Amiodarone (Cordarone X): reminder of risks of treatment and need for patient monitoring and supervision
Authored by Medicines and Healthcare products Regulatory Agency (MHRA)Originally published 20 May 2026
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Professional Reference articles are designed for health professionals to use. They are written by UK doctors and based on research evidence, UK and European Guidelines. You may find one of our health articles more useful.
Amiodarone has been associated with serious and potentially life-threatening side effects, particularly of the lung, liver, and thyroid gland. We remind healthcare professionals that patients should be supervised and reviewe…
Read the full update from MHRA
About MHRA alerts and recalls
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s regulator for medicines, vaccines and medical devices. One of its key responsibilities is to monitor the safety and effectiveness of products in use across the NHS and wider healthcare system. When new safety concerns are identified, or when issues arise with the manufacture or distribution of a medicine or device, the MHRA issues alerts and recalls to protect patients and support healthcare professionals.
These alerts can take several forms. Some provide updated guidance on prescribing or monitoring requirements for medicines and vaccines. Others may highlight newly recognised side effects, or remind clinicians of important risk-mitigation steps. In the case of medical devices, alerts may cover field safety notices, product recalls, or urgent device modifications. All of these communications are designed to ensure that products are used safely and that any risks are managed appropriately.
Patient.info republishes MHRA alerts and recalls so that this information is available quickly and accessibly to both healthcare professionals and the public. The summary above is taken directly from the MHRA’s official publication. To read the full advice, including detailed recommendations for prescribers, manufacturers and patients, please follow the “Read more” link to the MHRA website.
If you are a healthcare professional, you should consult the full notice to confirm the latest prescribing information, monitoring requirements and any actions you need to take in your practice. If you are a patient or carer, do not stop treatment or make changes to your medication or device without first seeking professional advice. If you have any concerns about your medicine or device, speak to your GP, pharmacist or specialist nurse.
Contains public sector information licensed under the Open Government Licence v3.0.
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About the authorView full bio

Medicines and Healthcare products Regulatory Agency (MHRA)
UK Government Agency
Article history
The information on this page is written and peer reviewed by qualified clinicians.
Article also available in English, German, Spanish, French, Italian, Portuguese, Hindi, Hebrew, Arabic, and Swedish.
20 May 2026 | Originally published
Authored by:
Medicines and Healthcare products Regulatory Agency (MHRA)

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