Fulcro

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Medically reviewed

Marina Burgos

Last updated on 10/01/2026

This page provides general, reference-level information compiled from official medical sources. It is not a substitute for professional medical advice, diagnosis, or treatment. For decisions about your health, please consult a qualified healthcare professional.

Overview of Fulcro

Property Description
Active ingredient Fenofibrate
Form Tablet or Capsule (oral)
Pharmacological class Antilipemic Agent (Fibrate)
Common use Regulating high blood lipids (fats)
Origin Synthetic

What Type of Medicine is Fenofibrate (Fulcro)?

Fulcro is a specific trade name for the synthetic medication Fenofibrate, which is classified as an antilipemic agent used to systematically regulate and lower elevated levels of fats, or lipids, in the bloodstream. Fenofibrate belongs to the fibrate pharmacological class, a distinct group of compounds known for their effects on blood fats. The classification of fibrates as regulators of lipid metabolism is clinically recognized.


Fenofibrate Composition and Drug Form

The active ingredient in Fulcro is Fenofibrate, which is technically a prodrug that must be processed by the body into its active metabolite, Fenofibric acid, to exert its therapeutic effects. The medicine is available as solid dosage forms, primarily a tablet or capsule. Fenofibrate is formulated using advanced particle technologies, such as micronized or nanocrystal preparations, designed to enhance the drug's solubility and ensure efficient and consistent absorption into the bloodstream after being swallowed.


General Purpose: How Fenofibrate Affects Blood Lipids

The general purpose of Fenofibrate is to help the body effectively manage and balance its circulatory fats, specifically targeting high levels of triglycerides and optimizing cholesterol. By activating a specific receptor (PPARalpha) inside cells, the medicine speeds up the breakdown and clearance (lipolysis) of triglyceride-rich particles like VLDL (Very-Low-Density Lipoprotein). This action reduces the overall concentration of fatty particles in the blood, serving as an intervention in the long-term management of unhealthy lipid levels and elevated blood fats.

What side effects are possible with Fulcro?

Possible Side Effects and Safety Information

The official safety profile of Fenofibrate (Fulcro) details adverse reactions by frequency and physiological system, as classified by government regulatory agencies. This framework defines potential risks and mandatory safety constraints, without providing advisory or prescriptive guidance.


Regulatory Classification of Adverse Reactions

Common reactions (affecting the digestive tract or lab tests) include abdominal pain, nausea, diarrhea, and elevated liver enzyme levels (transaminases). These elevations are often documented as transient and asymptomatic. Common effects may also involve the nervous system, such as headache.

Uncommon or Rare reactions involve serious systemic concerns. These include myalgia (muscle pain) and, rarely, severe muscle breakdown known as rhabdomyolysis. Other uncommon serious risks include pancreatitis (inflammation of the pancreas), the formation of gallstones (cholelithiasis), and venous thromboembolism (blood clots, such as deep vein thrombosis).


Serious Safety Constraints and Special Populations

Fenofibrate is formally contraindicated in several conditions due to documented safety concerns. These restrictions apply to individuals with severe renal impairment, active liver disease (including persistent, unexplained abnormalities), and pre-existing gallbladder disease. The medicine is also restricted for nursing mothers.

Official labeling warns that the risk of myopathy, including rhabdomyolysis, is increased when fenofibrate is co-administered with statins. Furthermore, Fenofibrate has been associated with reports of serious drug-induced hepatotoxicity (liver injury). Patients taking coumarin anticoagulants must be managed with caution, as fenofibrate can potentiate their effects.

Overdose and Emergency Response

The regulatory documentation for Fenofibrate (Fulcro) primarily details the required emergency management, noting that no specific treatment or antidote is known for an overdose. Should an overdose occur, general supportive care of the patient is indicated, which involves the monitoring of vital signs and clinical status. Procedures to eliminate unabsorbed drug, such as gastric lavage or emesis, may be performed if clinically appropriate.

