The majority of patients use and take paracetamol responsibly. However, the Medicines and Healthcare products Regulatory Agency (MHRA) is aware that paracetamol can be a favoured drug of choice for impulsive or intentional overdose. The MHRA takes these issues seriously as patient safety is our priority. The MHRA monitors the safety of medicines, including the sale of paracetamol without prescription.

In March 2025, the MHRA updated the voluntary Best Practice Guidance on the sale of medicines for pain relief, for general sales, to further highlight the risks of overdose, and to address public concerns and recognise current sales techniques. This guidance is available at the following link:

https://assets.publishing.service.gov.uk/media/67e69e9e085277e9961b201b/Best_practice_guidance_on_the_sale_of_medicines_2025.pdf

Further risk mitigation measures are also being considered. These are voluntary guidelines concerning the sale of solid oral forms, both tablets or capsules, and have been agreed with retailers to minimise the risk of impulse buying and reduce the risk of overdose. While the guidance was for solid formulations, many retailers also apply the guidance to liquid formulations, with bars at their checkout to prevent the sale of more than two packs of medicines for pain. The guidance was to address the potential risk of overdose if a person chose to consume multiple tablets at once, which is likely to be more difficult with the syrup liquid formulations.

The Human Medicines Regulations 2012 stipulate specific warnings for all paracetamol products to ensure that patients are warned of the risks of overuse. In addition, bottles should have child resistant caps to minimise the risk of access by the child.

The MHRA undertook a review of paracetamol safety in 2024 to examine the pack size of the solid dose forms. A reduction in pack size was not considered to provide additional risk minimisation as individuals are able to buy more than one pack in a single transaction. The risk of overdose associated with the use of liquid paracetamol is less likely owing to the difficulty in swallowing a large volume of a viscous liquid. However, regulations also stipulate the maximum quantity that should be included in a container, whether it is in liquid or solid form.

However, the MHRA is exploring legislative actions to address excessive sales and reduce the potential for harm, while remaining supportive of genuine patients.

The Medicines and Healthcare products Regulatory Agency (MHRA) is an executive agency of the Department with responsibility for ensuring medicines meet appropriate standards of quality, efficacy, and safety. The MHRA recently reviewed the safety of paracetamol and sought advice from the Commission on Human Medicines (CHM) on 27 September 2024 on the potential risk mitigation measures to address the risk of self-harm. CHM recommended that actions need to be educational and legislative to address excessive sales and reduce potential for harm, although supportive of genuine patients.

The MHRA has recently updated voluntary Best Practice Guidance on the general sale of medicines for pain, to further highlight the risks of overdose. The update was undertaken in collaboration with retailers, stakeholders and healthcare professionals, and the updated guidance is available at the following link:

https://assets.publishing.service.gov.uk/media/67e69e9e085277e9961b201b/Best_practice_guidance_on_the_sale_of_medicines_2025.pdf

Most retailers adhere to the guidelines on not promoting multiple purchases and have introduced in store measures such as till bars that restrict sales to a maximum of two packs across a range of products containing aspirin, paracetamol, or ibuprofen.

The use of paracetamol and accidental overdose is a safety concern, especially in relation to the many trade names of non-prescription and prescription medicines containing paracetamol. Therefore, the Human Medicines Regulations 2012 contain a number of conditions for the presentation of these medicines to highlight the presence of paracetamol.

Schedule 25, Part 4 of the Human Medicines Regulations sets out statutory labelling requirements for paracetamol medicines to highlight the presence of paracetamol in that product. Paragraph 14 states that, except where the name of the product includes the word “paracetamol” and appears on the outer and immediate packaging, the words “contains paracetamol” should be displayed. Paragraph 15 states that the labelling must highlight paracetamol on the front face of the carton or label and should also contain the warning: “Do not take more medicine than the label tells you to. If you do not get better, talk to your doctor”.

Statutory warnings are also in place to warn of liver damage with overdose including the words “Do not take anything else containing paracetamol while taking this medicine” and “Talk to a doctor at once if you take too much of this medicine, even if you feel well” in the patient information leaflet. If the product does not contain a leaflet, then the words “Talk to a doctor at once if you take too much of this medicine, even if you feel well. This is because too much paracetamol can cause delayed, serious liver damage” should be displayed on the label.

