Respuestas rápidas
- ¿Para qué se usa Fenofibric acid (choline fenofibrate)?
- La etiqueta aprobada por la FDA (Fenofibric acid, Macleods Pharmaceuticals Limited, 3 de julio de 2025) dice, en inglés: “Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. …” Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Cuáles son los efectos secundarios de Fenofibric acid (choline fenofibrate)?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Fenofibric acid, Macleods Pharmaceuticals Limited, 3 de julio de 2025) comienza así, en inglés: «The following serious adverse reactions are described below and elsewhere in the labeling: • Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1)] • Hepatoxicity [see Warnings and Precautions (5.2)] • Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3)] • Increases in Serum Creatinine [see Warnings and Precautions (5.4)] • Cholelithiasis [see Warnings and Precautions (5.5)] • Increased Bleeding Risk with Coumarin Anticoagulants [see …» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Fenofibric acid (choline fenofibrate)?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Fenofibric acid, Macleods Pharmaceuticals Limited, 3 de julio de 2025) comienza así, en inglés: «Table 2 presents clinically important drug interactions with fenofibric acid. Table 2. Clinically Important Drug Interactions with fenofibric acid delayed-release capsules Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Fenofibric acid (choline fenofibrate) tiene una advertencia en recuadro?
- No. Ninguna de las 2 etiquetas de la FDA que encontramos para este medicamento tiene advertencia en recuadro.
- ¿Hay escasez de Fenofibric acid (choline fenofibrate)?
- La FDA no indica una escasez actual para los productos de este medicamento (datos de la FDA del 30 de octubre de 2026).
- ¿Se ha retirado del mercado Fenofibric acid (choline fenofibrate)?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Fenofibric acid (choline fenofibrate)?
- 2 empresas tienen productos con receta de Fenofibric acid (choline fenofibrate) en el directorio NDC de la FDA, entre ellas Lupin Pharmaceuticals, Inc. y Macleods Pharmaceuticals Limited.
Para qué se usa Fenofibric acid (choline fenofibrate)
Cita de la sección «Indications and Usage» (indicaciones y uso) de la etiqueta aprobada por la FDA. Se muestra en inglés, tal como la publica la FDA.
Fenofibric acid delayed-release capsules is indicated as adjunctive therapy to diet: • to reduce triglyceride (TG) levels in adults with severe hypertriglyceridemia (TG greater than or equal to 500 mg/dL). • to reduce elevated low-density lipoprotein cholesterol (LDL-C) in adults with primary hyperlipidemia when use of recommended LDL-C lowering therapy is not possible. …
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (capsule, delayed release, oral), Fenofibric acid, Macleods Pharmaceuticals Limited; abarca 2 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.
La FDA tiene 2 etiquetas para productos de este medicamento (distintos fabricantes y presentaciones); los usos pueden variar. Revise la etiqueta de su propio medicamento.
Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
Enfermedades que menciona la etiqueta
Estos nombres aparecen tal cual en la sección «Indications and Usage» de la etiqueta (según una tabla revisada). Cada página muestra los hospitales cuyos sitios web mencionan la enfermedad.
Especialidades médicas relacionadas
Advertencia en recuadro
La advertencia en recuadro («caja negra») es la advertencia más seria de la FDA en la etiqueta de un medicamento, para riesgos graves o mortales.
La etiqueta citada arriba no tiene advertencia en recuadro.
0 de 2 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Efectos secundarios de Fenofibric acid (choline fenofibrate)
Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.
The following serious adverse reactions are described below and elsewhere in the labeling:
- Mortality and coronary heart disease morbidity [see Warnings and Precautions (5.1)]
- Hepatoxicity [see Warnings and Precautions (5.2)]
- Myopathy and Rhabdomyolysis [see Warnings and Precautions (5.3)]
- Increases in Serum Creatinine [see Warnings and Precautions (5.4)]
- Cholelithiasis [see Warnings and Precautions (5.5)]
- Increased Bleeding Risk with Coumarin Anticoagulants [see …
Tabla de la etiqueta
| Adverse Reaction | Placebo (N =365) | Fenofibrate (N = 439) |
|---|---|---|
| Abnormal Liver Tests | 1% | 8% |
| Abdominal Pain | 4% | 5% |
| Increased ALT | 2% | 3% |
| Increased AST | 1% | 3% |
| Increased Creatine Phosphokinase | 1% | 3% |
| Constipation | 1% | 2% |
| Rhinitis | 1% | 2% |
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Fenofibric acid (choline fenofibrate)
Cita de la sección «Drug Interactions» (interacciones) de la etiqueta aprobada por la FDA. Se muestra en inglés. Dígale a su farmacéutico todos los medicamentos, vitaminas y productos herbales que toma.
