Rezdiffra Side Effects

Generic name: resmetirom

Note: This document contains side effect information about resmetirom. Some dosage forms listed on this page may not apply to the brand name Rezdiffra.

Applies to resmetirom: oral tablet.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• fever, nausea, vomiting;

• liver problems--loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes); or

• gallbladder problems--chalky-colored stools, stomach pain after eating, heartburn, bloating, and severe upper stomach pain that may spread to your back.

Common side effects may include:

• diarrhea;

• stomach pain, constipation;

• nausea, vomiting;

• dizziness; or

• itching.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects.

For Healthcare Professionals

Applies to resmetirom: oral tablet.

General

The most common adverse reactions reported in at least 5% of patients included diarrhea, nausea, pruritus, vomiting, constipation, abdominal pain, and dizziness.^[Ref]

Cardiovascular

Frequency not reported: Arrythmia, palpitations

Dermatologic

Very common (10% or more): Pruritus (up to 10%)

Frequency not reported: Urticaria, rash, erythema

Endocrine

Very common (10% or more): Decreased prohormone free T4 (up to 17%)

Gastrointestinal

Very common (10% or more): Diarrhea (up to 33%), nausea (up to 18%)

Common (1% to 10%): Constipation, vomiting, abdominal pain

Frequency not reported: Cholelithiasis, acute cholecystitis, obstructive pancreatitis (gallstone), flatulence, abnormal feces, dysgeusia

Genitourinary

Frequency not reported: Abnormal uterine bleeding

Hepatic

Very common (10% or more): ALT greater than 3 times the upper limit of normal (3 x ULN; up to 13%), AST greater than 3 x ULN (up to 12%)

Common (1% to 10%): ALT greater than 5 x ULN, AST greater than 5 x ULN, total bilirubin elevations greater than 2 x ULN

Frequency not reported: Hepatotoxicity

Hypersensitivity

Frequency not reported: Hypersensitivity reactions

Metabolic

Frequency not reported: Hypoglycemia

Musculoskeletal

Frequency not reported: Tendinopathy

Nervous system

Common (1% to 10%): Dizziness

Frequency not reported: Vertigo

Other

Frequency not reported: Decreased appetite

Psychiatric

Frequency not reported: Depression

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.

Medical Disclaimer