Reporting a suspected side effect takes about ten minutes if you have the details ready, and considerably longer if you have thrown the box away. This checklist covers what to collect first, where to submit it in South Africa, and what happens next.
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. You do not need proof, a diagnosis, or a health professional’s agreement. Before you start, put three things in front of you: the packaging, a note of dates, and a list of everything else being taken.
Where reporting fits into medicine safety
Reports from the public are a primary source of safety information after a medicine is licensed. See reporting side effects in South Africa for the full picture.
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, note their age, sex and relevant history rather than your own. See who can report medicine side effects.
Where reporting fits into medicine safety
You can report even if a health professional has told you the medicine was probably not responsible. Disagreement is not a barrier, and suspected is the standard.
What information should you collect before reporting?
What information to record
- The product. Name, strength, dose form, batch number and expiry date, all printed on the carton or strip. Keep the packaging until the report is done.
- The person. Age, sex, and relevant history such as pregnancy, breastfeeding, kidney or liver conditions, allergies and previous drug reactions.
- The timing. When the medicine started, the dose taken, when the reaction began, and how long it lasted.
- The reaction. What happened in plain description, how severe it was, and whether it needed treatment or hospital care.
- The outcome. Whether it resolved, is ongoing, or left lasting effects, and what happened if the medicine was stopped or restarted.
- Everything else taken. All other medicines, contraceptives, herbal products and supplements, including anything bought without a prescription.
Where reporting fits into medicine safety
Do not hold a report back because part of the list is missing. Incomplete reports are accepted and still useful. The batch number and the list of other products are the two most valuable entries if you have to prioritise.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- The SAHPRA Med Safety App. A mobile app for reporting suspected adverse reactions, designed for use by the public as well as health professionals. See the Med Safety App guide.
- SAHPRA’s online reporting. South Africa’s public reporting runs through the reporting routes listed on SAHPRA’s health products vigilance page, linked from SAHPRA’s health products vigilance page. See SAHPRA adverse drug reaction reporting.
- The ADR reporting form. A structured form covering the patient, the product and the reaction. See the ADR form guide.
- Through your doctor or pharmacist. 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.
- Through the company that markets the medicine. Licence holders are obliged to collect safety reports and pass them to the regulator.
A quality problem with the product itself, such as a damaged tablet, wrong contents or suspected counterfeit, follows a different route. See reporting a medicine quality problem.
Where reporting fits into medicine safety
Pick one route and use it once. See the Med Safety App compared with online reporting if you are unsure which suits you.
What counts as a serious or unexpected side effect?
Red-flag symptoms
In medicine safety, a reaction is treated as serious when it results in death, threatens life, requires or prolongs hospital admission, causes lasting disability, causes a birth defect, or is judged medically important for another reason. That definition is about consequence, not about how unpleasant the experience was.
Unexpected means the reaction is not described in the approved product information for that medicine. Unexpected reactions matter to regulators even when they are mild, because they may be the first sign of something not yet known about the product.
If any of the following are happening now, get emergency help and report later:
- Difficulty breathing, wheeze, or a tightening throat
- Swelling of the face, lips, tongue or throat
- Chest pain, fainting or collapse
- Seizure, or sudden confusion or unresponsiveness
- A rash that blisters or peels, or sores in the mouth or eyes with fever
- Vomiting blood, or black tarry stools
- Thoughts of harming yourself
When to contact a doctor, pharmacist, or emergency service
Filing a report does not get anyone to review your care. If you need advice about what to do next, ask a pharmacist or your prescriber as a separate step.
What happens after a report is submitted?
What information to record
Keep a copy of what you sent and any reference number. If the same reaction happens again, or worsens, a second report referencing the first is more useful than a repeat of the same information.
Where reporting fits into medicine safety
Reports are assessed alongside others for the same product to look for patterns. Most individual reports produce no visible outcome, which is expected. The value is cumulative. 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.