Simvastatin and Elafibranor: Interaction Details
AI-assisted, pharmacist-reviewed · AI content regenerated Jul 11, 2026 · Source data updated Jul 4, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Simvastatin
Elafibranor
How we grade severity & evidence
Severity levels
- Contraindicated: These should generally not be used together.
- Major: Potentially serious — often needs a change or close monitoring.
- Moderate: Can be significant — usually manageable with monitoring.
- Minor: Usually limited clinical impact.
Evidence grades
- Established: Well documented — supported by controlled studies or strong clinical data.
- Probable: Good supporting evidence, though not definitively proven.
- Suspected: Some evidence suggests this interaction, but it is not well established.
- Possible: Limited or conflicting evidence; the interaction may occur.
- Theoretical: Predicted from the drugs' pharmacology; not yet confirmed in people.
Ratings come from the documented interaction literature and are reviewed by a pharmacist. They describe the documented risk of the combination, not what will necessarily happen to you — your dose, timing, and health picture all matter.
Both of these medicines can, on their own, sometimes affect your muscles. Simvastatin (Zocor) is a cholesterol medicine, and one of its known side effects is muscle aches or, rarely, more serious muscle damage. Elafibranor (Iqirvo) is a liver medicine that may add to that muscle risk when taken together.
This is mostly a theoretical concern, meaning it is based on how the drugs work rather than lots of proven cases. Watch for new or worsening muscle pain, tenderness, weakness, or dark urine, and tell your care team if that happens. Your doctor and pharmacist can manage this safely by keeping an eye on you.
Effect: Additive risk of CPK elevation, myalgia, and myopathy when elafibranor is combined with an HMG-CoA reductase inhibitor (simvastatin).
- Direction: Increased risk of statin-associated muscle toxicity.
- Mechanism: Unknown; not clearly attributable to a defined PK enzyme/transporter interaction.
- Onset: Unspecified.
- Evidence: Theoretical.
- Management: Monitor for muscle injury signs/symptoms; consider periodic clinical exam and CPK. Interrupt elafibranor if new onset or worsening myalgia/myopathy occurs.
Neither agent's active moiety depends on the other for activation, so the concern is pharmacodynamic (additive muscle toxicity) rather than reduced efficacy.
What happens
Increased risk of CPK elevation/myalgia and an increased risk of myopathy
Interaction Deep Dive
When elafibranor is given together with HMG-CoA Reductase Inhibitors, the combination may raise the likelihood of CPK elevation/myalgia as well as the likelihood of myopathy. Watch for signs and symptoms indicating muscle injury. Periodic evaluation (clinical examination and CPK) during the course of therapy should be considered. Should new or worsening muscle pain or myopathy occur, discontinue elafibranor treatment1.
Why it happens (mechanism)
Unknown
How to manage this interaction
Keep taking both medicines as prescribed unless your care team tells you otherwise. Here is what typically happens:
- Your team may monitor you more closely, including a physical check and periodic CPK blood tests, to catch any muscle problems early.
- If you develop new or worsening muscle pain, weakness, or tenderness, your prescriber may pause the elafibranor.
Report muscle aches, unusual tiredness, or dark-colored urine to your pharmacist or doctor promptly. This can be safely managed with monitoring and individualized adjustments by your care team.
Management is individual — confirm any change with your pharmacist or prescriber.
Common questions
Can I take Simvastatin and Elafibranor together?
Taking simvastatin with elafibranor may add to the risk of muscle pain or damage, so watch for muscle symptoms and let your care team monitor you. Report new or worsening muscle pain right away. Always confirm with your pharmacist or prescriber before making any change.
How serious is the Simvastatin and Elafibranor interaction?
It is rated major. Potentially serious — often needs a change or close monitoring.
How quickly could this interaction happen?
The documented onset is "unspecified". The timing of this interaction is not well characterized.
How is the Simvastatin and Elafibranor interaction managed?
Keep taking both medicines as prescribed unless your care team tells you otherwise. Here is what typically happens: Your team may monitor you more closely, including a physical check and periodic CPK blood tests, to catch any muscle problems early. If you develop new or worsening muscle pain, weakness, or tenderness, your prescriber may pause the elafibranor. Report muscle aches, unusual tiredness… Management is individual — always follow your own care team's guidance.
How strong is the evidence for this interaction?
The evidence is graded "theoretical". Predicted from the drugs' pharmacology; not yet confirmed in people.
From our Q&A
Real reader questions about these medications, each personally answered by our pharmacist:
Questions for your pharmacist
- Does my dose of Simvastatin or Elafibranor need adjusting while I take them together?
- What symptoms should prompt me to call you or my prescriber right away?
- Does the timing of my doses matter for this combination?
- Is there a safer alternative to one of these medications for me?
References (1)
- Product Information: IQIRVO(R) oral tablets, elafibranor oral tablets. Ipsen Biopharmaceuticals, Inc. (Per FDA), Cambridge, MA, 2024. DailyMed
Keep reading about Simvastatin
Keep reading about Elafibranor
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