What Side Effects Should Be Reported?
If you think a medicine, vaccine, herbal product or other health product has caused a side effect, you do not have to be certain before reporting it. In South Africa, SAHPRA encourages patients, consumers and healthcare professionals to report suspected adverse events. Reports are particularly important when a reaction is serious, unexpected, involves a new health product or may involve an interaction between medicines or vaccines.
The purpose of reporting is not to prove that a medicine caused a particular symptom. Reports help SAHPRA build a wider picture of medicine safety and identify possible problems that may not have been clear when a product was first approved.
This guide focuses on helping South African medicine users decide when a suspected side effect may justify a report and what to do next.
Important: reporting a side effect is not a substitute for urgent medical treatment. If you have severe or rapidly worsening symptoms, get medical help first.
How suspected side effects can be linked to medicines or supplements
A side effect is an unwanted effect or symptom that occurs while using a health product. SAHPRA describes an adverse event broadly as an unfavourable and unintended sign, symptom, disease or other occurrence associated with the use of a medicine, vaccine or medical device. An adverse event does not automatically mean that the product caused the problem.
Timing can provide a useful clue. A symptom may begin after starting a medicine, after a dose change, after adding another medicine or supplement, or after receiving a vaccine. In other cases, symptoms may develop after a medicine has been used for some time.
However, timing alone cannot establish the cause. Illnesses, other medicines, supplements, alcohol, interactions and unrelated health conditions can sometimes produce similar symptoms. This is why reporting systems collect information about the product, the reaction and the person affected rather than requiring the reporter to prove causation.
SAHPRA specifically says that reporters do not need to be certain that a health product caused an adverse event. Suspicion is enough to submit a report.
If you are trying to decide whether a symptom could be medicine-related, a doctor or pharmacist can help review the timing, your medicines and other possible causes.
Which side effects and product problems should be reported?
SAHPRA encourages reporting of suspected side effects and says that every report contributes to medicine-safety monitoring. Some reports are particularly important because they may identify a previously unknown risk or a more serious problem.
You should particularly consider reporting:
- Serious suspected side effects, including events that are life-threatening, cause death, result in admission to hospital or prolong an existing hospital stay, cause significant disability or incapacitation, or are associated with a birth defect.
- Unexpected side effects that do not appear in the medicine’s professional information or patient information leaflet.
- Suspected side effects involving a new health product, because less may be known about rare effects when a product first reaches wider use.
- Suspected medicine or vaccine interactions, including situations where a reaction seems to have appeared after products were used together.
- Side effects from herbal products or other health products, not only prescription medicines.
- Suspected vaccine-related adverse events, which form part of medicine-safety monitoring.
- Product quality concerns where there may also be a safety issue.
You can also report a suspected side effect even if it is already known or listed. SAHPRA has publicly encouraged patients, caregivers and healthcare professionals to report suspected side effects, because accumulated reports can help regulators understand how often problems occur and whether further investigation is needed.
Does a side effect have to be severe before you report it?
No. A side effect does not have to meet the definition of a serious adverse event before it can be reported.
A mild or moderate reaction may still be useful to report, particularly if it is unexpected, involves a newer product, appears after combining medicines or supplements, keeps recurring, or concerns you.
For personal medical advice about whether a symptom requires treatment, speak to a doctor or pharmacist. Reporting and medical treatment serve different purposes.
Red flags: when a side effect may need urgent medical attention
Some suspected side effects should be treated as medical emergencies rather than simply recorded for later reporting.
Seek immediate medical help if you develop difficulty breathing, severe wheezing, sudden swelling of the tongue or throat, difficulty swallowing, collapse, loss of consciousness or other signs of a severe allergic reaction. Anaphylaxis can progress rapidly and requires emergency treatment.
Other emergency warning signs can include seizures, severe or uncontrollable bleeding, severe chest pain, sudden severe confusion, being difficult to wake, fainting or other rapidly worsening symptoms.
If you are experiencing an emergency, do not delay treatment while completing a side-effect report. Get emergency medical help first. The reaction can be reported once the immediate situation is being managed.
For more information about warning signs, see the guide to serious side effect symptoms.
What to track before speaking to a doctor or pharmacist
Good information makes a side-effect report more useful, but you should not delay a report simply because you do not have every detail.
SAHPRA says the minimum information requested includes an identifier for the patient, information about the product involved, a description of the suspected adverse event and contact details for the person making the report. The patient’s full name is not required as the patient identifier; details such as initials, age or date of birth may be used.
Where possible, note the name of the medicine or product, including the trade name if known. Keep the packaging or patient information leaflet if available.
Record what happened in plain language. Describe the symptoms, when they began, how severe they were, whether they improved or worsened and whether medical treatment or hospitalisation was needed.
