Answer side-effect and tolerability questions around levonorgestrel, including expected changes, warning signs and safe escalation guidance.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 24/10/2023) and professional information (approved 24/10/2023) for this product: patient information leaflet, professional information. Retrieved 2026-09-03. Where this page and the approved leaflet differ, the leaflet is correct.
What is levonorgestrel?
Levonorgestrel contains the active ingredient Levonorgestrel.
- Active ingredient — Levonorgestrel
- Registration number — 53/21.8.2/0608
- Registration holder — Unicorn Pharmaceuticals (Pty) Ltd
It is approved for:
- LEVONORGESTREL 1,5 UNICORN is an emergency oral contraceptive, which is used to prevent pregnancy
- LEVONORGESTREL 1,5 UNICORN must be used within 72 hours (3 days) of having unprotected sexual intercourse or if your usual contraceptive method has failed
- LEVONORGESTREL 1,5 UNICORN should only be used as an emergency contraceptive and is not suitable for regular contraception
- It is not as reliable as regular oral hormonal contraceptives
Who should take extra care
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you are hypersensitive (allergic) to levonorgestrel or any of the other ingredients of LEVONORGESTREL 1,5 UNICORN
- If you have severe liver problems
- If you are or think you may be pregnant. This may be possible if you had unprotected sexual intercourse in the same cycle or if the last menstrual period has not occurred. LEVONORGESTREL 1,5 UNICORN will not work if you are already pregnant
- You have depression, which is not well controlled with treatment
- You have had depression with previous use of hormonal contraceptives
Use with care, and tell your doctor, if
- You had unprotected sex more than 72 hours ago, and since your last period
- Your menstrual period is more than 5 days late
- You have experienced abnormal bleeding when your next period is due. The use of LEVONORGESTREL 1,5 UNICORN is not advised:
- If you have ever had an ectopic pregnancy (when your baby develops outside the uterus/womb)
- If you have ever had a disease called salpingitis (inflammation of the fallopian tubes)
- If you have a disease of your small bowel that interferes with the way you digest or absorb your food (for example, Crohn’s disease)
- If you are worried about sexually transmitted diseases. LEVONORGESTREL 1,5 UNICORN, or any other hormonal contraceptives, will not protect you against sexually transmitted diseases. Only condoms can do this. Consult your healthcare professional for advice if you are worried about this
- If you are overweight or have a high body mass index (BMI). LEVONORGESTREL 1,5 UNICORN may be less effective with increasing body weight or BMI. This information is limited and inadequate, therefore, LEVONORGESTREL 1,5 UNICORN is still recommended for all women irrespective of their weight or BMI. It is recommended that all women should take emergency contraception as soon as possible after unprotected intercourse
- Hormonal contraceptives including LEVONORGESTREL 1,5 UNICORN, may cause mood changes and depression, which may be severe. Severe depression is associated with a higher risk of suicidal thoughts/behaviour (e.g. talking about suicide, withdrawing from social contact, having mood swings, being preoccupied with death or violence, feeling hopeless about a situation, increasing use of alcohol/drugs, doing self-destructive things, personality changes), and suicide. If you experience mood changes or depression, contact your healthcare provider for advice. Children and adolescents
- If you are younger than 16 years old. LEVONORGESTREL 1,5 UNICORN should not be used unless your healthcare professional has advised you to. Other medicines with LEVONORGESTREL 1,5 UNICORN: Always tell your health care provider if you are taking any other medicine. (This includes complementary or traditional medicines)
- Medicines used in the treatment for HIV infection (such as efavirenz and ritonavir)
- Medicines used to treat epilepsy (such as carbamazepine, phenytoin and primidone)
- Herbal remedies containing St John’s wort (Hypericum perforatum)
- Medicines used to treat tuberculosis (such as rifampicin and rifabutin)
- Griseofulvin, a medicine used to treat fungal infections
- Antibiotics such as ampicillin
- Cyclosporin, a medicine that suppresses the immune system. Taking LEVONORGESTREL 1,5 UNICORN with food, drink and alcohol: LEVONORGESTREL 1,5 UNICORN can be taken with or without food
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 taking this medicine
- Pregnancy Do not take LEVONORGESTREL 1,5 UNICORN if you are pregnant
- LEVONORGESTREL 1,5 UNICORN cannot interrupt a pregnancy
- LEVONORGESTREL 1,5 UNICORN will not work if you had unprotected sex more than 72 hours ago, and since your last menstrual period
- If you do become pregnant after taking LEVONORGESTREL 1,5 UNICORN, it is important that you consult your doctor
- There is no information that suggests that LEVONORGESTREL 1,5 UNICORN will harm your baby, but your doctor should confirm that the pregnancy is not ectopic (when your baby develops outside your uterus/womb)
Common side effects of levonorgestrel
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.
