Respuestas rápidas
- ¿Para qué se usa Dabigatran etexilate?
- La etiqueta aprobada por la FDA (Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., 25 de junio de 2025) dice, en inglés: “PRADAXA Capsules is a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days To reduce the risk of recurrence of DVT and PE in adult patients who have been previously …” 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 Dabigatran etexilate?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., 25 de junio de 2025) comienza así, en inglés: «The following clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with PRADAXA were related to bleeding [see Warnings and Precautions (5.2)].» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Dabigatran etexilate?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., 25 de junio de 2025) comienza así, en inglés: «P-gp inducers: Avoid coadministration with PRADAXA (5.5) P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid (7) P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended (7) 7.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)].» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Dabigatran etexilate tiene una advertencia en recuadro?
- Sí. La etiqueta de la FDA de Pradaxa tiene una advertencia en recuadro, la advertencia más seria de la FDA. Léala en la etiqueta completa y pregunte a su farmacéutico.
- ¿Hay escasez de Dabigatran etexilate?
- 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 Dabigatran etexilate?
- Los informes de la FDA indican 9 retiros de productos de este medicamento; el más reciente comenzó el 16 de julio de 2026 (Clase III). Un retiro suele afectar a lotes concretos, no a todos los productos.
- ¿Quién fabrica Dabigatran etexilate?
- 17 empresas tienen productos con receta de Dabigatran etexilate en el directorio NDC de la FDA, entre ellas Boehringer Ingelheim Pharmaceuticals, Inc., A-S Medication Solutions y Novadoz Pharmaceuticals LLC.
Para qué se usa Dabigatran etexilate
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.
PRADAXA Capsules is a direct thrombin inhibitor indicated: To reduce the risk of stroke and systemic embolism in adult patients with non-valvular atrial fibrillation For the treatment of deep venous thrombosis (DVT) and pulmonary embolism (PE) in adult patients who have been treated with a parenteral anticoagulant for 5-10 days To reduce the risk of recurrence of DVT and PE in adult patients who have been previously …
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (capsule, oral), Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc.; abarca 3 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 20 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.
Esta etiqueta tiene una advertencia en recuadro. Leerla en la etiqueta completa →
20 de 20 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Dabigatran etexilate: lo que dice la advertencia en recuadro
Cita de la advertencia en recuadro (Boxed Warning) de la etiqueta aprobada por la FDA. Se muestra en inglés.
WARNING: (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS, and (B) SPINAL/EPIDURAL HEMATOMA See full prescribing information for complete boxed warning (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS: Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events.
Leer más de esta sección
To reduce this risk, consider coverage with another anticoagulant if PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy (2.6, 2.7, 2.8, 5.1). (B) SPINAL/EPIDURAL HEMATOMA: Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis (5.3). Monitor patients frequently for signs and symptoms of neurological impairment and if observed, treat urgently. Consider the benefits and risks before neuraxial intervention in patients who are or who need to be anticoagulated (5.3). (A) PREMATURE DISCONTINUATION OF PRADAXA INCREASES THE RISK OF THROMBOTIC EVENTS Premature discontinuation of any oral anticoagulant, including PRADAXA, increases the risk of thrombotic events. If anticoagulation with PRADAXA is discontinued for a reason other than pathological bleeding or completion of a course of therapy, consider coverage with another anticoagulant [see Dosage and Administration (2.6, 2.7, 2.8) and Warnings and Precautions (5.1)]. (B) SPINAL/EPIDURAL HEMATOMA Epidural or spinal hematomas may occur in patients treated with PRADAXA who are receiving neuraxial anesthesia or undergoing spinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patients for spinal procedures. Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as non-steroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery optimal timing between the administration of PRADAXA and neuraxial procedures is not known [see Warnings and Precautions (5.3)]. Monitor patients frequently for signs and symptoms of neurological impairment. If neurological compromise is noted, urgent treatment is necessary [see Warnings and Precautions (5.3)]. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated [see Warnings and Precautions (5.3)].
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Leer la etiqueta completa en DailyMed →
Efectos secundarios de Dabigatran etexilate
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 clinically significant adverse reactions are described elsewhere in the labeling: Increased Risk of Thrombotic Events after Premature Discontinuation [see Warnings and Precautions (5.1)] Risk of Bleeding [see Warnings and Precautions (5.2)] Spinal/Epidural Anesthesia or Puncture [see Warnings and Precautions (5.3)] Thromboembolic and Bleeding Events in Patients with Prosthetic Heart Valves [see Warnings and Precautions (5.4)] Increased Risk of Thrombosis in Patients with Triple-Positive Antiphospholipid Syndrome [see Warnings and Precautions (5.6)] The most serious adverse reactions reported with PRADAXA were related to bleeding [see Warnings and Precautions (5.2)].
