Antara

Quick links to important sections

Medically reviewed

Rosario Oropesa

Last updated on 22/12/2025

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 Antara

Quick Facts

Property Description
Active ingredient Fenofibrate (Prodrug)
Form Oral Capsule
Pharmacological class Fibric acid derivative (Fibrate)
General purpose Lipid modification (lower high triglycerides)
Origin Synthetic Propanoic Acid Derivative

What Type of Medicine is Antara? (Classification and Identity)

Antara is a prescription-only medication classified as an antilipemic agent used to manage severely abnormal levels of fats, or lipids, in the blood. Its core active chemical substance is Fenofibrate, which places it within the pharmacological classification of fibric acid derivatives (Fibrates). Fibrates are a class of medications used for their lipid-modifying properties. This medication is primarily aimed at balancing the fat profile in the bloodstream and is indicated for use in patients requiring substantial reduction of triglyceride levels.

Fenofibrate functions as a Peroxisome Proliferator-Activated Receptor alpha (PPAR α) Agonist, which distinguishes its role from other cholesterol-lowering agents, such as statins. Its action is centered on reducing the concentration of triglyceride-rich particles. This mechanism highlights the drug’s specialized role in improving the profile of circulating blood fats, specifically in the management of high plasma triglycerides often associated with mixed dyslipidemia.


Fenofibrate: Composition, Form, and Origin

The active component, Fenofibrate, is a synthetic compound derived chemically as a propanoic acid derivative. It is supplied for use as an oral capsule and is a single-ingredient product. Crucially, Fenofibrate is categorized as a prodrug, meaning it requires metabolism in the body to become its active chemical form, Fenofibric acid.

The formulation of the oral dosage form is designed to facilitate consistent systemic delivery. Antara utilizes a specific capsule formulation to support the dissolution and absorption of the active ingredient. The conversion of the drug into Fenofibric acid within the body allows for the engagement of the necessary biological receptors, which is fundamental to the medicine's purpose of correcting lipid imbalances.

Regulatory References

  1. Fenofibrate: MedlinePlus Drug Information

What side effects are possible with Antara?

Possible Side Effects and Safety Information

The officially documented safety profile for Antara (fenofibrate) is organized by regulatory authorities, such as the FDA and EMA, into specific categories of adverse reactions and population-specific restrictions.


Frequency-Classified Adverse Reactions

The most frequent adverse reactions, classified as Common in regulatory documents, typically involve the Gastrointestinal System, including symptoms like abdominal pain, nausea, and flatulence. Elevations in liver enzymes (transaminases) are also common. Uncommon reactions may include thromboembolism, pancreatitis, cholelithiasis (gallstones), and muscle-related disorders such as myalgia.


Serious Adverse Reactions and Safety Constraints

The prescribing information highlights the potential for Serious Adverse Reactions, including Hepatotoxicity (severe liver injury), Myopathy and Rhabdomyolysis (severe muscle breakdown), and Pancreatitis.

Antara is subject to Absolute Contraindications as defined by regulatory bodies. It must not be used in individuals with Severe Renal Impairment, Active Liver Disease, or pre-existing Gallbladder Disease. The risk of muscle toxicity is recognized as being increased in certain groups, such as Geriatric Patients and those with underlying conditions like Hypothyroidism.


Time-Related Safety Patterns

Some documented safety patterns are tied to the duration of exposure. Increases in serum creatinine and liver enzymes (transaminases) are often noted as being transient and may reverse upon discontinuation of the medicine or stabilize during continued administration.

Overdose and Emergency Response

Overdose and when to seek help

The official regulatory documentation states that experience with acute fenofibrate overdose is limited and the clinical presentation is often non-specific. Immediate medical attention is required for any suspected overdose or the manifestation of severe, life-threatening symptoms.

