Reporting adverse effects

What should you do in the event of an adverse effect?

After taking a medicinal product or undergoing treatment, a patient may experience side effects, which are also known as adverse effects.

In the first instance, it is important to consult the product leaflet (or Summary of Product Characteristics - SPC) to see whether the effect is expected or not.

These effects may be non-serious (i.e., mild or moderate in intensity) and disappear within a few days, or serious (i.e., requiring hospitalisation or a longer hospital stay; or life-threatening; or resulting in death, lasting or significant disability or incapacity, or a congenital anomaly or malformation).

Some adverse effects are unexpected because they are not mentioned in the product leaflet. It is vital that they are reported in order to ensure the safety of the product concerned.

In all circumstances, patients who experience an adverse effect that they suspect may be drug-related should discuss it with their doctor or pharmacist.

Report immediately any adverse effects that:

are serious;
are unexpected;
are suspicious because, although known, they occur with abnormal frequency, severity or outcomes;
affect a vulnerable group (pregnant or breast-feeding women, elderly patients, etc.);
occur when medical treatment is changed;
occur following exposure at work;
occur in connection with the use of a medicinal product subjected to additional surveillance, identified by the symbol '▼'.

How to file a report

Please contact the Nancy Regional Pharmacovigilance Centre (Centre régional de pharmacovigilance de Nancy) or the Health Directorate's Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments de la Direction de la santé):

You can use the downloadable adverse effects reporting form to file your report:

Notification of adverse effects form for patients (on www.guichet.lu)
Notification of adverse effects form for healthcare professionals (on www.guichet.lu)