Reporting a suspected side effect as a healthcare professional

Healthcare professionals (including doctors, dentists, pharmacists and nurses) are requested to report suspected adverse reactions (side effects) observed in their practice. The HPRA greatly appreciates the time healthcare professionals take to report suspected adverse reactions.

While all reports are encouraged, it is especially important to report suspected adverse reactions associated with:

  • Newly authorised medicines
  • Vaccines
  • Reactions associated with use in pregnancy (including outcomes) or breastfeeding, in paediatric or elderly populations
  • Any serious adverse reaction to a medicine (i.e. that results in death, is life-threatening, requires inpatient hospitalisation or prolongation of existing hospitalisation, results in persistent or significant disability or incapacity, is a birth defect, or is medically significant)
  • Any medicine subject to additional monitoring, identifiable as they have an inverted triangle on their product information, together with the following statement: “▼ This medicinal product is subject to additional monitoring.”

Healthcare professionals play a critical role in pharmacovigilance. The limitations of clinical trials mean that when a medicine is first marketed, much may be known about its efficacy, while relatively less may be known about its safety profile. Therefore, ongoing surveillance is essential to help identify drug safety concerns that were not detected during pre-authorisation evaluation.

How can I make a report?

You can use the online form to report a suspected side effect.

Alternatively, download and complete the side effect from medicine for human use form or the side effect for COVID-19 vaccines form as appropriate and email it to medsafety@hpra.ie or send it by Freepost to:

Pharmacovigilance Section,

HPRA,

Kevin O'Malley House

Earlsfort Centre

Earlsfort Terrace

Dublin 2, D02 XP77, Ireland

You can contact the HPRA's pharmacovigilance section by phone at +353-1-6764971

What information is needed to make a report?

When making a report, we ask that you provide as much detail as possible. However, you can still submit a report even if some information is missing or unknown.

At a minimum, please include

  • Your name and contact information
  • A patient identifier such as age or gender,
  • Details of the medicine(s) suspected to cause the side effect,
  • The suspected reaction (signs, symptoms or diagnosis if available).

Other helpful information to include in the report is the brand and batch number of the suspect medicine, if known. It is particularly important to include the batch number in reports for vaccines and biological medicines.   

If available, please include any relevant details, such as the dose and duration of treatment with the suspect medicine, information on the patient's medical history or other concomitant medicines being taken. Information about the clinical course and outcome of the reaction, any actions taken with the medicine, key investigations carried out, and the patient's status at the time of reporting can also be valuable.

What happens after I make a report?

  • Our pharmacovigilance team carefully review all reports received.
  • After you submit a report, it will be assigned a unique number, which will be provided for your reference.
  • Our pharmacovigilance team may contact you for more information. The initial information is often sufficient, so we will only contact you if necessary.
  • To enable further evaluation, your report is recorded and stored in the HPRA's national adverse reactions database, along with other suspected side effect reports we have received. See below for further details on what information may be shared with other parties.

How is the information reported, processed, and shared?

Under our legal obligations, the HPRA may share a copy of the report you submitted with other organisations involved in the safety monitoring of medicines. However, your contact details and patient identifiers are removed before reports are shared. Please see the HPRAs privacy notice for full details of how your information is processed in line with GDPR.

Reports of suspected side effects are submitted (with personal identifiers and contact details removed) to the EudraVigilance database, operated and managed by the European Medicines Agency (EMA). The EudraVigilance database is regularly analysed to detect any possible safety signals related to medicines.

Partially anonymised details of reports are also shared with other organisations involved in the safety monitoring of medicines. These organisations include the World Health Organisation and, where appropriate, the companies holding the medicines' licences (i.e., marketing authorisation holders or MAHs). Sharing this information ensures that all parties responsible for the ongoing safety monitoring of medicines have access to it.