FOI release

Request for Adverse Event Information

Case reference FOI2025/01233

Received 24 November 2025

Published 31 December 2025

Request

I am writing to request information regarding reported adverse events associated with the following medicinal products: Amgevita, Humira and Imraldi. Specifically seeking clarity on whether the MHRA has received any reports of alopecia (hair loss) linked to the use of these products. Would it be possible to provide the following details: - The number of reports received for each medicine - The nature and severity of the cases - any other additional information. Please note I have reviewed the Yellow Card drug analysis profiles and there is only data available for the active ingredient (ADALIMUMAB) and no information for the individual products as mentioned above.

Response

See attached

Documents

• Amgevita PRODUCT ANALYSIS PRINT Up to and including 08.12.2025.pdf (3.6 MB)
• DAP guidance.pdf (119.6 KB)
• FOI2025_01233 (redacted).pdf (984.7 KB)
• Humira PRODUCT ANALYSIS PRINT Up to and including 08.12.2025.pdf (389.7 KB)
• Imraldi PRODUCT ANALYSIS PRINT Up to and including 08.12.2025.pdf (150.2 KB)

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