Pharmacovigilance has been defined by the World Health Organization as "the science and activities related to the identification, evaluation, understanding and prevention of adverse reactions or any other problems related to the use of medicines".
What is meant by adverse reaction?
An adverse reaction is a harmful and unwanted effect resulting from the use of a medicinal product:
• in accordance with the indications contained in the marketing authorisation, or
• not in accordance with the indications contained in the marketing authorization (including overdose, misuse, abuse, medication errors), or
• associated with exposure for professional reasons.
How to report an adverse drug reaction:
Spontaneous reporting by doctors, pharmacists, other healthcare professionals and by patients themselves is essential to allow the Authorities Healthcare departments responsible for health activities of Pharmacovigilance and the Pharmaceutical Companies themselves to define and keep updated the tolerability profile and drug safety (risk/benefit ratio).
Reports of suspected adverse reactions (ADR, Adverse Drug Reaction in English) from drugs and vaccines allow the detection of potential alarm signals relating to the use of medicines in this way. to make them more safe, for the benefit of all patients.
European legislation on pharmacovigilance requires all healthcare professionals and citizens to report any suspected adverse reaction (serious and non-serious, known and unknown).
A suspected adverse reaction may be reported by healthcare professionals and/or citizens according to one of the following methods:
- directly online on the AIFA website at:
and sending it to the Pharmacovigilance Manager of your institution via e-mail or fax
- directly to the Marketing Authorization Holder (AIC) of the medicine suspected of having caused the adverse reaction.
Before reporting an adverse reaction, we invite you to read the information on the processing of personal data pursuant to the Regulation ( EU) 2016/679 for the activity of Pharmacovigilance.
The contact details for the pharmacovigilance service are:
Tel: +39 3440226822