Mirena Side Effects

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Answer side-effect and tolerability questions around mirena, including expected changes, warning signs and safe escalation guidance.

What is Mirena?

Mirena contains the active ingredient Levonorgestrel.

• Active ingredient — Levonorgestrel
• Registration holder — BAYER (PTY) LTD

It is approved for:

• MIRENA is a T shaped intrauterine delivery system (IUS) which after insertion releases the hormone levonorgestrel into the womb
• The purpose of the T-body is to adjust the system to the shape of the womb
• The vertical arm of the T-body carries a cylinder containing levonorgestrel
• Two removal threads are tied to the loop at the lower end of the vertical arm

Interactions and medicines to check

The approved leaflet names these interactions.

• Always tell your health care provider if you are taking other medicines on a regular basis, including complementary or traditional medicines, and medicines obtained without a prescription
• The mechanism of action of MIRENA is mainly local, the intake of other medicines is not believed to increase the risk of pregnancy while using MIRENA

Who should take extra care

The approved leaflet identifies the following cautions and factors.

Do not use it at all if

• if you are pregnant or think you might be pregnant
• if you currently or recurrently have an infection of the female reproduction organs
• if you have a lower genital tract infection
• if you have an infection of the womb after delivery
• if you have had an infection of the womb after abortion during the past 3 months
• if you have infection of the cervix (neck of womb)
• if you have cell abnormalities in the cervix
• if you have cancer of suspected cancer of the cervix or womb
• if you have tumours which depend on progestogen hormone to grow
• if you have unexplained abnormal uterine bleeding
• if you have abnormality of the cervix or womb including fibroids if they
• distort the cavity of the womb
• if you have conditions associated with increased susceptibility to infections
• if you have active liver disease or liver tumour

Use with care, and tell your doctor, if

• Your menstrual periods have ceased and then you start having persistent bleeding or pain
• You have vague or very bad pain in your lower abdomen
• You have normal signs of pregnancy, but you also have bleeding and feel dizzy. Faintness Some women feel dizzy after MIRENA is inserted
• This is a normal physical response. Your doctor will tell you to rest for a while after you have had MIRENA inserted. Enlarged ovarian follicle (cells that surround a maturing egg in the ovary) Since the contraceptive effect of MIRENA is mainly due to its local effect, ovulatory cycles with follicular rupture usually occur in women of fertile age. Sometimes degeneration of the follicle is delayed, and the development of the follicle may continue. Most of these follicles give no symptoms, although some may be accompanied by pelvic pain or pain during intercourse. These enlarged follicles may require medical attention, but they usually disappear on their own. Additional information on special population Children and adolescents MIRENA is for use in women of childbearing age. There is no relevant indication for the use of MIRENA before menarche (first menstrual bleeding). Elderly patients MIRENA has not been studied in women over the age of 65 years. Patients with impaired liver function MIRENA must not be used in women with liver impairment. Patients with impaired kidney function MIRENA has not been studied in women with kidney impairment

Pregnancy and breastfeeding

• Pregnancy If MIRENA comes out, you are no longer protected and must use another form of contraception until you see your doctor
• Some women may not have their periods while using MIRENA
• Not having a period is not necessarily a sign of pregnancy
• If you do not have your period and have other symptoms of pregnancy (for example nausea, tiredness and breast tenderness) you should see your doctor for an examination and have a pregnancy test
• If you become pregnant with MIRENA in place, you should have MIRENA removed as soon as possible
• If MIRENA is left in place during pregnancy, the risk of having a miscarriage, infection or preterm labour will be increased

Common side effects of Mirena

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.

Frequent side effects

• Headache
• Abdominal/pelvic pain
• Bleeding changes including increased and decreased menstrual bleeding, spotting, oligomenorrhoea (infrequent periods) and amenorrhoea (absence of bleeding)
• Vulvovaginitis (inflammation of the external genital organs or vagina)
• Genital discharge
• Depressed mood/ depression
• Migraine
• Nausea (feeling sick)
• Acne
• Hirsutism (excessive body hair)
• Back pain
• Upper genital tract infection
• Ovarian cysts
• Dysmenorrhoea (painful menstruation)
• Breast pain
• Intrauterine contraceptive device expelled (complete or partial)

Less frequent side effects

• Alopecia (loss of hair)
• Uterine perforation (piercing of the womb) Unknown frequency
• Hypersensitivity (allergic reaction) including rash, urticaria (hives) and angioedema (characterised by sudden swelling of e.g. the eyes, mouth, throat.)
• Blood pressure increase The removal threads may be felt by the partner during intercourse. If you become pregnant while using MIRENA, there is a possibility that pregnancy is outside the womb. Cases of sepsis (very severe systemic infection, which may be fatal) have been reported following intrauterine device insertions. The risk of breast cancer is unknown when MIRENA is used in the indication protection from endometrial hyperplasia (excessive growth of the lining of the womb) during oestrogen replacement therapy. Cases of breast cancer have been reported (frequency unknown). The following side effects have been reported in connection with MIRENA insertion or removal procedure Procedural pain, procedural bleeding, insertion-related vasovagal reactions with dizziness or syncope (fainting). The procedure may result in seizure (fit) in an epileptic patient. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist or other health care professional for advice

Bleeding, cycle and hormonal changes

Changes to bleeding and to the menstrual cycle are among the most commonly reported experiences with hormonal contraception, and they are one of the main reasons people stop a method. Knowing what pattern to expect with Mirena makes it easier to tell an expected change from one worth checking.

Bleeding patterns can include lighter or shorter periods, irregular spotting between periods, or periods stopping altogether. Which of these is expected depends on the method, and on how long it has been used.

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.

What happens after stopping or changing the method?

What happens after stopping or changing Mirena depends on the method. Some methods stop working as soon as they are removed or discontinued; others take longer to clear. This matters both for side effects and for whether you are still protected against pregnancy.

Contraceptive cover

If you are changing method, there is often a window where you need additional protection. Getting that timing right is the single most important part of switching — ask a pharmacist, nurse or doctor to confirm it for your specific change rather than working it out from a general description.

Side effects and cycle after stopping

Side effects linked to a hormonal method usually ease once the hormone clears, though the time this takes varies by method. Cycles may take several months to settle into their own pattern, and that pattern may not be the same as before the method was started.

When to contact a healthcare professional urgently

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

• IUD side effects

← Back to more contraception side effects.