Leer más de esta sección
Most common adverse reactions (> 15%) are gastrointestinal adverse reactions and bleeding (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Boehringer Ingelheim Pharmaceuticals, Inc. at (800) 542-6257 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 reactions 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 practice. Adult Trials Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation The RE-LY (Randomized Evaluation of Long-term Anticoagulant Therapy) study provided safety information on the use of two doses of PRADAXA Capsules and warfarin [see Clinical Studies (14.1)]. The numbers of patients and their exposures are described in Table 2. Limited information is presented on the 110 mg dosing arm because this dose is not approved. Table 2 Summary of Treatment Exposure in RE-LY PRADAXA Capsules 110 mg twice daily PRADAXA Capsules 150 mg twice daily Warfarin Total number treated 5,983 6,059 5,998 Exposure > 12 months 4,936 4,939 5,193 > 24 months 2,387 2,405 2,470 Mean exposure (months) 20.5 20.3 21.3 Total patient-years 10,242 10,261 10,659 Drug Discontinuation in RE-LY The rates of adverse reactions leading to treatment discontinuation were 21% for PRADAXA Capsules 150 mg and 16% for warfarin. The most frequent adverse reactions leading to discontinuation of PRADAXA Capsules were bleeding and gastrointestinal events (i.e., dyspepsia, nausea, upper abdominal pain, gastrointestinal hemorrhage, and diarrhea). Bleeding [see Warnings and Precautions (5.2)] Table 3 shows the number of adjudicated major bleeding events during the treatment period in the RE-LY study, with the bleeding rate per 100 subject-years (%). Major bleeding is defined as bleeding accompanied by one or more of the following: a decrease in hemoglobin of ≥ 2 g/dL, a transfusion of ≥ 2 units of packed red blood cells, bleeding at a critical site or with a fatal outcome. Intracranial hemorrhage included intracerebral (hemorrhagic stroke), subarachnoid, and subdural bleeds. Table 3 Adjudicated Major Bleeding Events in Treated Patients a Event PRADAXA Capsules 150 mg N = 6,059 n (%/year b) Warfarin N = 5,998 n (%/year b) PRADAXA Capsules 150 mg vs Warfarin HR (95% CI) a Patients during treatment or within 2 days of stopping study treatment. Major bleeding events within each subcategory were counted once per patient, but patients may have contributed events to multiple subcategories. b Annual event rate per 100 pt-years = 100 * number of subjects with event/subject-years.
Tabla de la etiqueta
| PRADAXA Capsules 110 mg twice daily | PRADAXA Capsules 150 mg twice daily | Warfarin | |
|---|---|---|---|
| Total number treated | 5,983 | 6,059 | 5,998 |
| Exposure | |||
| > 12 months | 4,936 | 4,939 | 5,193 |
| > 24 months | 2,387 | 2,405 | 2,470 |
| Mean exposure (months) | 20.5 | 20.3 | 21.3 |
| Total patient-years | 10,242 | 10,261 | 10,659 |
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Dabigatran etexilate
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.
P-gp inducers: Avoid coadministration with PRADAXA (5.5) P-gp inhibitors in adult patients with CrCl 30-50 mL/min: Reduce dosage or avoid (7) P-gp inhibitors in adult patients with CrCl < 30 mL/min: Not recommended (7) 7.1 Reduction of Risk of Stroke and Systemic Embolism in Non-valvular Atrial Fibrillation in Adult Patients The concomitant use of PRADAXA with P-gp inducers (e.g., rifampin) reduces exposure to dabigatran and should generally be avoided [see Clinical Pharmacology (12.3)].
