Elafibranor Side Effects

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

Applies to elafibranor: oral tablet.

Important Warnings This medicine can cause some serious health issues

Elafibranor can cause the breakdown of muscle tissue, which can lead to kidney failure.

Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Also call your doctor if you have swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, or jaundice (yellowing of the skin or eyes).

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

Elafibranor can cause the breakdown of muscle tissue, which can lead to kidney failure. Call your doctor right away if you have unexplained muscle pain, tenderness, or weakness especially if you also have fever, unusual tiredness, or dark urine.

Call your doctor at once if you have:

• stomach pain, nausea, vomiting, diarrhea, weight loss, loss of appetite;

• new or worsening tiredness, weakness;

• fever, chills;

• feeling light-headed;

• urination problems;

• sudden pain or trouble moving your hip, wrist, or back; or

• liver problems--swelling around your midsection, right-sided upper stomach pain, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Your treatment with elafibranor may be delayed or permanently discontinued if you have certain side effects.

Common side effects may include:

• diarrhea, constipation, nausea, vomiting, stomach pain, dry mouth;

• heartburn, chest pain, trouble swallowing;

• joint pain, broken bones, muscle problems;

• weight changes; or

• rash.

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 elafibranor: oral tablet.

General

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.

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

Medical Disclaimer