Respuestas rápidas
- ¿Para qué se usa Tiagabina?
- La etiqueta aprobada por la FDA (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., 30 de septiembre de 2021) dice, en inglés: “Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.” 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 Tiagabina?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., 30 de septiembre de 2021) comienza así, en inglés: «The most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Tiagabina?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., 30 de septiembre de 2021) comienza así, en inglés: «In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Tiagabine HCl is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients).» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Tiagabina 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 Tiagabina?
- La lista de escasez de medicamentos de la FDA indica «Se dejará de fabricar» para un producto de este medicamento (actualizado el 15 de abril de 2026). Pregunte a su farmacéutico por alternativas.
- ¿Se ha retirado del mercado Tiagabina?
- Los informes de la FDA indican 1 retiro de productos de este medicamento; el más reciente comenzó el 10 de julio de 2023 (Clase II). Un retiro suele afectar a lotes concretos, no a todos los productos.
- ¿Quién fabrica Tiagabina?
- 3 empresas tienen productos con receta de Tiagabina en el directorio NDC de la FDA, entre ellas Novadoz Pharmaceuticals LLC, Teva Pharmaceuticals USA, Inc. y Sun Pharmaceutical Industries, Inc.
Para qué se usa Tiagabina
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.
Tiagabine HCl is indicated as adjunctive therapy in adults and children 12 years and older in the treatment of partial seizures.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, film coated, oral), Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc.; abarca 4 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 Tiagabina
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 most commonly observed adverse events in placebo-controlled, parallel-group, add-on epilepsy trials associated with the use of tiagabine HCl in combination with other antiepilepsy drugs not seen at an equivalent frequency among placebo-treated patients were dizziness/light-headedness, asthenia/lack of energy, somnolence, nausea, nervousness/irritability, tremor, abdominal pain, and thinking abnormal/difficulty with concentration or attention.
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Approximately 21% of the 2531 patients who received tiagabine HCl in clinical trials of epilepsy discontinued treatment because of an adverse event. The adverse events most commonly associated with discontinuation were dizziness (1.7%), somnolence (1.6%), depression (1.3%), confusion (1.1%), and asthenia (1.1%). In Studies 1 and 2 (U.S. studies), the double-blind, placebo-controlled, parallel-group, add-on studies, the proportion of patients who discontinued treatment because of adverse events was 11% for the group treated with tiagabine HCl and 6% for the placebo group. The most common adverse events considered the primary reason for discontinuation were confusion (1.2%), somnolence (1.0%), and ataxia (1.0%). Adverse Event Incidence in Controlled Clinical Trials: Table 5 lists treatment-emergent signs and symptoms that occurred in at least 1% of patients treated with tiagabine HCl for epilepsy participating in parallel-group, placebo-controlled trials and were numerically more common in the tiagabine HCl group. In these studies, either tiagabine HCl or placebo was added to the patient’s current antiepilepsy drug therapy. Adverse events were usually mild or moderate in intensity. The prescriber should be aware that these figures, obtained when tiagabine HCl was added to concurrent antiepilepsy drug therapy, cannot be used to predict the frequency of adverse events in the course of usual medical practice when patient characteristics and other factors may differ from those prevailing during clinical studies. Similarly, the cited frequencies cannot be directly compared with figures obtained from other clinical investigations involving different treatments, uses, or investigators. An inspection of these frequencies, however, does provide the prescribing physician with one basis to estimate the relative contribution of drug and non-drug factors to the adverse event incidences in the population studied.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Tiagabina
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.
In evaluating the potential for interactions among co-administered antiepilepsy drugs (AEDs), whether or not an AED induces or does not induce metabolic enzymes is an important consideration. Carbamazepine, phenytoin, primidone, and phenobarbital are generally classified as enzyme inducers; valproate and gabapentin are not. Tiagabine HCl is considered to be a non-enzyme inducing AED (see PRECAUTIONS, General, Use in Non-Induced Patients).