For those medicines containing paracetamol which are prescribed to a patient, the statutory warnings should be added to the prescribing label which is applied to the box by the pharmacist. These are highlighted in the British National Formulary, with further information available at the following link:

https://bnf.nice.org.uk/about/labels/

The Department recognises that recent claims suggesting a link between acetaminophen and autism may have caused concern among some individuals. The Government, my Rt. Hon. Friend, the Secretary of State for Health and Social Care, and I have provided clear reassurance through traditional media and social media channels that there is no evidence to link the use of acetaminophen, also known as paracetamol, by pregnant women to autism in their children. The Medicines and Healthcare products Regulatory Agency swiftly published a press release confirming that taking paracetamol during pregnancy remains safe and there is no evidence it causes autism in children. The press release is available at the following link:

https://www.gov.uk/government/news/mhra-confirms-taking-paracetamol-during-pregnancy-remains-safe-and-there-is-no-evidence-it-causes-autism-in-children

Paracetamol and ibuprofen are well-known medicines for pain, which, when taken in line with the recommended posology, have well-established safety profiles. The vast majority of patients use paracetamol responsibly, as an effective pain-reliever. However, if taken in excess, it can cause serious physical harm.

The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of medicines, including the sale of paracetamol and ibuprofen without a prescription. Paracetamol and ibuprofen may be obtained without a prescription, under the supervision of a pharmacist, or through general sales outlets. The Human Medicines Regulations 2012, Schedule 15, states that the maximum pack size for both paracetamol and ibuprofen that may be sold through general sales is 16 tablets. Larger packs, up to a maximum of 100 tablets, may be sold under the supervision of a pharmacist, where it becomes a prescription item.

The MHRA has recently updated the voluntary best practice guidance on the general sale of medicines for pain, to further highlight the risks of overdose, to address public concerns, and to recognise current sales techniques. Further risk mitigation measures are also being considered.

The update to the best practice guidance forms part of the suicide prevention strategy that is currently being developed, Suicide prevention strategy for England: 2023 to 2028, which includes a reference to paracetamol, and which is available at the following link:

https://www.gov.uk/government/publications/suicide-prevention-strategy-for-england-2023-to-2028

The information requested is not held centrally.

The information requested is not held centrally.

In 2018 NHS England published guidance for integrated care boards (ICBs) on conditions for which over the counter items should not routinely be prescribed in primary care. This provides recommendations on a number of minor conditions where prescribing of over the counter products, such as paracetamol, should be restricted. However, this does not include patients prescribed an over-the-counter treatment for a long-term condition such as regular pain relief for chronic arthritis.

Decisions about what medicines to prescribe are made by the doctor or healthcare professional responsible for that part of the patient’s care and prescribers are accountable for their prescribing decisions, both professionally and to their service commissioners. Where general practitioners prescribe drugs that are widely available over the counter, we expect it to be for good clinical reasons and to represent value for money to the wider National Health Service.

The Medicines and Healthcare products Regulatory Agency (MHRA) monitors the safety of all medicines on the market in the United Kingdom. The MHRA recently reviewed a research paper on the effects of paracetamol on blood pressure in patients with hypertension without pain and sought expert advice from the Pharmacovigilance Expert Advisory Group of the Commission on Human Medicines. The experts considered the limitations of the study as it was not representative of the whole population who experience pain and recommended that further evidence is needed to determine effect on blood pressure within the wider population.

The MHRA keeps all new evidence on the safety of paracetamol kept under review. Alternative medicines which can be used to treat pain have known and significant risks on the heart and therefore, the MHRA does not recommend patients change their pain medicine without the advice of their healthcare professional.

The information requested falls under the remit of the UK Statistics Authority. I have therefore asked the Authority to respond.

Assessments on the potential reliance on medication in alleviating possible side effects of the COVID-19 vaccination are not finalised as we do not yet know the full characteristics, including side effects, of any of the vaccines in development. All plans for deployment remain flexible as there are no certainties in the development, production, formulation and timing of any new vaccines.

Detailed planning is underway building on the National Health Service’s expertise to deliver immunisation programmes, such as the flu vaccination programme. Planning considerations, includes the supporting infrastructure required, including warehousing, transport, logistics for transport across the nation and end-destination ‘clinic’ storage.

Medication such as paracetamol can also be purchased from supermarkets and other retail outlets, as a ‘general sales’ medicine. Paracetamol can also be purchased online, including in a larger quantity from an online pharmacy.