Documented Overdose Manifestations and Risks

The primary risks documented in regulatory labeling involve severe systemic outcomes. These manifestations include rhabdomyolysis (severe muscle breakdown), which can lead to acute renal failure (kidney failure). Signs of severe hepatotoxicity (liver injury) and acute hypersensitivity reactions (such as anaphylaxis) are also critical concerns that warrant emergency care. Individuals with existing renal impairment are noted as having an increased risk for severe muscle toxicity.

Official Emergency Management

No specific antidote is known for fenofibrate overdose. Treatment is strictly limited to general supportive care and continuous monitoring of the patient’s clinical status and vital signs.

Urgent action is mandated:

  • Contact emergency services or a Poison Control Center immediately for severe symptoms, including collapse, difficulty breathing, or the inability to awaken the affected person.
  • Procedures such as emesis (induced vomiting) or gastric lavage may be attempted to remove unabsorbed medication, using appropriate airway precautions.
  • Regulatory constraints explicitly state that hemodialysis is not effective due to the drug's high plasma protein binding.

Therapeutic Uses of Antara

What Antara Treats: Main Uses and Benefits

Antara (fenofibrate) is applied as an adjunctive therapy to a modified diet and exercise plan in contexts involving heightened systemic burden due to fat (lipid) levels. Its primary therapeutic role is to provide support that contributes to easing the overall symptom load during symptomatic phases, a focus directed toward the management of these lipid levels.


Therapeutic Domains and Clinical Scenarios

This medication is commonly used as supportive symptom management for conditions characterized by periods of heightened symptoms. The specific condition categories addressed include severe hypertriglyceridemia, primary hypercholesterolemia, and mixed dyslipidemia. It is relevant in areas where short-term symptom management is appropriate for symptoms related to systemic imbalance.

In clinical settings involving acute or unstable symptom patterns, Antara is used when additional support for symptom management is needed. This action assists with maintaining a sense of stability when symptoms are more noticeable.


Quick Facts

Quick Fact: Support for Systemic Imbalance

Antara may assist patients with coping more steadily during episodes marked by increased physiological tension due to high levels of fats in the blood.

Regulatory References

  1. NIH MedlinePlus overview of Fenofibrate

Eligibility and Restrictions for Use

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

This section defines the populations eligible or restricted from using Antara (fenofibrate) as established in government regulatory documents.

Eligibility Scope

Classification Population/Condition
Allowed Adults with approved indications (severe hypertriglyceridemia, primary hypercholesterolemia, mixed dyslipidemia).
Restricted Use Patients with Mild to Moderate Renal Impairment (requiring monitoring and reduced initial dose).
Not Recommended Pediatric patients (children and adolescents), as safety and efficacy are not established.
Contraindicated Severe Renal Impairment, including dialysis.
Contraindicated Active Liver Disease, including unexplained persistent liver function abnormalities and primary biliary cirrhosis.
Contraindicated Preexisting Gallbladder Disease.
Contraindicated Nursing Mothers (Lactation).
Contraindicated Known Hypersensitivity to fenofibrate, fenofibric acid, or excipients.

Eligibility Summary

Official regulatory documents strictly define who can and cannot use Antara by formalizing contraindications based on compromised metabolic and excretory pathways. Absolute prohibitions are in place for severe renal impairment, active liver disease, and preexisting gallbladder disease. The medication is also explicitly contraindicated for use in nursing mothers. Use in the pediatric population is not established, and older adults' eligibility requires attention to their renal function.

What should I know about interactions with other medicines?

Interactions with other medicines and products

Antara (fenofibrate) has officially documented interaction patterns that influence how it can be administered with other medicinal products and substances. These patterns are defined by regulatory authorities based on pharmacokinetic and pharmacodynamic effects.

Documented Pharmacokinetic and Pharmacodynamic Interactions

Co-administration with HMG-CoA Reductase Inhibitors (Statins) is strongly discouraged due to an officially documented increased risk of myopathy and rhabdomyolysis. This risk is noted to be particularly elevated in elderly patients, and those with renal impairment, diabetes, or hypothyroidism.