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The drug interaction data described in this section were obtained from studies involving either healthy subjects or patients with epilepsy. Effects of Tiagabine HCl on other Antiepilepsy Drugs (AEDs): Phenytoin: Tiagabine had no effect on the steady-state plasma concentrations of phenytoin in patients with epilepsy. Carbamazepine: Tiagabine had no effect on the steady-state plasma concentrations of carbamazepine or its epoxide metabolite in patients with epilepsy. Valproate: Tiagabine causes a slight decrease (about 10%) in steady-state valproate concentrations. Phenobarbital or Primidone: No formal pharmacokinetic studies have been performed examining the addition of tiagabine to regimens containing phenobarbital or primidone. The addition of tiagabine in a limited number of patients in three well-controlled studies caused no systematic changes in phenobarbital or primidone concentrations when compared to placebo. Effects of other Antiepilepsy Drugs (AEDs) on Tiagabine HCl: Carbamazepine: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking carbamazepine with or without other enzyme-inducing AEDs. Phenytoin: Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenytoin with or without other enzyme-inducing AEDs. Phenobarbital (Primidone): Population pharmacokinetic analyses indicate that tiagabine clearance is 60% greater in patients taking phenobarbital (primidone) with or without other enzyme-inducing AEDs. Valproate: The addition of tiagabine to patients taking valproate chronically had no effect on tiagabine pharmacokinetics, but valproate significantly decreased tiagabine binding in vitro from 96.3 to 94.8%, which resulted in an increase of approximately 40% in the free tiagabine concentration. The clinical relevance of this in vitro finding is unknown. Interaction of Tiagabine HCl with Other Drugs: Cimetidine: Co-administration of cimetidine (800 mg/day) to patients taking tiagabine chronically had no effect on tiagabine pharmacokinetics. Theophylline: A single 10 mg dose of tiagabine did not affect the pharmacokinetics of theophylline at steady state. Warfarin: No significant differences were observed in the steady-state pharmacokinetics of R-warfarin or S-warfarin with the addition of tiagabine given as a single dose. Prothrombin times were not affected by tiagabine. Digoxin: Concomitant administration of tiagabine did not affect the steady-state pharmacokinetics of digoxin or the mean daily trough serum level of digoxin. Ethanol or Triazolam: No significant differences were observed in the pharmacokinetics of triazolam (0.125 mg) and tiagabine (10 mg) when given together as a single dose.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Tiagabina
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.
General: The blood level of tiagabine obtained after a given dose depends on whether the patient also is receiving a drug that induces the metabolism of tiagabine. The presence of an inducer means that the attained blood level will be substantially reduced. Dosing should take the presence of concomitant medications into account. Tiagabine HCl is recommended as adjunctive therapy for the treatment of partial seizures in patients 12 years and older.
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The following dosing recommendations apply to all patients taking tiagabine HCl: Tiagabine HCl is given orally and should be taken with food. Do not use a loading dose of tiagabine HCl. Dose titration: Rapid escalation and/or large dose increments of tiagabine HCl should not be used. Missed dose(s): If the patient forgets to take the prescribed dose of tiagabine HCl at the scheduled time, the patient should not attempt to make up for the missed dose by increasing the next dose. If a patient has missed multiple doses, patient should refer back to his or her physician for possible re-titration as clinically indicated. Dosage adjustment of tiagabine HCl should be considered whenever a change in patient’s enzyme-inducing status occurs as a result of the addition, discontinuation, or dose change of the enzyme-inducing agent. Induced Adults and Adolescents 12 Years or Older: The following dosing recommendations apply to patients who are already taking enzyme-inducing antiepilepsy drugs (AEDs) (e.g., carbamazepine, phenytoin, primidone, and phenobarbital). Such patients are considered induced patients when administering tiagabine HCl. In adolescents 12 to 18 years old, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 mg at the beginning of Week 2. Thereafter, the total daily dose may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or up to 32 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 32 mg/day have been tolerated in a small number of adolescent patients for a relatively short duration. In adults, tiagabine HCl should be initiated at 4 mg once daily. Modification of concomitant antiepilepsy drugs is not necessary, unless clinically indicated. The total daily dose of tiagabine HCl may be increased by 4 to 8 mg at weekly intervals until clinical response is achieved or, up to 56 mg/day. The total daily dose should be given in divided doses two to four times daily. Doses above 56 mg/day have not been systematically evaluated in adequate and well-controlled clinical trials. Experience is limited in patients taking total daily doses above 32 mg/day using twice daily dosing. A typical dosing titration regimen for patients taking enzyme-inducing AEDs (induced patients) is provided in Table 7.
