FOI release
Post-Finasteride Syndrome (PFS), MedDRA PT 10082430 and MHRA Yellow Card Coding
Some or all of the information requested was not provided because we didn't hold it.
Case reference FOI2026/00904
Received 14 August 2026
Published 18 September 2026
Request
Freedom of Information Act 2000 request I request recorded information held by the Medicines and Healthcare products Regulatory Agency concerning the relationship between Post-Finasteride Syndrome (PFS) and MedDRA Preferred Term (PT) 10082430, “Post 5-alpha-reductase inhibitor syndrome”, within the MHRA Yellow Card/pharmacovigilance system. For precise identification, I refer to MedDRA Change Request 2018325008 and MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, implemented on 29 November 2018. The principal purpose of this request is to establish from existing MHRA records whether “Post 5-alpha-reductase inhibitor syndrome” is the broader pharmacovigilance/coding concept under which a finasteride-specific case described by a reporter as “Post-Finasteride Syndrome” or “PFS” can fall. I am requesting existing recorded information only. I am not asking the MHRA to create a new medical opinion, establish individual causation, or make a new determination concerning the clinical status of PFS. 1. Implementation of MedDRA PT 10082430 Please provide recorded information establishing: * whether MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, is or has been implemented within the terminology used by the MHRA for Yellow Card/pharmacovigilance reports; * the date and MedDRA version from which it became available within the relevant MHRA system; * whether PT 10082430 can be used to code, classify, retrieve, aggregate or analyse suspected adverse-reaction reports; and * its relevant MedDRA terminology status and hierarchy as implemented or used by the MHRA. Where this information exists as a database or terminology entry rather than a conventional document, please provide an extract, screenshot, printout or equivalent recorded representation where reasonably practicable. 2. Finasteride and PT 10082430 Please provide existing recorded information establishing whether finasteride, as a 5-alpha-reductase inhibitor, is a medicinal product whose suspected adverse-reaction reports are capable of falling within or being associated with MedDRA PT 10082430. Specifically, please provide recorded information showing whether a Yellow Card report involving finasteride can be: * coded under PT 10082430; * mapped to PT 10082430; * retrieved through PT 10082430; * aggregated or analysed using PT 10082430; or * otherwise represented under PT 10082430 for pharmacovigilance or signal-detection purposes. 3. Post-Finasteride Syndrome / PFS This is the principal part of my request. Where a Yellow Card report: (a) identifies finasteride as the suspected medicinal product; and (b) expressly describes a persistent post-treatment condition using the reporter terminology “Post-Finasteride Syndrome” or “PFS”, please provide the existing recorded information establishing whether that report is capable of being: * coded under; * mapped to; * classified under; * retrieved through; * aggregated under; or * otherwise represented by MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”. If “Post-Finasteride Syndrome” or “PFS” is not itself a MedDRA Preferred Term or Lowest Level Term, please provide any existing MHRA coding rule, terminology mapping, guidance, database documentation or other recorded information identifying how reporter wording expressly describing PFS is represented. If another MedDRA term would instead apply, please identify that term and its code where this information is held. 4. Broader/umbrella relationship Please provide any recorded information establishing whether MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”, functions as the broader pharmacovigilance or coding concept capable of encompassing a finasteride-specific report described as Post-Finasteride Syndrome/PFS. In particular, please provide any existing terminology hierarchy, mapping, coding rule, guidance, database documentation or other recorded information demonstrating the relationship, if any, between: Finasteride → Post-Finasteride Syndrome/PFS → MedDRA PT 10082430 “Post 5-alpha-reductase inhibitor syndrome”. For clarity, by “broader/umbrella concept” I mean a pharmacovigilance or terminology category capable of encompassing a finasteride-specific report. I am not asking the MHRA to adopt “umbrella term” as a new clinical definition. 5. Persistent post-treatment effects and scope Please provide any recorded definition, MedDRA documentation, coding guidance or other information held or used by the MHRA concerning the scope of PT 10082430. In particular, please provide recorded information establishing whether PT 10082430 encompasses reports of effects or symptoms which develop during or following exposure to a 5-alpha-reductase inhibitor and persist following discontinuation. Please also provide any recorded information establishing whether this includes reports involving finasteride. Where held, please provide recorded information concerning the categories of persistent effects capable of being represented or associated with PT 10082430, including reported: * cognitive or neurological symptoms; * psychiatric symptoms; * sexual or reproductive symptoms; * fatigue or related systemic symptoms; and * any other categories recorded as falling within the scope of PT 10082430. For clarity, I am requesting information concerning the scope and coding of reported effects, not asking the MHRA to establish a particular biological mechanism. 6. Central question To ensure that the principal information sought is unambiguous: Where finasteride is the suspected medicinal product and a Yellow Card reporter describes a persistent post-treatment condition as “Post-Finasteride Syndrome” or “PFS”, is that report capable of falling within, being coded or mapped to, or being retrieved or aggregated under MedDRA PT 10082430, “Post 5-alpha-reductase inhibitor syndrome”? Please provide the existing recorded information establishing the answer. If MHRA records establish that the answer is yes, please provide the relevant record(s), terminology entry, database extract, mapping, coding guidance or other recorded information establishing that relationship. If MHRA records establish that the answer is no, please provide the recorded information establishing that distinction and, where held, identify the alternative MedDRA terminology under which a report expressly described as PFS would be represented. If the MHRA holds no recorded information establishing either position, please state explicitly that no such recorded information is held. 7. Historical information Where held and readily identifiable, please also provide: * the date on which PT 10082430 was first implemented within the MHRA pharmacovigilance system; * the earliest date on which the MHRA recorded a Yellow Card report under PT 10082430, without disclosure of patient-identifiable information; and * any existing MHRA coding or terminology guidance specifically addressing finasteride in connection with PT 10082430. 8. Form and provenance of disclosure Please provide the information electronically. Where responsive information exists as a database entry, terminology record, electronic field, coding rule or other electronic record rather than a conventional document, please provide an extract, screenshot, printout or equivalent copy where reasonably practicable. Where reasonably practicable, please preserve identifying information associated with the disclosed records, including: * document titles and dates; * MedDRA/terminology version numbers; * database field headings; * originating MHRA department where recorded; and * other contextual metadata necessary to establish the source and date of the disclosed information. If responsive information is already publicly available, please identify the specific document, terminology record and relevant section or entry, rather than referring generally to the MHRA, Yellow Card or MedDRA websites. If any requested information is withheld, please identify the specific exemption under the Freedom of Information Act 2000 relied upon and explain its application. If compliance with any discrete part of this request would exceed the appropriate cost limit, please provide the remainder of the information that can be supplied and provide advice and assistance concerning how the affected portion may be refined.
Response
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