Reporting undesirable effects
What should you do in the event of an undesirable effect?
After taking a medicinal product, being vaccinated, or receiving treatment, it is possible that a patient could experience secondary effects described as 'undesirable'.
In the first instance, it is important to consult the product's instructions for use (or Summary of Product Characteristics - SPC) to see whether the effect is expected or not.
These effects may be non-serious (mild or moderate in intensity) and disappear after a few days, or serious (requiring hospitalisation or a longer period of hospitalisation; life-threatening; resulting in death, lasting or significant disability or incapacity, or a congenital anomaly or malformation).
Some undesirable 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 undesirable effect that they suspect may be drug-related should discuss it with their doctor or pharmacist.
Do not hesitate to report undesirable effects that:
- are serious
- are unexpected
- are suspicious because, although known, they occur with abnormal frequency, severity or outcome
- affect a vulnerable group (pregnant or breast-feeding women, elderly patients, etc.)
- occur when medical treatment is changed
- occurs following exposure at work
- relate to use of a drug under additional supervision, identified by the symbol '▼'
How to file a report
To report an undesirable effect that is suspected of being linked to a medicinal product, please contact the Nancy Regional Pharmacovigilance Centre (Centre régional de pharmacovigilance de Nancy) or the Division of Pharmacy and Medicines (Division de la pharmacie et des médicaments) of the Health Directorate:
For further information on pharmacovigilance, see the FAQ (Pdf, 998 Kb) on this subject.
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