Prescription medicine
Resmetirom Brand names: Rezdiffra
Resmetirom (Rezdiffra) is a prescription medicine with an FDA approval on record since 2024. No generic is listed in FDA's NDC Directory.
- No generic listed
Check it at the source: the resmetirom FDA label on DailyMed (effective July 29, 2026, Madrigal Pharmaceuticals, Inc.); the NDA 217785 record on Drugs@FDA; every resmetirom label on DailyMed.
Highlights of the record
FDA label of July 29, 2026; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026
Used for
From the label: indications and usageREZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
Forms and strengths
- 60 mg
- 80 mg
- 100 mg
Coated tablet.
On the market
- Earliest approval on file
- March 14, 2024 Rezdiffra, Madrigal; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- No generic approved
- Labelers listed (NDC)
- 1 of which 0 under generic applications, 1 under brand applications, repackagers included
- Last listed patent
- February 4, 2045 Rezdiffra tablets; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- Not in the survey
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- No recall recorded
- FAERS reports
- 1,893 through July 30, 2026
What is resmetirom used for?
From the label: indications and usageREZDIFFRA ® is indicated in conjunction with diet and exercise for the treatment of adults with noncirrhotic metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis). This indication is approved under accelerated approval based on improvement of MASH and fibrosis [see Clinical Studies (14) ]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. […]
FDA pharmacologic class: Thyroid Hormone Receptor beta Agonist.
Source: FDA drug label (REZDIFFRA), Madrigal Pharmaceuticals, Inc., effective July 29, 2026 (SPL set e67ea09f-a840-439c-86c8-f98585f978b2), via openFDA; the full label on DailyMed
Is there a generic for resmetirom (Rezdiffra)?
No generic resmetirom is approved (Drugs@FDA, October 8, 2026).
The Orange Book lists 8 patents for Rezdiffra tablets: the compound patent runs to September 17, 2033, and the last listed entry to February 4, 2045. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2024 earliest approval on file
- 2045 last listed patent
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What does the resmetirom label say about other medicines?
The resmetirom label names 6 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atorvastatin | drug interactions | Clinical Impact; REZDIFFRA increased plasma concentrations of some statins (atorvastatin, pravastatin, rosuvastatin and simvastatin) [see ], which may increase the risk of adverse reactions related to these drugs. |
| Clopidogrel | drug interactions | Intervention; Concomitant use of REZDIFFRA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. Reduce REZDIFFRA dosage if used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel) [ see ]. |
| Gemfibrozil | drug interactions | Intervention; Concomitant use of REZDIFFRA with strong CYP2C8 inhibitors (e.g., gemfibrozil) is not recommended. Reduce REZDIFFRA dosage if used concomitantly with a moderate CYP2C8 inhibitor (e.g., clopidogrel) [ see ]. |
| Pravastatin | drug interactions | Clinical Impact; REZDIFFRA increased plasma concentrations of some statins (atorvastatin, pravastatin, rosuvastatin and simvastatin) [see ], which may increase the risk of adverse reactions related to these drugs. |
| Rosuvastatin | drug interactions | Clinical Impact; REZDIFFRA increased plasma concentrations of some statins (atorvastatin, pravastatin, rosuvastatin and simvastatin) [see ], which may increase the risk of adverse reactions related to these drugs. |
| Simvastatin | drug interactions | Clinical Impact; REZDIFFRA increased plasma concentrations of some statins (atorvastatin, pravastatin, rosuvastatin and simvastatin) [see ], which may increase the risk of adverse reactions related to these drugs. |
Source: FDA drug label (REZDIFFRA), Madrigal Pharmaceuticals, Inc., effective July 29, 2026 (SPL set e67ea09f-a840-439c-86c8-f98585f978b2), via openFDA; the full label on DailyMed
What do FAERS reports show for resmetirom?
The FDA Adverse Event Reporting System holds 1,893 reports that list resmetirom among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 100 are coded as a death and 142 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What next?
- Resmetirom side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other