Fenofibric acid, the active form of Antara, is classified as a mild-to-moderate inhibitor of the CYP2C9 enzyme. This inhibition can increase the exposure of other medicines that are primarily metabolized by CYP2C9.

Interaction with Coumarin Anticoagulants (e.g., Warfarin) can lead to a potentiated anticoagulant effect, increasing the risk of bleeding. Fenofibric acid is known to displace these compounds from plasma protein binding sites.

Administration with Immunosuppressants (e.g., Cyclosporine) carries a warning of compounding risk that may lead to deterioration of renal function.

Administration Constraints

An official contraindication exists for co-administration with Ketoprofen due to a documented risk of photoallergic reactions.

To prevent interference with absorption, regulatory labeling mandates that Bile Acid Binding Resins (e.g., Cholestyramine) must be separated from fenofibrate by at least 1 hour before or 4 to 6 hours after administration. Furthermore, the absorption of fenofibrate is increased with food.

Mechanism of Action

How Antara Works

Antara’s pharmacodynamic action is driven by its active metabolite, Fenofibric acid, which functions as a high-affinity agonist for the nuclear receptor Peroxisome Proliferator-Activated Receptor alpha ( PPARalpha). The activation of PPARalpha, which is primarily expressed in the liver, initiates significant transcriptional changes influencing lipid metabolism.

This binding directly upregulates the gene expression of the enzyme Lipoprotein Lipase ( LPL) while simultaneously downregulating the synthesis of LPL's endogenous inhibitor, Apolipoprotein C-III ( ApoCIII). The resulting molecular cascade promotes the catabolism of Very-Low-Density Lipoprotein ( VLDL) and other triglyceride-rich particles from the plasma, influencing the kinetics of systemic fat clearance. Furthermore, PPARalpha activation increases ApoA-I production, a key structural component of High-Density Lipoprotein ( HDL), and contributes to the reorganization of lipoprotein profiles and altered physiological characteristics of circulating lipids.

Dosage and Administration Information

Antara (fenofibrate) is administered exclusively as an oral capsule and is taken once daily, aligning with established administration protocols.

Administration Guidelines

Feature Administration Guideline
Route of Administration Oral
Standard Dosing Regimens For primary hyperlipidemia or mixed dyslipidemia, the recommended dose is 130 mg once daily. For severe hypertriglyceridemia, the recommended dose is 43 mg or 130 mg once daily. The maximum dose is 130 mg per day.
Timing in Relation to Meals The capsule can be administered as a single dose with or without food.
Administration Constraints Capsules must be swallowed whole and should not be crushed, broken, dissolved, or chewed.
Dose Adjustment Timeline Dose adjustments, if needed, are generally made at intervals of 4 to 8 weeks following repeat lipid level determinations.
Special Co-Administration Timing If taking a bile acid binding resin (another type of lipid-modifying agent), Antara should be taken at least 1 hour before or 4 to 6 hours after the resin to ensure proper absorption.
Dosing for Mild/Moderate Renal Impairment Treatment in patients with mild to moderately impaired kidney function should be initiated at a lower dose of 43 mg once daily.
Missed Dose Rule Patients are instructed not to take an extra dose if a scheduled dose is missed; treatment should be resumed with the next scheduled dose.

These instructions define a structured usage protocol. The fixed once-daily oral schedule and the ability to take it irrespective of meals simplify the general administration pattern. However, the precise handling requirement (swallow whole) and the necessary time separation from certain other drugs are critical procedural steps for the correct use of the medicine.

Recent Clinical Evidence

Research evidence / Overview of studies for Antara (Fenofibrate)


Evidence for Use in Severe Hypertriglyceridemia

Antara was studied for its effects in people with very high blood fats, a condition often referred to as severe hypertriglyceridemia. Research examined short-term studies, including randomized trials, focusing on how outcomes related to systemic or functional imbalance (triglycerides) changed over defined time intervals. These studies primarily included adults whose triglyceride levels were extremely elevated, often above 500 mg/dL.