Table 2 presents clinically important drug interactions with fenofibric acid. Table 2. Clinically Important Drug Interactions with fenofibric acid delayed-release capsules Statins Clinical Impact: Fibrates may cause myopathy when given alone. The risk of myopathy and rhabdomyolysis is increased with concomitant use of fibrates with statins.
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Intervention: Consider if the benefit of using fenofibric acid concomitantly with statin therapy outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of statin therapy. Colchicine Clinical Impact: Cases of myopathy and rhabdomyolysis have been reported with concomitant use of colchicine with fenofibrates. Intervention: Consider if the benefit of using colchicine concomitantly with fenofibric acid outweighs the increased risk of myopathy and rhabdomyolysis. If concomitant use is decided, monitor patients for signs and symptoms of myopathy, particularly during initiation of therapy and during upward dosage titration of colchicine. Coumarin Anticoagulants Clinical Impact: Fibrates may cause potentiation of coumarin-type anticoagulant effects with prolongation of the PT/INR. Intervention: Caution should be exercised when coumarin anticoagulants are given in conjunction with fenofibric acid. The dosage of the anticoagulants should be reduced to maintain the PT/INR at the desired level to prevent bleeding complications. Frequent PT/INR determinations are advisable until it has been definitely determined that the PT/INR has stabilized Immunosuppressants Clinical Impact: Immunosuppressants such as cyclosporine and tacrolimus can produce nephrotoxicity with decreases in creatinine clearance and rises in serum creatinine, and because renal excretion is the primary elimination route of fibrate drugs including fenofibric acid, there is a risk that an interaction will lead to deterioration of renal function. Intervention: The benefits and risks of using fenofibric acid with immunosuppressants and other potentially nephrotoxic agents should be carefully considered, and the lowest effective dosage employed and renal function monitored. Bile-Acid Binding Resins Clinical Impact: Bile-acid binding resins may bind other drugs given concurrently. Intervention: In patients taking a bile acid resin, administer fenofibric acid at least 1 hour before or 4 to 6 hours after the bile acid resin to avoid impeding its absorption.
- Consider if the benefit of concomitant use of statins or colchicine outweighs the increased risk of myopathy and rhabdomyolysis. Monitor patients for signs and symptoms of myopathy (7).
- Exercise caution in concomitant treatment with coumarin anticoagulants. Reduce the dosage of coumarin to maintain the PT/INR at the desired level to prevent bleeding complications (7).
- Consider the benefits and risks of concomitant use with immunosuppressants and other potentially nephrotoxic agents. Use the lowest effective dosage and monitor renal function (7).
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Fenofibric acid (choline fenofibrate)
Cita de la sección «Dosage and Administration» (dosis y administración) de la etiqueta aprobada por la FDA. Se muestra en inglés. Su dosis es la que le receta su médico: no la cambie por su cuenta.
- Severe hypertriglyceridemia: 45 to 135 mg orally once daily; the dosage should be adjusted according to patient response (2.2).
- Primary hyperlipidemia: 135 mg orally once daily (2.2).
- Administer as a single dose, at any time of day, with or without food (2.2).
- Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibric acid delayed-release capsules.
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Discontinue fenofibric acid delayed-release capsules in patients who do not have an adequate response after 2 months of treatment (2.2).
- Swallow capsules whole. Do not crush, break, dissolve, or chew (2.2).
- Renal impairment: Initial dosage of 45 mg orally once daily (2.3).
