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 scheme was set up in response to the thalidomide tragedy, which highlighted the urgent need for routine monitoring of the safety of medicines by a central body, independent of the pharmaceutical industry.  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

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.

Healthcare Professionals

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
  • MiDatabank

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