Darolutamide and Rosuvastatin: Interaction Details
AI-assisted, pharmacist-reviewed · Source data updated Aug 8, 2026 · Sources: FDA labeling, DDInter 2.0, cited literature
Rosuvastatin
Darolutamide
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 rosuvastatin exposure and an increased risk of myopathy and rhabdomyolysis
Interaction Deep Dive
Avoid concomitant use of darolutamide1 and rosuvastatin (OATP1B1/BCRP substrate). Concomitant use of darolutamide and rosuvastatin increases exposure to rosuvastatin and may increase the risk of myopathy/rhabdomyolysis. Darolutamide 600 mg twice daily for 5 days followed by a single dose of rosuvastatin 5 mg resulted in a clinically significant 5.2-fold increase in rosuvastatin AUC and approximately 5-fold increase in rosuvastatin Cmax. If coadministration is required, the rosuvastatin dose should be limited to 5 mg once daily 2.
Why it happens (mechanism)
Inhibition of BCRP-mediated efflux transport of rosuvastatin; inhibition of OATP1B1-mediated efflux transport of rosuvastatin
Literature reports
1 report — tap to read
a) Darolutamide 600 mg twice daily for 5 days followed by a single dose of rosuvastatin 5 mg resulted in a clinically significant 5.2-fold increase in rosuvastatin AUC and approximately 5-fold increase in rosuvastatin Cmax 2.
Common questions
Can I take Darolutamide and Rosuvastatin together?
Increased rosuvastatin exposure and an increased risk of myopathy and rhabdomyolysis Always confirm with your pharmacist or prescriber before making any change.
How serious is the Darolutamide and Rosuvastatin 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 Darolutamide or Rosuvastatin 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 (2)
Keep reading about Rosuvastatin
Keep reading about Darolutamide
These medications also interact with supplements
Prescription drugs aren't the whole picture — herbal and dietary supplements can interact with them too. From the evidence-graded Natural Medicines database:
major · moderate · minor — check everything you take with our drug–supplement interaction checker.
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