The Health Products Regulatory Authority (HPRA) is asking patients, carers and healthcare professionals in Ireland to report suspected side effects from medicines during #MedSafetyWeek, which runs from 2 to 8 November 2026. The campaign message is "Don't ignore side effects, report them", and reports can be made online at hpra.ie/report.
The HPRA announced Ireland's participation in a press release on 2 November 2026. It said it received over 8,500 reports of suspected side effects in 2025, and that this year's global campaign, the largest to date, involves more than 130 organisations across 120 countries, with the message shared in 60 languages.
- Dates: #MedSafetyWeek runs from 2 to 8 November 2026.
- Message: "Don't ignore side effects, report them", according to the HPRA.
- Irish reports: The HPRA received over 8,500 reports of suspected side effects in 2025.
- Global reach: More than 130 organisations in 120 countries, in 60 languages (HPRA figures).
- How to report: Online at hpra.ie/report, by email to medsafety@hpra.ie, or by post or phone.
- Who can report: Patients, carers and healthcare professionals, including on behalf of someone else.
What is #MedSafetyWeek and who runs it?
#MedSafetyWeek is an annual international social media campaign led by Uppsala Monitoring Centre (UMC), the World Health Organization (WHO) Collaborating Centre for International Drug Monitoring. According to the HPRA, it is supported by WHO, members of the International Coalition of Medicines Regulatory Authorities (ICMRA) and a range of national and international organisations with an interest in medicines safety.
The 2026 planning team includes UMC, the HPRA, the UK's Medicines and Healthcare products Regulatory Agency (MHRA) and pharmacovigilance bodies from Colombia, Egypt and the Philippines, according to the HPRA.
UMC's campaign page gives the 2026 theme as "Side effects: don't ignore them, report them". An image on that page states "139 partner organisations, 129 countries, 61 languages", which is consistent with the HPRA's description of more than 130 organisations across 120 countries in 60 languages.
What does the HPRA say?
The HPRA noted that some side effects appear suddenly, while others develop gradually, even after long-term use, and some are only detected from tests.
Dr Darren Scully, Medicines Safety Manager at the HPRA, said: "Reports from the public and healthcare professionals have a vital role in helping us monitor the safety of medicines. Every report matters. By taking the time to report a suspected side effect, people contribute to a better understanding of medicine safety and help us identify and manage potential risks. This information can help protect others and improve patient safety."
He added: "Side effects may be more likely to occur when starting a new medicine, changing the dose, or when also taking other medicines. Always take the time to read the information leaflet that comes with your medicine and remember to discuss any questions you have with a healthcare professional."
What counts as a side effect?
The HPRA describes a side effect, also known as an adverse reaction, as something unintended or unwanted that happens after taking a medicine. A person does not need to be certain that the medicine caused the problem. The HPRA's guidance for patients states that you can report "even if you suspect the medicine may have caused the side effect but are unsure", and that "if you are in doubt about reporting a side effect, please report".
Who can report, and how?
Anyone can report a suspected side effect directly to the HPRA. Patients can report for themselves or on behalf of someone else, such as a friend, relative or person they care for. Doctors, dentists, pharmacists and nurses are asked to report suspected adverse reactions seen in their practice.
Reports can be made using the online form at hpra.ie/report, by emailing a completed form to medsafety@hpra.ie, by Freepost to the Pharmacovigilance Section, HPRA, Kevin O'Malley House, Earlsfort Centre, Earlsfort Terrace, Dublin 2, D02 XP77, or by phoning the pharmacovigilance section on +353 1 676 4971.
| Information | Details |
|---|---|
| Reporter details | Your name and contact information |
| Patient identifier | Such as age or gender, if reporting for someone else |
| Suspect medicine | The medicine you think caused the reaction, with brand, dose and batch number if known |
| Description of the reaction | Symptoms and, if available, any diagnosis |
| Other useful context | Other medicines being taken and any background medical conditions |
| Vaccines and biological medicines | The HPRA says including the batch number is particularly important |
The HPRA says you can still report if some of this information is missing or unknown.
What happens to a report after it is sent?
According to the HPRA, its pharmacovigilance team reviews every report. Each report gets a unique reference number, and the team may follow up if needed. Reports are stored in the HPRA's national adverse reactions database.
The HPRA then submits reports, with personal identifiers and contact details removed, to EudraVigilance, the database operated by the European Medicines Agency (EMA). EudraVigilance is analysed regularly to detect possible safety signals. Reports are also shared with WHO and, where appropriate, with the companies that hold the licence for the medicine.
What does the black triangle on a medicine mean?
Some medicines carry a black inverted triangle (▼) in their package leaflet and summary of product characteristics, with the sentence "This medicinal product is subject to additional monitoring." The EMA says this means the medicine is being monitored even more intensively than others, generally because less information is available, for example because it is new or there is limited data on long-term use. The EMA states clearly that "it does not mean that the medicine is unsafe".
According to the EMA, additional monitoring always applies to medicines with a new active substance or biological medicines, such as vaccines, authorised in the EU after 1 January 2011, and to medicines given conditional approval. It lasts five years or until the EMA's safety committee (PRAC) removes the medicine from the list. The HPRA says reporting is especially important for black triangle medicines, vaccines and any serious reaction.
Frequently asked questions
When is #MedSafetyWeek 2026?
The campaign runs from 2 to 8 November 2026. The HPRA notes that reporting matters throughout the year, not only during the campaign week.
Do I need to be sure the medicine caused the problem?
No. The HPRA accepts reports of suspected side effects and encourages people to report if they are unsure.
Can the HPRA give me medical advice?
No. The HPRA says it cannot provide clinical advice. If you think you are having a side effect, talk to your doctor or pharmacist; do not stop a medicine without advice.
How many reports does Ireland receive?
The HPRA received over 8,500 reports of suspected side effects in 2025. A breakdown by reporter type or medicine was not disclosed in the press release.
Outlook
The HPRA is inviting organisations to share its campaign posters, email signatures and video backgrounds and to use the #MedSafetyWeek hashtag. Whether the campaign lifts Irish reporting will only be clear when the HPRA publishes its 2026 figures. Until then, its message is simple: anyone who notices a suspected side effect can report it.
Sources
- Health Products Regulatory Authority, Ireland joins global medicines safety campaign: 'Don't ignore side effects, report them', 2 November 2026
- Health Products Regulatory Authority, Reporting suspected side effects to the HPRA, accessed 3 November 2026
- Health Products Regulatory Authority, Reporting a suspected side effect as a patient or carer, accessed 3 November 2026
- Health Products Regulatory Authority, Reporting a suspected side effect as a healthcare professional, accessed 3 November 2026
- Uppsala Monitoring Centre, #MedSafetyWeek, accessed 3 November 2026
- European Medicines Agency, Medicines under additional monitoring, accessed 3 November 2026
Cover image: AI-generated illustration.
