What the label lists and what reports show
Resmetirom side effects
Resmetirom's FDA label: “The most common adverse reactions with REZDIFFRA (reported in at least 5% of patients and higher compared to placebo) are: diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.” FAERS holds 1,893 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is diarrhoea (309 reports).
- No generic listed
Check it at the source: the resmetirom FDA label on DailyMed (effective July 29, 2026, Madrigal Pharmaceuticals, Inc.); the FDA FAERS public dashboard.
What does the patient leaflet say about side effects?
From the patient leaflet: What are the possible side effects of REZDIFFRA?REZDIFFRA may cause serious side effects, including: • liver injury (hepatotoxicity). Stop taking REZDIFFRA and call your healthcare provider right away if you develop the following signs or symptoms of hepatotoxicity: o tiredness o fever o pain or tenderness in the upper o nausea o rash middle or upper right area of o vomiting o your skin or the white part of your your stomach (abdomen) eyes turns yellow (jaundice) • gallbladder problems. Gallbladder problems such as gallstones, or inflammation of the gallbladder, or inflammation of the pancreas from gallstones can occur with MASH and may occur if you take REZDIFFRA. Call your healthcare provider right away if you develop any signs or symptoms of these conditions, including nausea, vomiting, fever, or pain in your stomach area (abdomen) that is severe and will not go away. […]
Source: FDA drug label, Madrigal Pharmaceuticals, Inc., effective July 29, 2026 (SPL set e67ea09f-a840-439c-86c8-f98585f978b2), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions with REZDIFFRA (reported in at least 5% of patients and higher compared to placebo) are: diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.
Table 1: Exposure-Adjusted Incidence Rates (EAIR) of Common Adverse Reactions Reported with REZDIFFRA in Adult Patients with Noncirrhotic MASH (Trial 1) a, b, c
| Adverse Reaction | Placebo N=294 n (EAIR d ) | REZDIFFRA 80 mg Once Daily N=298 n (EAIR d ) | REZDIFFRA 100 mg Once Daily N=296 n (EAIR d ) |
|---|---|---|---|
| Diarrhea | 52 (14) | 78 (23) | 98 (33) |
| Nausea | 36 (9) | 65 (18) | 51 (15) |
| Pruritus | 18 (4) | 24 (6) | 36 (10) |
| Vomiting | 15 (4) | 27 (7) | 30 (8) |
| Constipation | 18 (4) | 20 (5) | 28 (8) |
| Abdominal pain | 18 (4) | 22 (5) | 27 (7) |
| Dizziness | 6 (1) | 17 (4) | 17 (4) |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedThe following clinically significant adverse reactions are described elsewhere in labeling: Hepatotoxicity [see Warnings and Precautions (5.1) ] Gallbladder-Related Adverse Reactions [see Warnings and Precautions (5.2) ] The most common adverse reactions with REZDIFFRA (reported in at least 5% of patients and higher compared to placebo) are: diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Madrigal Pharmaceuticals, Inc. at 1-800-905-0324 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in clinical trials of another drug and may not reflect the rates observed in clinical practice. The safety of REZDIFFRA was evaluated in two randomized, double-blind, placebo-controlled trials that enrolled a total of 2019 patients. Trial 1 Trial 1 included patients who had noncirrhotic MASH with stages F2 and F3 fibrosis at eligibility (n=888) [see Clinical Studies (14) ]. …
Source: FDA drug label, 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?
1,893 reports list resmetirom among the medicines taken, 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. Of the 20 reactions below, 9 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Resmetirom: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions