Reporting a side effect as a patient

What to have ready before you start

Fetch the pack before you open the form. The form asks for the product name, the dose and, if you have it, the batch number, which is printed on the carton and usually on the blister. With the pack in hand the report takes ten to fifteen minutes.

• The medicine pack, with the product name and batch number
• When you first took it and at what dose
• When the symptoms started and how they developed
• Every other medicine you take, including over-the-counter products and supplements
• Known conditions and allergies, as far as you know them

The report in five steps

Swissmedic provides a dedicated web form for patients and relatives. It needs no login and sends an automatic acknowledgement of receipt. The flow is the same whether the product was a tablet, a vaccine or a patch.

1. Open the Swissmedic online reporting form for patients and relatives.
2. Enter the medicine: name, dose, start date and, if available, the batch number.
3. Describe the symptoms in your own words, with onset, duration and course.
4. Add your other medicines, pre-existing conditions and contact details for follow-up.
5. Submit and keep the acknowledgement. A copy for your doctor is worth having.

Should I report through my doctor instead?

Either is right, and both together is best. A report from your doctor or pharmacy carries laboratory values, diagnoses and prior findings that make the case clinically usable. Your own report carries what you experienced, in your words. Raise the symptoms at the practice, and report yourself as well if you are unsure whether a report was made.

What happens to your report?

Swissmedic checks your report, records it in the national database and forwards it pseudonymised to the WHO database VigiBase. Your name is not given to the marketing authorisation holder. You will not normally receive an individual clinical opinion, because Swissmedic does not assess treatment, but follow-up questions about the facts are possible.

A single report rarely changes anything. Several similar reports create a signal, and a confirmed signal leads to a change in the patient information leaflet, a letter to healthcare professionals or, rarely, a withdrawal. That is exactly what your report feeds.

Common hesitations

Many people do not report because they think their case is too small or cannot be proven. That is the most common reason rare side effects are recognised late. Report even if the symptoms have gone, even if you stopped the medicine, and even if you cannot tell which of several products was responsible.