Freedom of Information request (FOI 22/1008)
Published 17 January 2024
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FOI 22/1008
Dear
Thank you for your FOI request dated 14th September 2022 in which you requested “1) For the 2019, 2020 and 2021 calendar years, could you please state the number of ‘adverse events’ reported relating to a) finasteride and b) minoxidil?
2) For the 2021 calendar year’s ‘adverse events’ could you please give me a complete breakdown of the side effects that reporters have claimed for a) finasteride and b) minoxidil?”.
For suspected side effects being reported, the MHRA publishes this information in the form of interactive Drug Analysis Profiles (iDAPs), of which the one for Finasteride can be accessed here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000844489605.zip&agency=MHRA
The iDAP for Minoxidil can be accessed here: https://info.mhra.gov.uk/drug-analysis-profiles/dap.html?drug=./UK_EXTERNAL/NONCOMBINED/UK_NON_000934622563.zip&agency=MHRA
| There is an iDAP for each licensed medicine by drug substance, which may be accessed here: [What is being reported | Making medicines and medical devices safer (mhra.gov.uk)](https://yellowcard.mhra.gov.uk/idaps). Within an iDAP you can see all suspected side effects, known as suspected adverse drug reactions, that have been reported to the MHRA and you may filter by type of reaction. It is important to note that reported adverse reactions have not been proven to be related to the drug and should not be interpreted as a list of known side effects. |
I hope the information provided is helpful; however, if you are dissatisfied with the handling of your request, you have the right to ask for an internal review. Internal review requests should be submitted within two months of the date of this response; and can be addressed to this email address.
Please remember to quote the reference number above in any future communications.
Yours sincerely,
FOI Team,
Safety and Surveillance Group