Yellow Card Scheme

What is it?

The Yellow Card Scheme is run by the Medicines and Healthcare Products Regulatory Agency (MHRA). It collects, collates and investigates reports of suspected adverse drug reactions (ADRs).  The MHRA and its predecessor organisations have collected reports of suspected ADRS through the YCS since its introduction in 1964. Over 1 million yellow card reports have been collected since the scheme was established. It was the world’s first spontaneous reporting scheme for the reporting of suspected adverse drug reactions and is the cornerstone of post marketing drug safety surveillance in the UK. The scheme is voluntary and relies on the identification and reporting of adverse drug reactions by health professionals and patients.

Visit www.mhra.gov.uk/yellowcard for more information on the scheme

What to report

An adverse reactions is a response to a medicine that is noxious (harmful or very unpleasant) and unintended and is suspected to be related to the medicine.

Adverse reactions resulting from the following can all be reported, even if there is any doubt about whether or not an adverse reaction has occurred:

  • All reactions to drugs which are under ‘additional monitoring’ (i.e. drugs marked with inverted black triangle ▼)
  • Any suspected serious reaction to all other drugs
    • Prescription medicines (including off-label use or unlicensed drugs)
    • OTC medications
    • Herbal medicines
    • Vaccines
    • X-ray contrast media
    • Blood products
    • Dental and surgical materials

The Yellow Card Scheme also collects reports of:

  • Incidents involving medical devices, including diagnostic tests, software and apps
  • Defective medicines
  • Fake medicines or medical devices
  • Side effects or safety concerns about e-cigarettes

Who can report

Anyone can report a suspected adverse drug reaction

  • Doctors
  • Dentists
  • Coroners
  • Pharmacists
  • Nurses, midwives and health visitors
  • Radiographers
  • Optometrists
  • Patients, or their parents or carers. Find more information on our patient page

How to report

The easiest way to report is electronically. You can submit reports:

The Yellow Card app includes the ability to receive updates on medicines of interest to you, and numbers of Yellow Cards reported to the MHRA.

Paper reporting forms are also available for healthcare professionals and members of the public. Patients can also report by telephone, by calling 0800 731 6789 for free, Monday to Friday between 9am and 5pm.

For more information visit the MHRA website.

Using healthcare systems to report

Several prescribing platforms and other electronic tools now support Yellow Card reporting. If you use one of the following systems you may be able to submit a report directly to the MHRA:

  • EMIS
  • SystmOne
  • Vision
  • Cerner
  • MiDatabank

Healthcare professionals can also find paper copies of the Yellow Card form in publications such as the BNF, MIMS and ABPI Medicines compendium.

The Yellow Card Biobank

The Yellow Card Biobank is a collaboration between the Medicines and Healthcare products Regulatory Agency (MHRA) and Genomics England. Its goal is to improve understanding of how a patient’s genetic makeup may increase their risk of harm from side effects of medications.

The Biobank is currently recruiting patients who have experienced side effects from specific medicines for a research project called the Yellow Card Biobank study.

The current phase of the project concentrates on:

  • GLP-1 medicines (semaglutide, tirzepatide, liraglutide). The Yellow Card Biobank is investigating whether the risk of acute pancreatitis from GLP-1 injections for weight loss and Type 2 diabetes may be influenced by an individual’s genes. Find more information about this topic here. 

By collecting genetic samples from patients who have experienced suspected side effects, the Yellow Card Biobank aims to create a rich resource of genetic information that could help researchers to determine whether a suspected side effect was caused by a specific genetic trait.

Read more about it by clicking this link Yellow Card biobank | Making medicines and medical devices safer (mhra.gov.uk)