Yellow Card reporting guide
The MHRA Yellow Card scheme is the UK's official route for reporting suspected adverse drug reactions, defective medicines, and counterfeit products. Patients can report directly — you don't need to go through a healthcare professional. This guide walks through what to report, how, and what happens next.
What Yellow Card is
The Yellow Card scheme is run by the MHRA and the Commission on Human Medicines. It collects reports of:
- Suspected side effects of medicines (including herbal medicines, vaccines, contraceptives, and OTC products).
- Defective medicines (broken packaging, wrong contents, missing PIL).
- Counterfeit and falsified medicines.
- Adverse incidents with medical devices.
- Suspected misuse of medicines.
Reports go into the MHRA’s pharmacovigilance database and feed into safety reviews, label updates, and (where relevant) enforcement.
Who can report
Anyone. Patients, carers, parents, and members of the public can report directly. Healthcare professionals also report. You don’t need to wait for a GP appointment, and you don’t need permission from your prescriber.
How to report (online)
- Go to yellowcard.mhra.gov.uk.
- Choose the type of report (side effect, defective medicine, fake medicine, etc.).
- Fill in product details, your details (or report anonymously where the form allows), and what happened.
- Submit. You’ll get a confirmation reference.
How to report (other routes)
- Yellow Card app — iOS and Android. Useful if you’re reporting recurring side effects.
- Through your pharmacist or GP — they can submit on your behalf.
- By phone — for serious or urgent reports where online submission isn’t practical.
What to include for a medicine side-effect report
- Product name as printed on the box (brand name and generic name if known).
- Dose and dose schedule.
- Batch number and expiry from the box and the pen / strip / bottle.
- When you started the medicine and when the reaction began.
- What the reaction was (symptoms, severity, duration).
- Whether you sought medical help and what was done.
- Whether the reaction settled, how, and how long it took.
- Whether you took other medicines or supplements at the same time.
- Your age, sex, and any relevant medical conditions.
What to include for a suspected counterfeit
- All of the above, plus:
- Photographs of the carton (all sides), the pen, the PIL (or its absence).
- Where you bought it (URL, clinic name, person).
- Payment method and date.
- Shipping route and arrival date.
- Anything that struck you as unusual on receipt.
For counterfeit reports also use the GOV.UK report-a-problem form and consider Action Fraud for fraudulent supply.
What happens after you submit
- MHRA logs the report and adds it to the pharmacovigilance database.
- Individual reports inform pattern analysis. A single report usually doesn’t trigger action; clustered or unusual reports can.
- Reports of suspected counterfeits feed enforcement intelligence — the Feb 2026 Mounjaro 15 mg KwikPen alert was built on accumulated reports.
- You generally won’t get a detailed personal response beyond receipt confirmation. The MHRA doesn’t share individual outcomes with reporters.
Why reporting matters even for ‘minor’ side effects
Pharmacovigilance signals come from many small reports adding up. A side effect that seems unimportant in your case may be one of dozens that together change a medicine’s safety profile. Under-reporting is the bigger problem; over-reporting is fine.
What Yellow Card doesn’t do
- It’s not a complaints process for your clinic or pharmacist.
- It’s not compensation or insurance.
- It doesn’t replace seeking medical care — call 111 or 999 for symptoms first.
- It’s not anonymous from MHRA — they may follow up — but the data is anonymised in published analyses.
Sources & further reading
- Yellow Card — yellowcard.mhra.gov.uk
- MHRA — gov.uk
- Report a problem with a medicine or medical device — gov.uk
- Action Fraud — actionfraud.police.uk
- NHS 111 — nhs.uk