Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Patient leaflets and SmPCs, drug interaction checker, official and paediatric dosages, pregnancy and breastfeeding guidance, and NHS pharmacy opening hours — all in one place.
Rezdiffra contains the active substance resmetirom. Rezdiffra is a medicine used in adults to treat metabolic dysfunction-associated steatohepatitis (MASH). MASH is a liver disease where fat builds up in the liver, which can result in inflammation and damage to the liver cells. Rezdiffra is used in adults who have experienced inflammation and cell damage, resulting in moderate scarring (consistent with stage 2 fibrosis) or significant scarring (consistent with stage 3 fibrosis). The active substance in Rezdiffra, resmetirom, works by binding to and activating a protein called thyroid hormone receptor beta (THR-β) in a type of liver cell called hepatocytes. In patients with MASH, THR-β is working less. By activating THR-β in the liver, resmetirom increases fat breakdown. This reduces the amount of fat stored in the liver which can help reduce inflammation, fibrosis and improve its function.
Warnings and precautions Talk to your doctor, pharmacist or nurse before taking Rezdiffra. In particular tell your doctor if you:
- have liver problems other than MASH, such as a liver infection including viral hepatitis (inflammation of the liver caused by a viral infection) or any liver disease involving the immune system (the body's natural defences). This includes autoimmune hepatitis (inflammation of the liver caused by the immune system attacking the body's own cells) and primary biliary cholangitis (liver damage caused when the immune system attacks the bile ducts, tubes which carry bile from the liver) - drink alcoholic beverages or have liver damage due to drinking alcohol - have gallbladder problems, including gallstones (small stones, usually made of cholesterol, that form in the gallbladder) Children and adolescents Do not give this medicine to children and adolescents under 18 years of age. It is not known if Rezdiffra is safe and effective for them. Other medicines and Rezdiffra Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines. Tell your doctor or pharmacist if you take any of the following medicines because these medicines may increase the level of Rezdiffra in your body which may increase your risk of side effects with Rezdiffra: - clopidogrel (to reduce clotting of the blood) - deferasirox (to remove excess iron from the body) - gemfibrozil (to lower blood fats) - teriflunomide (to treat multiple sclerosis) Tell your doctor or pharmacist if you take any of the following medicines because Rezdiffra may increase the levels of these medicines in your body which may increase your risk of side effects with these medicines: - atorvastatin, pravastatin, rosuvastatin, simvastatin (a group of medicines called statins, to lower cholesterol levels) - pioglitazone (or other so-called CYP2C8 substrates, a particular class of medicine to treat diabetes) Pregnancy and breast-feeding If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine. Rezdiffra has not been studied in pregnant women. Rezdiffra is not recommended for use during pregnancy. It is not known if Rezdiffra can pass into breast milk and affect the baby. Your doctor will help you to decide whether to stop breast-feeding or avoid Rezdiffra treatment, considering the benefit of breastfeeding to the baby and Rezdiffra to the mother.
Driving and using machines This medicine has no or negligible influence on your ability to drive or use machines. Rezdiffra contains sodium This medicine contains less than 1 mmol sodium (23 mg) per tablet, that is to say essentially 'sodiumfree'.
Like all medicines, this medicine can cause side effects, although not everybody gets them. You may experience nausea and diarrhoea when you start taking Rezdiffra. These side effects are generally mild and often stop on their own in less than 3 weeks. If these problems are not resolved within 3 weeks or if they become worse, contact your doctor. Very common (may affect more than 1 in 10 people): - diarrhoea - feeling sick (nausea) Common (may affect up to 1 in 10 people): - itching (pruritus)
Uncommon (may affect up to 1 in 100 people): - vomiting - belly (abdominal) pain - constipation - rash - dizziness Rare (may affect up to 1 in 1,000 people): - inflammation of the pancreas due to a blockage (obstructive pancreatitis) - gallstones (cholelithiasis) - inflammation of the gallbladder (cholecystitis) or problems with the pancreas or bile duct - itchy rash (urticaria) Not known (frequency cannot be estimated from the available data):
- Abnormal liver function tests (hepatoxicity) Reporting of side effects If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card scheme Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
This leaflet was last revised in 03/2026 This medicine has been given 'conditional approval'. This means that there is more evidence to come about this medicine. The Medicines and Healthcare products Regulatory Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary. Other sources of information Detailed information on this medicine is available on the Medicines and Healthcare products Regulatory Agency web site: https://www.gov.uk/government/organisations/medicines-andhealthcare-products-regulatory-agency.
- Rezdiffra 100 mg film-coated tablets also contain yellow iron oxide (E172) and red iron oxide (E172). What Rezdiffra looks like and contents of the pack Rezdiffra 60 mg film-coated tablets are white, 6.4 mm x 12.2 mm oval film-coated tablets with "P60" on one side and plain on the other side. Rezdiffra 80 mg film-coated tablets are yellow, 7.1 mm x 13.5 mm oval film-coated tablets with "P80" on one side and plain on the other side. Rezdiffra 100 mg film-coated tablets are beige to pinkish, 7.6 mm x 14.6 mm oval film-coated tablets with "P100" on one side and plain on the other side. Rezdiffra film-coated tablets are packed in PVC/PCTFE blisters with aluminium foil lidding. Pack size 28 film-coated tablets. Marketing Authorisation Holder Madrigal Pharmaceuticals EU Limited 1 Castlewood Avenue Dublin D06 H685 Ireland Manufacturer Corden Pharma GmbH Otto-Hahn-Strasse 1 68723 Plankstadt Germany
Rezdiffra 60 mg film-coated tablets comes as tablet containing 60 mg. Always follow the dose your doctor or pharmacist has given you, and read the leaflet that comes with the medicine.
The active substance in Rezdiffra 60 mg film-coated tablets is resmetirom.
This leaflet reproduces the patient information leaflet approved for Rezdiffra 60 mg film-coated tablets, as published on the electronic medicines compendium (emc). The version printed inside your medicine’s packaging is the one that applies to you.
Whether a medicine is available over the counter or on prescription only depends on its licence. Check the leaflet, or ask your pharmacist — they can tell you straight away.
The text above reproduces the patient information leaflet approved for this medicine, restructured for easier reading.
Ask anything about Rezdiffra 60 mg film-coated tablets. The assistant answers only from this leaflet — if the leaflet does not cover it, it will say so. It does not give medical advice.
Answers come from the patient leaflet published on the electronic medicines compendium (emc). They are not medical advice. Ask a pharmacist or your GP if you are unsure. For urgent help call NHS 111, or 999 in an emergency.
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