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Tinnitus: Yellow Card Scheme

Answer

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for ensuring medicines, medical devices, and blood components for transfusion meet applicable standards of safety, quality, and efficacy. The MHRA rigorously assesses available data, including from the Yellow Card scheme, and seeks advice from the Commission on Human Medicines, the MHRA’s independent advisory committee, where appropriate, to inform regulatory decisions, including amending the product information.

The MHRA has received a total of 11,348 United Kingdom reports through the Yellow Card scheme associated with reaction term tinnitus, including worsening of tinnitus, from 1 January 2014 up to and including 27 November 2025. The table in the document attached provides a yearly breakdown of reports associated with tinnitus. It also provides a yearly breakdown of reports received by the substance associated with tinnitus. Please note that each report may list more than one suspect drug. Therefore, the total number of reports received cannot be accurately derived from the figures presented in the table in the attached document. The following table shows a yearly breakdown of reports associated with tinnitus received from 1 January 2014 up to and including 27 November 2025:

Year	Number of reports
2014	147
2015	164
2016	230
2017	206
2018	197
2019	205
2020	212
2021	7,208
2022	1,248
2023	578
2024	495
2025	458
Total	11,348

It is important to note that anyone can report to the MHRA’s Yellow Card scheme and the recording of these reports in the Yellow Card database does not necessarily mean that the adverse reactions have been caused by the suspect drug. Many factors must be considered in assessing causal relationships, including temporal association, the possible contribution of concomitant medication, and the underlying disease. We encourage reporters to report suspected adverse reaction reports, and the reporter does not have to be sure of a causal association between the drug and the reactions, as a suspicion will suffice.

The number of reports received cannot be used as a basis for determining the incidence of a reaction, as neither the total number of reactions occurring, nor the number of patients using the drug, is known.

Secondary information

Type

Written question

Reference

HL12701

Session

2024-26

Attachment

Additional document

Related items

Tinnitus: Yellow Card Scheme
Monday, 1 December 2025
Written questions
House of Lords

Subjects

Drugs Yellow card scheme Tinnitus

Contains statistics

Yes

Link

View this Written question on www.parliament.uk