How to report a side effect with Yellow Card

Get care first, then report

Patients, carers and healthcare professionals can all report suspected reactions. Reports also help flag concerns about product quality, counterfeit medicines and devices. The reporting form depends on the type of problem. The official Yellow Card website has the forms and guidance.

Details to include

Give the medicine's name, strength, formulation and dose, your start date and when the suspected reaction happened. Describe in everyday words what happened, what treatment you needed and whether things improved after a change. Leave out any diagnosis no one has confirmed.

For quality concerns, the batch number and expiry date help most. Keep the packaging and take photos. List your other medicines and relevant health conditions to give the report context. If you do not know a detail, send what you have. Do not hold the report back for months or guess an answer.

What a report can and cannot show

A report records a suspicion. On its own, a report cannot prove the medicine caused the event or show how often the event happens across all users. Not every report reflects a confirmed diagnosis. Other medicines or health conditions may play a part, and reporting rises and falls with publicity and use.

So dividing the raw number of reports by an estimate of users will not give you a reliable personal risk. Regulators weigh reports alongside clinical trials, observational research and other evidence. A possible safety signal usually leads to more investigation before anyone draws a conclusion.

Keep your clinical care going

Tell your prescriber you have made a report, and keep up your agreed follow-up. If a suspected quality problem affects whether you should use a pen or tablet, ask the dispensing pharmacy to assess that item. If the concern is credible, set the item aside and store the pen or tablets safely while you wait for advice.

Keep your report reference. Add follow-up information later through the scheme. A report is no accusation against a clinician and does not claim every user faces the same risk. You add information to help make medicines safer, and your own care stays with your healthcare team.

Report what you saw, accurately

Use dates and a clear order of events. Avoid a long list of possible explanations. For example, say when a symptom began, whether your dose had changed recently and what a clinician found afterwards. Make clear which parts are a confirmed diagnosis and which are your own concern.

If a healthcare professional has also reported the event, give their reference where the form allows. Accurate facts are worth more than dramatic wording. Saying a detail is unknown beats a confident guess.