Drug Safety-related Labeling Changes (SrLC)

Get Email Alerts | Guide

Drug Safety-related Labeling Changes (SrLC) Database

ANDA	Abbreviated New Drug Application
BLA	Biologics License Application
CDER	Center for Drug Evaluation and Research
MG	Medication Guide
NDA	New Drug Application
PCI	Patient Counseling Information
PI	Patient Information
PLR	Physician Labeling Rule
PLLR	Pregnancy and Lactation Labeling Rule
Italics	For the most part, italics indicate an FDA comment such as: Additions and/or revisions underlined These italics usually appear at the beginning of the section. In some cases, italics may be an inherent part of the label, and will most often appear in the body of the section.
Underlines	Any text that is underlined indicates text that has been added or revised. There are exceptions where underlining occurs in a section subtitle or heading. This is the case when there is just one word underlined in the body of the text.

Sections

BW	Box Warning
WP	Warnings and Precautions all in one section (PLR-format) Warnings as one section (pre-PLR format) Precautions as one section (pre-PLR format)
AR	Adverse Reactions (in pre-PLR format, this may be a subheading under precautions).
DI	Drug Interactions (in pre-PLR format, this may be a subheading under precautions).
USP	Use in Specific Populations (Inclusive on one or more of the following: Pregnancy; Lactation (PLLR- format); Nursing Mothers (pre-PLLR format); Females and Males of Reproductive Potential (PLLR format only); Pediatric Use, Geriatric Use, Renal Impairment, Hepatic Impairment, Sex, Race (these last six may be a subheading of precautions if label in pre-PLLR format.
PCI/PI/MG	Patient Counseling Information (PLR format only) - summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy). Patient Information - FDA approved patient labeling. Medication Guide - paper handouts that come with many prescription medicines. The guides address issues that are specific to particular drugs and drug classes, and they contain FDA-approved information that can help patients avoid serious adverse events.

Only NDAs and CDER regulated BLAs are included in this database. ANDAs are not included.

Applications that remain active, even if the product has been discontinued, undergo safety-related labeling changes.

REZDIFFRA (NDA-217785)

(RESMETIROM)

Safety-related Labeling Changes Approved by FDA Center for Drug Evaluation and Research (CDER)

Download Data

Expand all

07/24/2026 (SUPPL-6)

Approved Drug Label (PDF)

6 Adverse Reactions

6.1 Clinical Trials Experience

…

Trial 1

Trial 1 included patients who had noncirrhotic MASH with stages F2 and F3 fibrosis at eligibility (n=888) [see Clinical Studies (14)].

…

Additional Safety Data

…

Data from the safety trial was combined with data from MASH patients…

8 Use in Specific Populations

8.1 Pregnancy

Risk Summary

There are no available data on REZDIFFRA use in pregnant women to evaluate for a drug-associated risk of major birth defects, miscarriage, or other adverse maternal or fetal outcomes. There are risks to the mother and fetus related to underlying MASH with liver fibrosis (see Clinical Considerations).

…

Clinical Considerations

Disease-Associated Maternal and/or Embryo/Fetal Risk

There are risks to the mother and fetus related to underlying maternal MASH with liver fibrosis, such as increased risks of gestational diabetes, hypertensive complications, preterm birth, and postpartum hemorrhage.

…

8.4 Geriatric Use

In Trial 1, of the 594 patients with MASH who received at least one dose of REZDIFFRA, 149 (25%) were 65 years of age and older and 13 (2%) were 75 years of age and older [see Clinical Studies (14)].

…

8.7 Hepatic Impairment

Additions and/or revisions underlined:

…

The safety and effectiveness of REZDIFFRA have not been established in patients with MASH cirrhosis.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT INFORMATION

Additions and/or revisions underlined:

What is REZDIFFRA?

REZDIFFRA is a prescribed medicine used along with diet and exercise to treat adults with metabolic dysfunction-associated steatohepatitis (MASH), formerly known as noncirrhotic nonalcoholic steatohepatitis (NASH), with moderate to advanced liver scarring (fibrosis) but not with cirrhosis of the liver.

…

Before you take REZDIFFRA, tell your healthcare provider about all of your medical conditions, including if you:

have any liver problems other than MASH.

…

REZDIFFRA may cause serious side effects, including:

…

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. The pain may be felt going from your abdomen to your back and the pain may happen with or without vomiting.

…

REZDIFFRA® is a registered trademark owned by Madrigal Pharmaceuticals, Inc.

12/19/2025 (SUPPL-2)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effects of Strong or Moderate CYP2C8 Inhibitors on REZDIFFRA

Section title revised

Title revision to Table 3; please refer to label for complete information

Table 3 includes clinically significant drug interaction effects of strong or moderate CYP2C8 inhibitors on REZDIFFRA.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Administration Instructions

Instruct patients to swallow REZDIFFRA tablets whole and not split, crush, or chew tablets [see Dosage and Administration (2.1)].