Findings describe patterns observed in the studies where lower measured values of triglycerides were reported within the first few months of use. Clinical reports examine the relationship between severely high TG levels and the risk of acute pancreatitis, and the research examined the context of this risk factor. Research highlights what is known, but long-term outcomes are not well characterized for this specific complication.


Evidence for Use in Managing Mixed Dyslipidemia

Antara was evaluated in adults with mixed dyslipidemia or high cholesterol, conditions characterized by fluctuating or episodic manifestations of abnormal blood fat levels. Studies monitored the impact on Total Cholesterol, LDL-C, HDL-C, and triglycerides over months or years.

Research highlights shifts observed during the study period, including measurements consistent with reductions in triglycerides and LDL-C, and increases in HDL-C. However, findings from the largest long-term trials reported that the outcomes related to major adverse cardiovascular events (MACE) for the overall study populations did not show a statistically clear difference when compared to the control groups. Subgroup findings are uncertain, and research results apply only to the specific populations studied.


Evidence for Use in Diabetic Retinopathy

Fenofibrate was studied for outcomes in people with Type 2 Diabetes (T2DM), relevant in trials assessing long-term disease progression. Studies explored the effect on the eye, specifically monitoring changes in the severity of diabetic retinopathy lesions and the need for procedures like retinal laser treatment.

Studies describe how characteristics changed in the observed populations, noting patterns of a slower rate of progression of diabetic retinopathy. Research also describes that trials monitored measurements that included lower instances where patients required retinal laser treatment. The specific way in which these eye outcomes were associated with the intervention is not fully established.


What Remains Uncertain and Areas of Research Gaps

Despite the research, evidence quality varies across studies, and several areas of uncertainty remain. Long-term effects are not fully established regarding cardiovascular outcomes for the broad population. While studies monitored changes in blood fat levels, the measured change in those biomarkers has not been established as a predictor of a change in outcomes related to physiological strain or stress like MACE. Comparative evidence is lacking for many new or combination therapies, and research is ongoing to better understand the role of fenofibrate within diverse patient profiles.

Key Studies & References ACCORD Study Group: Effects of fenofibrate on retinopathy and nephropathy in type 2 diabetes

Frequently Asked Questions (FAQ)

Common questions about Antara (FAQ)

Q: Is Antara generally considered a short-term or long-term medication?

A: Antara is typically used as a long-term treatment for persistent lipid disorders, requiring regular health monitoring. Regulatory documents state that if an adequate response is not measured after two months of treatment, the medication is discontinued.

Q: How does Antara compare to other common treatments for the same condition?

A: Official information indicates that Antara works through a different pathway than statin medications. Regulatory labeling includes a warning for increased risk of serious muscle disorders when these two types of medicines are used together.

Q: Is Antara a generic drug or is it only available as a brand name?

A: The active ingredient in Antara is fenofibrate, which is the generic name for the substance. This means that generic versions of fenofibrate are widely available, in addition to various brand-name products.

Q: How frequently do patients report serious adverse reactions to Antara?

A: Serious adverse reactions, such as severe liver injury (hepatotoxicity) and muscle breakdown (rhabdomyolysis), are documented in the official safety profile. Regulatory labels typically categorize these events as rare or very rare, but the importance of monitoring for symptoms is emphasized in the prescribing information, along with the need for prompt medical evaluation if symptoms occur.

Q: Is there a list of common over-the-counter pain relievers that interact with Antara?

A: Official prescribing information indicates that Antara may increase the levels and effects of non-steroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen. Therefore, use alongside these common pain relievers is noted in the labeling due to the potential for interaction.

Q: Is there information on how Antara is eliminated from the body?

A: Yes, the fate of the medicine in the body is well-documented. The active substance, fenofibric acid, is chemically altered through conjugation with glucuronic acid and is then primarily eliminated from the body through the urine.

