Anyone can report a suspected side effect in South Africa. You do not need to be a doctor, pharmacist or nurse, you do not need a diagnosis, and you do not need anyone’s permission or agreement.
That includes the person affected, a parent or caregiver reporting for someone else, a family member, and health professionals. SAHPRA treats reports from consumers as a meaningful part of its safety monitoring rather than as a lesser source. See can patients report side effects in South Africa.
Quick answer: when and how to report a suspected side effect
What information to record
Report when you suspect a medicine, vaccine or supplement caused an unwanted effect. Keep the packaging and note the dates before you start.
Where reporting fits into medicine safety
The threshold is deliberately low. Filtering genuine signals from coincidence is the regulator’s job, not yours.
Who can report a side effect or adverse drug reaction?
What information to record
Reporting for someone else. Record their age, sex and history rather than your own, and note your relationship to them. This is the usual situation for a parent reporting for a child, or an adult reporting for an older relative.
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.
Companies holding a product registration are legally obliged to collect and pass on safety reports.
Where reporting fits into medicine safety
You can report even if a clinician has told you the medicine was probably not responsible. Disagreement is not a barrier, and the standard is suspicion rather than proof.
What information should you collect before reporting?
What information to record
- The product. Name, strength, dose form, batch number and expiry date.
- The person. Age, sex and relevant history.
- The timing. When it started, when the reaction began, how long it lasted.
- The reaction and outcome, including whether hospital care was needed.
- Everything else taken, including supplements.
Where reporting fits into medicine safety
Incomplete reports are accepted. See the reporting checklist.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- SAHPRA online reporting via the reporting routes listed on SAHPRA’s health products vigilance page
- The Med Safety App
- The ADR and quality problem form
- Vaccines through AEFI reporting
- Through a doctor or pharmacist, or the company marketing the product
Where reporting fits into medicine safety
Use one route only. See reporting side effects in South Africa.
What counts as a serious or unexpected side effect?
Red-flag symptoms
A reaction counts as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is otherwise medically important. Unexpected means it is not described in the approved product information.
Deal with the reaction first. Difficulty breathing, facial or throat swelling, chest pain, seizures or a blistering rash need emergency care. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
Reporting does not get you advice. Contact a pharmacist or doctor separately if you need it.
What happens after a report is submitted?
What information to record
Keep a copy and any reference number.
Where reporting fits into medicine safety
Reports are pooled and assessed for patterns. Most produce no visible individual outcome, which is expected. See what pharmacovigilance means.
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.