Encyclopedia entry

MHRA Yellow Card scheme

The Yellow Card scheme is the UK system for reporting suspected adverse drug reactions, side effects, defective products, and counterfeit medicines. Run by the MHRA since 1964 (originally named after the yellow paper form), now operated online at yellowcard.mhra.gov.uk. Reports are accepted from anyone (patients, carers, healthcare professionals).

What to report

• · Any suspected side effect, even if the link to the medication is uncertain.
• · Side effects from over-the-counter medicines, prescribed medicines, herbal remedies, vaccines, e-cigarettes.
• · Counterfeit, suspected counterfeit, or substandard medicines.
• · Defective medicines (mislabelled, contaminated, damaged).
• · Medical device problems alongside medicines.

Why it matters for GLP-1 medications

GLP-1 weight management medications carry a Black Triangle (▼) on UK packaging and patient information leaflets. This indicates the medication is under additional MHRA monitoring because real-world safety data is still accumulating beyond the pivotal trial population. Yellow Card reports for any side effects on these medications carry particular weight in the safety surveillance system.

How to submit

Direct online at yellowcard.mhra.gov.uk. The form takes 10 to 15 minutes. The MHRA app is also available on iOS and Android. Patients do not need to consult their prescriber first; reports can be submitted independently.

Where the data goes

MHRA aggregates Yellow Card reports and uses the data to update SPCs, issue Drug Safety Updates, and inform regulatory action. Reports do not trigger personal medical follow-up; they are pharmacovigilance, not patient care. For personal medical concerns, contact your prescriber alongside any Yellow Card report.

Related: Patient Information Leaflet · MHRA medicines classification.