In South Africa, suspected side effects are reported to the South African Health Products Regulatory Authority (SAHPRA). You do not need to be a doctor or pharmacist, and you do not need to prove the medicine was responsible. A reasonable suspicion is enough to report.
Reporting is not treatment. If someone is unwell now, deal with that first and report afterwards. See what to do if a medicine causes side effects.
Start here: find the right side-effect guide
Category cards
- Reporting a medicine reaction. Use the routes below, or the reporting checklist to prepare.
- Reporting a vaccine reaction. See reporting vaccine side effects.
- Reporting a supplement reaction. See reporting supplement side effects.
- Reporting a faulty or suspect product. See medicine quality problems.
Common vs serious effects
Both are worth reporting, but serious and unexpected reactions matter most, because those are the ones clinical trials were too small to detect. See which side effects should be reported.
Common side effects vs serious side effects
Common examples linked to report side effects South Africa
In medicine safety, a reaction is treated as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is judged medically important for another reason. That definition is about consequence, not about how unpleasant the experience was.
Unexpected means the reaction is not described in the approved product information for that medicine. Unexpected reactions matter to regulators even when they are mild, because they may be the first sign of something not yet known about the product.
How to describe frequency without overclaiming
Write what you observed, not what you concluded. A report saying that a rash appeared on day three of a course of antibiotics and cleared four days after stopping is far more useful than one saying the antibiotic caused an allergy. Assessment is the regulator’s job; observation is yours.
Medicine, supplement and symptom categories covered
Priority related pages
- Who can report a side effect
- When to report and what should be reported
- What an adverse drug reaction is
- SAHPRA pharmacovigilance and what pharmacovigilance means
How to choose the right next guide
If you already know what happened and just want to submit, go to the routes below. If you are unsure whether it is worth reporting, it almost certainly is, and the checklist will take about ten minutes.
When to speak to a doctor or pharmacist
Red-flag symptoms
Do not delay care in order to file a report. Get emergency help for:
- Difficulty breathing, wheeze, or a tightening throat
- Swelling of the face, lips, tongue or throat
- Chest pain, fainting or collapse
- Seizure, or sudden confusion or unresponsiveness
- A rash that blisters or peels, or sores in the mouth or eyes with fever
- Vomiting blood, or black tarry stools
- Thoughts of harming yourself
When to contact a doctor, pharmacist, or emergency service
Reporting and treatment are separate systems. A submitted report does not reach anyone who will contact you about your care, so if you need advice, get it from a pharmacist or doctor as well.
How side effects can be reported in South Africa
What information to record
- The product. Name, strength, dose form, batch number and expiry date, all printed on the carton or strip. Keep the packaging until the report is done.
- The person. Age, sex, and relevant history such as pregnancy, breastfeeding, kidney or liver conditions, allergies and previous drug reactions.
- The timing. When the medicine started, the dose taken, when the reaction began, and how long it lasted.
- The reaction. What happened in plain description, how severe it was, and whether it needed treatment or hospital care.
- The outcome. Whether it resolved, is ongoing, or left lasting effects, and what happened if the medicine was stopped or restarted.
- Everything else taken. All other medicines, contraceptives, herbal products and supplements, including anything bought without a prescription.
Where reporting fits into medicine safety
- The SAHPRA Med Safety App. A mobile app for reporting suspected adverse reactions, designed for use by the public as well as health professionals. See the Med Safety App guide.
- SAHPRA’s online reporting. South Africa’s public reporting runs through the reporting routes listed on SAHPRA’s health products vigilance page, linked from SAHPRA’s health products vigilance page. See SAHPRA adverse drug reaction reporting.
- The ADR reporting form. A structured form covering the patient, the product and the reaction. See the ADR form guide.
- Through your doctor or pharmacist. Health professionals report through the same system and can submit on your behalf, which is often easiest if you are already seeing them about the reaction.
- Through the company that markets the medicine. Licence holders are obliged to collect safety reports and pass them to the regulator.
A quality problem with the product itself, such as a damaged tablet, wrong contents or suspected counterfeit, follows a different route. See reporting a medicine quality problem.
Reports are assessed alongside others for the same product. A single report rarely changes anything on its own; a pattern across many can lead to a leaflet change, a new warning, a restriction, or a recall. That system is called pharmacovigilance, and it only works if people submit.
Most useful next pages
Priority related pages
How to choose the right next guide
Prepare with the checklist, then pick whichever route you will actually complete. An imperfect report that gets submitted is worth more than a perfect one that does not.
Medical Disclaimer: This content is for informational and educational purposes only and does not constitute medical diagnosis, prescription, or professional advice. Always read the patient information leaflet and consult a qualified doctor or pharmacist regarding any medicine or health concern.