Pharmacovigilance in South Africa is run by the South African Health Products Regulatory Authority, SAHPRA. It covers the monitoring of medicines, vaccines and medical devices once they are in use, and it depends substantially on reports submitted by the public and by health professionals.
The practical point for anyone reading this: you can report directly, without going through a doctor, and you do not need to prove the product was responsible.
Quick answer: when and how to report a suspected side effect
What information to record
Report as soon as practical, while the packaging and the timeline are still available. Record the product name and batch number, the dates, what happened, and everything else being taken.
Where reporting fits into medicine safety
South Africa’s medicine use differs from the populations most clinical trials are conducted in, which is exactly why local reporting matters rather than relying on findings from elsewhere.
Who can report a side effect or adverse drug reaction?
What information to record
Members of the public, caregivers reporting on behalf of someone else, health professionals, and licence holders. If you are reporting for another person, record their details rather than your own. See who can report.
Where reporting fits into medicine safety
Under-reporting is the main limitation of every pharmacovigilance system worldwide. Most reactions that occur are never reported, so each submission counts for more than it might seem.
What information should you collect before reporting?
What information to record
- The product. Name, strength, dose form, batch number and expiry date from the carton.
- The person. Age, sex, and relevant history including pregnancy, breastfeeding, kidney or liver conditions and previous reactions.
- The timing. When the product was started, the dose, when the reaction began and how long it lasted.
- The reaction and outcome. What happened, how severe, whether treatment or hospital care was needed, and whether it resolved.
- Everything else taken, including supplements and anything bought without a prescription.
Where reporting fits into medicine safety
An incomplete report is still accepted and still useful. Do not withhold one because you cannot answer everything.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- SAHPRA’s online adverse drug reaction reporting. South Africa’s public reporting is handled through the reporting routes listed on SAHPRA’s health products vigilance page, which SAHPRA links to from its own vigilance pages.
- The Med Safety App. A mobile app for reporting suspected adverse reactions, intended for the public as well as health professionals. See the Med Safety App guide.
- The adverse drug reaction and quality problem reporting form. SAHPRA publishes a single form covering both suspected reactions and problems with the product itself. See the ADR form guide.
- Vaccine reactions follow a separate route through SAHPRA’s AEFI reporting system. See reporting vaccine side effects.
- Through your doctor or pharmacist, who report through the same system and can submit on your behalf.
- Through the company that markets the medicine, which is obliged to collect safety reports and pass them to the regulator.
SAHPRA’s own overview sits on its health products vigilance page. Use one route only, so the same reaction is not recorded twice.
Where reporting fits into medicine safety
A problem with the product itself, such as damaged tablets, wrong contents or a suspected counterfeit, is reported through the same combined form rather than as a side effect. See reporting a medicine quality problem.
What counts as a serious or unexpected side effect?
Red-flag symptoms
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 is about consequence, not about how unpleasant it felt.
Unexpected means the reaction is not described in the approved product information. Unexpected reactions matter even when mild, because they may be the first sign of something not yet known.
Deal with the reaction first. If someone has difficulty breathing, facial or throat swelling, chest pain, a seizure, or a blistering rash, get emergency help and report afterwards. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
A submitted report does not reach anyone who will contact you about your care. Treatment and reporting are separate systems.
What happens after a report is submitted?
What information to record
Keep your own copy and any reference number. If the reaction recurs or worsens, a follow-up referencing the first report is more useful than repeating it.
Where reporting fits into medicine safety
Reports are assessed alongside others for the same product. Where a pattern emerges, SAHPRA can require leaflet changes, issue safety alerts, restrict how a product is used, or recall it. Those actions appear publicly through SAHPRA safety alerts and product recalls. See medicine recalls in South Africa.
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.