Pharmacovigilance
Reporting Side effects
What to Report
You can report suspected side effects from any medicine, vaccine, herbal medicine, or homeopathic remedy, whether it was prescribed, purchased over the counter, or bought online. Report side effects that have occurred to:
- You personally
- Your child
- Someone you care for or are responsible for
- Someone who has asked you to report on their behalf
You only need suspicion to report a side effect.
Ways to Report
There are four main ways you can report:
- complete the attached form, and send it back in
- online at www.mhra.gov.uk/yellowcard
- the envelope provided (there’s no need for a stamp).
- call the Yellow Card reporting line on freephone 0800 731 6789 (10am to 2pm Monday-Friday only)
- using the free app – search ‘Yellow Card’.
How are Yellow Card reports used?
The UK medicines regulator, the Medicines and Healthcare products Regulatory Agency (MHRA), runs the Yellow Card Scheme. It collects reports of side effects from people taking medicines, as well as from healthcare professionals such as doctors, pharmacists and nurses also reporting suspected side effects experienced by a patient.
These reports are used to identify side effects and other safety information about medicines which might not have been known about before. If a new side effect is found,
the MHRA will review the way that the medicine can be used, and the warnings that are given to people taking it.
Completing the Yellow Card Form
When using the attached form, complete as much as possible, especially all fields marked with an asterisk (*). It is helpful to have your medicines on hand while completing the form.
About the Suspected Side Effect
Provide detailed information. Include if the harm was due to a medication error (e.g., wrong drug, dose, or route).
About the Person Who Had the Suspected Side Effect
Include age, sex, height, and weight to help differentiate patients in the MHRA database and identify vulnerable groups.
About the Medicine(s) Which Might Have Caused the Side Effect
Include the batch number (found on the medicine box) and any other medicines or herbal remedies being taken.
About Your Doctor (Optional)
Provide contact details if you permit the MHRA to contact your doctor.
About You, the Reporter
Provide your name and contact details. This helps the MHRA contact you for more information if needed.
What Happens Next?
The MHRA will send an acknowledgment upon receiving your Yellow Card report. If you permitted, a copy will be sent to your doctor.
Protecting Your Personal Information
What is the MHRA?
The MHRA is a UK government body. Its aim is to protect the public’s health. It does this by making sure that medicines and medical devices work properly and are acceptably safe.
When any possible problem is found, the MHRA takes prompt action to protect the public.
For more information about the MHRA:
visit www.gov.uk/mhra or telephone 0203 080 6000
You can also report online at the Yellow Card website any suspected safety problems or incidents involving:
a medical device adverse incident.
defective medicines (those that are not of an acceptable quality).
a fake (counterfeit) medicine or medical device.
safety concerns for e-cigarettes or their refills (e-liquids).
Help MHRA raise awareness about reporting to the Yellow Card Scheme.
If You Need Help Reporting
- Call the Yellow Card reporting line on freephone 0800 731 6789 (10am to 2pm Monday-Friday)
- Ask a healthcare professional (doctor, nurse, or pharmacist) for assistance
- Or Contact Us using the link below for more information