Respuestas rápidas
- ¿Para qué se usa Rilpivirina?
- La etiqueta aprobada por la FDA (Edurant, Janssen Products, LP, 28 de agosto de 2025) dice, en inglés: “EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.. Limitations of Use …” 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 Rilpivirina?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Edurant, Janssen Products, LP, 28 de agosto de 2025) comienza así, en inglés: «The following adverse reactions are discussed below and in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Depressive Disorders [see Warnings and Precautions (5.3)] The most common adverse reactions to EDURANT or EDURANT PED (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Rilpivirina?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Edurant, Janssen Products, LP, 28 de agosto de 2025) comienza así, en inglés: «Rilpivirine is primarily metabolized by cytochrome P450 (CYP)3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of EDURANT or EDURANT PED and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Rilpivirina tiene una advertencia en recuadro?
- No. Ninguna de las 3 etiquetas de la FDA que encontramos para este medicamento tiene advertencia en recuadro.
- ¿Hay escasez de Rilpivirina?
- 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 Rilpivirina?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Rilpivirina?
- 3 empresas tienen productos con receta de Rilpivirina en el directorio NDC de la FDA, entre ellas Janssen Products, LP, Somerset Therapeutics, LLC y Laurus Labs Limited.
Para qué se usa Rilpivirina
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.
EDURANT and EDURANT PED are a human immunodeficiency virus type 1 (HIV-1) specific, non-nucleoside reverse transcriptase inhibitor (NNRTI) indicated in combination with other antiretroviral agents for the treatment of HIV-1 infection in treatment-naïve patients 2 years of age and older and weighing at least 14 kg with HIV-1 RNA less than or equal to 100,000 copies/mL.. Limitations of Use …
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, for suspension, oral), Edurant, Janssen Products, LP; 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 3 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.
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 3 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Efectos secundarios de Rilpivirina
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 adverse reactions are discussed below and in other sections of the labeling: Skin and Hypersensitivity Reactions [see Warnings and Precautions (5.1)] Hepatotoxicity [see Warnings and Precautions (5.2)] Depressive Disorders [see Warnings and Precautions (5.3)] The most common adverse reactions to EDURANT or EDURANT PED (incidence >2%) of at least moderate to severe intensity (≥ Grade 2) were depressive disorders, headache, insomnia and rash.
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(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Janssen Products, LP at 1-800-526-7736 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. Clinical Trials Experience in Adults The safety assessment is based on the Week 96 pooled data from 1368 patients in the Phase 3 controlled trials TMC278-C209 (ECHO) and TMC278-C215 (THRIVE) in antiretroviral treatment-naïve HIV-1 infected adult patients, 686 of whom received EDURANT (25 mg once daily) [see Clinical Studies (14.1)]. The median duration of exposure for patients in the EDURANT arm and efavirenz arm was 104.3 and 104.1 weeks, respectively. Most adverse reactions occurred in the first 48 weeks of treatment. The proportion of subjects who discontinued treatment with EDURANT or efavirenz due to adverse reaction, regardless of severity, was 2% and 4%, respectively. The most common adverse reactions leading to discontinuation were psychiatric disorders: 10 (1%) subjects in the EDURANT arm and 11 (2%) subjects in the efavirenz arm. Rash led to discontinuation in 1 (<1%) subject in the EDURANT arm and 10 (2%) subjects in the efavirenz arm. Common Adverse Reactions Adverse reactions of at least moderate intensity (≥Grade 2) reported in at least 2% of adult subjects are presented in Table 3. Selected laboratory abnormalities are included in Table 4. Table 3: Selected Adverse Reactions of at Least Moderate Intensity Intensities are defined as follows: Moderate (discomfort enough to cause interference with usual activity); Severe (incapacitating with inability to work or do usual activity).
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Rilpivirina
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.
Rilpivirine is primarily metabolized by cytochrome P450 (CYP)3A, and drugs that induce or inhibit CYP3A may thus affect the clearance of rilpivirine. Coadministration of EDURANT or EDURANT PED and drugs that induce CYP3A may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs.
