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
- 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
- Nurses, midwives and health visitors
- 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:
- online at mhra.gov.uk/yellowcard,
- by downloading the Yellow Card app from the Apple App Store or Google Play Store
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.
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:
Healthcare professionals can also find paper copies of the Yellow Card form in publications such as the BNF, Mims and ABPI Medicines compendium.