaflet, grouped using the leaflet’s own frequency wording.

Reported side effects

• swelling of your hands, feet, ankles, face, lips, 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 allergic reaction to Vagifem® 10 μg. You may need urgent medical attention or hospitalisation. Tell your doctor immediately or go to the casualty department at your nearest hospital if you notice any of the following: The following have been reported but the frequency is unknown:
• Aggravated migraine (severe headaches)
• Blood clot formation in a blood vessel (deep vein thrombosis)
• These are all serious side effects. You may need urgent medical attention. Tell your doctor if you notice any of the following: Frequent side effects include:
• Headache
• Feeling sick (nausea) or vomiting
• Stomach pain, swelling or discomfort
• Indigestion (heartburn)
• Passing wind (flatulence)
• Vaginal bleeding, discharge or discomfort
• An infection of the genitals caused by a fungus or inflamed vagina (itching, inflammation, discharge)
• Breast pain or tenderness
• Swelling of your hands, arms, legs or feet Less frequent side effects include:
• Anxiety
• Body mass increased
• Hot flush
• High blood pressure. The following have also been reported but the frequency is unknown:
• Breast cancer
• Fluid retention
• Diarrhoea
• Application site reactions (including a vulvovaginal burning sensation), minor trauma caused by the intravaginal applicator
• Changes in oestrogen levels when blood tests are done. Side effects of HRT The following side effects can occur with systemic oestrogen treatment:
• Myocardial infarction, congestive heart disease
• Stroke
• Gall bladder disease
• Skin disorders including brown patches in the face, skin rashes including red inflammation on the hands or the legs (erythema multiforme), a bruise-like rash and itching
• Risk of excessive growth of the lining of the womb (endometrial hyperplasia) and developing endometrial cancer (cancer of the lining of the womb) or an increase in size of fibroids (benign lumps) in the womb
• Being unable to sleep (insomnia)
• Epilepsy
• Loss of sex drive (libido)
• Deterioration of asthma
• Loss of memory and other mental powers (dementia)

Serious side effects and warning signs

This leaflet does not set out a separate list of serious side effects. The general warning signs below apply to any medicine.

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

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• You are allergic (hypersensitive) to estradiol or any of the other ingredients of Vagifem® 10 μg
• You have, have ever had, or you have a family history of breast cancer (mother, sister or grandmother)
• You have or have ever had, or think you might have a hormone dependent tumour, e.g. endometrial cancer (cancer of the lining of the womb)
• You have unusual vaginal bleeding which you have not told your doctor about
• You have been told by your doctor that you have excessive growth of the lining of the womb (endometrial hyperplasia) and you are not being treated for it
• You have or previously have had a blood clot inside the blood vessels of the legs or lungs (deep vein thrombosis or pulmonary embolism)
• If you have a blood clotting disorder (such as protein C, protein S or antithrombin deficiency)
• You have had a heart attack, stroke or have chest pain (angina)
• You have or have had a liver disease and your liver tests have not returned to normal
• You have porphyria
• You are pregnant
• Do not use Vagifem® 10 μg if any of the above applies to you. If you are not sure, talk to your doctor, pharmacist, nurse or other health care provider before using Vagifem® 10 μg. Before you use Vagifem® 10 μg, tell your doctor if:
• You are known to have inherited genetic changes called BRCA1 and/or BRCA2 genes
• You started your menstrual periods early (before the age of 12 years)
• You have a history of non-cancerous breast diseases, such as atypical hyperplasia or lobular carcinoma in situ
• You had any previous treatment using radiation therapy to the chest or breast
• You have been treated or exposed while in your mother’s womb to a medicine called diethylstilbestrol (DES)

