Yellow Card Scheme

Yellow card scheme - safety informationThe MHRA and the Commission on Human Medicines (CHM) run the UK's spontaneous adverse drug reaction (ADR) reporting scheme - called the Yellow Card Scheme. This receives reports of suspected adverse drug reactions (ADRs) or side effects from healthcare professionals and patients for medicines and vaccines.

The Yellow Card Scheme is the main ADR reporting scheme in the UK and was introduced in 1964 after the thalidomide tragedy highlighted the urgent need for routine monitoring of medicines. It receives more than 20,000 reports of possible side effects each year.

For information on reporting to the Yellow Card Scheme, please see the ‘reporting adverse drug reactions’ page of the website.


How does the Yellow Card Scheme work?

The Yellow Card Scheme relies on reports of possible or suspected adverse reactions from patients and health professionals made on a voluntary basis. Pharmaceutical companies also have a legal obligation to pass on reports that they receive about suspected side effects of their products that are defined as serious. The scheme acts as an early warning system for the identification of previously unrecognised reactions and enables us to identify risk factors, outcomes of the ADR and other factors that may affect clinical management. .

The value of the scheme has been demonstrated many times and it has helped to identify many safety issues. For example Yellow Cards reports on liver toxicity with black cohosh have resulted in improved safety warnings.

The Yellow Card scheme is administered by the MHRA with the support of five Yellow Card Centres:

These centres help to raising awareness of the Yellow Card Scheme and provide education and training in their region (including advice on what to report and help in completing the form). They also help provide information on drug safety matters at a regional level.


Page last modified: 12 August 2011