The short answer is whenever you suspect a medicine, vaccine or supplement caused an unwanted effect. There is no minimum severity, and you do not need to be sure.
If you want to prioritise, the reports that matter most are those that are serious, those that are not listed in the product information, and those involving a newer product where less is known. See what side effects should be reported.
Quick answer: when and how to report a suspected side effect
What information to record
Report as soon as is practical, because accuracy fades. Dates blur, packaging gets thrown away, and the batch number becomes unrecoverable.
That said, a reaction from months or years ago is still worth reporting if you never did. There is no deadline, and an older report with partial detail is better than none.
Where reporting fits into medicine safety
Deal with the reaction first. Reporting is never urgent in the way treatment is.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone. See who can report.
Where reporting fits into medicine safety
Do not assume someone else has already reported it. Under-reporting, not duplication, is the standing problem in every country.
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
What happened when the medicine was stopped, and what happened if it was restarted, are particularly informative, because they speak to whether the medicine was responsible.
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
A fault with the product itself, rather than a reaction to it, goes through the same combined form. See reporting a 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. See serious medication side effects.
When to contact a doctor, pharmacist, or emergency service
If you are unsure whether something is worth reporting, it almost certainly is.
What happens after a report is submitted?
What information to record
Keep a copy. If the same reaction recurs, a follow-up referencing the first is more useful than a repeat.
Where reporting fits into medicine safety
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.