Side effects from contraception, HRT, fertility treatment and other hormonal medicines can be reported to SAHPRA like any other. You do not need your prescriber’s agreement or proof that the medicine was responsible.
This group is particularly worth reporting on. Several of the most significant effects, on mood, libido and bleeding patterns, are subjective, hard to measure in a trial, and have a documented history of being under-recorded. Patient reports carry information that is otherwise largely missing from the record.
Quick answer: when and how to report a suspected side effect
What information to record
Record the product name and strength, when you started it, when the effect began, and everything else you take. For a device such as an implant or intrauterine system, record when it was fitted and by whom.
Where reporting fits into medicine safety
Reporting is separate from your care. Raise anything troubling you with your clinic as well, since a report will not change your treatment.
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
You can report even if you were told the effect was unlikely to be related. Disagreement is not a barrier, and the standard is suspicion rather than proof.
What information should you collect before reporting?
What information to record
- Product name, strength and batch number, or the device type and when it was fitted
- When you started, and any change in brand or formulation
- What the effect is, when it began, and whether it is settling
- What happened if you stopped, or had the device removed
- All other medicines and supplements
Where reporting fits into medicine safety
A brand or formulation change is worth noting, since effects that appear after switching between products containing the same hormones are exactly what post-market monitoring exists to detect.
How to report through SAHPRA, Med Safety or the ADR form
What information to record
- The Med Safety App
- SAHPRA online reporting, linked from the health products vigilance page
- The adverse drug reaction and quality problem form
- Through your clinic, doctor or pharmacist
Where reporting fits into medicine safety
A problem with the device or product itself, such as an implant that could not be located or packaging that did not match, goes through the same form. See reporting a quality problem.
What counts as a serious or unexpected side effect?
Red-flag symptoms
Deal with the reaction first. Get emergency help for signs of a clot or stroke:
- Pain, swelling, warmth or redness in one calf or thigh
- Sudden breathlessness, chest pain worse on breathing in, or coughing up blood
- Sudden severe headache unlike any you have had before
- Weakness or numbness on one side, difficulty speaking, or sudden loss of vision
- Severe abdominal pain, or yellowing of the eyes or skin
A blood clot on hormonal contraception is exactly the kind of serious reaction that should be reported once the person is safe.
When to contact a doctor, pharmacist, or emergency service
Do not stop contraception without arranging an alternative if pregnancy would be unwanted. See when to see a doctor about hormonal medicine.
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. Much of what is now known about differences in clot risk between contraceptive formulations came from exactly this kind of accumulated post-market data. 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.