Lefamulin and Omaveloxolone: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Omaveloxolone
Lefamulin
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.
What happens
Increased omaveloxolone exposure, an increased risk of omaveloxolone-related adverse effects, reduced CYP3A4 substrate exposure and reduced efficacy of CYP3A4 substrate
Interaction Deep Dive
Omaveloxolone is a CYP3A4 substrate and also a weak CYP3A4 inducer. Avoid concomitant use of omaveloxolone with drugs that are both moderate CYP3A4 inhibitors and CYP3A4 substrates. Concomitant use may increase the omaveloxolone exposure, which may increase the risk of omaveloxolone-related adverse reactions and may also reduce the exposure of these drugs which may reduce the efficacy of these drugs. If the use cannot be avoided, reduce the dosage of omaveloxolone to 100 mg once daily with close monitoring for omaveloxolone adverse reactions. If adverse reactions emerge, further reduce the dosage of omaveloxolone to 50 mg once daily. If used concomitantly, monitor for lack of efficacy of concomitant treatment1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of omaveloxolone; induction of CYP3A4 substrate metabolism by omaveloxolone
Literature reports
2 reports — tap to read
a) In a drug interaction study, omaveloxolone Cmax and AUC increased approximately by 1.25-fold following concomitant use of omaveloxolone with verapamil (a moderate CYP3A inhibitor and P-gp inhibitor) 1.
b) In a drug interaction study, omaveloxolone when coadministered with midazolam decreased the AUC of midazolam (CYP3A4 substrate) by approximately 45% 1.
Common questions
Can I take Lefamulin and Omaveloxolone together?
Increased omaveloxolone exposure, an increased risk of omaveloxolone-related adverse effects, reduced CYP3A4 substrate exposure and reduced efficacy of CYP3A4 substrate Always confirm with your pharmacist or prescriber before making any change.
How serious is the Lefamulin and Omaveloxolone 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 strong is the evidence for this interaction?
The evidence is graded "probable". Good supporting evidence, though not definitively proven.
Questions for your pharmacist
- Does my dose of Lefamulin or Omaveloxolone 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: Skyclarys® oral capsules, omaveloxolone oral capsules. Biogen U.S. Corporation, Cambridge, MA, 2026. DailyMed
Keep reading about Omaveloxolone
Keep reading about Lefamulin
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