Our priority is to ensure that patients continue to have access to medicines and medical products they need. We are working closely with industry, the National Health Service and others in the supply chain to ensure that precautions are in place to reduce the likelihood of future shortages

The Government continues to hold stockpiles of medicines, including many of those medicines raised in the Rt. hon. Member’s questions, to cope with a range of scenarios, and robust contingency planning continues to ensure that the country is prepared for a possible second peak of COVID-19 infections and the end of the Transition period.

The Essential Medicines Buffer Stock (EMBS) supports the NHS in the event of a pandemic or other health emergency by ensuring the continued availability of medicines that are in routine use within the NHS in the event that the supply chain is interrupted. Volumes of the medicines listed in the EBMS for the requested dates are shown in the following table. The original EMBS contracts ended in October 2019 and the current ones expire on 31 March 2021.

In preparation for a potential imminent second wave of COVID-19 and to protect the security of the supply of critical life-saving medicines and patient health across the United Kingdom, a clinically-led assessment of medicines that should be stockpiled was undertaken in May and June 2020 and this was fed into a tender exercise that ran from 24 July to 10 August 2020.

Paracetamol and insulin are amongst the medicines that were identified and tendered for as part of this exercise and we will shortly be awarding contracts to secure supplies of these medicines for the autumn and winter. Details of the tender exercise can be found at the following links:

https://ted.europa.eu/udl?uri=TED:NOTICE:355937-2020:HTML:EN:HTML&tabId=1&tabLang=en#id4-VI

https://www.contractsfinder.service.gov.uk/Notice/b8bf439c-76d1-4fa6-952d-6b65bd659021

With regard to stocks of medicines on UK soil owned and held by suppliers themselves, commercially sensitive information has been shared confidentially with the Department by suppliers of medicines to the UK, to support various contingency programmes. For this reason, we cannot share information received from suppliers, including on their UK stock levels, with third parties.

Our priority is to ensure that patients continue to have access to medicines and medical products they need. We are working closely with industry, the National Health Service and others in the supply chain to ensure that precautions are in place to reduce the likelihood of future shortages

The Government continues to hold stockpiles of medicines, including many of those medicines raised in the Rt. hon. Member’s questions, to cope with a range of scenarios, and robust contingency planning continues to ensure that the country is prepared for a possible second peak of COVID-19 infections and the end of the Transition period.

The Essential Medicines Buffer Stock (EMBS) supports the NHS in the event of a pandemic or other health emergency by ensuring the continued availability of medicines that are in routine use within the NHS in the event that the supply chain is interrupted. Volumes of the medicines listed in the EBMS for the requested dates are shown in the following table. The original EMBS contracts ended in October 2019 and the current ones expire on 31 March 2021.

In preparation for a potential imminent second wave of COVID-19 and to protect the security of the supply of critical life-saving medicines and patient health across the United Kingdom, a clinically-led assessment of medicines that should be stockpiled was undertaken in May and June 2020 and this was fed into a tender exercise that ran from 24 July to 10 August 2020.

Paracetamol and insulin are amongst the medicines that were identified and tendered for as part of this exercise and we will shortly be awarding contracts to secure supplies of these medicines for the autumn and winter. Details of the tender exercise can be found at the following links:

https://ted.europa.eu/udl?uri=TED:NOTICE:355937-2020:HTML:EN:HTML&tabId=1&tabLang=en#id4-VI

https://www.contractsfinder.service.gov.uk/Notice/b8bf439c-76d1-4fa6-952d-6b65bd659021

With regard to stocks of medicines on UK soil owned and held by suppliers themselves, commercially sensitive information has been shared confidentially with the Department by suppliers of medicines to the UK, to support various contingency programmes. For this reason, we cannot share information received from suppliers, including on their UK stock levels, with third parties.

Our priority is to ensure that patients continue to have access to medicines and medical products they need. We are working closely with industry, the National Health Service and others in the supply chain to ensure that precautions are in place to reduce the likelihood of future shortages

The Government continues to hold stockpiles of medicines, including many of those medicines raised in the Rt. hon. Member’s questions, to cope with a range of scenarios, and robust contingency planning continues to ensure that the country is prepared for a possible second peak of COVID-19 infections and the end of the Transition period.

The Essential Medicines Buffer Stock (EMBS) supports the NHS in the event of a pandemic or other health emergency by ensuring the continued availability of medicines that are in routine use within the NHS in the event that the supply chain is interrupted. Volumes of the medicines listed in the EBMS for the requested dates are shown in the following table. The original EMBS contracts ended in October 2019 and the current ones expire on 31 March 2021.

