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

See also:

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