Adverse Events
To report a side effect (adverse drug reaction)
Side effects (adverse drug reactions) and any safety or usage issue should be reported.
If you are a patient or acting for a patient, tell your doctor, nurse or pharmacist about it and ask them to report it using the Yellow Card (UK residents) or report to the Health Products Regulatory Authority (Irish residents).
Alternatively, you can report it directly yourself using the links shown below under ‘To make a report directly to the regulatory agencies’.
In addition, please contact us at PV@drfalkpharma.co.uk or call the office on 01628 536600 or the Regulatory Manager on 07765 403015.
For all reports, please be prepared to provide the information described below.
Information required:
- The side effect – the name and/or description of the side effect(s).
- The name of the medicine that you think caused it.
- Information about the person who had the side effect (just initials, age/date of birth and sex).
Please indicate if it was you or someone else who had the side effect, or whether you are reporting on behalf of someone else. Please consider whether you need to have their agreement to report.
In addition to this essential information, you may have more details that you wish to provide. This can include the dates of the side effects, dates the medicine was taken, any relevant medical history, or any other medications taken at the time of the side effect. This added information is not essential, but any further information about the suspected side effect experienced will help in the investigations.
To make a report directly to the regulatory agencies:
For UK residents: Click on the Yellow Card link below to be taken directly to the page for reporting side effects in the UK.
For residents in Ireland: Click on the link below to be taken directly to the page for reporting side effects in Ireland.