By reporting suspected side effects, you help to make medicines safer for everyone. That is the core message of the #MedSafetyWeek campaign, which is celebrating its 10th anniversary this year. To mark this anniversary, the FAMHP is publishing statistics on side effect reporting in Belgium over the last ten years.
MedSafetyWeek
The FAMHP is one of 130 partner organisations in 117 countries worldwide participating in this campaign, which runs from 3 to 9 November 2025. Together, we encourage patients, their families or carers and healthcare professionals to report suspected side effects. Every report can help to protect others. Unfortunately, research shows that only about 5 to 10% of all suspected side effects are actually reported.
"Under-reporting of suspected side effects means that it can take longer to detect important safety issues. With #MedSafetyWeek, we want to make more people aware of the importance of reporting."
Hugues Malonne, Chief Executive Officer of the FAMHP
Common reasons for not reporting suspected side effects are that people do not know they can report, think it does not matter, or simply forget. That is why the #MedSafetyWeek campaign was launched in 2016: to raise awareness about why, how and where side effects can be reported.
More reports of side effects, especially from patients
In total, the FAMHP received 9,892 reports of suspected side effects between 2014 and 2024.
There is a clear upward trend in the number of reports of suspected side effects. We have seen this number double over the last decade.
MedSafetyWeek is focusing this year on how we can all contribute to safer medicines, showing that everyone has a role to play. More and more patients are actively participating in reporting side effects. The increase over the past 10 years is primarily due to them. This indicates that the overall increase in side effect reports is mainly due to increased awareness of the issue and to the development of user-friendly reporting tools, such as www.famhp.be/en/side_effect, launched in 2019.
The severity of reported side effects
A serious side effect is defined as an effect that requires hospitalisation or prolongation thereof, is life-threatening, results in death, in permanent or significant disability or incapacity, in congenital anomaly or malformation, or any other medically significant event.
Looking at the past 10 years, we see that the proportion of reports of non-serious side effects is higher among patients than among healthcare professionals.
The FAMHP emphasises that every side effect report is valuable. Both for known and unknown, serious and non-serious side effects. All reports help to better identify the medicine's safety profile.
The causal link between the suspected medicine and the side effect does not necessarily have to be proven. Report these side effects without hesitation:
· serious side effects;
· side effects whose nature, severity and/or course differs from what is stated in the Summary of Product Characteristics (SPC) or package leaflet;
· side effects in children or other vulnerable groups such as pregnant women, breastfeeding women, elderly patients, etc.;
· known side effects whose frequency, severity or outcome is abnormal;
· side effects after vaccination;
· side effects when switching medicines;
· side effects due to occupational exposure: exposure to or contact with a medicine during work;
· side effects in medicines under additional monitoring, indicated by the symbol ▼.
COVID-19 vaccination, exceptional figures
All the figures above do not take COVID-19 vaccines into account. During the COVID-19 vaccination campaign, an exceptional increase in the number of reports of side effects was observed, approximately forty times higher than usual. This increase can mainly be explained by the exceptionally large number of people vaccinated in a short period of time and by the increased awareness among both patients and healthcare professionals of the importance of reporting suspected side effects after COVID-19 vaccination. Meanwhile, the number of reports of side effects following COVID-19 vaccination has fallen sharply. In 2024, there were fewer than 200 reports.
How to report side effects?
- Preferably through www.famhp.be/en/side_effect
- By email to adr@fagg-afmps.be
- Using our paper forms for patients and healthcare professionals
- Please also report cases of medication errors or misuse or abuse of medicines
More information
Questions and answers about reporting side effects