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Coadministration of EDURANT or EDURANT PED and drugs that inhibit CYP3A may result in increased plasma concentrations of rilpivirine. Coadministration of EDURANT or EDURANT PED with drugs that increase gastric pH may result in decreased plasma concentrations of rilpivirine and loss of virologic response and possible resistance to rilpivirine or to the class of NNRTIs. EDURANT or EDURANT PED at the recommended doses are not likely to have a clinically relevant effect on the exposure of drugs metabolized by CYP enzymes. Table 6 shows the established and other potentially significant drug interactions based on which alterations in dose or regimen of EDURANT or EDURANT PED and/or coadministered drug may be recommended. Drugs that are not recommended for coadministration with EDURANT or EDURANT PED are also included in Table 6 [see Dosage and Administration (2), Contraindications (4), and Clinical Pharmacology (12.3)]. Table 6: Established and Other Potentially Significant Drug Interactions: Alterations in Dose or Regimen May Be Recommended Based on Drug Interaction Studies or Predicted Interaction [see Clinical Pharmacology (12.3)] Concomitant Drug Class: Drug Name Effect on Concentration of Rilpivirine or Concomitant Drug Clinical Comment ↑=increase, ↓=decrease, ↔=no change Antacids: antacids (e.g., aluminum or magnesium hydroxide, calcium carbonate) ↔ rilpivirine (antacids taken at least 2 hours before or at least 4 hours after rilpivirine) The combination of EDURANT or EDURANT PED and antacids should be used with caution as coadministration may cause significant decreases in rilpivirine plasma concentrations (increase in gastric pH). Antacids should only be administered either at least 2 hours before or at least 4 hours after EDURANT or EDURANT PED. ↓ rilpivirine (concomitant intake) Anticonvulsants: carbamazepine oxcarbazepine phenobarbital phenytoin ↓ rilpivirine Coadministration is contraindicated with EDURANT or EDURANT PED [see Contraindications (4)]. Antimycobacterials: rifampin rifapentine ↓ rilpivirine Coadministration is contraindicated with EDURANT or EDURANT PED [see Contraindications (4)]. Antimycobacterials: rifabutin The interaction between EDURANT and the drug was evaluated in a clinical study. All other drug-drug interactions shown are predicted. ↓ rilpivirine Concomitant use of EDURANT with rifabutin may cause a decrease in the plasma concentrations of rilpivirine (induction of CYP3A enzymes). Throughout coadministration of EDURANT with rifabutin, the EDURANT dose should be increased from 25 mg once daily to 50 mg once daily. When rifabutin coadministration is stopped, the EDURANT dose should be decreased to 25 mg once daily.
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Rilpivirina
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.
One 25 mg EDURANT tablet taken once daily with a meal for patients weighing at least 25 kg. (2.2) Pediatric patients 2 years of age and older and weighing at least 14 kg to less than 25 kg: Dosage of EDURANT PED is based on body weight. (2.3) EDURANT PED must be dispersed in drinking water and taken with a meal. (2.4) Do not substitute EDURANT tablets and EDURANT PED tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles.
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(2.1, 5.6) See full prescribing information for dosing information when used in combination with cabotegravir. (2.6) For pregnant patients who are already on a stable EDURANT regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) the recommended dosage in adults and pediatric patients weighing more than 25 kg is one 25 mg tablet once daily taken orally with a meal. (2.5, 12.3) Rifabutin coadministration: Take two 25 mg tablets of EDURANT once daily with a meal for the duration of the rifabutin coadministration. (2.7) 2.1 Overview of Different Dosage Forms EDURANT is available in two dosage forms: EDURANT 25 mg film-coated tablets for adults and pediatric patients weighing at least 25 kg. EDURANT PED 2.5 mg tablets for oral suspension should only be given to pediatric patients weighing at least 14 kg to less than 25 kg [see Dosage and Administration (2.3)]. Do not substitute EDURANT tablets and EDURANT PED tablets for oral suspension on a milligram-per-milligram basis due to differing pharmacokinetic profiles. A difference in bioavailability between 1 × 25 mg film-coated tablet and 10 × 2.5 mg tablets for oral suspension was observed; therefore, they are NOT substitutable [see Warnings and Precautions (5.6) and Clinical Pharmacology (12.3)]. Take EDURANT and EDURANT PED once daily with a meal in combination with other antiretrovirals [see Clinical Pharmacology (12.3)]. 2.2 Recommended Dosage in Treatment-Naïve Adult Patients The recommended dosage of EDURANT in adult patients is one 25 mg tablet taken orally once daily with a meal [see Use in Specific Populations (8.1) and Clinical Pharmacology (12.3)]. 2.3 Recommended Dosage in Treatment-Naïve Pediatric Patients 2 Years of Age and Older and Weighing at least 14 kg The recommended dosage of EDURANT and EDURANT PED in pediatric patients 2 years of age and older and weighing at least 14 kg is based on body weight (see Table 1). Both EDURANT and EDURANT PED should be taken orally once daily with a meal [see Use in Specific Populations (8.4) and Clinical Pharmacology (12.3)]. Table 1: Recommended Dosage of EDURANT and EDURANT PED for Pediatric Patients Body Weight (kg) EDURANT 25 mg Tablets EDURANT PED 2.5 mg Tablets for Oral Suspension Total Daily Dose 14 kg to less than 20 kg Not recommended 5 tablets once daily 12.5 mg EDURANT PED once daily 20 kg to less than 25 kg Not recommended 6 tablets once daily 15 mg EDURANT PED once daily Greater than or equal to 25 kg 1 tablet once daily Not recommended 25 mg EDURANT once daily 2.4 Preparation and Administration Instructions for EDURANT PED Only Advise patients or caregivers of patients taking EDURANT PED to refer to the Instructions for Use to properly prepare and take the medication.
