IUD Side Effects

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

What is IUD?

Hormonal intrauterine devices (IUS) 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:

• MIRENA — Levonorgestrel, BAYER (PTY) LTD (Intrauterine delivery system (IUS))
• KYLEENA — Levonorgestrel, Bayer (Pty) Ltd (Intrauterine devices.)
• AVIBELA — Levonorgestrel, Pharma Dynamics (Pty) Ltd (Intrauterine System/Device)

Who should take extra care

Cautions from each medicine’s approved leaflet.

MIRENA

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)

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

KYLEENA

Do not use it at all if:

• If you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of KYLEENA
• If you are pregnant
• If currently have pelvic inflammatory disease (infection of the female reproduction organs) or have had this condition multiple times in the past
• If you have conditions associated with increased susceptibility to pelvic infections
• If you have a lower genital tract infection (infection in the vagina or the cervix i.e. neck of the womb) that has not been treated
• If you have infection of the womb after delivery of a baby, an infected abortion or miscarriage during the past 3 months

AVIBELA

Do not use it at all if:

• below the age of 16 years

Use with care, and tell your doctor, if:

• had a heart attack
• had a stroke
• were born with heart disease or have problems with your heart valves
• have problems with blood clotting or take medicine to reduce clotting
• have high blood pressure
• recently had a baby or if you are breastfeeding

Common side effects of IUD

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.

MIRENA

• 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

The leaflet lists 8 more. Read the full leaflet.

KYLEENA

• Headache
• Abdominal/pelvic pain
• Acne/seborrhoea (greasy skin)
• Bleeding changes including increased and decreased menstrual bleeding, spotting, infrequent periods (oligomenorrhoea) and absence of bleeding (amenorrhoea)
• Ovarian cysts
• Vulvovaginitis (inflammation of the external genital organs or vagina)
• Depressed mood/depression
• Migraine
• Nausea (feeling sick)
• Upper genital tract infection
• Painful menstruation (dysmenorrhea)
• Breast pain/discomfort

The leaflet lists 5 more. Read the full leaflet.

AVIBELA

• ectopic pregnancy: If you get pregnant while using AVIBELA, you might have an ectopic pregnancy. This means that the pregnancy is not in the uterus. Unusual vaginal bleeding or abdominal pain especially with missed periods may be a sign of ectopic pregnancy. Ectopic pregnancy is a medical emergency that often requires surgery. Ectopic pregnancy can cause internal bleeding, infertility, and even death
• intrauterine pregnancy risks: There are also risks if you get pregnant while using AVIBELA and the pregnancy is in the uterus. Severe infection, miscarriage, premature labour, premature delivery, and even death can occur with pregnancies that continue with an intrauterine system (IUD). Because of this, your healthcare provider may try to remove AVIBELA, even though removing it may cause a miscarriage. If AVIBELA cannot be removed, talk with your healthcare provider about the benefits and risks of continuing the pregnancy. If, after seeing your healthcare provider, you choose to continue your pregnancy, see your healthcare provider regularly. Call your healthcare provider right away if you get flu-like symptoms, fever, chills, cramping, pain, bleeding, vaginal discharge, or fluid leaking from your vagina. These may be signs of infection. It is not known if AVIBELA can cause long-term effects on the foetus if it stays in place during a pregnancy
• life-threatening infection: Life-threatening infection can occur within the first few days after AVIBELA is placed. Call your healthcare provider immediately if you develop severe pain or fever shortly after AVIBELA is placed
• pelvic inflammatory disease (PID) or endometritis: Some IUD users get a serious pelvic infection called pelvic inflammatory disease (PID) or endometritis. PID and endometritis are usually sexually transmitted. You have a higher chance of getting PID or endometritis if you or your partner has sex with other partners. PID or endometritis can cause serious problems such as infertility, ectopic pregnancy, or pelvic pain that does not go away. PID is usually treated with antibiotics. More serious cases of PID or endometritis may require surgery. Removal of the uterus (hysterectomy) is sometimes needed. In rare cases, infections that start as PID or endometritis can even cause death. Tell your healthcare provider right away if you have any of these signs of PID or endometritis: long-lasting or heavy bleeding, unusual vaginal discharge, low abdominal pain, painful sex, chills, or fever
• perforation: AVIBELA may partially go into the wall of the uterus (become embedded) or go completely through the wall of the uterus (perforate). If this occurs, AVIBELA may no longer prevent pregnancy. If perforation occurs, AVIBELA may move outside the uterus and can cause internal scarring, infection, or damage to other organs
• You may need surgery to have AVIBELA removed if it is embedded, or perforation occurs. The risk of perforation is increased in breastfeeding women
• expulsion: AVIBELA may come out of your uterus (expulsion). Expulsion occurs in about 4 out of 100 women, most often in the first year of use. You may become pregnant if AVIBELA comes out. If you think that AVIBELA has come out, use another birth control method like condoms and spermicide or do not have sex (vaginal intercourse) until you are seen by a healthcare provider
• cysts on the ovary: Some women using AVIBELA develop a painful cyst on the ovary. These cysts usually disappear on their own in 2 – 3 months. However, a cyst can cause pain and sometimes cysts will need surgery
• changes in bleeding: You may have bleeding and spotting between menstrual periods, especially during the first 3 -to 6 months. Sometimes the bleeding is heavier than usual at first. However, the bleeding usually becomes lighter than usual and may be irregular. Call your healthcare provider if the bleeding remains heavier than usual or increases after it has been light for a while
• These are all serious side effects. You may need urgent medical attention. Very common and common side effects of AVIBELA include:
• vaginal infection caused by bacteria, yeast infection of the outer part of your vagina (vulvovaginal)
• anxiety, depression, mood changes, sleeplessness, lower sex drive

The leaflet lists 12 more. Read the full leaflet.

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 IUD 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

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.

What happens after stopping or changing the method?

What happens after stopping or changing IUD 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

• Mirena side effects

← Back to more contraception side effects.