Reporting Suspected Side Effects
Most of us will not experience any problems when using medicines. However, all medicines have some risks associated with their use and so a small number of people may experience side effects (also known as adverse reactions).
If you are concerned that you have had a suspected adverse reaction to a medicine, you may need to contact your healthcare professional who can advise on any treatment that may be needed. They can also report the issue to the HPRA on your behalf.
If you wish to directly report an adverse reaction, you can use our online reporting service. Anyone can report issues relating to the safety of medicines to the HPRA. This includes patients, carers, other members of the public and healthcare professionals.
How do I report an adverse reaction?
Reporting side effects during the COVID-19 response
Due to the COVID-19 public health measures, we ask that where possible reports of side effects for medicines are submitted through our online reporting system. Alternatively, please e-mail firstname.lastname@example.org. Post and fax should be avoided during this time.
COVID-19 vaccines: Reporting suspected side effects
To report a suspected adverse reaction (side effect) to a COVID-19 vaccine, please visit our Report an Issuewebpage. For more information, please visit Safety monitoring of COVID-19 vaccines.
You can report a suspected side effect in a number of ways:
- To your doctor, pharmacist or nurse who can then notify the HPRA.
- By using our online form.
- By downloading a copy of our adverse reaction report form (Word version). You can e-mail completed forms to email@example.com
- By printing our adverse reaction report form (Word version) and posting a completed copy to the HPRA by freepost.
- By calling us on (01) 676 4971.
We have published a Medicines and Side Effects consumer information leaflet. This leaflet provides more information about side effects and why it is important that they are reported to the HPRA.
Patient Reporting of Side Effects
Healthcare Professionals and Pharmacovigilance
Access to information from adverse reaction (i.e. side effect) reports
Adverse reaction reports received by the HPRA are processed and entered into the national database. These reports (with personal details excluded) are subsequently sent to EudraVigilance, the European Medicines Agency’s (EMA’s) database of suspected adverse reactions, where the data are analysed to detect new safety signals. Anonymised data from individual adverse reaction reports submitted to the EMA are publically accessible for review at www.adrreports.eu.