Error in patient leaflet: what to do and how to report
Found a mistake in a patient leaflet? Don’t ignore it. Leaflet errors happen — a wrong dose unit, missing interaction, or a bad translation can put you at real risk. This short guide tells you what to check, what to do right away, and how to report the problem so others don’t get harmed.
Quick steps if you already took the medicine
If you’ve already taken the medicine and feel fine, stay calm but watch for symptoms. If you have severe symptoms like difficulty breathing, swelling, fainting, or chest pain, call emergency services now. If symptoms are mild or you’re unsure, call your pharmacist or prescribing doctor and describe exactly what you took and how much.
If the leaflet gave a dose that looked wrong (for example mg versus mcg), tell your healthcare provider immediately. Don’t stop a prescribed medicine without checking first — some drugs must be continued or changed safely under a doctor’s guidance.
How to collect proof and report the error
Keep the package and leaflet. Take clear photos of the leaflet pages, the box, the batch number, and expiry date. Note where and when you bought it (pharmacy name or website and order number).
Check the same drug information from trusted sources: the manufacturer’s official website, the FDA label (US), the MHRA Yellow Card info (UK), or your national medicines agency. Compare the leaflet text to those sources — that helps show if it’s a printing error or an outdated leaflet.
Report the error to three places: the pharmacy where you bought the medicine, the manufacturer, and your national regulator. In the US use FDA MedWatch. In the UK use the Yellow Card scheme. In the EU contact your country’s medicine agency or the EMA contact point. Reporting triggers investigations, product corrections, and sometimes recalls.
If you bought the medicine online, check that the seller is a licensed pharmacy. Keep order records and screenshots. If the online seller won’t help, your regulator can advise on next steps and may block unsafe vendors.
Common leaflet mistakes to watch for: swapped dose units (mg vs mcg), missing allergy or pregnancy warnings, wrong mixing or dilution steps for injectables, incorrect dosing intervals, and typos that change meaning. These errors may be small on the page but can have big effects in real life.
To reduce risk in the future, always read the whole leaflet before taking a new medicine, ask the pharmacist to explain unclear parts, and keep a list of your medicines to check for interactions. Use the manufacturer’s online leaflet as a backup if the printed one looks odd.
Reporting a leaflet error helps you and everyone else. It’s quick, it can stop harm, and it forces companies to fix mistakes. If you want, show your photos and notes to your pharmacist — they can help file the report and explain the next steps.
