Mifepristone Side Effects

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

What is mifepristone?

Mifepristone contains the active ingredient Mifepristone.

• Active ingredient — Mifepristone
• Registration number — 55/21.12/0760
• Registration holder — Ruby Pharmaceuticals (Pty) Ltd

It is approved for:

• no later than 56 days after the first day of your last menstrual cycle
• in combination with a second medicine, a prostaglandin (a substance that triggers contraction of the womb and softens the cervix), which you take 36 to 48 hours after taking ACEGYNE. 2) For softening and opening of the cervix before surgical termination of pregnancy during the first trimester. 3) As pre-treatment before giving prostaglandins for termination of pregnancy for medical reasons beyond 3 months gestation. 4) To induce labour in cases where the foetus has died in the womb and where it is not possible to use other medical treatments (prostaglandin or oxytocin)

Common side effects of mifepristone

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

• dizziness
• uterine contractions or cramping
• diarrhoea
• feeling sick (nausea), or being sick (vomiting)
• heavy bleeding
• gastrointestinal cramping light or moderate
• infection of the uterus (endometritis and pelvic inflammatory disease)

Less frequent side effects

• blood pressure fall
• fever, headache
• Uterine rupture following prostaglandin administration within the second and third trimester of pregnancy, particularly in multiparous women or in women with a caesarean section scar

Frequency unknown side effects

• generally feeling unwell or tired
• vagal symptoms (hot flushes, dizziness, chills)
• hives, swelling under the skin, blistering and peeling of the skin and skin disorders which can be serious

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

• In all cases
• if you are allergic to mifepristone or any of the other ingredients of this medicine (listed in section 6)
• if you suffer from kidney failure
• if you suffer from severe asthma, which cannot be adequately treated with medication
• if you have hereditary porphyria (an inherited disorder of the blood)
• if you have an unremoved intra-uterine contraceptive device
• if pregnancy is not confirmed by ultrasound scan or biological tests
• if your doctor suspects an ectopic pregnancy
• If you are on long-term corticosteroid (used in the treatment of asthma or other inflammation treatments) treatment
• If you suffer from haemorrhagic disorders (illness that affects clotting of your blood) or taking anticoagulants (medicines that help prevent blood clots)

Use with care, and tell your doctor, if

• if you have liver or kidney disease
• if you suffer from anaemia or malnutrition
• if you have cardiovascular disease (heart or circulatory disease)
• if you are at increased risk of cardiovascular disease. Risk factors include being aged over 35 years and a cigarette smoker or having high blood pressure, high blood cholesterol levels or diabetes
• if you have an illness that affects the clotting of your blood
• if you suffer from asthma. If you use a contraceptive coil, it must be removed before you take ACEGYNE. Before taking ACEGYNE your blood will be tested for Rhesus factor. If you are Rhesus negative your doctor will advise you of the routine treatment required. It is essential that you attend a follow-up visit with your doctor 10 – 14 days after taking ACEGYNE to ensure that the pregnancy has been successfully terminated. If pregnancy continues or expulsion is incomplete, your doctor will advise you of the options for completion of the pregnancy termination

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 or other health care provider for advice before using ACEGYNE Pregnancy ACEGYNE is indicated for the termination of pregnancy and has no other use during pregnancy
• Breastfeeding If you are breastfeeding, talk to your doctor before using this medicine
• Do not breastfeed while taking ACEGYNE
• Fertility This medicine does not affect fertility
• You can become pregnant again as soon as your termination is completed
• You should start contraception immediately after the termination of the pregnancy is confirmed by your doctor

Interactions and medicines to check

The approved leaflet names these interactions.

• corticosteroids (used in the treatment of asthma or other inflammation treatments)
• ketoconazole, itraconazole (used in antifungal treatment)
• erythromycin, rifampicin (antibiotics)
• St John’s Wort (natural remedy used in the treatment of mild depression)
• phenytoin, phenobarbital, carbamazepine (used in the treatment of seizures, epilepsy)
• non-steroidal anti-inflammatory drugs (NSAIDs) such as acetyl salicylic acid or diclofenac. ACEGYNE with food and drink Grapefruit juice should not be taken when you are treated with ACEGYNE

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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