- Geriatric patients: Select the dosage on the basis of renal function (2.4). 2.1 Prior to Initiation of Fenofibric Acid Delayed-Release Capsules
- Assess lipid levels before initiating therapy. Identify other causes (e.g., diabetes mellitus, hypothyroidism, or medications) of high TG levels and manage as appropriate.
- Patients should be placed on an appropriate lipid-lowering diet before receiving fenofibric acid delayed-release capsules, and should continue this diet during treatment with fenofibric acid delayed-release capsules.
- In patients with diabetes and fasting chylomicronemia, improve glycemic control prior to considering starting fenofibric acid delayed-release capsules. 2.2 Recommended Dosage and Administration
- Severe hypertriglyceridemia: o The recommended dosage of fenofibric acid delayed-release capsules is 45 mg or 135 mg orally once daily. o Dosage should be individualized according to patient response, and should be adjusted if necessary following repeat lipid determinations at 4 to 8 week intervals.
- Primary hyperlipidemia: o The recommended dosage of fenofibric acid delayed-release capsules is 135 mg orally once daily.
- Administer fenofibric acid delayed-release capsules as a single dose at any time of day, with or without food.
- Advise patients to swallow fenofibric acid delayed-release capsules capsules whole. Do not crush, break, dissolve, or chew capsules.
- Assess TG when clinically appropriate, as early as 4 to 8 weeks after initiating fenofibric acid delayed-release capsules. Discontinue fenofibric acid delayed-release capsules in patients who do not have an adequate response after two months of treatment.
- If a dose is missed, advise patients not to take an extra dose. Resume treatment with the next dose.
- Advise patients to take fenofibric acid delayed-release capsules at least 1 hour before or 4 hours to 6 hours after a bile acid binding resin to avoid impeding its absorption. 2.3 Recommended Dosage in Patients with Renal Impairment
- Assess renal function prior to initiation of fenofibric acid delayed-release capsules and periodically thereafter [see Warnings and Precautions (5.4)].
- Treatment with fenofibric acid delayed-release capsules should be initiated at a dosage of 45 mg orally once daily in patients with mild to moderately impaired renal function (eGFR 30 to <60 mL/min/1.73m 2), and increased only after evaluation of the effects on renal function and TG levels at this dosage.
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Fenofibric acid (choline fenofibrate) en el embarazo
Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.
Risk Summary Limited available data with fenofibrate use in pregnant women are insufficient to determine a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes.
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In animal reproduction studies, no evidence of embryo-fetal toxicity was observed with oral administration of fenofibrate in rats and rabbits during organogenesis at doses less than or comparable to the maximum recommended clinical dosage of 135 mg of fenofibric acid delayed-release capsules daily, based on body surface area (mg/m 2). Adverse reproductive outcomes occurred at higher doses in the presence of maternal toxicity (see Data). Fenofibric acid delayed-release capsules should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Animal Data In pregnant rats given oral dietary doses of 14 mg/kg/day, 127 mg/kg/day, and 361 mg/kg/day from gestation day 6 to 15 during the period of organogenesis, no adverse developmental findings were observed at 14 mg/kg/day (less than the clinical exposure at the maximum recommended human dose [MRHD] of 300 mg fenofibrate daily, comparable to 135 mg fenofibric acid delayed-release capsules daily, based on body surface area comparisons). Increased fetal skeletal malformations were observed at maternally toxic doses (361 mg/kg/day, corresponding to 12 times the clinical exposure at the MRHD) that significantly suppressed maternal body weight gain. In pregnant rabbits given oral gavage doses of 15 mg/kg/day, 150 mg/kg/day, and 300 mg/kg/day from gestation day 6 to 18 during the period of organogenesis and allowed to deliver, no adverse developmental findings were observed at 15 mg/kg/day (a dose that approximates the clinical exposure at the MRHD, based on body surface area comparisons). Aborted litters were observed at maternally toxic doses (≥ 150 mg/kg/day, corresponding to ≥ 10 times the clinical exposure at the MRHD) that suppressed maternal body weight gain. In pregnant rats given oral dietary doses of 15 mg/kg/day, 75 mg/kg/day, and 300 mg/kg/day from gestation day 15 through lactation day 21 (weaning), no adverse developmental effects were observed at 15 mg/kg/day (less than the clinical exposure at the MRHD, based on body surface area comparisons), despite maternal toxicity (decreased weight gain). Post-implantation loss was observed at ≥ 75 mg/kg/day (≥ 2 times the clinical exposure at the MRHD) in the presence of maternal toxicity (decreased weight gain). Decreased pup survival was noted at 300 mg/kg/day (10 times the clinical exposure at the MRHD), which was associated with decreased maternal body weight gain/maternal neglect.
