Elafibranor Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 10, 2024.

Applies to elafibranor: oral tablets.

Side effects include:

Most common adverse reactions (≥5%): weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, rash.

For healthcare professionals

Applies to elafibranor: oral tablet.

General adverse events

The most common adverse reactions occurring in at least 5% of patients included weight gain, diarrhea, abdominal pain, nausea, vomiting, arthralgia, constipation, muscle injury, fracture, gastroesophageal reflux disease, dry mouth, weight loss, and rash.^[Ref]

Dermatologic

• Common (1% to 10%): Rash

Gastrointestinal

• Very common (10% or more): Diarrhea (11%), abdominal pain (11%), nausea (11%), vomiting (11%)
• Common (1% to 10%): Constipation, gastroesophageal reflux disease, dry mouth
• Frequency not reported: Gastroenteritis

Hematologic

• Frequency not reported: Anemia

Hepatic

• Common (1% to 10%): New-onset cholelithiasis, increased transaminases (ALT/AST), total bilirubin greater than 3 times the upper limit of normal (3 x ULN), drug-induced liver injury
• Frequency not reported: Cholecystitis requiring cholecystectomy

Hypersensitivity

• Uncommon (0.1% to 1%): Hypersensitivity reactions (rash or unspecified allergic reaction)

Metabolic

• Frequency not reported: Increased blood creatinine

Musculoskeletal

• Common (1% to 10%): Arthralgia, muscle pain, myalgia, fracture, creatine phosphokinase (CPK) increased greater than 3 x ULN, increased CPK and myalgia, rhabdomyolysis
• Frequency not reported: Myopathy

Nervous system

• Frequency not reported: Dizziness

Other

• Very common (10% or more): Weight gain (23%)
• Common (1% to 10%): Weight loss

Renal

• Common (1% to 10%): Acute kidney injury

Further information

Elafibranor side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer