No, but the Medicines and Healthcare products Regulatory Agency did have discussions on the underlying data in this area with officials responsible for the medical dictionary for regulatory activities, which resulted in them adding the lower level term “post-SSRI sexual dysfunction” to the regulatory dictionary under sexual dysfunction.

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 their independent advisory committee, the Commission on Human Medicines, where appropriate to inform regulatory decisions.

The MHRA uses the Medical Dictionary for Regulatory Activities (MedDRA) to code suspected adverse drug reactions reported by patients and healthcare professionals via the Yellow Card scheme. MedDRA is an international, clinically validated medical terminology used by regulatory authorities and the biopharmaceutical industry throughout the entire regulatory process, from pre-marketing to post-marketing safety monitoring. MedDRA is updated twice annually, and new terms can be proposed by any MedDRA users. The term Post Selective Serotonin Reuptake Inhibitor Sexual Dysfunction (PSSD) was added to MedDRA as a lower-level term in version 24.1 which was and implemented by the MHRA as a term available to users of the Yellow Card website in February 2022 as part of routine updates.

As part of current routine MHRA processes, Yellow Card reports are not recoded to reflect the changes in the reaction terms available but remain as reported with the terms selected by the original reporter.

As a lower-level term in MedDRA, PSSD is recorded if the reporter has specifically used this term at the time of the report, and since this term can include a wide range of symptoms it would not be appropriate to recode cases not reporting this specific term received prior to 2021. All Yellow Card reports received prior to the availability of PSSD as a MedDRA term will have the individual symptoms reported coded as MedDRA terms and available for signal detection and assessment processes.

A total of 52 reports that describe increased sexual arousal suspected to be associated with the use of medicines or vaccines have been received through the Yellow Card scheme. The reports were received between 2014 and 2025 for a wide range of medicinal products which include antidepressants, hormonal medicines, vaccines, antipsychotics, antibiotics, cardiovascular medicines, drugs used to treat attention deficit hyperactivity disorder, sedatives, drugs used to treat dementia and diabetes, and single reports for drugs used to treat osteoporosis, Parkinson’s disease, and pain.

The term increased sexual arousal itself is not in the product information for any of the above classes of medicines, however terms such as increased libido and hypersexuality are reflected in product information for medicines used to treat Parkinson’s disease. The following table shows a breakdown of all spontaneous Yellow Card Reports the Medicines and Healthcare products Regulatory Agency (MHRA) received from 1 January 2014 to 4 November 2025, where the MedDRA, a categorisation of medical terminology, Lowest Level Term (LTT) ‘increased sexual arousal’ was reported:

In addition, the following able shows a breakdown of all spontaneous Yellow Card Reports the MHRA received from 1 January 2014 to 4 November 2025 where the MedDRA LLT ‘increased sexual arousal’ was reported, broken down by substance:

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 the available data, including from the Yellow Card scheme, and seeks advice from their independent advisory committee, the Commission on Human Medicines, where appropriate, to inform regulatory decisions.

It is important to note that a reaction reported to the Yellow Card scheme does not necessarily mean that it has been caused by the medicine, only that the reporter had a suspicion it may have. Underlying or concurrent illnesses may be responsible, or the events could be coincidental. 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.

The MHRA can confirm that it has received 124 spontaneous suspected United Kingdom Adverse Drug Reaction reports from 1 January 2014 to, and including, 18 September 2025, where a reaction term within the Medical Dictionary for Regulatory Activities’ (MedDRA) High-Level Term "Sexual Arousal Disorders” was reported. MedDRA is a clinically validated international medical terminology dictionary. It’s organised by System Organ Class, divided into High-Level Group Terms, High-Level Terms, Preferred Terms, and finally into Lowest Level Terms.

The following table shows the number of UK spontaneous suspected Adverse Drug Reaction reports where a reaction within the High-Level Term “Sexual Arousal Disorders” was reported, from 1 January 2014 to, and including, 18 September 2025, by year:

In addition, the following table shows a breakdown of these reports by suspect medicine, for all suspect substances for which we received two or more reports:

Note: please be aware that reports received via the Yellow Card scheme can contain more than one suspect medicine and as such the numbers in the table cannot be summed up to the total number of reports.

Suspect substances for which a single report was received were amitriptyline, amoxycillin, atomoxetine, canagliflozin, candesartan, ciprofloxacin, clavulanic acid, clobetasol, clonazepam, diazepam, donepezil, doxycycline, drospirenone, dutasteride, elasomeran, estradiol, etonogestrel, flucloxacillin, flupenthixol, ibutamoren, levonorgestrel, linagliptin, mefloquine, methylphenidate, metronidazole, minoxidil, norelgestromin, pramipexole, propranolol, quetiapine, reboxetine, risperidone, ropinirole, sildenafil, solifenacin, teriparatide, tirzepatide, tramadol, ulipristal, and varenicline.

