Meta Information
ID:pravastatin
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 increases pravastatin exposure; risk of myopathy and rhabdomyolysis is increased.
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:
orine Clinical Impact: The risk of myopathy and rhabdomyolysis is increased with concomitant use of cyclosporine with pravastatin.
Label source:
FDA label: Pravastatin (PRAVACHOL)
Action type:
avoid
Target id:
/intervention/gemfibrozil
Target name:
Gemfibrozil/Fibrates
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Pravastatin combined with gemfibrozil increases myopathy/rhabdomyolysis risk; combination not recommended.
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:
domyolysis when pravastatin is administered with gemfibrozil Intervention: Avoid concomitant use of gemfibrozil with pravastatin.
Label source:
FDA label: Pravastatin (PRAVACHOL)
Action type:
avoid
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:
Lipid-modifying doses of niacin increase the risk of skeletal muscle adverse effects.
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:
in Clinical Impact: Cases of myopathy and rhabdomyolysis have been observed with concomitant use of niacin with pravastatin.
Label source:
FDA label: Pravastatin (PRAVACHOL)
Action type:
adjust_with_prescriber
Target id:
/class/macrolide-antibiotics
Target name:
Clarithromycin/Macrolides
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Clarithromycin and erythromycin increase pravastatin exposure; do not exceed 40 mg pravastatin daily.
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:
o Clarithromycin and Erythromycin The maximum recommended dosage is pravastatin sodium tablets 40 mg once daily.
Label source:
FDA label: Pravastatin (PRAVACHOL)
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:
Pravastatin can cause myopathy and rhabdomyolysis; discontinue if markedly elevated CK or myopathy occurs.
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:
Discontinue pravastatin if markedly elevated CK levels occur or myopathy is diagnosed or suspected.
Label source:
FDA label: Pravastatin (PRAVACHOL)
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:
Increases in transaminases reported; monitor liver function per label.
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:
Rare reports of fatal and non-fatal hepatic failure have occurred.
Label source:
FDA label: Pravastatin (PRAVACHOL)
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 statin therapy 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:
ent with pravastatin sodium tablets ( 8.2 ) 8.1 Pregnancy Risk Summary Discontinue pravastatin when pregnancy is recognized.
Label source:
FDA label: Pravastatin (PRAVACHOL)
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:
Pravastatin is excreted in human milk; use during breastfeeding is not recommended.
Actionable advice:
Not recommended while breastfeeding. If you are nursing, do not start pravastatin 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:
8.2 Lactation Risk Summary Based on one lactation study in published literature, pravastatin is present in human milk.
Label source:
FDA label: Pravastatin (PRAVACHOL)
Action type:
avoid
Target id:
/condition/renal-impairment
Target name:
Renal Impairment
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Use a starting dose of 10 mg daily in significant renal impairment.
Actionable advice:
Adjust dose per renal function; monitor SCr/eGFR.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
8.6 Renal Impairment Renal impairment is a risk factor for myopathy and rhabdomyolysis.
Label source:
FDA label: Pravastatin (PRAVACHOL)
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