Now there is also an online reporting form available for patient reporting of side effects of drugs

Reporting side effects contributes to the monitoring of the safety of medicines. To stimulate patient reporting of side effects, there is now a user-friendly online reporting form available.

Since 2012, patient can directly report side effects of drugs for human use to the Vigilance division of the Federal Agency for Medicines and Health Products (FAMHP).

Reports by patients are an increasing part of the total number of reports to the FAMHP. In 2012, the FAMHP received 23 reports from patients, compared to 365 in 2018. Patients make more reports of side effects every year that they think are attributable to a medicine.

To stimulate patient reporting of side effects there is now an online reporting form available. A patient fills in and sends this form online, which is much more user-friendly than the existing reporting methods.

This online form is also accessible via the portal “My health”.

Why should you report side effects?

When a medicine comes onto the market, not all of its effects are known. So it is possible that someone may experience an unknown (or not yet well) know side effect. Ever European country, therefore, has the obligation of collecting and evaluating data on known and unknown side effects of medicines. Scientific studies show that patient reports of side effects are a valuable supplement to the reports submitted by practitioners and the pharmaceutical industry.

You will find additional information on reporting side effects on the website of the FAMHP.
Your comments and/or suggestions are always welcomed at ADR@fagg.be.

For links see Dutch or French.

Last updated on
15/03/2019