Common Side Effects of Rezdiffra
Rezdiffra (resmetirom), approved for noncirrhotic non-alcoholic steatohepatitis (NASH) with moderate to advanced liver fibrosis, most often causes nausea, diarrhea, abdominal pain, fatigue, and nasopharyngitis (like a stuffy nose or sore throat). These affect 10-20% of patients in trials and are usually mild to moderate.[1][2]
Serious Side Effects and Risks
Serious issues include gallbladder disease (cholelithiasis or cholecystitis), seen in up to 9% of users, which may require surgery. Drug-induced liver injury occurred in 0.7% of trial participants. Other risks: elevated liver enzymes, thyroid issues, and potential for muscle damage (rhabdomyolysis) with statins. Avoid in patients with decompensated cirrhosis or recent liver decompensation.[1][3]
Side Effects by Frequency from Clinical Trials
- Very common (>10%): Diarrhea, nausea.[2]
- Common (1-10%): Vomiting, constipation, abdominal discomfort, fatigue, viral infections, weight loss, dizziness, COVID-19, hypertension.[1][2]
- Uncommon (<1%): Gallbladder problems, elevated ALT/AST, hypersensitivity reactions.[3]
Trials (MAESTRO-NASH/NAFLD) tracked over 900 patients; side effects led to discontinuation in 6.5% vs. 2.6% on placebo.[2]
How Long Do Side Effects Last?
Most gastrointestinal effects start early and resolve within weeks as patients adjust. Gallbladder issues can persist or worsen, needing monitoring via ultrasound every 3 months initially.[1][3]
Side Effects in Special Populations
Pregnant patients face fetal harm risks—use contraception. No data in kids under 18. Dose adjustments needed for severe kidney impairment. Common in older adults (65+), with higher fatigue rates.[1]
Managing Side Effects
Take with food to reduce nausea/diarrhea. Monitor liver function monthly for first 3 months, then quarterly. Report persistent symptoms; statins require dose cuts or alternatives.[3]
Sources
[1]: Rezdiffra Prescribing Information (Madrigal Pharmaceuticals)
[2]: MAESTRO-NASH Phase 3 Trial Results (NEJM)
[3]: Drugs.com - Rezdiffra Side Effects