Meta Information
ID:bempedoic-acid
Name:
Schema Version:2.4_uniform_evidence_2026_06_18
Created
2026-05-21T22:30:00Z
Model
phase-a-upgrade-claude-sonnet-4.6
Interactions
Target id:
/intervention/simvastatin
Target name:
Simvastatin
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid inhibits transporters (OATP1B1/1B3) needed to clear simvastatin, increasing its concentration by about 2-fold and raising the risk of muscle-related side effects (myopathy).
Actionable advice:
A daily dose of 20 mg of simvastatin should not be exceeded when taking bempedoic acid.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Simvastatin: Administration of simvastatin 20 mg with 240 mg of bempedoic acid or 40 mg with 180 mg of bempedoic acid in healthy subjects at steady-state resulted in approximately 2-fold (91% for 20 mg and 96% for 40 mg) and 1.5-fold (54% for 20 mg and 52% for 40 mg) increases in simvastatin acid AUC and C max , respectively [see Drug Interactions (7) ] .
Label source:
Action type:
informational_none
Target id:
/intervention/pravastatin
Target name:
Pravastatin
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid inhibits transporters (OATP1B1/1B3) needed to clear pravastatin, increasing its concentration by about 1.9-fold and raising the risk of muscle-related side effects (myopathy).
Actionable advice:
A daily dose of 40 mg of pravastatin should not be exceeded when taking bempedoic acid.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Pravastatin: Administration of pravastatin 40 mg with steady-state bempedoic acid 240 mg in healthy subjects resulted in 99% (2-fold) and 104% (2-fold) increases in pravastatin acid AUC and C max , respectively [see Drug Interactions (7) ] .
Label source:
Action type:
informational_none
Target id:
/class/statins
Target name:
Statins (e.g., Atorvastatin, Rosuvastatin)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid can increase the blood levels of most statins by inhibiting their uptake into the liver, which may increase the risk of muscle pain and weakness.
Actionable advice:
The lowest necessary statin dose is best used, and it is worth monitoring for any new or worsening muscle symptoms.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Statins The pharmacokinetic interactions between bempedoic acid (at systemic exposure relevant to the indicated CVD population) and simvastatin 20 mg, atorvastatin 10 mg, pravastatin 40 mg, and rosuvastatin 10 mg were evaluated in clinical trials.
Label source:
Action type:
adjust_with_prescriber
Target id:
/intervention/ezetimibe
Target name:
Ezetimibe
Severity:
moderate
Interaction type:
synergistic
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid (reduces cholesterol production) and ezetimibe (reduces cholesterol absorption) work via complementary pathways to provide a greater LDL cholesterol-lowering effect when used together.
Actionable advice:
This combination is often used intentionally for enhanced cholesterol management; they can be taken at the same time.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Ezetimibe Ezetimibe reduces blood cholesterol by inhibiting the absorption of cholesterol by the small intestine.
Label source:
Action type:
informational_none
Target id:
/biomarker/uric-acid
Target name:
Uric Acid
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid can slightly inhibit the kidney's ability to excrete uric acid by blocking the OAT2 transporter, leading to a small increase in blood uric acid levels.
Actionable advice:
A small, clinically insignificant rise in uric acid may occur during treatment.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Bempedoic acid weakly inhibits OAT2 in vitro , which is likely the mechanism responsible for minor elevations in serum creatinine and uric acid [see Adverse Reactions (6.1) ] .
Label source:
Action type:
monitor
Target id:
/condition/gout
Target name:
Gout or Hyperuricemia
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
By increasing blood uric acid levels, bempedoic acid may increase the risk of gout attacks in individuals with a history of the condition or high baseline uric acid.
Actionable advice:
If you have a history of gout, monitor for symptoms and discuss uric acid levels with your doctor.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Elevated blood uric acid may lead to the development of gout.
Label source:
Action type:
monitor
Target id:
/condition/geriatric
Target name:
Age Over 60
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
An increased risk of tendon rupture has been observed with bempedoic acid, and this risk is higher in patients over 60 years of age.
Actionable advice:
If you are over 60, be vigilant for any new tendon pain or swelling and report it promptly.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Ezetimibe Geriatrics : In a multiple-dose study with ezetimibe given 10 mg once daily for 10 days, plasma concentrations for total ezetimibe were about 2-fold higher in older (≥ 65 years) healthy subjects compared to younger subjects [see Use in Specific Populations (8.5) ] .
Label source:
Action type:
monitor
Target id:
/class/corticosteroids
Target name:
Corticosteroids (e.g., Prednisone)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Concurrent use of corticosteroids, which can weaken connective tissue, may further increase the risk of tendon rupture associated with bempedoic acid.
Actionable advice:
Concurrent use is best avoided if possible; otherwise, it is worth being extra cautious about tendon pain or injury.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Label source:
Action type:
avoid
Target id:
/class/fluoroquinolones
Target name:
Fluoroquinolone Antibiotics
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Concurrent use of fluoroquinolone antibiotics, which carry their own risk of tendon injury, may further increase the risk of tendon rupture associated with bempedoic acid.
Actionable advice:
Concurrent use is best avoided if possible; otherwise, it is worth being extra cautious about tendon pain or injury.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Tendon rupture may occur more frequently in patients over 60 years of age, in those taking corticosteroid or fluoroquinolone drugs, in patients with renal failure, and in patients with previous tendon disorders.
