Meta Information
ID:rosuvastatin
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-25T18:50:05.062584+00:00
Model
claude-sonnet-4.6-wave15-stub-rebuild
Interactions
Target id:
/intervention/cyclosporine
Target name:
Cyclosporine
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Cyclosporine significantly increases rosuvastatin exposure; dose adjustment required.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Reference ID: 5789376 Cyclosporine Do not exceed 5 mg once daily.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
avoid
Target id:
/intervention/gemfibrozil
Target name:
Gemfibrozil
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combination of rosuvastatin with gemfibrozil increases myopathy risk; if used, limit rosuvastatin dose.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
If use is Gemfibrozil unavoidable, initiate at 5 mg once daily and do not exceed 10 mg once daily.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
avoid
Target id:
/class/hiv-protease-inhibitors
Target name:
HIV/HCV Protease Inhibitors
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Certain HIV/HCV protease inhibitors increase rosuvastatin exposure; dose reduction may be required.
Actionable advice:
This combination should be avoided; if unavoidable, it should be managed under specialist supervision with intensive monitoring.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
QD, 14 days 5 mg, single dose 3.82 4.62 Enasidenib 100 mg QD, 28 days 10 mg, single 3.42 4.662 dose Atazanavir
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
avoid
Target id:
/class/vitamin-k-antagonists
Target name:
Coumarin Anticoagulants
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
May potentiate the anticoagulant effect of coumarin-type agents; monitor INR.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
ithout coadministered drug) No Effect=1.0 Name and Dosage Change in Change in AUC Cmax 40 mg QD for Warfarin
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
adjust_with_prescriber
Target id:
/intervention/niacin
Target name:
Niacin
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Skeletal muscle effects may be increased with lipid-modifying doses of niacin.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
sis have occurred with concomitant Clinical Effect(s): use of lipid-modifying dosages (≥1 g/day) of niacin with CRESTOR.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
adjust_with_prescriber
Target id:
/intervention/colchicine
Target name:
Colchicine
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Combination with colchicine may increase myopathy/rhabdomyolysis risk.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Niacin, fibrates, and colchicine may also increase the risk of myopathy and rhabdomyolysis [see Drug Interactions (7.1)].
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
adjust_with_prescriber
Target id:
/adverse/myopathy-rhabdomyolysis
Target name:
Myopathy / Rhabdomyolysis
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Risk of myopathy and rhabdomyolysis is dose-related; report unexplained muscle pain promptly.
Actionable advice:
Unexplained muscle pain, tenderness, weakness, or dark urine should be reported immediately; this may require CK measurement and drug discontinuation.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Renal impairment is a risk factor for myopathy and rhabdomyolysis.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
monitor
Target id:
/adverse/hepatotoxicity
Target name:
Hepatic Effects
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Elevations in transaminases have been reported.
Actionable advice:
Liver enzymes should be monitored per label, and it is worth reporting jaundice, dark urine, or persistent fatigue.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Marked persistent increases of hepatic transaminases have also occurred with CRESTOR.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
monitor
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Discontinue rosuvastatin when pregnancy is recognized.
Actionable advice:
Use should be avoided during pregnancy unless the benefit clearly outweighs the risk, and it is worth discussing with a prescriber.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
cy 2.3 Recommended Dosage in Pediatric Patients 8.1 Pregnancy Risk Summary Discontinue CRESTOR when pregnancy is recognized.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
avoid
Target id:
/condition/lactation
Target name:
Lactation
Severity:
major
Interaction type:
contraindication
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Use during breastfeeding is not recommended.
Actionable advice:
Not recommended while breastfeeding. If you are nursing, do not start rosuvastatin without your prescriber arranging an alternative or advising you to stop nursing.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Lactation Advise patients that breastfeeding during treatment with CRESTOR is not recommended [see Use in Specific Populations (8.2)].
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
avoid
Target id:
/condition/asian-patients
Target name:
Asian Patients (Higher Exposure)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Asian patients show approximately 2-fold higher exposure; consider starting at lower dose.
Actionable advice:
This is best used with caution, and it is a good idea to monitor for clinical effect; dose adjustment or monitoring may be required.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
2.4 Recommended Dosage in Asian Patients Initiate CRESTOR at 5 mg orally once daily due to increased rosuvastatin plasma concentrations.
Label source:
FDA label: Rosuvastatin (CRESTOR)
Action type:
adjust_with_prescriber
Target id:
/class/cns-depressants
Target name:
CNS Depressants
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
null
Description:
General caution when combined with other active therapeutic agents.
Actionable advice:
It is important to talk to a physician before combining this with other medications.
Validation status:
unvalidatable
Evidence tier:
tier_e
Evidence basis:
unvalidatable
Evidence anchors:
Source url:
Scientific literature support not found
Exact phrase from label:
Label source:
Generic placeholder row: the text is non-specific ('general caution') and there is no established CNS-depressant interaction for this agent. No validatable interaction claim - marked unvalidatable (candidate for removal).
Action type:
informational_none