…

Pregnancy

Inform patients that there is a pregnancy safety study that monitors pregnancy outcomes in women exposed to REZDIFFRA during pregnancy. Encourage patients to report their pregnancy by visiting https://pregnancyregistry.madrigalpharma.com or calling 1-800-905-0324 [see Use in Specific Populations (8.1)].

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Before you take REZDIFFRA, tell your healthcare provider about all of your medical conditions, including if you:

have any liver problems other than NASH.
have gallbladder problems or have been told you have gallbladder problems, including gallstones.
are pregnant or plan to become pregnant. It is not known if REZDIFFRA will harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for women who are or become pregnant during treatment with REZDIFFRA. The purpose of this pregnancy safety study is to collect information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by visiting https://pregnancyregistry.madrigalpharma.com/ or calling 1-800-905-0324.

…

How should I take REZDIFFRA?

Take REZDIFFRA exactly as your healthcare provider tells you to take it.
Your dose of REZDIFFRA is based on your body weight.
Take REZDIFFRA by mouth, 1 time a day with or without food.
Swallow REZDIFFRA tablets whole. Do not split, crush, or chew tablets.

If you miss a dose of REZDIFFRA, skip the missed dose and take your next dose at the regular time.

…

12/19/2025 (SUPPL-4)

Approved Drug Label (PDF)

8 Use in Specific Populations

8.4 Pediatric Use

Additions and/or revisions underlined:

The recommended dosage of REZDIFFRA in patients with mild, moderate, or severe renal impairment is the same as in patients with normal kidney function [see Clinical Pharmacology (12.3)].

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Administration Instructions

Instruct patients to swallow REZDIFFRA tablets whole and not split, crush, or chew tablets [see Dosage and Administration (2.1)].

…

Pregnancy

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Before you take REZDIFFRA, tell your healthcare provider about all of your medical conditions, including if you:

have any liver problems other than NASH.
have gallbladder problems or have been told you have gallbladder problems, including gallstones.
are pregnant or plan to become pregnant. It is not known if REZDIFFRA will harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for women who are or become pregnant during treatment with REZDIFFRA. The purpose of this pregnancy safety study is to collect information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by visiting https://pregnancyregistry.madrigalpharma.com/ or calling 1-800-905-0324.

…

How should I take REZDIFFRA?

Take REZDIFFRA exactly as your healthcare provider tells you to take it.
Your dose of REZDIFFRA is based on your body weight.
Take REZDIFFRA by mouth, 1 time a day with or without food.
Swallow REZDIFFRA tablets whole. Do not split, crush, or chew tablets.

If you miss a dose of REZDIFFRA, skip the missed dose and take your next dose at the regular time.

…

12/19/2025 (SUPPL-5)

Approved Drug Label (PDF)

7 Drug Interactions

7.1 Effects of Strong or Moderate CYP2C8 Inhibitors on REZDIFFRA

Section title revised

Title revision to Table 3; please refer to label for complete information

Table 3 includes clinically significant drug interaction effects of strong or moderate CYP2C8 inhibitors on REZDIFFRA.

17 PCI/PI/MG (Patient Counseling Information/Patient Information/Medication Guide)

PATIENT COUNSELING INFORMATION

Additions and/or revisions underlined

…

Administration Instructions

Instruct patients to swallow REZDIFFRA tablets whole and not split, crush, or chew tablets [see Dosage and Administration (2.1)].

…

Pregnancy

PATIENT INFORMATION

Additions and/or revisions underlined:

…

Before you take REZDIFFRA, tell your healthcare provider about all of your medical conditions, including if you:

have any liver problems other than NASH.
have gallbladder problems or have been told you have gallbladder problems, including gallstones.
are pregnant or plan to become pregnant. It is not known if REZDIFFRA will harm your unborn baby.

Pregnancy Safety Study. There is a pregnancy safety study for women who are or become pregnant during treatment with REZDIFFRA. The purpose of this pregnancy safety study is to collect information about your health and your baby’s health. You or your healthcare provider can report your pregnancy by visiting https://pregnancyregistry.madrigalpharma.com/ or calling 1-800-905-0324.

…

How should I take REZDIFFRA?

Take REZDIFFRA exactly as your healthcare provider tells you to take it.
Your dose of REZDIFFRA is based on your body weight.
Take REZDIFFRA by mouth, 1 time a day with or without food.
Swallow REZDIFFRA tablets whole. Do not split, crush, or chew tablets.

If you miss a dose of REZDIFFRA, skip the missed dose and take your next dose at the regular time.

…