The Prescription Cost Analysis (PCA) provides the total number of prescription items of each medicine dispensed in the community in England. The following table shows the total number of items in each calendar year from 2014 to 2025 that have been dispensed in England:

This is based on the information within the PCA for the British National Formulary chemical substance of Isotretinoin and Finasteride.

The Prescription Cost Analysis (PCA) provides the total number of prescription items of each medicine dispensed in the community in England. The table shows the total number of items in each calendar year from 2014 to 2024, as well as the data for January to November 2025 that has been dispensed in England regardless of where prescribed:

This is based on the information within the PCA for the British National Formulary chemical substance of isotretinoin and spironolactone.

The Medicines and Healthcare products Regulatory Agency (MHRA) obtains independent advice from the Commission on Human Medicines (CHM). The Isotretinoin Expert Working Group was convened by CHM to evaluate the latest data on risk of psychiatric adverse reactions and sexual dysfunction suspected to be associated with the use of isotretinoin and to consider whether regulatory action is required to minimise risks or raise awareness of the risks. The report of this review will be published shortly, and more information on the working group is available at the following link:

https://www.gov.uk/guidance/isotretinoin-an-expert-review-of-suspected-psychiatric-and-sexual-side-effects

The matter of redress sat outside the scope of the expert review and is also outside the remit of MHRA. Our primary focus currently is on improving future medicines and medical devices safety.

An Expert Working Group has reviewed the available evidence relating to isotretinoin (Roaccutane). We expect the report to be published shortly.

Roaccutane is a brand name for the medicine isotretinoin which is authorised for the treatment of severe forms of acne. National data on the total number of patients who have experienced side effects after using isotretinoin is not available. The Yellow Card scheme operated by the Medicines and Healthcare products Regulatory Agency (MHRA) collects information on suspected side effects in the United Kingdom. Since 2014, between 87 and 135 reports of side effects suspected to be associated with the use of isotretinoin have been received each year.

It is estimated that approximately 35,000 individuals receive isotretinoin each year in the UK. Estimates of the exact number of people treated with isotretinoin is not available as the dose is individualised based on the patient’s weight and their response to the medicine.

The product information for all medicines, including isotretinoin, contains advice about possible side effects and how to report them. Healthcare professionals receive the MHRA’s Drug Safety Update which includes information about possible side effects and any action which needs to be taken. Since 2014, the Drug Safety Update has included a number of articles on isotretinoin, including reminders on important risks and precautions.

The terms of the ongoing review of the risk of psychiatric and sexual side effects for isotretinoin include consideration of whether regulatory action is needed to ensure awareness of the risks associated with this medicine.

Roaccutane is a brand name for the medicine isotretinoin which is authorised for the treatment of severe forms of acne. National data on the total number of patients who have experienced side effects after using isotretinoin is not available. The Yellow Card scheme operated by the Medicines and Healthcare products Regulatory Agency (MHRA) collects information on suspected side effects in the United Kingdom. Since 2014, between 87 and 135 reports of side effects suspected to be associated with the use of isotretinoin have been received each year.

It is estimated that approximately 35,000 individuals receive isotretinoin each year in the UK. Estimates of the exact number of people treated with isotretinoin is not available as the dose is individualised based on the patient’s weight and their response to the medicine.

The product information for all medicines, including isotretinoin, contains advice about possible side effects and how to report them. Healthcare professionals receive the MHRA’s Drug Safety Update which includes information about possible side effects and any action which needs to be taken. Since 2014, the Drug Safety Update has included a number of articles on isotretinoin, including reminders on important risks and precautions.

The terms of the ongoing review of the risk of psychiatric and sexual side effects for isotretinoin include consideration of whether regulatory action is needed to ensure awareness of the risks associated with this medicine.

As with all medicines in the United Kingdom, the Medicines and Healthcare products Regulatory Agency continuously monitors the safety of isotretinoin-containing medicines. This includes reports of suspected adverse drug reactions submitted by healthcare professionals, patients and carers through the Yellow Card scheme, as well as published and unpublished data. As new evidence on safety emerges it is carefully evaluated and, where appropriate, product information is updated and advice for prescribers and patients is issued.

Specific assessments of possible psychiatric side effects associated with isotretinoin were considered by an Expert Working Group of the Commission on Human Medicines in 2005 and 2014. In addition, the risk of neuropsychiatric disorders was evaluated in a European review which was completed in 2018. This review concluded that the warnings in the product information for medicines containing isotretinoin regarding possible psychiatric adverse effects reflected what was known.

Since 1998, warnings regarding the possible risk of developing depression and other psychiatric side effects have been included in the product information for Roaccutane and the generic versions of isotretinoin (the Summary of Product Characteristics for healthcare professionals and the patient information leaflet). The product information for isotretinoin warns that treatment may be associated with possible psychiatric side effects, that particular care needs to be taken in patients with a history of depression; and that all patients on isotretinoin should be monitored for signs of depression and referred for appropriate treatment if necessary. It also states that stopping isotretinoin may not lead to improvement and therefore further psychiatric or psychological evaluation may be necessary.

Reports of ‘suspected’ Adverse Drug Reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. Reporting to the Yellow Card Scheme is voluntary for healthcare professionals and members of the public. There is however also a legal obligation for pharmaceutical companies to report all serious ADRs for their products that they are aware of.

MHRA has received 138 UK spontaneous reports of depressive disorders, depressed mood or depressive symptoms suspected to be associated with isotretinoin between 1 January 2010 and 31 December 2016. A breakdown of the reports received by year is displayed in the table below. This data includes all reports for isotretinoin irrespective of the brand name, which in some cases will not have been provided by the reporter.

UK, spontaneous reports of depressive ADRs suspected to be associated with isotretinoin between 1 January 2010 and 31 December 2016

*Data extracted from MHRA’ s Yellow Card Database of spontaneous case reports received in the UK.

It is important to note that Yellow Card reports are not proof of a side effect occurring but only a suspicion by the reporter that the medicine may have caused the side effect. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of medicine.

The information requested is shown in the following table. Information is provided for the total of isotretinoin, of British National Formulary (BNF) 13.6.2, and is shown by the brand Roaccutane and the non-branded isotretinoin.

Source: Prescription Cost Analysis system data provided by NHS Digital

¹Total figure may not sum due to rounding

The Medicines and Healthcare products Regulatory Agency has met with various stakeholders regarding the possible link between Roaccutane (isotretinoin) and psychiatric disorders including depression since the late 1990’s.

Warnings regarding the possible risk of developing depression or aggravating existing depression have been included in the product information for Roaccutane and the generic versions of isotretinoin since 1998. As further data has emerged the warnings have been updated.

A scientific advisory group of the Commission on Human Medicines (CHM), the Government’s independent expert advisory body on medicines licensing and safety, was first convened in 2003 to specifically consider the safety of isotretinoin.

The members of the group included experts in clinical pharmacology, pharmacovigilance, dermatology, psychiatry, psychopharmacology, epidemiology and general practice, as well as lay members. The group considered the risks of psychiatric disorders including depression suspected to be associated with isotretinoin in 2003, 2005 and 2014 and reported their findings to the CHM.

The recommendations of the expert group were endorsed by CHM and were communicated to healthcare professionals, including clinicians and pharmacists.

Reports of ‘suspected’ adverse drug reactions (ADRs) are collected by the Medicines and Healthcare products Regulatory Agency (MHRA) and Commission for Human Medicines (CHM) through the spontaneous reporting scheme, the Yellow Card Scheme. The scheme collects suspected ADR reports from the whole of the United Kingdom in relation to all medicines and vaccines. Reporting to the Yellow Card Scheme is voluntary for health care professionals and members of the public, there is however also a legal obligation for pharmaceutical, companies to report all serious ADRs for their products that they are aware of.

Between 1 January 2003 and 16 December 2013 the MHRA has received a total of 294 UK spontaneous suspected ADR reports describing a total of 657 psychiatric reactions in association with the use of isotretinoin. Of these reports, 36 report a completed suicide. These data include all reports for isotretinoin irrespective of the brand name, which in some cases will not have been provided by the reporter.

It is important to note that Yellow Card reports are not proof of a side effect occurring but only a suspicion by the reporter that the medicine may have caused the side effect. Yellow Card reports may therefore relate to true side effects of the medicine, or they may be due to coincidental illnesses that would have occurred in the absence of the medicine.