SAHPRA publishes a reporting form that covers two things at once: suspected adverse drug reactions and quality problems with a product. That combination is useful, because people often cannot tell which they are dealing with. A tablet that looked wrong and was followed by feeling unwell is both questions at once, and one form handles it.
The form is available from SAHPRA’s website. Current versions and links are published on the health products vigilance page.
Quick answer: when and how to report a suspected side effect
What information to record
Have the packaging in front of you before you start. Most of what the form asks for is printed on the carton, and it is the part people cannot reconstruct afterwards.
Where reporting fits into medicine safety
The form suits situations where you want a written record, where there is a product fault as well as a reaction, or where a health professional is submitting on your behalf. For a quick report from a phone, the Med Safety App is usually easier.
Who can report a side effect or adverse drug reaction?
What information to record
Members of the public as well as healthcare professionals. If you are reporting for someone else, complete the patient details for them rather than yourself. See who can report.
Where reporting fits into medicine safety
Do not be put off by fields that look clinical. Sections you cannot complete can be left blank, and an incomplete form is accepted.
What information should you collect before reporting?
What information to record
The form is organised around four blocks, and gathering them first makes it straightforward:
- Patient details. Age, sex, weight where known, and relevant history including pregnancy, kidney or liver conditions and previous reactions. Identifying details are handled confidentially.
- Product details. Name, strength, dose form, batch number, expiry date, the dose taken, and the start and stop dates.
- The reaction. What happened in plain description, when it started, how long it lasted, how severe it was, any treatment given, and the outcome.
- Everything else taken, including other prescriptions, over-the-counter products, supplements and herbal remedies.
Where reporting fits into medicine safety
Two questions on the form carry unusual weight: what happened when the medicine was stopped, and what happened if it was restarted. Improvement on stopping, and recurrence on restarting, is among the strongest available evidence that a medicine was responsible. Answer those carefully if you can.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- The Med Safety App, SAHPRA’s mobile route for self-reporting by the public and health professionals. See the Med Safety App guide.
- SAHPRA online reporting. Current links are published on the SAHPRA health products vigilance page.
- The adverse drug reaction and quality problem reporting form. See the ADR form guide.
- Vaccines through SAHPRA’s AEFI reporting system.
- Through your doctor or pharmacist, or the company marketing the product.
Where reporting fits into medicine safety
For a quality problem, describe what is wrong with the product and keep it rather than discarding it, since it may be needed for investigation. See reporting a medicine quality problem.
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, not a report. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
The form is not a route to advice. Nobody will contact you about your care as a result of submitting it.
What happens after a report is submitted?
What information to record
Keep a copy of the completed form before sending it. If you are asked for further detail later, that copy is what you will need.
Where reporting fits into medicine safety
Your report joins others for the same product and is assessed for patterns. See the SAHPRA ADR reporting guide and 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.