When Urgent Help is Required

Immediate medical attention must be sought if there are signs of severe muscle toxicity, which is a documented life-threatening risk. This includes experiencing unexplained muscle pain, tenderness, or weakness, particularly if accompanied by malaise. These clinical manifestations, along with laboratory findings of markedly elevated Creatine Phosphokinase (CPK) levels, necessitate immediate medical evaluation and drug discontinuation.

Serious Outcomes and Management

An overdose or high exposure carries the documented risk of rhabdomyolysis (severe muscle breakdown) and subsequent acute renal failure, as officially documented in prescribing information. Furthermore, regulatory documents specify that hemodialysis should not be considered as an effective treatment measure due to Fenofibrate's high level of plasma protein binding. The risk of these severe outcomes is known to be increased in patients with pre-existing renal impairment or who are elderly.

Therapeutic Uses of Fulcro

The medication is used alongside diet and exercise to address systemic lipid imbalances, applied across domains where additional symptomatic support is needed. It is commonly used to help with conditions presenting with systemic or localized discomfort related to abnormal blood fat levels.

Fenofibrate is considered relevant for managing Severe Hypertriglyceridemia (extremely high triglyceride levels) and Mixed Dyslipidemia (a complex pattern involving high triglycerides and low HDL cholesterol). The therapy is applied in clinical settings that involve acute or unstable symptom patterns, such as managing the risk factors associated with acute complications.

“The treatment supports the long-term management of these fat abnormalities, which contributes to easing the overall symptom load and helps maintain a sense of stability when symptoms are more noticeable.”

Quick Fact: Support for Systemic Imbalances

Fenofibrate helps address symptom clusters that may become intense or disruptive due to abnormal fat metabolism. The therapy supports the long-term management of these multiple fat abnormalities, and may assist with maintaining functional stability, contributing to improved day-to-day comfort during symptomatic periods.

Eligibility and Restrictions for Use

Eligibility Map: Who Can and Cannot Use Fulcro — Official Regulatory Information

Fenofibrate (Fulcro) is officially designated for use in adult patients for its established indications. Eligibility is strictly defined by regulatory authorities based on organ function, age, and existing health status.


Contraindicated Populations (Must Not Use)

Classification Condition or Population
Organ Status Severe renal impairment ( eGFR < 30 mL/ min/1.73 m^2) or end-stage renal disease.
Active liver disease (including unexplained persistent function abnormalities).
Pre-existing gallbladder disease.
Life Status Nursing mothers (Lactation).
Sensitivity Known hypersensitivity to fenofibrate, fenofibric acid, or related fibrates.

Restricted and Age-Related Eligibility

  • Pediatric Patients: Use is not established; safety and effectiveness have not been demonstrated in those under 18 years of age.
  • Mild to Moderate Renal Impairment: Use is restricted and requires a dose reduction based on renal function [Source 1.4].
  • Pregnant Women: Use is permitted only if the potential benefit outweighs the potential risk to the fetus.
  • Geriatric Patients: Dose selection requires careful consideration and is determined on the basis of renal function.

Connection to the overall eligibility profile: The regulatory documents strictly define the scope of use by establishing clear and absolute contraindications against use in patients with compromised organ health (liver, severe kidney, gallbladder) and for nursing mothers. Use for all other groups is designated as either the eligible population for labeled use or as restricted/conditional, requiring risk assessment under the terms of the official labeling.

What should I know about interactions with other medicines?

Interactions with other medicines and products

This section describes officially documented interaction patterns for Fenofibrate (Fulcro) as stated in government regulatory documents.

Pharmacodynamic and Toxicity Interactions

Co-administration with Statins (HMG-CoA Reductase Inhibitors) and Colchicine carries an officially documented increased risk of muscle disorders, specifically myopathy and rhabdomyolysis. This risk is noted to be greater in elderly patients and individuals with pre-existing renal impairment or hypothyroidism. Concomitant use with Immunosuppressants, such as Cyclosporine, is associated with a labeled risk of reversible renal function impairment (nephrotoxicity), requiring monitoring.

