Side effects from over-the-counter medicines can be reported to SAHPRA in exactly the same way as those from prescription medicines. Nothing about buying something without a prescription puts it outside the safety monitoring system.
Pharmacy medicines are heavily under-reported, for an understandable reason: people assume that something sold openly must already be fully understood, and that a reaction to it is not worth mentioning. Both assumptions are wrong. These products are used by enormous numbers of people, often without any professional involvement, which makes reports about them particularly valuable.
Common side effects of this pharmacy medicine or category
Worth reporting: any reaction you suspect an over-the-counter product caused, an interaction with a prescription medicine, an effect not described on the label, and anything serious.
Accidental overdose is also worth reporting, particularly where duplicate ingredients across products were involved. Those reports are what identify labelling and packaging problems that make the mistake easy to make. See taking two medicines with paracetamol.
Interactions and duplicate-ingredient risks
If you suspect an interaction, list every product involved including supplements. Interaction reports depend on that full list, and it cannot be reconstructed afterwards. See OTC medicine interactions.
Children, pregnancy, older adults and chronic medicine cautions
Reactions in children, in pregnancy, and in older adults are especially useful to report, because these groups are typically under-represented in the studies done before a product reaches the market. If you are reporting for someone else, record their details rather than your own.
Warning signs and overdose concerns
Deal with the reaction first. Get emergency help for difficulty breathing or facial swelling, a rash that blisters or peels, vomiting blood or black tarry stools, severe abdominal pain, or any suspected overdose, including paracetamol, even when the person feels well. Report afterwards.
See when to see a doctor about an OTC medicine.
Questions to ask a pharmacist before using it
What to collect before reporting:
- Product name, strength, dose form, and the full active ingredient list
- Batch number and expiry date from the carton
- How much was taken and over what period
- What happened, when it started, and what happened after stopping
- Every other medicine and supplement being taken
Your pharmacist can also submit a report on your behalf, which is often the easiest route if you are speaking to them about the reaction anyway.
How to report:
- The Med Safety App
- SAHPRA online reporting, linked from the health products vigilance page
- The adverse drug reaction and quality problem form
- Through your pharmacist or doctor
Related OTC and medicine-safety guides
- OTC medicine side effects
- Reporting side effects in South Africa
- Side effect reporting checklist
- Report a medicine quality problem
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.