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Reporting suspected side effects and other adverse events

At Boehringer Ingelheim we are committed to improving human and animal health. The safety of our medicines is of paramount importance. We monitor the safety of our medicines at discovery, during development and when they are prescribed for treatment. Our responsibility continues after the medicine is used.

A medicine is licensed for use after it has been shown to be effective, is made to an established quality standard and, in the view of the national and European regulatory bodies1, is accepted for human or animal use.

No medicinal product is without risk, however, and this is taken into account when a licence is granted. Sometimes an adverse event can occur. An adverse event is any untoward occurrence in a person or animal who has received a pharmaceutical product.

Information about adverse events provides us, and the regulatory bodies, with the opportunity to expand our knowledge about the safety characteristics of the medicine and improve our understanding of how the medicine should be used.

Find out about reporting an adverse event below.

If you’re a patient or carer

If you’re an animal owner

If you’re a healthcare professional

If you’re a veterinary professional

Your privacy

1 The regulatory bodies include: the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK, Veterinary Medicines Directorate (VMD) in the UK, Health Products Regulatory Authority (HPRA) in Ireland and European Medicines Agency (EMA) in the European Union.

 

If you’re a patient or carer

If you think you may be experiencing a side-effect, or if a medicine or medical device is giving you any other cause for concern, this is known as an “adverse event”. Adverse events should always be reported. 

If you get a side effect or other adverse event, please report these to your doctor, pharmacist or nurse as soon as possible. This includes any possible side effects not listed in the package leaflet.

If you’re not sure who to contact:

In the UK – contact the NHS

  • NHS 111 in England and Scotland on 111 (textphone 18001 111)
  • NHS Direct Wales/Galw IECHYD Cymru on 0845 46 47 (textphone 0845 606 46 47)
  • NHS Northern Ireland

In Ireland – find your nearest hospital, GP or other healthcare professional.

In the UK, you can also report any adverse event to the Yellow Card Scheme, run by the Medicines and Healthcare products Regulatory Agency (MHRA).  

In Ireland, you can report any adverse event to the Health Products Regulatory Authority.

And, of course, you can also report any adverse event to Boehringer Ingelheim. Please contact our Pharmacovigilance team:

If you’re an animal owner

If you think your animal may be experiencing a side-effect, or if a medicine or medical device is giving you any other cause for concern, this may be an “adverse event”. Adverse events should always be reported. 

If your animal gets any side effects, please talk to your veterinary professional as soon as possible. This includes any possible side effects not listed in the package leaflet.

In the UK, you can report an adverse event directly to the Veterinary Medicines Directorate (VMD): www.gov.uk/report-veterinary-medicine-problem

In Ireland, you can report an adverse event directly to the HPRA: www.hpra.ie/homepage/about-us/report-an-issue

And, of course, you can also report any adverse event to Boehringer Ingelheim. Please contact our Technical Services Team: 

If you’re a healthcare professional

In the UK, please report any adverse event to the Yellow Card Scheme, run by the Medicines and Healthcare products Regulatory Agency (MHRA).  

In Ireland, please report any adverse event to the Health Products Regulatory Authority.

And, of course, you can also report any adverse event to us. Please contact our Pharmacovigilance team:

If you’re a veterinary professional

In the UK, you can report an adverse event directly to the Veterinary Medicines Directorate (VMD):  www.gov.uk/report-veterinary-medicine-problem

In Ireland, you can report an adverse event directly to the HPRA: www.hpra.ie/homepage/about-us/report-an-issue

And, of course, you can also report any adverse event to us. Please contact our Technical Services Team: 

Your privacy

We are obliged to report side effects and other adverse event information to health authorities worldwide (including to countries that may have another level of data protection compared to the EU). The reports will contain details about the incident but only limited personal data. You have rights to access your data. For more information on these rights and how we process personal data, please see our Privacy Policy. Thank you.

 

NP-GB-101641  V2   November 2022