About these frequency terms
This leaflet groups effects on the very common/common/uncommon scale.
Reported side effects
- Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing
- Rash or itching
- Fainting
- Yellowing of the skin and eyes, also called jaundice
- These are all very serious side effects. If you have them, you may have had a serious allergic reaction to LEVONORGESTREL 1,5 UNICORN. 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:
- Chest pain
- Angina
- Changes in the way your heart beats e.g. if you notice it beating faster
- Difficulty in breathing
- Less urine than is normal for you
- These are all serious side effects. You may need medical attention. Tell your doctor if you notice any of the following: The following side effects have frequently been reported:
- Headaches and dizziness
- Diarrhoea, lower abdominal pain, nausea or being sick (vomiting). If you experience vomiting, please read the section “If you vomit after taking LEVONORGESTREL 1,5 UNICORN”
- Irregular bleeding or spotting before your next menstrual period
- Brest tenderness
- Your period may be different. It may be earlier or later than the expected date. If your period is more than 5 days late, is unusually light or unusually heavy, contact your healthcare professional as soon as possible
- Feeling tired. The following side effects have been reported less frequently:
- Abdominal pain
- Itching, rash or hives (raised, itchy areas of skin)
- Painful menstruation or pain in the pelvic area
- Swelling of the face
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 levonorgestrel 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.
Evidence required before publish — source the following for levonorgestrel from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- The bleeding pattern the approved information for levonorgestrel describes as expected
- How long the source says an irregular pattern typically continues before settling
- What the source says about periods stopping, and whether that is described as harmless
- Bleeding that the source says should prompt medical review
Bleeding that needs checking
Very heavy bleeding that soaks through protection hourly, bleeding with severe pain or dizziness, or bleeding after sex that is new for you should be looked at by a healthcare professional rather than waited out.
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
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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.
Evidence required before publish — source the following for levonorgestrel from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for levonorgestrel says about how long specific effects last
- Whether the source describes any effect as usually temporary, or as needing review if it persists
- Whether any effect is described as continuing after the product is stopped
What happens after stopping or changing the method?
What happens after stopping or changing levonorgestrel 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.
Evidence required before publish — source the following for levonorgestrel from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- What the approved information for levonorgestrel says about stopping or removal
- How long the source says it takes for the effect to wear off
- What the source says about return of fertility
- Any symptom the source says to expect after stopping, and any that needs review
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.
Call for emergency help now if any of these happen
- Difficulty breathing, wheezing, or tightness in the throat or chest
- Swelling of the face, lips, tongue or throat
- A widespread rash with blistering or peeling skin, or sores in the mouth, eyes or genitals
- Fainting, collapse, or a sudden severe drop in alertness
- Chest pain, or sudden weakness or numbness on one side of the body
- A fit (seizure), or confusion that comes on suddenly
In South Africa call 10177 for an ambulance, or 112 from a mobile phone. Go to your nearest emergency department if it is faster. Do not wait to see whether the symptom settles.
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
If you are having thoughts of harming yourself
Help is available in South Africa. The SADAG helpline is 0800 567 567, or you can go to your nearest emergency department. You do not have to wait until it feels like an emergency.
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
Reporting is not a substitute for medical care
If someone is unwell now, get medical help first and report afterwards. Urgent symptoms always take precedence over paperwork.
For a fuller walkthrough see how to report an adverse drug reaction.
Related pages
← Back to more contraception side effects.
Report a side effect
If you think you have had a side effect, you can report a suspected side effect in South Africa. Report a suspected side effect through the appropriate SAHPRA pathway where relevant.
Information only
This page gives general medicine-safety information for people in South Africa. It is not a diagnosis and not personalised medical advice. It cannot tell you whether a symptom you are having is caused by a particular product. Speak to a pharmacist or doctor about your own situation, and do not stop or change a prescribed treatment on the basis of a web page.
Editorial status: draft — not for publication
Brief SE-00317 · build rank 317 · Phase 2 · Tier 2. Every evidence slot on this page must be completed from the SAHPRA-approved source and the page signed off by a qualified clinical or pharmacy reviewer before it is published. Target length 1,300–2,000 words.