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Fenofibric acid (choline fenofibrate)
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Fenofibric acid delayed-release capsules are contraindicated in patients with:
- Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis [see Clinical Pharmacology (12.3)].
- Active liver disease, including those with unexplained persistent liver function abnormalities [see Warnings and Precautions (5.2)].
- Pre-existing gallbladder disease [see Warnings and Precautions (5.5)].
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- Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules. Serious hypersensitivity reactions including anaphylaxis and angioedema have been reported with fenofibrate [see Warnings and Precautions (5.9)].
- Severe renal impairment, including those with end-stage renal disease (ESRD) and those receiving dialysis (4).
- Active liver disease including those with unexplained persistent liver function abnormalities (4).
- Pre-existing gallbladder disease (4).
- Hypersensitivity to fenofibric acid, fenofibrate, or any of the excipients in fenofibric acid delayed-release capsules (4).
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Leer la etiqueta completa en DailyMed →
Sobredosis de Fenofibric acid (choline fenofibrate)
Cita de la sección «Overdosage» (sobredosis) de la etiqueta aprobada por la FDA. Se muestra en inglés. Si alguien pudo haber tomado demasiado, llame a Poison Help al 1-800-222-1222 (o al 911 en una emergencia).
In the event of an overdose of fenofibric acid, consider contacting the Poison Help line (1-800-222-1222) or a medical toxicologist for additional overdosage management recommendations. There is no specific treatment for overdose with fenofibric acid. General supportive care of the patient is indicated, including monitoring of vital signs and observation of clinical status, should an overdose occur.
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If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. Because fenofibric acid is highly bound to plasma proteins, hemodialysis should not be considered.
— Etiqueta de la FDA: Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Cápsula, de liberación retardada |
|---|---|
| Vía | Oral |
| Productos con receta | 4 en el directorio NDC de la FDA |
Empresas que tienen este medicamento
Empresas en el directorio NDC de la FDA: la empresa que aparece en el envase (fabricante o distribuidor), con su número de productos con receta.
- Lupin Pharmaceuticals, Inc.2 productos
- Macleods Pharmaceuticals Limited2 productos
Historial de aprobación de la FDA
- ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
Aprobaciones de genéricos (2)
- ANDA200750Chartwell Rx · 4 de diciembre de 2013
- ANDA207796Macleods Pharms · 8 de febrero de 2024
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
No aparece ningún retiro vinculado a estos productos (por su código NDC) en los informes de la FDA.
Identificadores oficiales
| RxCUI (RxNorm) | 828373, 828379 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | af225492-73b0-49bb-b32f-5399c3c3ec6d |
| Etiquetas de la FDA (SPL) | 2 |
| Solicitudes de la FDA | 2 ANDA |
| Principios activos (FDA) | CHOLINE FENOFIBRATE |
Siguientes pasos
- Encuentre una farmacia cerca de ustedPregunte qué precio le corresponde y si su producto está afectado por un retiro
- Últimos retiros de medicamentos de la FDATodos los medicamentos, los más recientes primero
- Enfermedad de las arterias coronariasEnfermedad que menciona la etiqueta: hospitales que la tratan
- DiabetesEnfermedad que menciona la etiqueta: hospitales que la tratan
- Lupin Pharmaceuticals, Inc.Fabricante o distribuidor
- Macleods Pharmaceuticals LimitedFabricante o distribuidor
- Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español
Fuentes
- Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Fenofibric acid, Macleods Pharmaceuticals Limited, vigente desde el 3 de julio de 2025; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
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