Answer the side-effect intent for amoxicillin 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 16/05/2023) and professional information (approved 16/05/2023) 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 amoxicillin?
Amoxicillin contains the active ingredient Amoxicillin Trihydrate.
- Active ingredient — Amoxicillin Trihydrate
- Registration holder — Portfolio Laboratories (Pty) Ltd
It is approved for:
- AMOXICILLIN PORTFOLIO is an antibiotic, belonging to a group of medicines called penicillins
- AMOXICILLIN PORTFOLIO is used to treat infections caused by bacteria in different parts of the body
- AMOXICILLIN PORTFOLIO may also be used in combination with other medicines to treat stomach ulcers
Common side effects of amoxicillin
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 as “Frequent” and “Less frequent” rather than the very common/common/uncommon scale used in some other markets.
Frequent side effects
- diarrhoea, nausea
- skin rash
Less frequent side effects
- thrush (a yeast infection of the vagina, mouth or skin folds)
- low number of white blood cells, low number of cells involved with blood clotting, blood may take longer to clot than it normally would. You may notice this if you have a nosebleed or you cut yourself
- fits (convulsions), dizziness, hyperactivity
- vomiting, inflammation of the colon, tongue may have a hairy, black appearance
- skin reactions such as rashes
- kidney problems
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 amoxicillin from the SAHPRA-approved patient information leaflet or professional information, and cite what you actually used.
- Anything the approved information for amoxicillin 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 amoxicillin, penicillin or any of the other ingredients of AMOXICILLIN PORTFOLIO (listed in section 6)
- if you have ever had an allergic reaction to any antibiotic. This can include a skin rash or swelling of the face or throat
- if you have infectious mononucleosis, also known as glandular fever (fever, sore throat, swollen glands and extreme tiredness). A high percentage of patients with mononucleosis who receive amoxicillin develop an erythematous skin rash
Use with care, and tell your doctor, if
- if you had seizures, have epilepsy or had inflammation of the membranes and fluids surrounding the brain and spinal cord (meningeal disorders). You might experience convulsions when taking high dosages of AMOXICILLIN PORTFOLIO
- if you have kidney problems or are not urinating regularly. Your doctor may need to change the dose of AMOXICILLIN PORTFOLIO
- if you had a skin rash that looks like measles. It may be more likely that you will have a severe skin reaction when taking AMOXICILLIN PORTFOLIO
- if you develop a Jarisch-Herxheimer’s reaction. This reaction has been reported during amoxicillin treatment of syphilis or tick-borne diseases like Lyme disease. Symptoms include high fever, a general feeling of discomfort, illness, or unease, nausea, vomiting, headache, muscle pain, aggravated skin rashes, fast heartbeat and chills
- if you develop diarrhoea. This may happen while you are taking AMOXICILLIN PORTFOLIO, or within a few months after you stop taking it. This may be a sign of a new infection. If you have diarrhoea that is watery or bloody, stop taking AMOXICILLIN PORTFOLIO and call your doctor. Do not use anti- diarrhoea medicine unless your doctor tells you to
- if you are having laboratory tests, because AMOXICILLIN PORTFOLIO can affect the results of some of these tests. If you are not sure if any of the above apply to you, talk to your doctor or pharmacist before taking AMOXICILLIN PORTFOLIO
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
- AMOXICILLIN PORTFOLIO is excreted in small quantities into breast milk and it is possible that your baby can experience diarrhoea and fungus infection
- Breastfeeding while taking AMOXICILLIN PORTFOLIO is not advised
Interactions and medicines to check
The approved leaflet names these interactions.
- If you are taking allopurinol (used for gout) with AMOXICILLIN PORTFOLIO, it may be more likely that you will have an allergic skin reaction
- If you are taking probenecid (used for gout), your doctor may decide to adjust your dose of AMOXICILLIN PORTFOLIO
- If you are taking medicines to help stop your blood from clotting (such as warfarin), you may need extra blood tests
- If you are taking other antibiotics (such as tetracycline) AMOXICILLIN PORTFOLIO may be less effective
- If you are taking methotrexate (used for the treatment of cancer and severe psoriasis) AMOXICILLIN PORTFOLIO may cause an increase in side effects
- If you are taking birth control pills, as AMOXICILLIN PORTFOLIO may affect the efficacy of some of these pills
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-00130 · build rank 130 · Phase 1 · Tier 1. 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 1,500–2,200 words.