Both routes reach the same place. A report submitted through the Med Safety App and one submitted through SAHPRA’s online reporting enter the same national safety system and are assessed the same way. The choice is about convenience, not about which counts for more.
Use whichever you will actually complete. A submitted report through the less elegant route beats an abandoned one through the better route.
Quick answer: when and how to report a suspected side effect
What information to record
Either route asks for broadly the same things: the product and batch number, who it happened to, the dates, what happened, and everything else being taken.
Where reporting fits into medicine safety
The app tends to suit reporting in the moment, with the packet in hand. The web form tends to suit a longer or more complicated history, where typing on a keyboard is easier.
Who can report a side effect or adverse drug reaction?
What information to record
Both routes are open to the public and to health professionals. Neither requires clinical qualification. See who can report.
Where reporting fits into medicine safety
If you have no smartphone or limited data, the web form removes the download step. If you have limited fixed internet access, the app may be the more practical option.
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
Gather this before you start on either route. See the reporting checklist.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- Med Safety App. Downloaded from your device’s app store; suits reporting at the moment it happens. See the app guide.
- SAHPRA online reporting. Through the reporting routes listed on SAHPRA’s health products vigilance page, linked from SAHPRA’s vigilance page.
- The ADR and quality problem form. Useful if you also need to report a fault with the product itself. See the form guide.
- Vaccines follow the separate AEFI reporting route.
Where reporting fits into medicine safety
Do not submit the same reaction through both. Duplicates have to be identified and merged later, which costs assessment time.
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 rather than a report. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
Neither route provides clinical advice or triggers a call back about your care.
What happens after a report is submitted?
What information to record
Keep a copy or reference number whichever route you use.
Where reporting fits into medicine safety
From the assessment point onwards the two routes are indistinguishable. See reporting side effects 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.