Following the next meeting of the Expert Working group (EWG), the Medicines and Healthcare products Regulatory Agency (MHRA) will seek advice from the Commission on Human Medicines on the recommendations of the EWG, on a wide range of regulatory options for the communication of the risk of sexual dysfunction where symptoms continue after taking antidepressants.

Once the regulatory procedure is completed, a public assessment report will be published which will contain the evidence underpinning any regulatory action. The MHRA anticipates that regulatory action will be finalised in Autumn 2025.

The product information for selective serotonin reuptake inhibitors (SSRIs) provides advice on the risk of withdrawal/discontinuation reactions, and advises patients not to stop their medication suddenly. Integrated care boards (ICBs) are responsible for planning health services for their local population. This includes consideration of services for patients taking medicines associated with dependence and withdrawal symptoms, based on local population needs.

An increasing number of non-pharmacological alternatives have become available on the National Health Service, such as NHS Talking Therapies for anxiety and depression, with over 670,000 courses of treatment provided in 2022/23. NHS England is encouraging ICBs to address inappropriate antidepressant prescribing and to consider commissioning services for patients wishing to reduce or stop prescribed medicines that can cause dependence and withdrawal.

Medicines and Healthcare products Regulatory Agency (MHRA) approved product information, provided to healthcare professionals and patients for all SSRIs, was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction, where symptoms continue despite discontinuation of the SSRI. The MHRA was an integral part of the European Union wide review of the available evidence which underpinned the current warnings.

The term Post SSRI Sexual Dysfunction was added to the regulatory dictionary in 2021, which will help with the recording and retrieval of Yellow Card data and literature cases, and in the future, will contribute to the much-needed research into this important health issue. Persistent sexual dysfunction following withdrawal of an SSRI as a disorder was added to the electronic health records system, known as SNOMED, in October 2024, as a code that will help with the clinical identification of patients with persistent sexual dysfunction, including those after taking SSRIs.

An Expert Working Group of the Commission on Human Medicines has been established by the MHRA to consider how the risk of sexual dysfunction which continues after stopping antidepressants is communicated in patient information leaflets, however this work will not address the clinical recognition of post-SSRI sexual dysfunction, as that is outside the remit of the MHRA.

The current Medicines and Healthcare products Regulatory Agency (MHRA) approved product information for selective serotonin reuptake inhibitors (SSRIs) has a warning for the risk of sexual dysfunction where symptoms continue despite stopping treatment.

The term Post SSRI Sexual Dysfunction was added to the regulatory dictionary in 2021, which will help with the recording and retrieval of Yellow Card data and literature cases, and in the future, will contribute to the much needed research into this important health issue.

Persistent sexual dysfunction following withdrawal of an SSRI, as a disorder, was added to the electronic health records system SNOMED in October 2024, as a code that will help with the clinical identification of patients with persistent sexual dysfunction, including after taking SSRIs.

An Expert Working Group of the Commission on Human Medicines has been established by the MHRA to consider how the risk of sexual dysfunction which continues after stopping antidepressants use is communicated in patient information leaflets, however this work will not address the clinical recognition of post-SSRI sexual dysfunction, as that is outside the remit of the MHRA.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information provided to healthcare professionals and patients for all selective serotonin reuptake inhibitors (SSRIs) was updated in 2019 to inform them that reports had been received of long-lasting sexual dysfunction where symptoms continue despite discontinuation of the SSRI. The MHRA was an integral part of the European Union-wide review of the available evidence, which underpinned the current warnings.

An Expert Working Group of the Commission on Human Medicines has been established to review evidence from patients and the scientific literature available since 2019, to address concerns about the ongoing lack of awareness of the existing warnings in the product information. A range of regulatory options are under consideration to help improve the communication of the risk of sexual dysfunction where symptoms continue after taking SSRIs.

In the United Kingdom there are two authorised products containing bupropion. The first contains bupropion hydrochloride and is prescribed to help individuals stop smoking, when they also have motivational support, for instance through a stop smoking programme. The second is a combination product containing bupropion hydrochloride and naltrexone hydrochloride, and is prescribed in obese or overweight adults to manage weight, together with a reduced calorie diet and physical exercise.

The Medicines and Healthcare products Regulatory Agency (MHRA) has received three Yellow Card reports of sexual dysfunction related reactions suspected to be associated with bupropion hydrochloride, the single constituent, and one Yellow Card report of sexual dysfunction for the combination product, bupropion hydrochloride and naltrexone hydrochloride, between 1 January 2014 and 29 October 2024.