Tabla de la etiqueta
| Body Weight (kg) | EDURANT 25 mg Tablets | EDURANT PED 2.5 mg Tablets for Oral Suspension | Total Daily Dose |
|---|---|---|---|
| 14 kg to less than 20 kg | Not recommended | 5 tablets once daily | 12.5 mg EDURANT PED once daily |
| 20 kg to less than 25 kg | Not recommended | 6 tablets once daily | 15 mg EDURANT PED once daily |
| Greater than or equal to 25 kg | 1 tablet once daily | Not recommended | 25 mg EDURANT once daily |
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Rilpivirina 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.
Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to EDURANT during pregnancy. Healthcare providers are encouraged to register patients by calling the Antiretroviral Pregnancy Registry (APR) 1-800-258-4263.
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Risk Summary Available data from the APR show no difference in the overall risk of birth defects for rilpivirine compared with the background rate for major birth defects of 2.7% in the Metropolitan Atlanta Congenital Defects Program (MACDP) reference population (see Data). The rate of miscarriage is not reported in the APR. The estimated background rate of miscarriage in clinically recognized pregnancies in the U.S. general population is 15% to 20%. The background risk for major birth defects and miscarriage for the indicated population is unknown. Methodologic limitations of the APR include the use of MACDP as the external comparator group. The MACDP population is not disease-specific, evaluates women and infants from a limited geographic area, and does not include outcomes for births that occurred at <20 weeks gestation. In a clinical trial, total rilpivirine exposures were generally lower during pregnancy compared to the postpartum period (see Data). In animal reproduction studies, no adverse developmental outcomes were observed when rilpivirine was administered orally at exposures up to 15 (rats) and 70 (rabbits) times the exposure in humans (≥12 years of age and weighing at least 32 kg) at the recommended dose of 25 mg once daily (see Data). Clinical Considerations Dosing During Pregnancy and the Postpartum Period Based on the experience of HIV-1-infected pregnant women who completed a clinical trial through the postpartum period with a rilpivirine-based regimen, no dose adjustments are required for pregnant patients who are already on a stable EDURANT regimen prior to pregnancy and who are virologically suppressed (HIV-1 RNA less than 50 copies per mL) [see Dosage and Administration (2.5)]. Lower exposures of rilpivirine were observed during pregnancy, therefore viral load should be monitored closely [see Clinical Pharmacology (12.3)]. Data Human Data Based on prospective reports to the APR of over 550 exposures to rilpivirine during the first trimester of pregnancy resulting in live births, there was no significant difference between the overall risk of birth defects with rilpivirine compared to the background birth defect rate of 2.7% in the U.S. reference population of the MACDP. The prevalence of birth defects in live births was 1.4% (95% CI: 0.6% to 2.8%) and 1.5% (95% CI: 0.3% to 4.3%) following first and second/third trimester exposure, respectively, to rilpivirine-containing regimens. Rilpivirine in combination with a background regimen was evaluated in a clinical trial of 19 HIV-1 infected pregnant women during the second and third trimesters and postpartum. Each of the women were on a rilpivirine-based regimen at the time of enrollment.
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Rilpivirina
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
EDURANT and EDURANT PED are contraindicated for coadministration with the drugs in Table 2 for which significant decreases in rilpivirine plasma concentrations may occur due to CYP3A enzyme induction or gastric pH increase, which may result in loss of virologic response and possible resistance to EDURANT or EDURANT PED or to the class of NNRTIs [see Drug Interactions (7) and Clinical Pharmacology (12.3)].
