Patient reporting of suspected adverse drug reactions

A side effect from your medicine?  Report it through the Yellow Card Scheme

What to report
If you think a medicine or herbal remedy has caused an unwanted side effect (an adverse drug reaction), please report the problem on a Yellow Card.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the medicines safety watchdog. The Yellow Card scheme has been used for over 40 years to collect information on suspected side effects from all types of medicines. These include prescription medicines, medicines you can buy without a prescription, and herbal and other complementary remedies. 

The MHRA welcomes Yellow Card reports on any suspected side effect. It is especially useful to know about:

  • a suspected side effect that is not mentioned in the patient information leaflet that came with the medicine; or
  • a suspected side effect that has caused problems bad enough to interfere with everyday activities. 

Sometimes it is difficult to tell whether a possible side effect is due to a medicine or something else. Even if you are not sure whether a medicine or combination of medicines has caused a side effect, but suspect it has, please complete a Yellow Card.

If you are worried about a suspected side effect, contact a doctor or pharmacist, or call NHS Direct in England and Wales on 0845 46 47 or NHS24 in Scotland on 08454 24 24 24.

How to report a suspected side effect
You can report a suspected side effect:

Who can report?
You can send a Yellow Card report about a suspected side effect experienced by:

  • you
  • your child
  • someone else you are responsible for someone else (such as your spouse or partner, or an adult child), with their agreement.

The MHRA also collects Yellow Card reports of suspected side effects from health professionals such as doctors, pharmacists and nurses.

Safety of medicines
Medicines are designed to prevent or treat illnesses, or relieve symptoms. Any medicine can cause side effects. Side effects may not be discovered until many people have used the medicine over a period of time. Side effects can occasionally appear after a person has stopped taking a medicine.  You can help to make medicines safer for everyone by filling in a Yellow Card about a suspected side effect.

More information
If you are worried about a suspected side effect, contact a doctor or pharmacist. You can also get information from:

  • NHS Direct in England and Wales on 0845 46 47 (textphone 0845 606 4647)
  • NHS24 in Scotland on 08454 24 24 24 (textphone 18001 08454 24 24 24)

The MHRA advises that you consult your health professional about any suspected side effect or adverse reaction from a medicine that you are worried about.  The MHRA cannot provide medical advice in individual cases.

What is the MHRA?
The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency responsible for ensuring that medicines and medical devices work, and are acceptably safe. We keep watch over medicines and devices, and take necessary action to protect the public promptly if there is a problem.  If you would like to report a suspected safety problem involving a medical device or other healthcare product, please call 020 7084 3080.

For more information e-mail us at patientreporting@mhra.gsi.gov.uk.

Protecting personal information
We ask for contact details so we can get in touch if more information on the Yellow Card is needed. The information you provide will be kept safe, secure and confidential. The MHRA regularly publishes anonymised data on the Yellow Card reports that are received.  Your personal data will not be passed to any person outside the MHRA without your express permission.

Completing the report
Please complete as much of the form as possible.  It does not matter if you cannot complete all sections of the Yellow Card. 

If you wish to report a suspected side effect, but do not wish to tell us your name, please ask someone else to complete the form on your behalf. We may need to contact this person for further information about the report. 

The MHRA will acknowledge all Yellow Card reports received, and will send you a copy of the Yellow Card report you have completed for your records. If you are completing this report about someone else (for example, your partner, an adult child or someone you look after), we will send you an additional copy of the report for that person to pass to their health professional if they wish.

Downloading data collected through the Yellow Card Scheme on suspected side effects
Complete listings of the suspected adverse drug reactions (ADRs) reported to the MHRA through the Yellow Card Scheme by health professionals and patients are provided in drug analysis prints.  Drug analysis prints can be accessed at this link:

› Drug Analysis Prints

Information for patients on side effects from medicines and the Yellow Card Scheme
The Yellow Card Scheme is vital in helping the MHRA monitor the safety of the medicines that are on the market. 

Before a medicine is granted a licence so that it can be made available in the United Kingdom, it must pass strict tests and checks to ensure that it is acceptably safe and effective.  All effective medicines, however, can cause side effects (also known as adverse drug reactions), which can range from being minor to being very serious.  For a medicine to be granted a licence, the expected benefits of the medicine must outweigh the possible risks of the medicine causing adverse effects in patients.  Sometimes, it is difficult to tell whether a possible side effect is due to a medicine, or something else.  Even if it is only a suspicion that a medicine or combination of medicines has caused a side effect, we ask patients and health professionals to send us a Yellow Card.   

Yellow Card reports that we receive on suspected side effects are evaluated, together with additional sources of information such as clinical trial data, medical literature or data from international medicines regulators, in order to identify previously unidentified safety issues or side effects. 

Information gathered from Yellow Card reports made by patients and health professionals is continually assessed at the MHRA by a team of medicine safety experts made up of doctors, pharmacists and scientists who study the benefits and risks of medicines.  If a new side effect is identified, information is carefully considered in the context of the overall side effect profile for the medicine, and how the side effect profile compares with other medicines used to treat the same condition.  The MHRA takes action, whenever necessary, to ensure that medicines are used in a way that minimises risk, while maximising patient benefit.

In assessing the safety of medicines, the MHRA is advised by the Commission on Human Medicines (CHM), which is the Government’s independent scientific advisory body on medicines safety.  The CHM is made up of experts from a range of health professionals and includes lay representatives.

› More information for patients on the Yellow Card Scheme is available here.

Evaluation of patient reporting to the Yellow Card Scheme - April 2006
The NHS Research and Development methodology Programme, in conjunction with the MHRA, has developed proposals for an evaluation of the patient reporting component of the Yellow Card Scheme, which is the UK’s national reporting system for Adverse Drug Reactions.

› Evaluation of patient reporting to the Yellow Card Scheme (53Kb)

The Methodology Programme is a Department of Health funded research programme managed by The National Co-ordinating Centre for the Methodology Programme.  The deadline for applications was 16 June 2006 and more information is available from the National Co-ordinating Centre for the Methodology Programme website


Page last modified: 08 April 2008