Label source:
Action type:
avoid
Target id:
/condition/renal-impairment
Target name:
Severe Renal Impairment (eGFR < 30)
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Severe kidney disease can increase blood levels of bempedoic acid and also independently increases the risk of tendon rupture, compounding the risk.
Actionable advice:
This is best used with caution and under close medical supervision in those with severe kidney disease.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Specific Populations Patients with Renal Impairment Bempedoic acid No clinically significant differences in the pharmacokinetics of bempedoic acid were observed in subjects with renal impairment (mild, moderate, and severe renal impairment or renal failure) compared to those with normal renal function.
Label source:
Action type:
informational_none
Target id:
/condition/hepatic-impairment
Target name:
Severe Hepatic Impairment (Child-Pugh C)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid is activated in the liver and has not been studied in patients with severe liver disease; its use is not recommended.
Actionable advice:
This should not be used in severe liver disease.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
The effect of severe hepatic impairment (Child-Pugh C) on bempedoic acid pharmacokinetics is unknown.
Label source:
Action type:
avoid
Target id:
/condition/pregnancy
Target name:
Pregnancy
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Bempedoic acid lowers cholesterol, which is essential for normal fetal development. Its use may cause fetal harm and is contraindicated during pregnancy.
Actionable advice:
This should be strictly avoided during pregnancy or when planning to become pregnant.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
( 7 )
8 USE IN SPECIFIC POPULATIONS Pregnancy: Based on mechanism of action, may cause fetal harm.
Label source:
Action type:
avoid
Target id:
/condition/lactation
Target name:
Breastfeeding (Lactation)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
It is unknown if bempedoic acid passes into breast milk, but due to the potential for serious adverse reactions in a breastfed infant, it is not recommended.
Actionable advice:
It should be avoided completely while breastfeeding.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
The mean daily infant dose of bempedoic acid through breast milk was approximately 0.03 mg/day (95% CI: 0.02; 0.05) with a mean calculated daily infant oral dosage of 0.012 mg/kg/day based on a standard infant milk intake of 150 mL/kg/day.
Label source:
Action type:
avoid
Target id:
/class/immunosuppressants
Target name:
Cyclosporine
Severity:
major
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Cyclosporine strongly inhibits transporters (OATP1B1/1B3) responsible for bempedoic acid uptake, which can significantly increase its concentration and risk of side effects.
Actionable advice:
Concurrent use with cyclosporine should be avoided.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Cyclosporine: Administration of ezetimibe with cyclosporine (75-150 mg BID) resulted in a 2.4- and a 2.9-fold increase in total ezetimibe AUC and C max , respectively [see Drug Interactions (7) ] .
Label source:
Action type:
informational_none
Target id:
/intervention/probenecid
Target name:
Probenecid
Severity:
moderate
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Probenecid can inhibit the metabolism (glucuronidation) of bempedoic acid's active form, potentially increasing its levels and the risk of adverse effects.
Actionable advice:
It is worth watching out for side effects if co-administration is necessary.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Probenecid Administration of bempedoic acid 180 mg with steady-state probenecid resulted in a 1.7- and a 1.2-fold increase in bempedoic acid AUC and C max , respectively.
Label source:
Action type:
monitor
Target id:
/class/fibrates
Target name:
Fibrates
Severity:
minor
Interaction type:
adverse
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
Although clinical trials with fenofibrate did not show increased muscle-related side effects, fibrates as a class can cause myopathy, warranting caution when combined with bempedoic acid.
Actionable advice:
This is best used with caution, and it is worth monitoring for any new or worsening muscle symptoms.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
Fibrates Clinical Impact: Concomitant administration of fibrates with NEXLETOL resulted in increased triglycerides and decreased high-density lipoprotein cholesterol (HDL-C) in some patients in clinical studies and post-marketing reports.
Label source:
Action type:
monitor
Target id:
/dietary/meal
Target name:
Any Caloric Meal
Severity:
minor
Interaction type:
informational
Nature:
absolute
Temporal spacing:
Hours before target:
0
Hours after target:
0
Description:
The absorption and effectiveness of bempedoic acid are not significantly affected by food, offering flexibility in administration.
Actionable advice:
It is generally best taken at the same time each day, with or without food, for consistency.
Validation status:
validated_via_fda_label
Evidence tier:
tier_a
Evidence basis:
fda_label_verbatim
Evidence anchors:
Source url:
Exact phrase from label:
2 DOSAGE AND ADMINISTRATION Administer one tablet (180 mg bempedoic acid and 10 mg ezetimibe) orally once daily with or without food.
Label source:
Action type:
informational_none
Target id:
/condition/end-stage-renal-disease
Target name:
End-Stage Renal Disease (on Dialysis)
Severity:
major
Interaction type:
adverse
Nature:
absolute
Description:
The use of bempedoic acid has not been studied in patients with end-stage renal disease receiving dialysis, so its safety is unknown.
Actionable advice:
Bempedoic acid should not be used by people on dialysis.
Validation status:
validated_via_class_inference
Evidence tier:
tier_c
Evidence basis:
class_inference_summary
Evidence anchors:
Source url:
Established mechanism / class pharmacology (no single primary source quoted)
Exact phrase from label:
Labeled data gap: bempedoic acid has not been studied in patients with ESRD on dialysis, so its safety/dosing there is unknown; use with caution. Regulatory/label-based caution.
Label source:
Class inference
Action type:
avoid
Temporal spacing:
Hours before target:
0
Hours after target:
0