Leer más de esta sección
P-gp inhibition and impaired renal function are the major independent factors that result in increased exposure to dabigatran [see Clinical Pharmacology (12.3)]. Concomitant use of P-gp inhibitors in patients with renal impairment is expected to produce increased exposure of dabigatran compared to that seen with either factor alone. In patients with moderate renal impairment (CrCl 30-50 mL/min), reduce the dosage of PRADAXA to 75 mg twice daily when administered concomitantly with the P-gp inhibitors dronedarone or systemic ketoconazole. The use of the P-gp inhibitors verapamil, amiodarone, quinidine, clarithromycin, and ticagrelor does not require a dosage adjustment of PRADAXA. These results should not be extrapolated to other P-gp inhibitors [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]. The concomitant use of PRADAXA and P-gp inhibitors in patients with severe renal impairment (CrCl 15-30 mL/min) should be avoided [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]. 7.2 Treatment and Reduction in the Risk of Recurrence of Deep Venous Thrombosis and Pulmonary Embolism in Adult Patients Avoid use of PRADAXA and P-gp inhibitors in patients with CrCl < 50 mL/min [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]. 7.3 Prophylaxis of Deep Vein Thrombosis and Pulmonary Embolism in Adult Patients Following Hip Replacement Surgery In patients with CrCl ≥ 50 mL/min who have concomitant administration of P-gp inhibitors such as dronedarone or systemic ketoconazole, it may be helpful to separate the timing of administration of PRADAXA and the P-gp inhibitor by several hours. The concomitant use of PRADAXA and P-gp inhibitors in patients with CrCl < 50 mL/min should be avoided [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.2, 12.3)]. 7.4 Treatment and Reduction in Risk of Recurrence of VTE in Pediatric Patients The concomitant use of PRADAXA with P-gp inhibitors has not been studied in pediatric patients but may increase exposure to dabigatran [see Warnings and Precautions (5.5)].
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Leer la etiqueta completa en DailyMed →
Dosis de Dabigatran etexilate
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.
Non-valvular Atrial Fibrillation in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily (2.2) For patients with CrCl 15-30 mL/min: 75 mg orally, twice daily (2.2) Treatment of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily after 5-10 days of parenteral anticoagulation (2.2) Reduction in the Risk of Recurrence of DVT and PE in Adult Patients: For patients with CrCl > 30 mL/min: 150 mg orally, twice daily …
Tabla de la etiqueta
| Indication | Dosage | |
|---|---|---|
| Reduction in Risk of Stroke and Systemic Embolism in Non-valvular AF | CrCl > 30 mL/min: | 150 mg twice daily |
| CrCl 15 to 30 mL/min: | 75 mg twice daily | |
| CrCl < 15 mL/min or on dialysis: | Dosing recommendations cannot be provided | |
| CrCl 30 to 50 mL/min with concomitant use of P-gp inhibitors: | Reduce dosage to 75 mg twice daily if given with P-gp inhibitors dronedarone or systemic ketoconazole. | |
| CrCl < 30 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
| Treatment of DVT and PE | CrCl > 30 mL/min: | 150 mg twice daily |
| Reduction in the Risk of Recurrence of DVT and PE | CrCl ≤ 30 mL/min or on dialysis: | Dosing recommendations cannot be provided |
| CrCl < 50 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration | |
| Prophylaxis of DVT and PE Following Hip Replacement Surgery | CrCl > 30 mL/min: | 110 mg for first day, then 220 mg once daily |
| CrCl ≤ 30 mL/min or on dialysis: | Dosing recommendations cannot be provided | |
| CrCl < 50 mL/min with concomitant use of P-gp inhibitors: | Avoid coadministration |
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dabigatran etexilate 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 The limited available data on PRADAXA use in pregnant women are insufficient to determine drug-associated risks for adverse developmental outcomes. There are risks to the mother associated with untreated venous thromboembolism in pregnancy and a risk of hemorrhage in the mother and fetus associated with the use of anticoagulants (see Clinical Considerations).
Leer más de esta sección
In pregnant rats treated from implantation until weaning, dabigatran increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition at an exposure 2.6 times the human exposure. At a similar exposure, dabigatran decreased the number of implantations when rats were treated prior to mating and up to implantation (gestation Day 6). Dabigatran administered to pregnant rats and rabbits during organogenesis up to exposures 8 and 13 times the human exposure, respectively, did not induce major malformations. However, the incidence of delayed or irregular ossification of fetal skull bones and vertebrae was increased in the rat (see Data). The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2%-4% and 15%-20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Pregnancy confers an increased risk for thromboembolism that is higher for women with underlying thromboembolic disease and certain high-risk pregnancy conditions. Published data describe that women with a previous history of venous thrombosis are at high risk for recurrence during pregnancy. Fetal/Neonatal adverse reaction Use of anticoagulants, including PRADAXA, may increase the risk of bleeding in the fetus and neonate. Monitor neonates for bleeding [see Warnings and Precautions (5.2)]. Labor or delivery All patients receiving anticoagulants, including pregnant women, are at risk for bleeding. PRADAXA use during labor or delivery in women who are receiving neuraxial anesthesia may result in epidural or spinal hematomas. Consider discontinuation or use of shorter acting anticoagulant as delivery approaches [see Warnings and Precautions (5.2, 5.3)]. Data Animal Data Dabigatran has been shown to decrease the number of implantations when male and female rats were treated at a dosage of 70 mg/kg (about 2.6 to 3.0 times the human exposure at MRHD of 300 mg/day based on area under the curve [AUC] comparisons) prior to mating and up to implantation (gestation Day 6). Treatment of pregnant rats after implantation with dabigatran at the same dose increased the number of dead offspring and caused excess vaginal/uterine bleeding close to parturition.
