On this page you will find information about what to report, how to report, what to include and assessing causality of adverse drug reactions (ADRs).
All healthcare professionals are able to contribute to making medicines safer by submitting reports about suspected ADRs to the Yellow Card Scheme. Please complete a Yellow Card if you have a suspicion that a drug has caused an adverse reaction. Do not delay reporting, even if you are in doubt about causality. Please remember that proof of an adverse drug reaction, e.g. by re-challenge, is not required.
Black Triangle drugs and vaccines
Please report all suspected ADRs to drugs marked with an inverted black triangle (▼) (i.e. new drugs on the market). The list of medicines under additional monitoring gives details of all black triangle drugs.
Established drugs and vaccines
For established drugs and vaccines (including over-the-counter and herbal medicines), report all suspected adverse reactions that you consider to be SERIOUS. They should be reported even if the effect is well recognised.
Serious reactions are those which are:
However, if you are unsure about the seriousness of a reaction please report it anyway.
Although the MHRA monitor adverse reactions associated with all medicines on the market, they have a number of areas in which they are particularly interested in receiving reports:
Please note that you can also report suspected ADRs that arise as a result of error, misuse, abuse or off-label use.
There are four methods for reporting a suspected adverse drug reactions (ADRs) to the Yellow Card scheme.
1: Reporting online
It is easiest and quickest to report ADRs online at http://www.mhra.gov.uk/yellowcard
Full instructions are given on the website. If you chose to register, you can also keep track of any Yellow Cards that you send.
The new dedicated COVID-19 reporting website should be used to report any suspected side effects from medicines, vaccines or medical devices relating to COVID-19 treatment and prevention.
Key features of the app include the ability to create a ‘watch list’ of medications for which you can receive news and alerts from the MHRA. You can view numbers of Yellow Cards reported to the MHRA for medicines of interest and see previous Yellow Cards you have submitted through the app.
At the moment account details are not synchronised between this website and the app, so you need to create separate accounts. The MHRA are also considering ways to report medical device adverse incidents, defective medicines and counterfeit products through the app.
3: Reporting directly from clinical systems
Electronic Yellow Card reporting is available in the Medicines Information system, MiDatabank, used by Medicines Information pharmacist throughout the UK.
Health professionals using the clinical systems SystmOne and Vision can also transmit Yellow Cards to the MHRA directly from the software.
4: Reporting by post
Yellow Card forms are available:
There are four critical pieces of information required for a Yellow Card report:
1: Suspect drug(s)
The name of the drug(s) suspected to have caused the reaction. If known, it is helpful to have the following:
2: Suspect reaction(s)
Describe the suspected reaction(s) including a diagnosis if relevant. Include:
If the reaction has already been reported (e.g. by another healthcare professional or the patient) but you have additional information to report, please submit a Yellow Card as duplicate reports will be detected and the information linked.
3: Patient details
Basic information about the patient is vital in assessing reports and obtaining further information. Please provide at least one of the following:
Providing this information does not breach confidentiality agreements between you and your patient.
For the identification number, you can use any number or code that will identify the patient to you, but not to the MHRA. For instance, you could use the patient's local practice or hospital number or you may wish to set up a file specifically for Yellow Cards.
We consider that it is vital that a copy of the Yellow Card report is included on the patient's notes for future reference.
4: Reporter details
This field must be completed in all cases. Please include your name and full address so that the MHRA can acknowledge receipt of the report and follow up for further information if necessary.
Any additional information
We would be grateful for any additional information in the report that you think might be relevant such as:
If the patient was not taking any other drugs, or if no other information is available, please indicate this.
All the information that you provide helps to interpret the case and evaluate safety issues. Please provide as much relevant information as is readily available to reduce the need for follow-up. However, please do not delay reporting just because some details are not known. The MHRA will contact you if they require additional information.
Nature of reaction
Some clinical events are commonly caused by medicines. For example:
When such conditions are seen, the possibility that they have been caused by a medicine should be considered.
Timing of reaction
The time period from when treatment with the medicine was started to when the reaction developed may be characteristic of the reaction. For example:
Relationship to dose
Adverse reactions are often dose-related and may be minimised by reducing the dose of the medicine being taken. If the symptoms resolve when the medicine is stopped, this suggests that they are associated with the medicine, although the symptom resolution may be coincidental.
If the medicine is re-introduced and the symptoms recur, this strongly suggests that the medicine is responsible, although deliberate re-challenge with the drug may not be justifiable following serious adverse reactions.
Other possible causes
You may also need to consider other possible causes for the reactions being experienced. For instance:
By filling in a Yellow Card you are simply reporting your suspicion. The report will be looked at in the context of any other information that is available about that particular reaction, and can therefore add to our knowledge and understanding of the reaction.