Resmetirom Side Effects
Applies to resmetirom: oral tablet.
Warning
Use only as directed. Tell your doctor if you use other medicines or have other medical conditions or allergies.
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:
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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
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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:
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stomach pain, constipation;
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nausea, vomiting;
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dizziness; or
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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
More about resmetirom
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- During pregnancy
- Drug class: miscellaneous metabolic agents
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References
1. (2024) "Product Information. Rezdiffra (resmetirom)." Madrigal Pharmaceuticals, Inc.
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.