Tabla de la etiqueta
| Initiation and Titration Schedule | Total Daily Dose | |
|---|---|---|
| Week 1 | Initiate at 4 mg once daily | 4 mg/day |
| Week 2 | Increase total daily dose by 4 mg | 8 mg/day (in two divided doses) |
| Week 3 | Increase total daily dose by 4 mg | 12 mg/day(in three divided doses) |
| Week 4 | Increase total daily dose by 4 mg | 16 mg/day(in two to four divided doses) |
| Week 5 | Increase total daily dose by 4 to 8 mg | 20 to 24 mg/day(in two to four divided doses) |
| Week 6 | Increase total daily dose by 4 to 8 mg | 24 to 32 mg/day(in two to four divided doses) |
| Usual Adult Maintenance Dose in Induced Patients: | 32 to 56 mg/day in two to four divided doses |
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Tiagabina 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.
Tiagabine has been shown to have adverse effects on embryo-fetal development, including teratogenic effects, when administered to pregnant rats and rabbits at doses greater than the human therapeutic dose. An increased incidence of malformed fetuses (various craniofacial, appendicular, and visceral defects) and decreased fetal weights were observed following oral administration of 100 mg/kg/day to pregnant rats during the period of organogenesis.
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This dose is approximately 16 times the maximum recommended human dose (MRHD) of 56 mg/day, based on body surface area (mg/m 2). Maternal toxicity (transient weight loss/reduced maternal weight gain during gestation) was associated with this dose, but there is no evidence to suggest that the teratogenic effects were secondary to the maternal effects. No adverse maternal or embryo-fetal effects were seen at a dose of 20 mg/kg/day (3 times the MRHD on a mg/m 2 basis). Decreased maternal weight gain, increased resorption of embryos and increased incidences of fetal variations, but not malformations, were observed when pregnant rabbits were given 25 mg/kg/day (8 times the MRHD on a mg/m 2 basis) during organogenesis. The no effect level for maternal and embryo-fetal toxicity in rabbits was 5 mg/kg/day (equivalent to the MRHD on a mg/m 2 basis). When female rats were given tiagabine 100 mg/kg/day during late gestation and throughout parturition and lactation, decreased maternal weight gain during gestation, an increase in stillbirths, and decreased postnatal offspring viability and growth were found. There are no adequate and well-controlled studies in pregnant women. Tiagabine should be used during pregnancy only if clearly needed. To provide additional information regarding the effects of in utero exposure to tiagabine HCl, physicians are advised to recommend that pregnant patients taking tiagabine HCl enroll in the NAAED Pregnancy Registry. This can be done by calling the toll free number 1-888-233-2334, and must be done by patients themselves. Information on the registry can also be found at the website http://www.aedpregnancyregistry.org/.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Leer la etiqueta completa en DailyMed →
Tiagabina y la lactancia
Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Use in Nursing Mothers: Studies in rats have shown that tiagabine HCl and/or its metabolites are excreted in the milk of that species. Levels of excretion of tiagabine and/or its metabolites in human milk have not been determined and effects on the nursing infant are unknown. Tiagabine HCl should be used in women who are nursing only if the benefits clearly outweigh the risks.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Tiagabina
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Tiagabine HCl is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Leer la etiqueta completa en DailyMed →
Sobredosis de Tiagabina
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).
Human Overdose Experience: Human experience of acute overdose with tiagabine HCl is limited. Eleven patients in clinical trials took single doses of tiagabine HCl up to 800 mg. All patients fully recovered, usually within one day. The most common symptoms reported after overdose included somnolence, impaired consciousness, agitation, confusion, speech difficulty, hostility, depression, weakness, and myoclonus.
