An adverse drug reaction is a response to a medicine that is harmful and unintended, occurring at doses normally used in people. The dose is the key part: a reaction at a normal dose is an adverse drug reaction, while harm from too large a dose is an overdose or poisoning, which is handled differently.
In everyday use, side effect and adverse drug reaction are treated as the same thing. In regulation they are not quite: side effect is the broader term and can include effects that are unintended but harmless or even useful, while an adverse drug reaction is specifically harmful. See side effects and adverse drug reactions compared.
Quick answer: when and how to report a suspected side effect
What information to record
Report as soon as you can, while the packaging and the timeline are still to hand. Record the product name and batch number, when the medicine started, when the reaction began, what happened, and everything else being taken. Full detail is below.
Where reporting fits into medicine safety
Adverse drug reaction is the term the reporting system is built around. When you submit a report in South Africa, you are submitting a suspected adverse drug reaction, and the word suspected does real work: certainty is not required. See reporting side effects in South Africa.
Who can report a side effect or adverse drug reaction?
What information to record
Patients, caregivers, family members, doctors, pharmacists, nurses and licence holders can all report. A caregiver reporting for someone else should record whose reaction it was, along with that person’s age and relevant history. See who can report.
Where reporting fits into medicine safety
Patient reports describe things clinical reports often miss, particularly effects on sleep, mood, sexual function and daily life. They are not a lesser form of evidence.
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
Two details carry disproportionate weight. The batch number lets a reaction be traced to a specific manufacturing run, which is how quality problems are separated from properties of the medicine itself. The full list of everything being taken is what allows an interaction to be spotted.
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
Use one route only. Submitting the same reaction through several channels creates duplicate records that have to be reconciled later.
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.
Get emergency help, before doing anything about a report, for:
- 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
Speak to a professional the same day for yellowing of the eyes or skin, much less urine than usual, fever with a new rash, or unexplained bruising. See serious medication side effects.
What happens after a report is submitted?
What information to record
Keep your own copy of what you submitted, along with the packaging if you still have it. If you are later asked for more detail, that record is what you will need.
Where reporting fits into medicine safety
Your report is added to the national safety database and assessed with others for the same product. You will not usually receive a response about your individual case, and that is not a sign it was ignored. Patterns are what the system looks for, and a pattern is built from single reports. Outcomes can include a change to the leaflet, a new warning, restrictions on use, or withdrawal of a product. See what pharmacovigilance means and medicine recalls 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.