Atorvastatin with Fenofibric Acid Interaction Details

Brand Names Associated with Atorvastatin

Medical Content Editor Dr. Brian Staiger, PharmD
Last updated Mar 04, 2024

Interaction Effect

An increased risk of myopathy or rhabdomyolysis

Interaction Summary

Serious muscle adverse events including myopathy and rhabdomyolysis with associated renal failure, have been reported following monotherapy with atorvastatin[1] or fibrates [2]. Concomitant use of atorvastatin and fenofibric acid may increase these risks. This appears due to additive muscle toxicity, as a pharmacokinetic study coadministering atorvastatin and fenofibrate (fenofibric acid is the active metabolite of fenofibrate) did not increase exposure to either medication. Avoid concurrent use of atorvastatin and fenofibric acid unless the potential benefit of added lipid level alterations outweighs the increased risk of adverse effects [2]. If coadministration is necessary, consider a lower atorvastatin dose, and monitor patients for signs and symptoms of myositis, myopathy or rhabdomyolysis (muscle pain, tenderness, or weakness), particularly during the initial months and with upward dose titrations of either medication. Periodic creatine phosphokinase (CPK) measurements may be helpful, but cannot assure prevention of severe myopathy [1]. In the event of suspected or diagnosed myopathy/myositis, consider discontinuing one or both agents.

Severity

Major

Onset

Unspecified

Evidence

Theoretical

How To Manage Interaction

Concomitant use of fenofibric acid and HMG-CoA reductase inhibitors, including atorvastatin, should be avoided unless the potential benefit from further lipid level adjustments outweighs the increased risk of rhabdomyolysis[2]. If concurrent therapy is necessary consider a lower atorvastatin dose and monitor patients for signs and symptoms of myositis, myopathy or rhabdomyolysis (muscle pain, tenderness, or weakness), particularly during the initial months and with upward dose titrations of either medication. Periodic creatine phosphokinase (CPK) measurements may be considered, but there is no assurance it will prevent severe myopathy [1]. In the event of suspected or diagnosed myopathy/myositis, consider discontinuing one or both of the agents.

Mechanism Of Interaction

Additive risk of myopathy

Literature Reports

A) Atorvastatin AUC values decreased by approximately 17% following the concomitant administration of fenofibrate 160 mg (fenofibric acid is the active metabolite of fenofibrate) and atorvastatin 20 mg once daily for 10 days. Fenofibrate did not significantly affect atorvastatin Cmax values. The pharmacokinetics of fenofibric acid were not significantly affected by atorvastatin [2].

References

1 ) Product Information: LIPITOR(R) oral tablets, atorvastatin calcium oral tablets. Pfizer (Per FDA), New York, NY, 2012.

2 ) Product Information: FIBRICOR(R) oral tablets, fenofibric acid oral tablets. AR Scientific, Inc. (per FDA), Philadelphia, PA, 2012.

Atorvastatin Overview

• Atorvastatin is used together with diet, weight loss, and exercise to reduce the risk of heart attack and stroke and to decrease the chance that heart surgery will be needed in people who have heart disease or who are at risk of developing heart disease. Atorvastatin is also used to decrease the amount of fatty substances such as low-density lipoprotein (LDL) cholesterol ('bad cholesterol') and triglycerides in the blood and to increase the amount of high-density lipoprotein (HDL) cholesterol ('good cholesterol') in the blood. Atorvastatin may also be used to decrease the amount of cholesterol and other fatty substances in the blood in children and teenagers 10 to 17 years of age who have familial heterozygous hypercholesterolemia (an inherited condition in which cholesterol cannot be removed from the body normally). Atorvastatin is in a class of medications called HMG-CoA reductase inhibitors (statins). It works by slowing the production of cholesterol in the body to decrease the amount of cholesterol that may build up on the walls of the arteries and block blood flow to the heart, brain, and other parts of the body.

• Accumulation of cholesterol and fats along the walls of your arteries (a process known as atherosclerosis) decreases blood flow and, therefore, the oxygen supply to your heart, brain, and other parts of your body. Lowering your blood level of cholesterol and fats with atorvastatin has been shown to prevent heart disease, angina (chest pain), strokes, and heart attacks.

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Definitions

Severity Categories

Contraindicated

These drugs, generally, should not be used together simultaneously due to the high risk of severe adverse effects. Combining these medications can lead to dangerous health outcomes and should be strictly avoided unless otherwise instructed by your provider.

Major

This interaction could result in very serious and potentially life-threatening consequences. If you are taking this drug combination, it is very important to be under close medical supervision to minimize severe side effects and ensure your safety. It may be necessary to change a medication or dosage to prevent harm.

Moderate

This interaction has the potential to worsen your medical condition or alter the effectiveness of your treatment. It's important that you are monitored closely and you potentially may need to make adjustments in your treatment plan or drug dosage to maintain optimal health.

Minor

While this interaction is unlikely to cause significant problems, it could intensify side effects or reduce the effectiveness of one or both medications. Monitoring for changes in symptoms and your condition is recommended, and adjustments may be made if needed to manage any increased or more pronounced side effects.

Onset

Rapid: Onset of drug interaction typically occurs within 24 hours of co-administration.

Delayed: Onset of drug interaction typically occurs more than 24 hours after co-administration.

Evidence

Level of documentation of the interaction.

Established: The interaction is documented and substantiated in peer-reviewed medical literature.

Theoretical: This interaction is not fully supported by current medical evidence or well-documented sources, but it is based on known drug mechanisms, drug effects, and other relevant information.

How To Manage The Interaction

Provides a detailed discussion on how patients and clinicians can approach the identified drug interaction as well as offers guidance on what to expect and strategies to potentially mitigate the effects of the interaction. This may include recommendations on adjusting medication dosages, altering the timing of drug administration, or closely monitoring for specific symptoms.

It's important to note that all medical situations are unique, and management approaches should be tailored to individual circumstances. Patients should always consult their healthcare provider for personalized advice and guidance on managing drug interactions effectively.

Mechanism Of Interaction

The theorized or clinically determined reason (i.e., mechanism) why the drug-drug interaction occurs.

Disclaimer: The information provided on this page is for informational purposes only and should not be considered medical advice. Always consult with a qualified healthcare professional regarding your specific circumstances and medical conditions.

Where Does Our Information Come From?

Information for our drug interactions is compiled from several drug compendia, including:

• Gold Standard Drug Database
• Micromedex
• Lexicomp
• DrugBank

The prescribing information for each drug, as published on DailyMED, is also used. 

Individual drug-drug interaction detail pages contain references specific to that interaction. You can click on the reference number within brackets '[]' to see what reference was utilized.

The information posted is fact-checked by HelloPharmacist clinicians and reviewed quarterly.