Ribociclib and Bedaquiline: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Ribociclib
Bedaquiline
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 bedaquiline exposure and an increased risk of QT interval prolongation
Interaction Deep Dive
The concomitant use of bedaquiline (a CYP3A4 substrate) with a CYP3A4 inhibitor that also prolongs QT interval may increase bedaquiline exposure, which may increase the risk of adverse reactions. And, concomitant use may result in additive prolongation effects on the QT interval. Closely monitor patient safety (eg, liver function) when bedaquiline is coadministered with CYP3A4 inhibitors. Monitor ECG before initiation of treatment, 2 weeks after initiation and during treatment. Obtain electrolytes at baseline and during treatment and correct electrolytes. Discontinue bedaquiline if there is evidence of serious ventricular arrhythmia or QTc interval greater than 500 ms1.
Why it happens (mechanism)
Inhibition of CYP3A4-mediated metabolism of bedaquiline; additive QT interval prolongation
Literature reports
3 reports — tap to read
a) In a pharmacokinetic study in healthy subjects, the bedaquiline AUC at 24 hours, Cmax, and minimum concentration were increased by 22% (90% CI, 12% to 32%), 9% (90% CI, -2% to 21%), and 33% (90% CI, 24% to 43%), respectively, during coadministration of bedaquiline 400 mg/day for 14 days and ketoconazole 400 mg/day for 4 days 1.
b) Coadministration of a single 100 mg dose of bedaquiline with clarithromycin at steady-state in healthy adults increased the mean bedaquiline exposure, AUC (240h) by 14% 1.
c) In a study, where bedaquiline was administered with the QTc prolonging drugs clofazimine and levoFLOXacin, 5% of patients in the 40-week bedaquiline treatment group experienced a QTc 500 ms or greater and 43% of patients experienced an increase in QTc 60 ms or greater over baseline. Of the clofazimine-and levoFLOXacin-treated patients in the 40-week control arm, 7% of patients experienced a QTc 500 ms or greater and 39% experienced an increase in QTc 60 ms or greater over baseline 1.
Common questions
Can I take Ribociclib and Bedaquiline together?
Increased bedaquiline exposure and an increased risk of QT interval prolongation Always confirm with your pharmacist or prescriber before making any change.
How serious is the Ribociclib and Bedaquiline 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 Ribociclib or Bedaquiline 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: SIRTURO(R) oral tablets, bedaquiline oral tablets. Janssen Products, LP (per FDA), Horsham, PA, 2024. DailyMed
Keep reading about Ribociclib
Keep reading about Bedaquiline
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Prescription drugs aren't the whole picture — herbal and dietary supplements can interact with them too. From the evidence-graded Natural Medicines database:
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