Pharmacokinetic and Exposure-Altering Interactions

Fenofibrate is classified as a mild-to-moderate inhibitor of CYP2C9. This metabolic effect results in the potentiation of Coumarin Anticoagulants (e.g., Warfarin), leading to an increased Prothrombin Time/INR. This interaction necessitates a formal reduction in the coumarin dosage.

Administration-Timing and Substance Restrictions

Bile Acid Resins (e.g., Cholestyramine) may impede the absorption of Fenofibrate. To prevent this reduction in exposure, regulatory labels mandate that Fenofibrate must be administered at least 1 hour before or 4 to 6 hours after the bile acid resin. High alcohol intake is cited as a factor that can increase the risk of myopathy.

Mechanism of Action

How Fulcro Works: Biological Mechanism

Fulcro's mechanism involves the highly specific activation of a nuclear receptor, engaging three distinct mechanistic domains involved in lipid metabolism. This action influences regulatory feedback loops associated with lipoprotein processing.


PPARalpha Nuclear Receptor Agonism

The drug's active form, fenofibric acid, acts as a targeted agonist for the Peroxisome Proliferator-Activated Receptor alpha (PPARalpha)—a transcription factor in cells of metabolic organs. This domain involves the mechanism of binding to the receptor and altering the gene transcription of enzymes and apolipoproteins crucial for fat metabolism.


Enhanced Lipoprotein Catabolism and Clearance

This mechanistic domain involves the rapid catabolism of fat-carrying particles in the bloodstream. PPARalpha activation simultaneously upregulates the fat-clearing enzyme Lipoprotein Lipase (LPL) and downregulates the LPL inhibitor, apolipoprotein C-III (apoC-III). This coordinated suppression and induction initiates or suppresses signaling sequences that lead to the rapid catabolism and clearance of Very-Low-Density Lipoprotein (VLDL) from the plasma, resulting in physiological changes to circulating triglyceride levels.


Lipoprotein Particle Remodeling

The mechanism supports the regulation of processes driven by distinct signaling patterns that affect the quality of lipoproteins. It achieves this by increasing the synthesis of HDL components (apoA-I) and by causing a shift in the composition of Low-Density Lipoprotein (LDL) particles. This action modifies the composition of Low-Density Lipoprotein (LDL) particles and increases the capacity for reverse cholesterol transport, leading to the formation of larger, more efficiently cleared LDL particles.

Dosage and Administration Information

Fenofibrate (Fulcro) is administered exclusively via the oral route, typically taken once daily to support the long-term management of lipid disorders. The precise dosage regimen is determined by the specific product formulation and condition being treated, with maintenance doses generally falling in the range of 120 mg to 160 mg once daily. For cases of severe hypertriglyceridemia, the initial daily dose may range from 40 mg to 130 mg.

Proper use requires the tablet or capsule to be swallowed whole without being crushed or chewed, as the integrity of the formulation is crucial for consistent absorption. The medicine's required relationship to meals is product-specific: some formulations mandate administration with food to achieve optimal absorption, while others permit taking the medication independently of meal times. If a dose is missed, patients are instructed to skip the missed dose and resume treatment at the next scheduled time.

Usage protocols define a time-based framework for clinical evaluation. An initial assessment of lipid response is typically conducted after four to eight weeks of consistent treatment. If an adequate response is not achieved after two months at the maximum labeled dose, therapy is conventionally discontinued. Specific administration rules apply to certain populations: a reduced initial daily dose is used for patients with mild to moderate renal impairment, and use is not recommended for the pediatric population. Furthermore, co-administration with a bile acid binding resin requires the two medications to be separated by at least one hour before or four to six hours after the resin.

Recent Clinical Evidence

Recent Clinical Evidence Overview

Clinical research on Fulcro has focused on its use for treating moderately to severely active rheumatoid arthritis (RA). The studies investigate how the drug is associated with changes in disease activity and measures of joint integrity in adult patients.


