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 100 mg film-coated tablets comes as tablet containing 100 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 100 mg film-coated tablets is resmetirom.
This leaflet reproduces the patient information leaflet approved for Rezdiffra 100 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.
Rezdiffra is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH) with moderate to advanced liver fibrosis (consistent with fibrosis stages F2 to F3).
Posology
The posology is based on the patient's body weight (see section 5.2):
• For patients weighing < 100 kg, the recommended dose is 80 mg taken orally once daily.
• For patients weighing ≥ 100 kg, the recommended dose is 100 mg taken orally once daily.
Missed or delayed doses
If a dose of resmetirom is missed, the patient should take the next dose at the scheduled time. A double dose should not be taken to make up for the missed dose.
CYP2C8 inhibitors
Concomitant use of resmetirom with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. If resmetirom is used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel, deferasirox, teriflunomide), the dose of resmetirom should be reduced from 100 mg to 80 mg for patients weighing ≥ 100 kg and from 80 mg to 60 mg for patients weighing < 100 kg (see section 4.5).
Special populations
Hepatic impairment
• Mild hepatic impairment
No dose adjustment is required in patients with mild hepatic impairment (Child Pugh A). Safety and efficacy have not been demonstrated in Child-Pugh A cirrhosis (see section 5.2).
• Moderate or severe hepatic impairment
Increased exposure (Cmax and AUC) of resmetirom has been observed in patients with moderate or severe hepatic impairment. Resmetirom should not be used in patients with moderate or severe (Child-Pugh B or C) hepatic impairment (see section 5.2).
Renal impairment
• Mild renal impairment (eGFR 60 to 89 mL/min), moderate renal impairment (eGFR 30 to 59 mL/min) and severe renal impairment (eGFR 15 to 29 mL/min)
No dose adjustment of resmetirom is recommended in patients with mild, moderate or severe renal impairment. In moderate or severe renal impairment the increase in exposure is within the expected variability of exposure (see section 5.2).
Elderly
No dose adjustment is required in patients aged ≥ 65 years (see section 5.2).
Paediatric population
The safety and efficacy of resmetirom in children and adolescents less than 18 years old have not yet been established. No data are available.
Method of administration
Oral use.
Resmetirom may be taken with or without food (see section 5.2).
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Resmetirom is partially metabolised by CYP2C8.
Effects of other medicinal products on resmetirom
CYP2C8 inhibitors
Clopidogrel, a moderate CYP2C8 inhibitor, increased resmetirom exposure (1.3-fold in Cmax and 1.7-fold in AUC) in healthy adult subjects. Dose adjustment of resmetirom is recommended when used concomitantly with moderate CYP2C8 inhibitors. As greater increases are expected with strong inhibitors (e.g. gemfibrozil), their use is not recommended (see section 4.2).
OATP1B1, OATP1B3 and BCRP inhibitors
No clinically significant differences in the pharmacokinetics of resmetirom were observed when used concomitantly with ciclosporin (an OATP1B1/1B3 and BCRP inhibitor).
Effects of resmetirom on other medicinal products
HMG-CoA reductase inhibitors (statins)
The effect of resmetirom on the pharmacokinetics of statins (i.e., simvastatin, rosuvastatin, pravastatin and atorvastatin) was evaluated in studies in healthy subjects:
• Simvastatin: AUC increased by 1.7-fold and Cmax by 1.4-fold following a single dose of simvastatin 20 mg with resmetirom (100 mg/day).
• Rosuvastatin: AUC increased by 1.4-fold and Cmax by 1.8-fold following a single dose of rosuvastatin 20 mg with resmetirom (100 mg/day).
• Pravastatin: AUC increased by 1.4-fold and Cmax by 1.3-fold following a single dose of pravastatin 40 mg with resmetirom (100 mg/day).
• Atorvastatin: AUC increased by 1.4-fold with no change in Cmax following a single dose of atorvastatin 20 mg with resmetirom (100 mg/day).
The dose of rosuvastatin and simvastatin should be limited to a daily dose of 20 mg and the dose of pravastatin and atorvastatin should be limited to a daily dose of 40 mg.
CYP2C8 substrates
Resmetirom is a substrate and mild inhibitor of CYP2C8. In a clinical study in healthy subjects, co-administration of a single oral dose of pioglitazone (15 mg), a moderately sensitive CYP2C8 substrate, with resmetirom (100 mg/day) resulted in a 1.5 fold increase in the AUC of pioglitazone, with no change in Cmax.
Although no dose adjustment is required, clinical monitoring is recommended when resmetirom is used with certain CYP2C8 substrates for which small increases in exposure may lead to serious or dose-related adverse reactions.
Warfarin
In healthy subjects with stable INR, administration of resmetirom (100 mg/day) for multiple days had minimal effect on the AUC and Cmax of R- and S-warfarin. No dose adjustment is required.
Pregnancy
There are no data from the use of resmetirom in pregnant women. Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity (see section 5.3).
As a precautionary measure, it is preferable to avoid the use of resmetirom during pregnancy.
Breast-feeding
It is unknown whether resmetirom and/or its metabolites are excreted in human milk. A risk to newborns/infants cannot be excluded.
A decision must be made whether to discontinue breast-feeding or to abstain from resmetirom therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility
No fertility data are available in humans. Animal studies do not indicate any direct or indirect effects on fertility (see section 5.3).
Resmetirom has no or negligible influence on the ability to drive and use machines.
In clinical studies in healthy subjects, the highest dose of resmetirom tested was 200 mg once daily for up to 14 days, without reports of any additional adverse reactions.
If overdose occurs the patient should be monitored for signs or symptoms of adverse reactions (see section 4.8), and supportive care should be provided as needed.
The medicinal product is unlikely to be removed by haemodialysis due to high protein binding (see section 5.2).
Ask anything about Rezdiffra 100 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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