“Don’t ignore side effects – report them” – this is the theme of #MedSafetyWeek 2026. In Austria, AGES and the Federal Office for Health Safety (BASG) are taking part. Medicines save lives and improve the health of millions of people. However, they can also have undesirable effects. Some side effects occur immediately. Others develop gradually, often only after prolonged use. Still others go unnoticed and are only revealed by laboratory test results. “The safety of a medicine does not end with its authorisation. It is only afterwards that it is used in the everyday lives of a great many people, and some issues that were not apparent in clinical trials only become evident during this widespread use. That is why we need the observations of patients, doctors and pharmacists,” says AGES Managing Director Johannes Pleiner-Duxneuner. “Reporting a side effect is not an accusation against a medicine, nor is it a criticism of the treatment. It is a contribution to a system that protects us all. Trust in medicines is built where risks are openly identified and taken seriously.”
Just the tip of the iceberg
Studies show that, worldwide, only around 5 to 10 per cent of all suspected adverse reactions are reported. The reasons cited include a lack of time, the perceived high effort involved, and the assumption that reporting will not make any difference anyway. “Every side effect that goes unreported is a piece of information we are missing. We can only identify rare risks when many individual observations are collated, both in Austria and across Europe,” says Günter Waxenecker, Head of AGES’s Medicines Market Surveillance Unit and Head of Proceedings at the BASG. “No one needs to be certain that a medicine is the cause. A suspicion is sufficient, for example due to a temporal link. Our experts carry out an initial technical assessment; the safety evaluation of an active substance is then conducted at European level based on data collected across the EU.”
What happens to a report
The BASG reviews every report and categorises it from a technical perspective. It is then forwarded to the EudraVigilance database of the European Medicines Agency (EMA). There, it is made available to all European medicines regulatory authorities for ongoing safety monitoring. If new findings emerge, the authorities can take action. For example, they can amend the patient information leaflet, inform healthcare professionals or order risk-mitigation measures. In serious cases, a medicinal product may also be withdrawn from the market. In 2025, the BASG received a total of 14,528 pharmacovigilance reports concerning adverse reactions, interactions and medication errors. Of these, 12,439 came from marketing authorisation holders, 1,006 from patients and 1,083 from healthcare professionals. Since 2018, there have been a total of 236,567 reports. Compared with the figures from the previous year, the numbers are lower, as since 2025 initial and follow-up reports are no longer added together; only the initial reports are included in the statistics. This allows for a more transparent presentation of events relating to medicines. See also: Statistics on adverse reactions – BASG
Reporting is easy
Anyone who notices a possible side effect should first discuss it with their doctor or at the pharmacy. Patients and their relatives can also report side effects themselves. This can be done directly and at any time via the BASG’s online reporting portal. All reports are treated confidentially and are subject to data protection regulations. Healthcare professionals are even legally obliged to report side effects.
About #MedSafetyWeek
#MedSafetyWeek was launched in 2016 and is taking place for the eleventh time this year. It runs from 2 to 8 November. More than 130 organisations from over 120 countries are spreading the message in more than 60 languages. The campaign is coordinated by the Uppsala Monitoring Centre (UMC), the World Health Organisation’s (WHO) collaborating centre for international pharmacovigilance. It is supported by the members of the International Coalition of Medicines Regulatory Authorities (ICMRA) and numerous other organisations. Austria is represented by the BASG as a partner organisation. Free campaign materials are available on the #MedSafetyWeek website.