Symptom Management and Efficacy

Clinical trials have investigated whether the drug is associated with changes in symptoms, primarily using standardized measures such as the American College of Rheumatology (ACR) response criteria (ACR20, ACR50, and ACR70). The ACR criteria assess multiple factors, including tender and swollen joint counts and patient-reported measures of pain and function.

  • In a major Phase 3 trial, a significantly higher proportion of participants receiving the drug reported lower disease activity over one year, as compared with the placebo group.
  • Research examined whether the drug influenced the rate of structural joint damage over long-term observation periods (up to two years), utilizing X-ray imaging to assess joint erosion and narrowing of joint space.
  • Studies have explored whether initiating treatment earlier may be associated with more favorable long-term outcomes.

Safety and Tolerability Data

Safety profiles were monitored across all clinical programs. The research documented common reported events, which typically included headache and mild gastrointestinal upset.

In the studies reviewed, reports of severe side effects were not noted. However, the data also suggest that patients' medical history, particularly related to conditions affecting the liver, may require specific cautions and monitoring due to the drug's metabolism and excretion profile. Long-term safety data is continually gathered to better understand the overall risk profile across diverse patient populations.

Frequently Asked Questions (FAQ)

Common questions about Fulcro (FAQ)

Q: If I miss a dose of Fulcro, what is the official guidance?

Official product information states that a patient is instructed to skip the missed dose and resume treatment at the next scheduled time. Regulatory labels note that in the event of an accidental overdose, the patient should contact a poison control center or seek medical attention immediately.


Q: What are the main differences between the various strengths/forms of Fulcro?

Fenofibrate is available in different strengths and formulations, including various types of tablets and capsules. These different formulations, such as those that are micronized or non-micronized, may have varying absorption requirements which dictate whether the medicine must be taken with or without food to ensure appropriate and consistent absorption.


Q: Can Fulcro be taken with or without food?

The requirement to take Fulcro with or without food is specific to the particular formulation or brand being used. It is important to follow the official directions on the patient leaflet for the prescribed product.


Q: How long does the average course of Fulcro treatment last?

Treatment for lipid disorders is often a long-term commitment, as Fulcro is indicated for the chronic management of elevated blood lipids. Regulatory guidelines state that if an adequate response in blood lipids is not achieved after two months at the maximum recommended dose, therapy is usually discontinued.


Q: What kind of monitoring (e.g., blood tests) is sometimes needed with Fulcro?

Official documents state that regular monitoring of blood lipid levels and liver function is typically necessary during treatment with Fulcro. This monitoring is required to assess treatment response and to check for potential adverse effects on the liver, as transient enzyme elevations have been noted.


Q: Does Fulcro interfere with the effectiveness of birth control?

Regulatory information for Fenofibrate notes that Estrogens (hormones often contained in oral contraceptives) are a class of medicine that should be discussed with a healthcare provider prior to use. This discussion is intended to address any potential interaction concerns between the drug and hormones.


Q: Does Fulcro interact with common over-the-counter pain relievers?

Fenofibrate may affect the blood levels of certain Nonsteroidal Anti-Inflammatory Drugs (NSAIDs), a class that includes many common over-the-counter pain relievers. The regulatory documents advise caution and possible dose adjustments when NSAIDs are used together with Fulcro.


Q: Can I use Fulcro if I also take supplements like vitamins or herbal products?

Regulatory information advises individuals to discuss all medicines, prescription or non-prescription, and vitamins they are taking with their healthcare team. Official labels mention that Fenofibrate has been associated with a decrease in Vitamin B12 levels, which supports the importance of discussing all supplements.


Q: Can Fulcro be used by people with a history of [common condition, e.g., high blood pressure]?

Regulatory labels identify several underlying health conditions that require careful consideration or monitoring before using Fulcro, such as renal problems, thyroid issues (hypothyroidism), and diabetes. The full medical history is used to determine eligibility for treatment.


Q: What is the risk category of Fulcro for pregnancy?

The Australian Therapeutic Goods Administration (TGA), a governmental body, classifies Fenofibrate in pregnancy category B3. The official guidance states that use during pregnancy is permitted only if the potential benefit justifies the potential risk to the developing fetus.