The following table shows the number of suspected Yellow Card reports of sexual dysfunction related reactions and bupropion containing products received by the MHRA between 2014 and 2024:

Source: data provided by the MHRA.
Note: the data includes reactions grouped under the Medical Dictionary for Regulatory Activities’ (MedDRA) Higher Level Terms: erection and ejaculation conditions and disorders; orgasmic disorders and disturbances; sexual and gender identity disorders NEC; sexual arousal disorders; sexual desire disorders; sexual dysfunction NEC; sexual function and fertility disorders NEC; and spermatogenesis and semen disorders.

Persistent sexual dysfunction does not represent a specific medical condition, so this precise term is not a category available to undertake a structured search of the MHRA’s Adverse Drug Reaction database, and would rely on manual assessment of individual cases. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as the Diagnostic and Statistical Manual of Mental Disorders or the International Classification of Diseases.

It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not 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.

The product information, which includes the patient information leaflet, for single constituent bupropion reflects the data currently available, and does not include sexual dysfunction as a possible side effect. The product information for the combination bupropion and naltrexone product contains the terms loss of libido, libido disorder, and erectile dysfunction. As with other medicines, the safety of bupropion is kept under review by the MHRA, and consideration will be given to any emerging evidence on this issue.

The first meeting of the Expert Working Group (EWG) on antidepressant risk minimisation convened by the Medicine and Healthcare products Regulatory Agency, on the advice of the Commission on Human Medicines, was held on 4 July 2024.

At the initial meeting of the EWG, the terms of reference, scope of work, additional expertise, and plans for patient engagement were discussed. The EWG will consider whether the patient information can be improved and whether additional risk minimisation measures are required for all antidepressants, including selective serotonin reuptake inhibitors.

The Medicines and Healthcare products Regulatory Agency (MHRA) approved product information outlines the details of possible adverse reactions associated with each medicine. Whilst post-acute withdrawal syndrome is not currently recognised as being associated with antidepressant use, the product information for the most commonly prescribed antidepressants contain advice about the risk of withdrawal reactions associated with antidepressant use, and advises users not to stop these types of medication abruptly.

The product information for some antidepressants contains advice that they can be associated with sexual dysfunction where symptoms continue despite stopping the antidepressant. An expert working group of the Commission on Human Medicines has been established to review how the risk of sexual dysfunction, where symptoms may continue, is communicated to patients. Separately, a review of the communication of the risk of withdrawal reactions in the product information will be taken forward in the MHRA’s project, to improve the information supplied with known dependency-forming medicines. Patients can visit either their general practice, or a sexual health clinic, for support with erectile dysfunction.

Patients can visit either their general practice (GP), or a sexual health clinic, for support with erectile dysfunction. Anyone experiencing mental health issues, including those related to selective serotonin reuptake inhibitor (SSRI) use, is encouraged to seek help by consulting to their GP or by self-referring to their local NHS Talking Therapies service.

The product information for individual SSRI medicines describe a range of side-effects, including potential sexual dysfunction during treatment. Some products specifically note that these symptoms may persist even after discontinuing the medication. Patients are encouraged to discuss the benefits and risks associated with medicines with their prescriber for individual support.

As with all medicines, the evidence available for the safety of antidepressants remains under continual review by the Medicines and Healthcare products Regulatory Agency after they are authorised for use. In response to patient and family feedback, an Expert Working Group under the Commission of Human Medicines has been established. This group is currently considering the risk minimisation measures for antidepressants in relation to suicide and suicidal behaviour. The scope of this review has been expanded to include the risk of persistent sexual dysfunction after stopping the medication for all 30 antidepressants currently marketed in the United Kingdom.

The National Institute for Health and Care Research (NIHR) has funded previous studies focused on the effects of antidepressant medication on sexual function. For example, a systematic review to determine the effectiveness of management strategies for sexual dysfunction caused by antidepressants, and to determine the adverse effects and acceptability of these different management strategies.

The Department funds research through the National Institute for Health and Care Research (NIHR). The NIHR has funded previous studies focused on the effects of antidepressant medication on sexual function. For example, a systematic review to determine the effectiveness of management strategies for sexual dysfunction caused by antidepressants, and to determine the adverse effects and acceptability of these different management strategies. The NIHR is not currently funding any research with a focus on the permanency of antidepressant induced sexual dysfunction. The NIHR welcomes funding applications for research into any aspect of human health, including antidepressant-associated sexual dysfunction.

The following table shows the total number of items issued for trazodone from 2014 to 2023, and from January to May 2024:

Source: data was provided by the NHS Business Service Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance trazodone hydrochloride.
Note: items have been dispensed, but not necessarily prescribed, in England.