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Table 2: Drugs That are Contraindicated with EDURANT and EDURANT PED Drug Class Contraindicated Drugs in Class Clinical Comment Anticonvulsants Carbamazepine Oxcarbazepine Phenobarbital Phenytoin Potential for significant decreases in rilpivirine plasma concentrations due to CYP3A enzyme induction, which may result in loss of virologic response. Antimycobacterials Rifampin Rifapentine Glucocorticoid (systemic) Dexamethasone (more than a single-dose treatment) Herbal Products St. John's wort (Hypericum perforatum) Proton Pump Inhibitors e.g., Esomeprazole Lansoprazole Omeprazole Pantoprazole Rabeprazole Potential for significant decreases in rilpivirine plasma concentrations due to gastric pH increase, which may result in loss of virologic response. Coadministration of EDURANT or EDURANT PED is contraindicated with drugs where significant decreases in rilpivirine plasma concentrations may occur, which may result in loss of virologic response and possible resistance and cross-resistance. (4)
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Leer la etiqueta completa en DailyMed →
Sobredosis de Rilpivirina
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).
There is no specific antidote for overdose with EDURANT or EDURANT PED. Human experience of overdose with EDURANT or EDURANT PED is limited. Treatment of overdose with EDURANT or EDURANT PED consists of general supportive measures including monitoring of vital signs and ECG (QT interval) as well as observation of the clinical status of the patient. It is advisable to contact a poison control center to obtain the latest recommendations for the management of an overdose.
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Since rilpivirine is highly bound to plasma protein, dialysis is unlikely to result in significant removal of the active substance.
— Etiqueta de la FDA: Edurant, Janssen Products, LP, vigente desde el 28 de agosto de 2025. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Tableta, recubierta con película · Tableta, para suspensión |
|---|---|
| Vía | Oral |
| Productos con receta | 4 en el directorio NDC de la FDA |
| Nombres de marca | Edurant Ped, Edurant |
Lo que pagan las farmacias (NADAC)
El Costo Promedio Nacional de Adquisición de Medicamentos (NADAC, por sus siglas en inglés) es el precio promedio que pagaron las farmacias minoristas de los EE. UU. por comprar una unidad de un medicamento (una tableta, un mL o un gramo), según una encuesta mensual de facturas de farmacias de los Centros de Servicios de Medicare y Medicaid (CMS). Los programas estatales de Medicaid lo usan para pagar a las farmacias.
Este no es el precio que usted paga. Lo que usted paga depende de su seguro médico (copago o coseguro), de su farmacia y de los descuentos, y las farmacias también cobran por despachar una receta. Pregunte a su farmacéutico o a su plan de salud cuál será su precio.
| Concentración y forma | Genérico o de marca | Pagan las farmacias |
|---|---|---|
| rilpivirine hydrochloride 25 mg tableta, recubierta con película | De marca: Edurant | $48.00 por tableta |
Lista NADAC del 4 de noviembre de 2026; estos precios rigen desde el 21 de octubre de 2026. Solo se muestra cuando el código NDC de un envase coincide exactamente con la lista NADAC, y solo para esa concentración y forma: no se promedia entre concentraciones. Las concentraciones y formas que no aparecen aquí no tienen precio NADAC.
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.
- Janssen Products, LP2 productos
- Somerset Therapeutics, LLC1 producto
- Laurus Labs Limited1 producto
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
- ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA202022 EDURANT | Janssen Prods | 20 de mayo de 2011 | 18, el último 15 de marzo de 2024 2024: Eficacia · 2024: Eficacia · 2022: Etiquetado |
| NDA219016 EDURANT PED | Janssen Prods | 15 de marzo de 2024 | — |
Aprobaciones de genéricos (2)
- ANDA218798Somerset Theraps LLC · 29 de enero de 2026
- ANDA219788Laurus · 10 de julio de 2026
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) | 1102273, 1102277, 2678244, 2678248 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 03880372-2c68-45c6-a53a-f420c49541d6 |
| Etiquetas de la FDA (SPL) | 3 |
| Solicitudes de la FDA | NDA202022, NDA219016, 2 ANDA |
| Principios activos (FDA) | RILPIVIRINE |
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
- EdurantPágina de marca: productos, fabricante y precio
- Edurant PedPágina de marca: productos, fabricante y precio
- Janssen Products, LPFabricante o distribuidor
- Somerset Therapeutics, LLCFabricante o distribuidor
- Laurus Labs 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) — Edurant, Janssen Products, LP, vigente desde el 28 de agosto 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
- Nombre en español: RxNorm (Biblioteca Nacional de Medicina de EE. UU.) y Wikidata, vinculados por el identificador RxNorm (RxCUI) del principio activo, sin coincidencias aproximadas.
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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