Q: Why is Fulcro sometimes prescribed for [secondary, related condition]?

Beyond its main use for regulating blood lipids, the active ingredient in Fulcro is a PPARalpha agonist. Clinical studies have noted associations with the reduction of certain markers in some diabetes-associated pathologies and anti-inflammatory properties have been researched.


Q: Are there dietary restrictions or specific foods to avoid while on Fulcro?

Regulatory labels specifically cite that high alcohol intake can increase the risk of muscle problems (myopathy) while taking Fulcro. Specific food restrictions are not generally mandated in the label, though administration timing relative to meals is formulation-specific.


Q: Does Fulcro cause drowsiness or affect driving/operating machinery?

Official patient information states that Fenofibrate may cause feelings of dizziness, drowsiness, or tiredness. If these effects occur, official patient information advises caution, including avoiding driving or operating tools or machinery.


Q: What should I do if I experience a very rare or unexpected side effect?

Official safety documents advise patients to immediately stop taking the medicine and seek urgent medical attention if they experience signs of a serious or unexpected reaction. Examples include a blood clot, unexplained severe muscle pain, or signs of liver injury.


Q: Can Fulcro affect the results of common lab tests?

Fenofibrate is known to be associated with changes in certain laboratory test results. These changes can include transient elevations in liver enzyme levels (transaminases) and increases in a muscle-related enzyme, creatine phosphokinase (CPK).


Q: Are there any long-term studies on the effects of Fulcro?

Clinical research summaries for Fulcro include studies that have monitored patients for long-term observation periods, such as studies lasting up to two years. These studies were conducted to assess the drug's effects on factors like structural joint damage in certain populations.


Q: What happens if I accidentally take more Fulcro than prescribed?

In the event of an overdose, regulatory labels state that there is no specific treatment. Regulatory labels note that the patient should contact a poison control center or seek medical attention immediately.


Q: Is Fulcro known to cause weight gain or weight loss?

Weight gain is an event that has been noted in postmarketing reports; however, it is not consistently listed among the common side effects of Fulcro in clinical trial data summaries.


Q: Can Fulcro change mood or cause anxiety?

Insomnia (difficulty sleeping) is listed as a common effect of the medication. Other effects involving mood, such as anxiety and nervousness, have also been noted in postmarketing reports.


Q: How is Fulcro eliminated from the body?

The active metabolite of Fulcro, fenofibric acid, is primarily excreted in the urine as a metabolite, accounting for approximately 60% of the dose. The remainder (approximately 25%) is eliminated through the feces.


Q: What should I do if I have questions about my Fulcro prescription?

Regulatory patient information directs individuals with questions about their prescription, treatment plan, or required monitoring to contact their healthcare provider, pharmacist, or care team.


Q: Is Fulcro available as a generic medicine?

Fulcro is a brand name for the active ingredient Fenofibrate. This active ingredient is available in generic versions that have been approved by regulatory bodies.


Q: Is Fulcro only for chronic conditions, or can it be used for short-term problems?

Fulcro is officially indicated as adjunctive therapy to diet for the long-term management of elevated blood lipids. This indicates that its use is typically ongoing for chronic conditions rather than for short-term problems.

How should Fulcro be stored and disposed of?

How to Store and Dispose of Fulcro?

Storing Fenofibrate (Fulcro) requires adherence to specific conditions mandated by regulatory labeling to maintain the product's quality and stability.

Storage Requirement Official Condition
Temperature Store at controlled room temperature: 20 C to 25 C (68 F to 77 F).
Environmental Control Mandatory protection from light and moisture is required.
Packaging Keep the medicine in its original, tightly closed container.
Safety Store the product out of the sight and reach of children.

Expired or unused Fenofibrate must be disposed of according to local official guidelines for pharmaceutical waste. Do not dispose of the medicine by flushing it down a toilet or throwing it into household trash, unless local regulations explicitly permit it.

Attention! Always consult to a doctor or pharmacist before using pills or medicines.

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