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 the available data, including from the Yellow Card scheme, and where appropriate it seeks advice from its independent advisory committee, the Commission on Human Medicines, to inform on regulatory decisions, including the amending of product information.

The MHRA has received a total of 20 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with trazodone, between 1 January 2014 and 29 July 2024. This includes reactions grouped under the medical dictionary’s (MedDRA) Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction, and include erection and ejaculation conditions and disorders, orgasmic disorders and disturbances, sexual arousal disorders, and others. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with trazodone in the United Kingdom, received by the MHRA each year from 2014 to 2024:

Source: data provided by the MHRA.

“Persistent sexual dysfunction” does not represent a specific medical condition, so this precise term is not a category available for a structured search of the MHRA’s Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, MedDRA, or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.

It is important to note that the inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not 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.

The product information for trazodone, which includes the patient information leaflet, reflects the data currently available, and does not include sexual dysfunction as a possible side effect but does include priapism, the prolonged erection of the penis. The Summary of Product Characteristics for healthcare professionals states that there have been reports of priapism which have required surgical intervention, or led to permanent sexual dysfunction. Patients developing priapism should stop using trazodone immediately.

The following table shows the number of items issued for vortioxetine and the net ingredient cost (NIC) from 2014 to 2023, and from January to May of 2024:

Source: data provided by the NHS Business Services Authority, based on information within the Prescription Cost Analysis published statistics, using British National Formulary chemical substance vortioxetine.

Note: items have been dispensed, but not necessarily prescribed, in England.

"Persistent sexual dysfunction" does not represent a specific medical condition, so this term is not a category available for a structured search of the Medicines and Healthcare products Regulatory Agency’s (MHRA) Adverse Drug Reaction database. The structured data field search terms are drawn from the regulatory drugs dictionary, the medical dictionary (MedDRA), or from terms adopted in clinical coding guidance such as The Diagnostic and Statistical Manual of Mental Disorders Fifth Edition, or the International Classification of Diseases 11th Revision. A search of the database would therefore rely on manual assessment of individual cases.

The MHRA has received a total of 29 Yellow Card reports of sexual dysfunction related reactions, suspected to be associated with vortioxetine, between 1 January 2014 and 21 July 2024. This includes reactions grouped under MedDRA Higher Level Terms, which are more specific than sexual dysfunction and persistent sexual dysfunction. The following table shows the number of spontaneous suspected Yellow Card reports of sexual dysfunction related reactions suspected to be associated with vortioxetine in the United Kingdom, received by the MHRA each year from 2014 to 2024:

Source: data provided by the MHRA.

The inclusion of a particular report on the MHRA’s system does not necessarily mean that the adverse reactions reported have been caused by the suspect drug. Additionally, the number of reports received should not 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.

Sexual dysfunction was assessed as part of the clinical studies to support the authorisation of vortioxetine. The clinical studies indicated that doses between 5 milligrams and 15 milligrams did not show a difference from placebo in relation to the risk of sexual dysfunction. However, the 20 milligram dose was associated with an increase in sexual dysfunction. This information was included in the Summary of Product Characteristics (SmPC) for healthcare professionals for all strengths of vortioxetine since authorisation in 2021. The SmPC and patient information leaflet were subsequently updated in April 2024 to list sexual dysfunction as a possible side effect for all strengths, following reports of sexual dysfunction associated with doses below 20 milligrams.

Over the next year, the Medicines and Healthcare products Regulatory Agency (MHRA) plans to review the risk of sexual dysfunction and whether these side effects persist for all antidepressants marketed in the United Kingdom. As a result of the review product information will be updated, as necessary, and consideration will be given to whether additional risk minimisation measures are needed.

The following table shows the total number of items in each calendar year between 2014 and 2023, as well as January 2024:

Data Source: NHS Business Services Authority Open Data Portal, PCA data

The MHRA has received a total of 38 Yellow Card reports of sexual dysfunction related reactions suspected to be associated with amitriptyline, atomoxetine, and imipramine. Of these, 8 were for amitriptyline, 21 for atomoxetine, and 2 for imipramine.

‘Persistent sexual dysfunction’ does not represent a specific medical condition.

The following table shows a summary of these side effects listed in the product information:

The Medicines and Healthcare products Regulatory Agency receives reports of suspected side effects for medicines, including reports related to sexual dysfunction associated with antidepressants, through the Yellow Card Scheme, from patients and healthcare professionals in the United Kingdom.

There is currently a warning about the risk of sexual dysfunction in the product information for Selective Serotonin Reuptake Inhibitors and this information can be updated if new data becomes available about the nature or occurrence of these side effects, particularly if there are any measures which could be taken to minimise the risk.