Use with care, and tell your doctor, if

• Asthma
• Epilepsy
• Diabetes
• Gallstones
• High blood pressure
• Migraines or severe headaches
• Liver problems such as ‘liver adenoma’ (a benign tumour)
• Endometrial hyperplasia (thickening of the lining of your womb)
• Otosclerosis
• This is when you lose your hearing over a period of time
• Systemic lupus erythematosus (a disease affecting the skin, joints and kidneys)
• Blood clots or risk factors for blood clots
• Leiomyoma (benign tumours of the womb) or endometriosis (growth of the womb lining outside the womb). If any of the above applies to you, or if you are not sure, talk to your doctor or pharmacist before using Vagifem® 10 μg. Stop using Vagifem® 10 μg and consult a doctor straight away if you notice any of the following side effects:
• Yellow colouring of your skin or eyes (jaundice) or other liver problems
• An increase in blood pressure
• A migraine-type headache you have not had before
• If you become pregnant
• If you notice signs of a blood clot, such as painful swelling and redness of the legs; − sudden chest pain; − difficulty in breathing If you develop any of the illnesses listed in “Section 2 What you need to know before you use Vagifem 10 μg: Do not use Vagifem® 10 μg.” Medical check-ups Before you start using Vagifem® 10 μg, your doctor will tell you about the risks and benefits of the treatment. Before you start using Vagifem® 10 μg and regularly during treatment, your doctor will check whether Vagifem® 10 μg is the right treatment for you. Your doctor will tell you how often to go for regular checkups, and will consider your general state of health. If you have a close relative (e.g. mother, sister, maternal or paternal grandmother), who has suffered from any serious illness such as blood clots or breast cancer, you might be at a higher risk for serious illness. Always tell your doctor about any close relative(s) suffering from serious illness. As well as regular check-ups with your doctor, you should:
• Regularly examine your breasts for any changes, such as dimpling or sinking of the skin, changes in the nipple, or any lumps you can see or feel. Tell your doctor if you notice any changes
• Go for regular breast screening and cervical smear tests. Additionally, you are advised to join breast screening programs when offered to you. For mammogram screening, it is important that you inform the nurse/health care provider who is actually taking the x-ray that you use Vagifem®, as this medication may increase the density of your breasts which may affect the outcome of the mammogram. Where the density of the breast is increased, mammography may not detect all lumps. Endometrial hyperplasia (excessive growth of the lining of the womb) and endometrial cancer (cancer of the lining of the womb) Women who still have their womb and are taking systemic oestrogens have an increased risk of developing excessive growth of the lining of the womb (endometrial hyperplasia) and of developing endometrial cancer (cancer of the lining of the womb). Breast cancer Evidence suggests that using Vagifem® 10 μg does not increase the risk of breast cancer in women who had no breast cancer in the past. It is not known if Vagifem® 10 μg can be safely used in women who had breast cancer in the past. Breast cancer has been diagnosed more often in women who use hormone replacement therapy than in women of the same age who do not use hormone replacement therapy. This increase in the number of breast cancer diagnoses gradually disappears during the course of the 10 years after stopping use of hormone replacement therapy. When you are using Vagifem® 10 μg, you must perform monthly breast self-examinations. Your doctor will advise you on when to report for breast examinations and any other appropriate investigations. Stroke There may be a higher risk of having a stroke if you are taking combined oestrogen-progestagen and oestrogen-only hormone replacement therapy (HRT). If you get migraine-type headaches, with or without disturbed or blurred vision, stop using HRT and consult a doctor as soon as possible. Ovarian cancer Use of systemic oestrogen alone and oestrogen plus progestogen therapies for at least 5 years have been associated with an increased risk of ovarian cancer in epidemiological studies. Dementia There is evidence for an increased risk of dementia in women older than 65 years, who were using systemic oestrogen/progestagen combination. Gall bladder disease Gall bladder disease has been reported after treatment with systemic oestrogen/progestagen. Effects on the skin Brown patches in the face (chloasma), skin rashes including red inflammation on the hands or the legs (erythema multiforme) or a bruise-like rash have been reported after treatment with HRT. Other medicines with Vagifem® 10 μg Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines.)

Pregnancy and breastfeeding

• If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, please consult your doctor, pharmacist, nurse or other health care provider for advice before taking Vagifem® 10 μg
• Do not use Vagifem® 10 μg if you are pregnant, or if you are breast-feeding
• If you get pregnant while you are using Vagifem® 10 μg, stop using it and consult a doctor straight away

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.

Related pages

• minoxidil side effects

← Back to more medicine side effects.