In preparation for a potential imminent second wave of COVID-19 and to protect the security of the supply of critical life-saving medicines and patient health across the United Kingdom, a clinically-led assessment of medicines that should be stockpiled was undertaken in May and June 2020 and this was fed into a tender exercise that ran from 24 July to 10 August 2020.

Paracetamol and insulin are amongst the medicines that were identified and tendered for as part of this exercise and we will shortly be awarding contracts to secure supplies of these medicines for the autumn and winter. Details of the tender exercise can be found at the following links:

https://ted.europa.eu/udl?uri=TED:NOTICE:355937-2020:HTML:EN:HTML&tabId=1&tabLang=en#id4-VI

https://www.contractsfinder.service.gov.uk/Notice/b8bf439c-76d1-4fa6-952d-6b65bd659021

With regard to stocks of medicines on UK soil owned and held by suppliers themselves, commercially sensitive information has been shared confidentially with the Department by suppliers of medicines to the UK, to support various contingency programmes. For this reason, we cannot share information received from suppliers, including on their UK stock levels, with third parties.

My Rt Hon. Friend the Secretary of State for International Trade has held a number of discussions with her Indian counterpart, Minister Piyush Goyal, Minister of Commerce and Industry, including at the recent Extraordinary G20 Trade Ministerial meetings.

In these discussions, the Secretary of State has stressed the importance of making sure supply chains remain open and that any trade barriers introduced in response to Covid-19 are proportionate, transparent and time limited. The significance of export approval for essential shipments of medical supplies and medicines bound for the United Kingdom from India was also raised.

I am pleased to say that the Government of India has now removed export restrictions on paracetamol to the United Kingdom.

The country is well prepared to deal with the impacts of COVID-19 and we have stockpiles of medicines, including paracetamol, in the event of any supply issues or significant increases in demand.

The Department is also aware of some recent local food stockpiling issues and is in discussion with industry to ensure a continued supply of infant formula. This dialogue with the formula industry, including the British Specialist Nutrition Association Ltd, will remain active and we will continue to monitor the situation.

The Department is working closely with industry, the National Health Service and others in the supply chain to help ensure patients can access the medicines they need, and precautions are in place to reduce the likelihood of future shortages.

The steps being taken to protect United Kingdom supplies in response to the COVID-19 outbreak were set out in the Department’s press statement issued on 11 February 2020. This statement can be read at the following link:

https://www.gov.uk/government/news/government-to-monitor-impact-of-coronavirus-on-uk-medicine-supply

The United Kingdom already has just under 25% of paracetamol finished product sites, producing supplies for the UK, based in this country, and just under 20% of the manufacturing sites producing the active pharmaceutical ingredient required to make paracetamol.

We are aware that there has been a significant increase in paracetamol demand over the recent weeks. We are working with all suppliers of paracetamol to monitor and assess available supplies and demand, and to make additional stock available and prioritise further deliveries.

The information requested falls within the responsibility of the UK Statistics Authority. I have asked the Authority to reply.

The information requested falls within the responsibility of the UK Statistics Authority. I have asked the Authority to reply.

The Medicines and Healthcare products Regulatory Agency (MHRA) is the body responsible for regulating all medicines in the United Kingdom on behalf of health ministers. In 1998, smaller pack sizes were introduced for non-prescription medicines containing paracetamol or aspirin to manage the risk of misuse and overuse. The MHRA continues to monitor the safety in use of non-prescription medicines containing paracetamol and aspirin and will take further action to safeguard public health if necessary.

The National Institute for Health Research, funded by the Department, commissioned research published in 2013, which analysed deaths by poisoning by paracetamol since the restrictions to its sale were introduced in 1998, ‘Long term effect of reduced pack sizes of paracetamol on poisoning deaths and liver transplant activity in England and Wales: interrupted time series analyses’. This is available at the following link:

https://www.bmj.com/content/346/bmj.f403

The Medicines and Healthcare products Regulatory Agency (MHRA) continuously monitors the safety of all medicines on the market in the United Kingdom and seeks independent expert advice from the Commission on Human Medicines on important new safety issues. The MHRA is aware of recently published research looking at the effect on male offspring of giving paracetamol to pregnant mice. All new evidence on the safety of paracetamol is kept under close review and this latest study will be carefully considered and any new advice will be communicated.

There have not been any discussions with the Royal Colleges on this issue yet.

Pregnant women should speak to their doctor or midwife before taking any medicine, including paracetamol.