Within the framework of activities aimed at monitoring the safety of medicines and in line with initiatives recently undertaken at European level, the Italian Medicines Agency (AIFA) draws attention to the importance of the correct and informed use of paracetamol, with particular reference to cases of intentional overdose among adolescents.

The intake of doses exceeding those recommended may in fact lead to adverse reactions, including serious ones, particularly affecting the liver. This underlines the need to maintain a high level of awareness regarding the appropriate use of this medicine, especially within a vulnerable age group.

The reminder is based on a joint analysis of data available at national level, including those from the Italian National Pharmacovigilance Network and, in particular, data from the Pavia Poison Control Centre, which indicate a significant number of cases of intentional paracetamol overdose in this age group.

Although no increase in cases over time has been observed and there is no evidence attributable to imitative behaviours or alleged “social challenges”, the phenomenon represents a clinically relevant risk, especially in consideration of the vulnerability of adolescents.

Intentional overdose may be associated with impulsive or demonstrative acts, as well as with a misperception that paracetamol is a medicine without risks. For this reason, it is important that adolescents are aware of the risks associated with the inappropriate use of medicines, and that relevant adults play an active role in promoting appropriate information and responsible use.

Recommendations for safe use

Paracetamol is a medicine indicated for the symptomatic treatment of pain and fever. When used correctly, it is safe and effective. However, inappropriate use or the intake of doses exceeding those recommended may cause serious adverse reactions, which may be irreversible in the most severe cases, particularly affecting the liver.

AIFA encourages families, patients, caregivers and healthcare professionals to observe the following simple but essential precautions:

• strictly adhere to the doses indicated in the package leaflet or prescribed by a healthcare professional;
• respect the minimum interval between administrations and avoid the concomitant use of more than one medicine containing paracetamol or other potentially hepatotoxic substances;
• promptly contact emergency services or a Poison Control Centre in the event of suspected overdose, even in the absence of symptoms.

The importance of reporting suspected adverse reactions is reaffirmed in order to ensure continuous monitoring of the safety of medicines and to safeguard patients’ health.

Published on: 05 May 2026