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One patient who ingested a single dose of 400 mg experienced generalized tonic-clonic status epilepticus, which responded to intravenous phenobarbital. From post-marketing experience, reports of overdose involving tiagabine HCl alone have included cases in which patients required intubation and ventilatory support as part of the management of their status epilepticus. Overdoses involving multiple drugs, including tiagabine HCl, have resulted in fatal outcomes. Symptoms most often accompanying tiagabine HCl overdose, alone or in combination with other drugs, have included: seizures including status epilepticus in patients with and without underlying seizure disorders, nonconvulsive status epilepticus, respiratory arrest, coma, loss of consciousness, ataxia, dizziness, confusion, somnolence, drowsiness, impaired speech, aggression, agitation, lethargy, myoclonus, spike wave stupor, encephalopathy, amnesia, dyskinesia, tremors, disorientation, psychotic disorder, vomiting, hostility, and temporary paralysis. Respiratory depression was seen in a number of patients, including children, in the context of seizures. Management of Overdose: There is no specific antidote for overdose with tiagabine HCl. If indicated, elimination of unabsorbed drug should be achieved by emesis or gastric lavage; usual precautions should be observed to maintain the airway. General supportive care of the patient is indicated including monitoring of vital signs and observation of clinical status of the patient. Since tiagabine is mostly metabolized by the liver and is highly protein bound, dialysis is unlikely to be beneficial. A Certified Poison Control Center should be consulted for up to date information on the management of overdose with tiagabine HCl.
— Etiqueta de la FDA: Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Tableta, recubierta con película · Tableta |
|---|---|
| Vía | Oral |
| Productos con receta | 10 en el directorio NDC de la FDA |
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 |
|---|---|---|
| tiagabine hydrochloride 12 mg tableta | Genérico | $6.56 por tableta |
| tiagabine hydrochloride 2 mg tableta | Genérico | $2.75 por tableta |
| tiagabine hydrochloride 4 mg tableta | Genérico | $3.06 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.
- Novadoz Pharmaceuticals LLC4 productos
- Teva Pharmaceuticals USA, Inc.4 productos
- Sun Pharmaceutical Industries, Inc.2 productos
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 |
|---|---|---|---|
| NDA020646 GABITRIL | Cephalon | 30 de septiembre de 1997 | 19, el último 3 de marzo de 2023 2023: Etiquetado · 2016: Etiquetado · 2015: Etiquetado |
Aprobaciones de genéricos (2)
- ANDA077555Sun Pharm Inds · 4 de noviembre de 2011
- ANDA214816Msn · 16 de noviembre de 2021
Escasez
Se dejará de fabricar · actualizado el 15 de abril de 2026 · publicado por primera vez el 15 de abril de 2026
| Producto | Tiagabine Hydrochloride, Tablet, 12mg 30 count (NDC 0093-8072-56) |
|---|---|
| Empresa | Teva Pharmaceuticals USA, Inc. |
Pregunte a su farmacéutico si su producto está afectado y qué opciones hay.
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.
-
10 de julio de 2023 · Clase II · Cerrado por la FDA · D-0914-2023
Failed Impurities: Out of Specification (OOS) result observed during Related Substances testing
Tiagabine Hydrochloride Tablets, 2 mg, 30-count bottle, Distributed by Sun Pharmaceutical Industries. Inc. Cranbury NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Halol-Baroda Highway, Halol-389 350, Gu — SUN PHARMACEUTICAL INDUSTRIES INC
¿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) | 1299903, 1299909, 1299911, 1299917 |
|---|---|
| ID (SPL set ID) de la etiqueta citada | 953ef3cc-e3cb-480f-b9ea-256520fd62b8 |
| Etiquetas de la FDA (SPL) | 3 |
| Solicitudes de la FDA | NDA020646, 2 ANDA |
| Principios activos (FDA) | TIAGABINE |
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
- Novadoz Pharmaceuticals LLCFabricante o distribuidor
- Teva Pharmaceuticals USA, Inc.Fabricante o distribuidor
- Sun Pharmaceutical Industries, Inc.Fabricante 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) — Tiagabine Hydrochloride, Teva Pharmaceuticals USA, Inc., vigente desde el 30 de septiembre de 2021; 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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