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Dabigatran etexilate
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
PRADAXA is contraindicated in patients with: Active pathological bleeding [see Warnings and Precautions (5.2) and Adverse Reactions (6.1)] History of a serious hypersensitivity reaction to dabigatran, dabigatran etexilate, or to one of the excipients of the product (e.g., anaphylactic reaction or anaphylactic shock) [see Adverse Reactions (6.1)] Mechanical prosthetic heart valve [see Warnings and Precautions (5.4)] Active pathological bleeding (4) History of serious hypersensitivity reaction to PRADAXA (4) Mechanical prosthetic heart valve (4)
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Leer la etiqueta completa en DailyMed →
Sobredosis de Dabigatran etexilate
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).
Accidental overdose may lead to hemorrhagic complications. In the event of hemorrhagic complications, initiate appropriate clinical support, discontinue treatment with PRADAXA, and investigate the source of bleeding. A specific reversal agent (idarucizumab) is available for adult patients. Dabigatran is primarily eliminated by the kidneys with a low plasma protein binding of approximately 35%.
Leer más de esta sección
Hemodialysis can remove dabigatran; however, data supporting this approach are limited. Using a high-flux dialyzer, blood flow rate of 200 mL/min, and dialysate flow rate of 700 mL/min, approximately 49% of total dabigatran can be cleared from plasma over 4 hours. At the same dialysate flow rate, approximately 57% can be cleared using a dialyzer blood flow rate of 300 mL/min, with no appreciable increase in clearance observed at higher blood flow rates. Upon cessation of hemodialysis, a redistribution effect of approximately 7% to 15% is seen. The effect of dialysis on dabigatran's plasma concentration would be expected to vary based on patient specific characteristics. Measurement of aPTT or ECT may help guide therapy [see Warnings and Precautions (5.2) and Clinical Pharmacology (12.2)].
— Etiqueta de la FDA: Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio de 2025. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Cápsula · Capsule, coated pellets · Pellet |
|---|---|
| Vía | Oral |
| Productos con receta | 51 en el directorio NDC de la FDA |
| Nombres de marca | Pradaxa |
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 |
|---|---|---|
| dabigatran etexilate mesylate 110 mg cápsula | Genérico | $0.8961 por cápsula |
| dabigatran etexilate mesylate 110 mg cápsula | De marca: Pradaxa | $3.17 por cápsula |
| dabigatran etexilate mesylate 110 mg capsule, coated pellets | Genérico | $0.8961 por cápsula |
| dabigatran etexilate mesylate 150 mg cápsula | Genérico | $0.8005 por cápsula |
| dabigatran etexilate mesylate 150 mg cápsula | De marca: Pradaxa | $3.16 por cápsula |
| dabigatran etexilate mesylate 150 mg capsule, coated pellets | Genérico | $0.8005 por cápsula |
| dabigatran etexilate mesylate 75 mg cápsula | Genérico | $0.7152 por cápsula |
| dabigatran etexilate mesylate 75 mg cápsula | De marca: Pradaxa | $3.17 por cápsula |
| dabigatran etexilate mesylate 75 mg capsule, coated pellets | Genérico | $0.7152 por cápsula |
Lista NADAC del 4 de noviembre de 2026; estos precios rigen desde entre el 22 de julio de 2026 y 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.
