Side effects of mental health medicines can be reported to SAHPRA like any other. You do not need your prescriber’s agreement, and you do not need to prove the medicine was responsible.
This group is worth reporting on particularly, because several of its most significant effects are subjective. Sexual side effects, emotional blunting, sleep disruption and cognitive slowing are hard to measure in a trial and easy to under-record in clinical notes, so patient reports carry information that is otherwise largely missing.
Quick answer: when and how to report a suspected side effect
What information to record
Record the medicine name and strength, when you started it, any dose changes and their dates, when the effect began, and everything else you take. Dose changes matter more here than with most medicines, because several effects cluster around them.
Where reporting fits into medicine safety
Reporting is separate from your care. It does not reach your prescriber and will not change your treatment, so raise anything troubling you with them as well.
Who can report a side effect or adverse drug reaction?
What information to record
Anyone, including a family member or carer reporting for someone else. See who can report.
Where reporting fits into medicine safety
Effects people find embarrassing are systematically under-reported, which means the record is skewed. Reporting a sexual side effect is genuinely useful for that reason.
What information should you collect before reporting?
What information to record
- Medicine name, strength, dose form and batch number
- Start date, and the dates of any dose increases or decreases
- What the effect is, when it began, and whether it is improving
- Whether it followed a dose change
- All other medicines and supplements, including anything bought over the counter
Where reporting fits into medicine safety
If the effect persisted after stopping, say so. Persistence after discontinuation is important information and is not always captured.
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
Use one route only. See reporting side effects in South Africa.
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.
New or worsening thoughts of self-harm need urgent contact with a doctor or emergency services, whatever else you do about reporting.
When to contact a doctor, pharmacist, or emergency service
Do not stop a mental health medicine abruptly while deciding whether to report. See should I stop my mental health medication.
What happens after a report is submitted?
What information to record
Keep a copy and any reference number.
Where reporting fits into medicine safety
Reports are pooled and assessed for patterns. Several changes to how antidepressant side effects are described in product information came about because patients reported effects that had been under-recognised. 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.