The Med Safety App is a mobile route for reporting suspected side effects to SAHPRA. It is listed among SAHPRA’s electronic services alongside its online adverse drug reaction reporting, and it is intended for the public as well as for healthcare professionals.
Its practical advantage is timing. Reports are most accurate when made while the packaging is still in front of you and the dates are fresh, and a phone is usually closer to hand than a computer.
Quick answer: when and how to report a suspected side effect
What information to record
Before you open the app, have the medicine carton with you. The details most often missing from reports are the batch number and the exact product strength, and both are printed on the pack.
Where reporting fits into medicine safety
Reports submitted through the app enter the same national safety system as those submitted any other way. The route does not change how the report is treated.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone: the person affected, a parent or caregiver reporting for someone else, or a health professional. If you are reporting for another person, enter their age and history rather than your own. See can patients use the Med Safety App.
Where reporting fits into medicine safety
You do not need a health professional’s agreement, and you can report even if you have been told the medicine was probably not responsible.
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
An incomplete report is accepted and still useful. Do not abandon one because a field is unknown. See the reporting checklist.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
Download the app from your device’s official app store, checking that the listing is the one associated with the regulator rather than a similarly named product. SAHPRA lists the Med Safety App among its electronic services, and its health products vigilance page is the authoritative starting point if you want to confirm the current route.
The alternatives, if you would rather not use an app:
- SAHPRA’s online reporting through the reporting routes listed on SAHPRA’s health products vigilance page
- The adverse drug reaction and quality problem form
- Vaccine reactions through SAHPRA’s AEFI reporting system
- Through your doctor or pharmacist
Where reporting fits into medicine safety
Use one route only, so the same reaction is not recorded twice. See the app compared with online reporting.
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
The app is not a way to get medical advice, and no one will respond to it clinically. For advice, contact a pharmacist or doctor.
What happens after a report is submitted?
What information to record
Keep any confirmation or reference the app gives you. If the reaction recurs or worsens, a follow-up referencing the original is more useful than a duplicate.
Where reporting fits into medicine safety
Your report is assessed with others for the same product. You will not usually hear back about your individual case, which is normal rather than a sign it was disregarded. 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.