Q: Is there a specific maximum time frame recommended for continuous use of Antara?

A: There is no fixed maximum duration for continuous treatment listed in regulatory documents. However, the official guidance describes that the medication is discontinued if it fails to achieve an adequate lipid response after two months.

Q: How does the time of day a person takes Antara affect its impact or side effects?

A: Antara is formulated as a single, once-daily dose. Official administration guidelines indicate that the capsule can be taken at any time of the day, and it can be taken with or without food.

Q: How long does it usually take to notice the initial effects of Antara?

A: Studies show that the stable, therapeutic levels of the active metabolite are reached in the bloodstream within about five days. However, official guidelines advise that treatment effectiveness should be formally assessed and dose adjustments are considered after four to eight weeks.

Q: What is the generally reported rate of treatment success in Antara clinical studies?

A: Clinical studies show measured shifts in blood fat levels, including reductions in triglycerides and increases in HDL-C. However, official reports note that the overall success in reducing serious clinical events, such as major adverse cardiovascular events (MACE), has not been statistically established for the general population studied.

Q: Why might a healthcare professional choose to prescribe Antara over a generic equivalent?

A: Official labeling states that certain brand-name formulations, including Antara, utilize specific technologies like micronization to optimize how the active ingredient is absorbed into the bloodstream. This specific formulation is documented as a difference compared to other fenofibrate products.

Q: Is Antara a controlled substance in the US or other regions?

A: The regulatory classification confirms that fenofibrate is not considered a controlled substance under the U.S. Controlled Substances Act. It is classified as an antilipemic agent.

Q: Can Antara cause changes in body weight (gain or loss)?

A: The adverse reaction profile includes weight gain among the possible side effects that have been reported by users. Official documents specify that the frequency of this particular event is not known.

Q: Is it common for Antara to affect sleep patterns or mood?

A: Adverse reactions affecting the central nervous system have been reported in official documents. These effects include somnolence (drowsiness), dizziness, and headache.

Q: Is hair loss a recognized, though uncommon, side effect of Antara?

A: Yes, alopecia, which is the technical term for hair loss, is listed as a documented, though rare, adverse reaction. Official reports indicate this occurred in a small fraction of patients (between 0.01% to 0.1%) during clinical trials.

Q: What general safety information is available regarding Antara use during pregnancy?

A: Official regulatory information states that data on fenofibrate use during pregnancy is limited and insufficient to determine a specific drug-associated risk. The official label describes that use of the medication is considered only if the potential benefit to the patient is considered to outweigh the potential risk to the fetus.

Q: What are the next generally accepted treatment steps if Antara does not provide the desired effect?

A: The regulatory guidance outlines a specific endpoint for the treatment response. If the medication does not achieve an adequate response after two months of treatment, the regulatory guidance describes that the medication is formally withdrawn.

Q: Why are there warnings about alcohol consumption listed for Antara?

A: Heavy alcohol consumption is documented as increasing the risk of serious side effects, such as liver damage and pancreatitis. Furthermore, excessive alcohol intake can counteract the drug's intended effect by raising triglyceride levels in the blood.

How should Antara be stored and disposed of?

How to Store and Dispose of Antara

Antara (fenofibrate) capsules must be handled according to official regulatory requirements to ensure product integrity and safety.


Storage Conditions

  • Temperature: Store at Controlled Room Temperature between 20 C and 25 C (68 F to 77 F). Excursions are permitted from 15 C to 30 C.
  • Protection: Keep the capsules away from excess heat and moisture.
  • Packaging: Keep the medicine in the container it came in and ensure the container is tightly closed.

Safety and Disposal

  • Child Safety: The medication must be kept out of the sight and reach of children, with safety caps always locked.
  • Disposal: Dispose of unused or expired Antara and all related waste material in accordance with local requirements for pharmaceutical products.

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

Available in countries:

Equivalent of Antara found in:

A-Z Index: