Adverse Reactions to medicinal products | Italian Medicines Agency Aifa toggle bar Search Search keywords The Agency The Agency Mission and values Organisation Scientific and Economic Committee for Medicines Support and Coordination Secretariats and Advisory Committees International Collaborations EU Projects Legislation Forms Competition notices Resolutions Tenders and contracts Quality assurance Guarantee Committee Atti di notifica Associazioni dei pazienti AIFA Incontra Contacts Certified email COVID-19 COVID-19 Communications about COVID-19 COVID-19 Vaccines Medicines usable for treatment of COVID-19 disease Use of monoclonal antibodies for COVID-19 Use of antivirals for COVID-19 Monitoring of medicinal products used during the COVID-19 epidemic Clinical Trials - COVID-19 Compassionate Use Programs - COVID-19 Access to medicinal products Access to medicinal products Early access and off-label use Authorisation of medicinal products Medicine shortages Antibiotic medicinal products Biological medicinal products Vaccines Blood derivatives Generic medicinal products Biosimilar medicinal products Orphan medicinal products Advanced therapies Homeopathic medicinal products Allergens Medicinali di origine vegetale Ancillary medicinal substances incorporated in medical devices Safety of medicinal products Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Quality and Inspections Quality and Inspections Quality defects Inspections and authorisations Qualified person Fight of pharmaceutical crime Research and Clinical trials Research and Clinical trials Clinical trials concerning medicinal products EU Regulation on Clinical trials National Observatory on Clinical Trials Registro Studi Osservazionali Comitati Etici Nazionali (CEN) Ethics Committees Coordination Centre Independent clinical research Mappa dei centri di Sperimentazione Clinica Pricing and reimbursement Pricing and reimbursement Negotiation and reimbursement Economic evaluations Monitoring Registers AIFA Notes Lists of Class A and Class H medicinal products Innovative medicinal products Transparency Lists Consumption and pharmaceutical expenditure Consumption and pharmaceutical expenditure The Medicines Utilization Monitoring Centre (OsMed) Governance of pharmaceutical expenditure Monitoring pharmaceutical expenditure Innovation and planning Innovation and planning Innovation and scientific advice Horizon scanning Information and communication Information and communication FarmaciLine Medical and scientific information FAQ Publications Communication campaigns Eventi AIFA Scientific Seminars Press releases Dossier AIFA Mobile APP AIFA APP Firstline AIFA - Antibiotici ABC della Ricerca Clinica Presentations and speeches Public consultations and documents Documents shared with scientific communities Calendario eventi Archivio AIFA data AIFA data OsMed Data Open Data Companies Section Companies Section Requests for authorisation of conferences and meetings Payment of fees and annual duties MA Electronic invoicing Application for reimbursement and pricing Access information Notifica concessionari di vendita Comunicazione prima commercializzazione Open governance Open governance Disposizioni Generali Organizzazione Consulenti e collaboratori Personale Bandi di Concorso Performance Enti controllati Attività e procedimenti Provvedimenti Bandi di gara e contratti Sovvenzioni, contributi, sussidi, vantaggi economici Bilanci Beni immobili e gestione patrimonio Controlli e rilievi sull'Amministrazione Servizi Erogati Pagamenti dell'Amministrazione Opere pubbliche Pianificazione e governo del territorio Informazioni ambientali Interventi straordinari di emergenza Altri Contenuti Adverse Reactions to medicinal products How to report an adverse reaction The reports of suspected adverse reactions (Adverse Drug Reactions, ADRs) to drugs and vaccines allow the detection of potential alert signals relating to the use of medicines, to make them safer for the benefit of all patients. The EU pharmacovigilance legislation requires all healthcare professionals and citizens to report any suspected adverse reactions (serious and not serious, known and not known). You can report a suspected adverse reaction in one of the following ways By filling in the reporting form and sending it via e-mail to the Pharmacovigilance contact point of your facility, or to the Marketing Authorization Holder (MAH) of the drug suspected to have caused the adverse reaction; Online on the AIFA website. You can report suspected adverse reactions relating to the use of dietary supplements, herbal products, magistral preparations (e.g., cannabis-based for medical use), homeopathic medicines (not registered as medicines) and other products of natural origin, on the VigiErbe online phytovigilance system ( www.vigierbe.it ). Untitled Box link correlati Report an adverse reaction (ADR) online Related Links Adverse reaction (ADR) reporting forms Persons in charge of Pharmacovigilance Pharmacovigilance legislation Segnala online su VigiErbe (sistema di fitovigilanza) Safety of medicinal products Pharmacovigilance National Pharmacovigilance Network Adverse Reactions to medicinal products Persons in charge of Pharmacovigilance European Eudravigilance System Accesso alle segnalazioni - ADRreports Regional pharmacovigilance funds Segnali di sicurezza Risk management measures Medicinal products subject to additional monitoring Share Nested Applications Highlights 21/04/2026 - Medicine Use: 2024 Regional Reports Now Available Online 26/03/2026 - How to protect yourself from fake ‘miracle cures’: AIFA recommendations ALL NEWS ALL NEWS News 21/04/2026 Medicine Use: 2024 Regional Reports Now Available Online 15/04/2026 AIFA updates the Transparency Lists 13/04/2026 Medicine Shortage Communication on Endoxan (ciclofosfamide) All news Nested Applications Press From one-size-fits-all treatments to personalised care: the revolution in precision medicine All press releases Last tweets 📢 #AIFA comunica il calendario degli incontri nell’ambito delle iniziative dedicate al dialogo e al... 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