- Boehringer Ingelheim Pharmaceuticals, Inc.9 productos
- A-S Medication Solutions5 productos
- Novadoz Pharmaceuticals LLC3 productos
- Major Pharmaceuticals3 productos
- Alembic Pharmaceuticals Inc.3 productos
- Alembic Pharmaceuticals Limited3 productos
- Ascend Laboratories, LLC3 productos
- Camber Pharmaceuticals, Inc.3 productos
- Dr.Reddys Laboratories Inc3 productos
- Apotex Corp.3 productos
- Aurobindo Pharma Limited3 productos
- XLCare Pharmaceuticals, Inc.2 productos
- American Health Packaging2 productos
- AvKARE2 productos
- Mylan Pharmaceuticals Inc.2 productos
- AvPAK1 producto
- NorthStar RxLLC1 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 |
|---|---|---|---|
| NDA022512 PRADAXA | Boehringer Ingelheim | 19 de octubre de 2010 | 31, el último 17 de junio de 2025 2025: Etiquetado · 2023: Etiquetado · 2021: Eficacia |
| NDA214358 PRADAXA | Boehringer Ingelheim | 21 de junio de 2021 | 4, el último 17 de junio de 2025 2025: Etiquetado · 2023: Etiquetado · 2022: Etiquetado |
Aprobaciones de genéricos (8)
- ANDA208040Alkem Labs Ltd · 11 de marzo de 2020
- ANDA207961Hetero Labs Ltd III · 6 de mayo de 2020
- ANDA208070Apotex · 15 de diciembre de 2023
- ANDA213879Msn · 22 de mayo de 2024
- ANDA215233Alembic · 14 de junio de 2024
- ANDA208048DR Reddys · 28 de enero de 2025
- ANDA208067Mylan · 3 de febrero de 2025
- ANDA208039Aurobindo Pharma · 14 de mayo de 2025
Escasez
La lista de escasez de la FDA no incluye estos productos.
Retiros del mercado
De los informes de la FDA, vinculados por el código NDC del producto. Un retiro suele afectar solo a lotes concretos: revise el número de lote del envase y pregunte a su farmacéutico. No deje un medicamento por su cuenta.
-
16 de julio de 2026 · Clase III · En curso · D-0737-2026
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN — Ascend Laboratories, LLC
-
16 de julio de 2026 · Clase III · En curso · D-0738-2026
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 46 — Ascend Laboratories, LLC
-
16 de julio de 2026 · Clase III · En curso · D-0739-2026
Failed impurity/degradation specification: an OOS result observed in Related substance test analysis w.r.t Impurity II, Impurity III and Total impurities for 12-month stability
Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further packaged in a carton, Rx only, Manufactured by: Alkem Laboratories Ltd., Mumbai, INDIA, Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN 4 — Ascend Laboratories, LLC
-
30 de junio de 2026 · Clase III · En curso · D-0735-2026
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7254-68. — Ascend Laboratories, LLC
-
30 de junio de 2026 · Clase III · En curso · D-0736-2026
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manufactured by: Alkem Laboratories, Mumbai, INDIA, Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-7255-10. — Ascend Laboratories, LLC
-
12 de diciembre de 2024 · Clase II · En curso · D-0129-2025
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60 — Ascend Laboratories, LLC
-
12 de diciembre de 2024 · Clase II · En curso · D-0130-2025
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60 — Ascend Laboratories, LLC
-
14 de marzo de 2023 · Clase II · En curso · D-0533-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60. — Ascend Laboratories, LLC
-
14 de marzo de 2023 · Clase II · En curso · D-0534-2023
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60. — Ascend Laboratories, LLC
¿Qué significan las clases de retiro?
Clase I: El tipo más grave: existe una probabilidad razonable de que usar el producto cause problemas de salud graves o la muerte.
Clase II: Usar el producto puede causar problemas de salud temporales o reversibles con tratamiento, o la probabilidad de problemas graves es remota.
Clase III: No es probable que usar el producto cause problemas de salud (por ejemplo, un problema de etiquetado o de envase).
Identificadores oficiales
| RxCUI (RxNorm) | 1037045, 1037049, 1037179, 1037181, 1723476, 1723478, 2590616, 2590619, 2590620, 2590621 … (+8) |
|---|---|
| ID (SPL set ID) de la etiqueta citada | ba74e3cd-b06f-4145-b284-5fd6b84ff3c9 |
| Etiquetas de la FDA (SPL) | 20 |
| Solicitudes de la FDA | NDA022512, NDA214358, 8 ANDA |
| Principios activos (FDA) | DABIGATRAN ETEXILATE |
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
- PradaxaPágina de marca: productos, fabricante y precio
- Fibrilación auricularEnfermedad que menciona la etiqueta: hospitales que la tratan
- Trombosis venosa profundaEnfermedad que menciona la etiqueta: hospitales que la tratan
- Accidente cerebrovascularEnfermedad que menciona la etiqueta: hospitales que la tratan
- Boehringer Ingelheim Pharmaceuticals, Inc.Fabricante o distribuidor
- A-S Medication SolutionsFabricante o distribuidor
- Novadoz Pharmaceuticals LLCFabricante 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) — Pradaxa, Boehringer Ingelheim Pharmaceuticals Inc., vigente desde el 25 de junio 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 →
Informar un error → · Información para fabricantes de medicamentos