Answer the side-effect intent for ivermectin without diagnosing; distinguish common from serious reactions and give safe next-step/reporting guidance.
Source
Clinical statements on this page are taken from the SAHPRA-approved patient information leaflet (approved 10/08/2022) and professional information (approved 10/08/2022) 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 ivermectin?
Which leaflet this comes from
There is no approved leaflet for Ivermectin in SAHPRA’s public repository. The information below is from the approved leaflet for ILADEK 3, another South African product containing Ivermectin. Products with the same active ingredient can still differ in strength, formulation and approved uses, so check the leaflet in your own pack.
Ivermectin contains the active ingredient Ivermectin.
- Active ingredient — Ivermectin
- Registration holder — Trinity Pharma (Pty) Ltd
It is approved for:
- an infestation of the intestine called intestinal strongyloidosis (anguillulose). It is caused by a type of roundworm called Strongyloides stercoralis
- an infestation of blood called microfilaraemia due to lymphatic filariasis. It is caused by an immature worm called Wuchereria bancrofti
- onchocerciasis, a disease caused by infestation with a parasite: the Onchocerca volvulus filariae
- skin mites (scabies)
- This is when tiny mites burrow under your skin. This can cause you severe itching
- the safety and effectiveness of ivermectin for the treatment of COVID-19 has not been established
Common side effects of ivermectin
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
- Sudden fever
- Sudden skin reactions (such as skin rash or itching) or other serious skin reactions
- Difficulty breathing These are all very serious side effects
- If you have them, you may have had a serious reaction to ILADEK 3. You may need urgent medical attention or hospitalisation. Other side effects
- liver disease (acute hepatitis)
- modification of some laboratory tests (increase of liver enzymes
- increase of bilirubin on blood, increase of eosinophil levels)
- presence of blood in urine
- These are all serious side effects. You may need urgent medical attention. The side effects listed below depend on what you are taking ILADEK 3 for. They also depend on the presence or absence of other infections: People with intestinal strongyloidiasis (anguillulosis) may have the following side effects:
- feeling unusually weak
- loss of appetite, stomach pain, constipation, or diarrhoea
- nausea or vomiting
- feeling sleepy or dizzy
- shaking or tremors. In case of intestinal strongyloidosis (anguillulosis), adult roundworms can also be found in your stool. People with microfilaraemia caused by Wuchereria bancrofti may have the following side effects:
- sweats or fever
- headache
- feeling unusually weak
- muscle, joint and whole-body pain
- loss of appetite, nausea
- stomach pain (abdominal and epigastric pain)
- painful cough or throat
- difficulty breathing
- low blood pressure when standing up – you may feel dizzy or light-headed
- chills
- dizziness
- pain or discomfort in the testicles. People with scabies may have the following side effects:
- itching (pruritus) may get worse at the start of treatment. This does not usually last long. Highly infested individuals with Loa loa worm may have the following side effects:
- disorders of the brain function
- neck pain or back pain
- bleeding in the white of the eye (also called red eye)
- shortness of breath
- loss of control of the bladder or intestines
- difficulty standing or walking
- disorders of the mental state
- feeling drowsy or confused
- unable to respond to other people or coma. Infected individuals with the worm (Onchocerca volvulus) responsible for river blindness may have the following side effects:
- itching or rash
- joint or muscle pain
- fever
- nausea or vomiting
- swelling of the lymph nodes
- swelling, especially in the hands, ankles or feet
- diarrhoea
- dizziness
- low blood pressure (hypotension). You may feel dizzy or lightheaded when standing up
- fast heart rate
- headache or feeling tired
- vision problems and other eye problems such as infection, redness or unusual sensations
- bleeding in the white of the eye or swelling of the eyelids
- worsening of asthma
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 ivermectin from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for ivermectin 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
Factors that may affect side effects
The approved leaflet identifies the following cautions and factors.
Do not use it at all if
- If you are hypersensitive (allergic) to ivermectin or any of the other ingredients of ILADEK 3 (listed in section 6). Symptoms of an allergic reaction to a medicine may include skin rash, difficulty breathing of fever
Use with care, and tell your doctor, if
- If you have a deficient immune system
- If you live or have lived in parts of Africa where there are cases of human parasitic infestation with the Loa loa filarial worm also called eye-worm
- If you currently live or have lived in parts of Africa. The use of diethylcarbamazine citrate (DEC) to treat Onchocerca volvulus infestation may increase the risk of adverse effects that can sometimes be serious. Children The safety of using ivermectin in children weighing less than 15 kg has not been evaluated
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
- • If you are pregnant, do not take ILADEK 3 tablet
- The decision will be made in agreement with your doctor
- • If you are breastfeeding or intend to breastfeed, as ILADEK 3 passes into breast milk
- Your doctor may decide to start your treatment one week after the birth of your child
Interactions and medicines to check
The approved leaflet names these interactions.
- Always tell your health care provider if you are taking any other medicine (This includes all complementary or traditional medicines)
Bring the actual products to the conversation
A pharmacist can check for interactions much faster from the packaging than from remembered names.
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
Do not stop a prescribed treatment on your own
Stopping some treatments suddenly causes its own problems, and the condition being treated may get worse. If you want to stop, ask a pharmacist or doctor how to do it safely — they can usually offer an alternative.
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.
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 medicine 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-00286 · build rank 286 · 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.