Report a side effect as a health care professional


Logging in with your electronic identity card (eID) is recommended, but not mandatory. If you login with your eID, you can consult your (in)complete reports on the start page.

Which side effects should I report?
Report every damaging and adverse reaction to a medicine you consider medically significant. The causal connection between the suspected medicine and the side effect does not necessarily need to be established. 

Always report these side effects:

  • serious side effects that have led to:
  • a life-threatening situation or death;
  • a hospital admission or extended hospital stay;
  • significant or persisting inability to work or invalidity;
  • a congenital deformity;
  • another medically significant event.
  • new and unexpected side effects: side effects whose type, severity and/or evolution is not consistent with the summary of product characteristics (SPC) and patient information leaflet;
  • side effects in children and other vulnerable population groups such as pregnant women, woman who are breast-feeding and the elderly;
  • suspicious side effects: known side effects whose frequency, severity or outcome is abnormal;
  • side effects of vaccines;
  • side effects experienced when switching from one medicine to another;
  • side effects caused by professional exposure to a medicine: exposure to/contact with a medicine while executing a profession;
  • side effects of a medicine under additional monitoring, indicated with the symbol ▼. The FAMHP and the EMA publish lists of medicines under additional monitoring in Belgium and in Europe.

Why do I need to give my e-mail address?
If our experts require more information, we can contact you by e-mail.

The FAMHP adheres to privacy regulation. This means we treat your report anonymously and do not record your e-mail address in the European database. We will also not give your e-mail address to the company selling the medicine.

Will the FAMHP contact me if I report a side effect?
You will receive a confirmation e-mail telling you the FAMHP has received your report.

If your report contains all necessary information, we won't contact you. The FAMHP will only contact you if your report lacks important information.

Can I report side effects for someone else?
Yes, you can report side effects for someone else.

What should I do if there’s not enough space to write down all the information?

  • The fields in the electronic reporting form are limited in length, but the allowed number of characters should suffice for providing sufficient information.
  • If you use the paper report form, you can add an extra sheet with the missing information.

What should I do if the application for reporting side effects is not working?
You can also report side effects using the paper report form. You can request a paper copy of the report form via

Where can I pose urgent medical questions?
Do you have an urgent question on what to do in the event of a side effect? Contact the Poison Control Centre. A doctor or pharmacist will answer your questions 24/7. Calling the Poison Control Centre at + 32 70 245 245 is free in Belgium.

Last updated on 31/01/2020