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How to report suspected medicine side effects to SAHPRA

You do not need proof that a medicine caused a symptom to report it. SAHPRA explains the reporting routes and why medical care still matters.

Assorted tablets and capsules on a plain surface.
Assorted tablets and capsules on a plain surface. Tablets and capsules in a contextual 2016 file photograph. The image does not identify a recalled medicine or establish harm. Photo: Pixabay / Wikimedia Commons. Source: https://commons.wikimedia.org/wiki/File:Pill_1.jpg . CC0 1.0: https://creativecommons.org/publicdomain/zero/1.0/ . Cropped and resized for display.

South Africans do not need to be certain that a medicine caused their symptoms before reporting a suspected side effect, the South African Health Products Regulatory Authority says.

SAHPRA is encouraging reports during MedSafetyWeek, which runs from 2 to 8 November. Its statement is dated 4 November; this is an ongoing public-health campaign, not a new medicine recall.

Patients can use the Med Safety App or speak to a healthcare professional. SAHPRA’s health-products vigilance page also links to its online reporting system and an adverse-reaction form that can be emailed to [email protected].

The regulator asks for details of the medicine, the suspected reaction, a patient identifier such as age or initials rather than a full name, and the reporter’s contact details. It does not accept anonymous reports, but says missing information should not delay reporting.

Reporting helps SAHPRA identify possible safety concerns, but it does not establish that a medicine caused a particular symptom.

A report is not a substitute for medical care. Anyone worried about a possible reaction should contact a doctor, pharmacist or nurse for advice on treatment. Seek urgent care for severe symptoms.

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