It is also helpful to know when the medicine was started, when the suspected reaction began and whether there had recently been a change in dose, a new prescription, an over-the-counter product or a supplement.
Tell your doctor, pharmacist or the reporting system about other medicines and health products being used at the same time. This may help identify possible interactions or other explanations.
If you do not have all this information, that should not stop you reporting. SAHPRA specifically advises against delaying a report merely because some information is unavailable. It may contact the reporter if additional information is needed.
What not to do without medical advice
Do not assume that every new symptom is definitely caused by your medicine. Symptoms can have several possible causes, and establishing the relationship may require a clinical assessment.
Do not change a prescription dose, skip doses or stop long-term treatment simply because a side effect is suspected, unless a healthcare professional who understands your situation has advised you to do so. Some medicines can cause problems if they are stopped or changed suddenly.
Instead, speak to your doctor or pharmacist about the symptom, how severe it is and when it started. They can advise whether treatment needs to be reviewed and whether the symptom requires further investigation.
The exception is an immediate medical emergency: if you have severe breathing difficulty, throat or tongue swelling, collapse, a seizure or another life-threatening reaction, seek emergency care immediately rather than waiting for routine advice.
Reporting a suspected reaction also does not mean that the medicine has been proven unsafe. SAHPRA explains that an individual report may not establish whether a particular health product caused an event. Reports are assessed together with other safety information.
Related side-effect guides and reporting options in South Africa
In South Africa, patients and consumers can report suspected adverse events directly to SAHPRA. Healthcare professionals can also submit reports, and a doctor, nurse or pharmacist can report an event on a patient’s behalf. SAHPRA states that anyone can report an adverse event, including consumers and healthcare workers in both the public and private sectors.
For step-by-step South African reporting guidance, see how to report side effects in South Africa.
SAHPRA currently provides several reporting routes. Its website links to an electronic adverse-drug-reaction reporting portal, and the Med Safety App is available for patients and healthcare providers to report suspected adverse drug reactions. SAHPRA also provides an adverse drug reaction and quality problem reporting form; its vigilance page states that the completed form can be emailed to [email protected].
The Med Safety App can be used for suspected adverse drug reactions and adverse events following immunisation, while SAHPRA’s electronic reporting services cover medicines, vaccines, herbal products, biological medicines and product-quality issues.
You do not need to wait until a healthcare professional confirms that the medicine caused the reaction before reporting it. SAHPRA’s guidance is clear that suspected events are reportable even when causality is uncertain.
What happens after a side effect is reported?
A report becomes part of the information SAHPRA uses to monitor the safety of medicines and other health products in South Africa. Individual reports may contribute to a larger pattern that helps identify a new or changing safety concern.
When a safety concern is identified, possible regulatory actions can include changes to product warnings or patient information, safety communications to healthcare professionals or the public, restrictions on how a product is used, further safety studies, or in some circumstances suspension or cancellation of a product’s registration.
This is one reason reporting matters even when you are unsure whether your experience is unusual. A single report may not establish the cause, but many well-documented reports can help regulators detect patterns that would otherwise be difficult to see.
Frequently asked questions
Is this a common side effect?
Whether a symptom is common depends on the specific medicine, dose, person and condition being treated. Check the medicine’s patient information leaflet or ask a pharmacist if you are unsure.
A reaction does not need to be rare before it can be reported. SAHPRA encourages suspected side-effect reporting and particularly wants reports involving serious, unexpected or new-product events.
How long can a side effect last?
There is no single timeframe that applies to all side effects. Some symptoms may be brief, while others may continue until the medicine is reviewed or may require treatment.
Speak to a doctor or pharmacist if a symptom is persistent, worsening, unusual or interfering with normal activities. Seek urgent medical help for severe or rapidly developing symptoms.
Should I stop the medicine if I want to report a side effect?
Do not make a general decision to stop a prescription medicine simply because you intend to report a suspected reaction. Reporting a side effect and deciding how treatment should be managed are separate issues.
A doctor or pharmacist can advise whether your medicine should be continued, adjusted, changed or reviewed based on the specific medicine and your circumstances.
When should I seek medical help rather than just report the side effect?
Get urgent medical help when symptoms suggest an immediate danger, such as serious breathing difficulty, swelling of the tongue or throat, collapse, loss of consciousness, seizures or other severe and rapidly worsening symptoms.
For less urgent symptoms, contact a doctor or pharmacist if the reaction is persistent, worsening, difficult to manage, unexpected or concerning. You can still report the suspected side effect to SAHPRA whether or not it ultimately proves to have been caused by the medicine.
Medical information notice: This article provides general educational information and cannot diagnose a medicine reaction or tell you whether to start, stop or change treatment. For advice about your own medicines or symptoms, speak to a doctor or pharmacist. For severe or life-threatening symptoms, seek emergency medical care immediately.