Respuestas rápidas
- ¿Para qué se usa Fluvoxamina?
- La etiqueta aprobada por la FDA (Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., 27 de junio de 2026) dice, en inglés: “Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults. …” 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 Fluvoxamina?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., 27 de junio de 2026) comienza así, en inglés: «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.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Fluvoxamina?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., 27 de junio de 2026) comienza así, en inglés: «Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following: Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19) (7.1). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration (7.2).» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Fluvoxamina tiene una advertencia en recuadro?
- Sí. La etiqueta de la FDA de Fluvoxamine maleate extended-release tiene una advertencia en recuadro («WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS»), la advertencia más seria de la FDA. Léala en la etiqueta completa y pregunte a su farmacéutico.
- ¿Hay escasez de Fluvoxamina?
- 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 Fluvoxamina?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Fluvoxamina?
- 18 empresas tienen productos con receta de Fluvoxamina en el directorio NDC de la FDA, entre ellas Bionpharma Inc., ANI Pharmaceuticals, Inc. y Bryant Ranch Prepack.
Para qué se usa Fluvoxamina
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.
Fluvoxamine maleate extended-release capsules are a selective serotonin reuptake inhibitor (SSRI) indicated for the treatment of obsessive compulsive disorder (OCD). Efficacy was demonstrated in: One 12-week study with fluvoxamine maleate extended-release capsules in adults. …
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (capsule, extended release, oral), Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc.; 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 23 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. Su título: WARNING: SUICIDALITY AND ANTIDEPRESSANT DRUGS
. Leerla en la etiqueta completa →
22 de 23 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.
Fluvoxamina: 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: SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressive disorder (MDD) and other psychiatric disorders. Anyone considering the use of fluvoxamine maleate extended-release capsules or any other antidepressant in a child, adolescent or young adult must balance this risk with the clinical need.
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Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction in risk with antidepressants compared to placebo in adults aged 65 and older. Depression and certain other psychiatric disorders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepressant therapy should be monitored appropriately and observed closely for clinical worsening, suicidality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. (See Warnings and Precautions-Clinical Worsening and Suicide Risk [5.1] and Use in Specific Populations-Pediatric Use [8.4].) WARNING: SUICIDALITY and ANTIDEPRESSANTS See full prescribing information for complete boxed warning. Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants for major depressive disorder and other psychiatric disorders (5.1).
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Leer la etiqueta completa en DailyMed →
Efectos secundarios de Fluvoxamina
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.
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.
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Most common reactions in controlled trials with OCD patients and patients from another studied population (incidence ≥ 5% and at least twice that for placebo) were abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor (6.2). The following additional reactions occurred: anxiety, decreased libido, myalgia, pharyngitis, and vomiting in the OCD population; and dyspepsia, dizziness, insomnia and yawning in another studied population. To report SUSPECTED ADVERSE REACTIONS, contact Zydus Pharmaceuticals (USA) Inc. at 1-877-993-8779 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch 6.1 Clinical Trial Data Sources Fluvoxamine maleate extended-release capsules were studied in one 12-week controlled trial in patients with OCD (N = 124; mean exposure 66.6 days) and in two 12-week controlled trials for another condition (N = 279; mean exposure 59.2 days). Patients in these trials were initiated on 100 mg/day and were titrated in 50 mg increments over the first 6 weeks to within a range of 100 mg to 300 mg/day. The reactions listed in Table 2 show reactions from the two populations separately. Table 3 shows reactions from the three controlled studies combined. 6.2 Adverse Reactions Observed in Controlled Trials Adverse Reactions Associated with Discontinuation of Treatment: Of the 124 patients with OCD and 279 patients in other studies treated with fluvoxamine maleate extended-release capsules in controlled clinical trials, 19% and 26% discontinued treatment due to an adverse reaction. The most common reactions (≥ 1%) associated with discontinuation and considered to be drug related (i.e., those reactions associated with dropout at a rate at least twice that of placebo) were anorexi a (including, but not limited to, loss of appetite and decreased appetite) (1%), anxiety (3%), asthenia (3%), diarrhea (2%), dizziness (4%), headache (2%), insomnia (5%), nausea (7%), nervousness (1%), somnolence (5%) and thinking abnormal (1%). Commonly Observed Adverse Reactions: Fluvoxamine maleate extended-release capsules have been studied in one controlled trial in patients with OCD (N = 124) and two controlled trials for another condition (N = 279). In general, adverse reaction rates were similar in the two data sets as well as in a study of pediatric patients with OCD treated with immediate- release fluvoxamine maleate tablets. The most commonly observed treatment-emergent adverse reactions associated with the use of fluvoxamine maleate extended-release capsules and likely to be drug-related (incidence of 5% or greater and at least twice that for placebo) and derived from Table 2 were: abnormal ejaculation, anorexia, anorgasmia, asthenia, diarrhea, nausea, somnolence, sweating and tremor.
Tabla de la etiqueta
| Fluvoxamine Maleate Extended-Release N = 403 | Placebo N = 400 | |
|---|---|---|
| Abnormal Ejaculation | 11 | 2 |
| Anorgasmia | ||
| Male | 4 | 1 |
| Female | 5 | 0 |
| Impotence | 2 | 2 |
| Libido Decreased | ||
| Male | 8 | 5 |
| Female | 4 | 2 |
| Sexual Function Abnormal | ||
| Male | 3 | 1 |
| Female | 2 | 0 |
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Fluvoxamina
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.
Drug Interactions (not described in Contraindications or Warnings and Precautions) include the following: Drugs Inhibiting or Metabolized by Cytochrome P450: Fluvoxamine inhibits several cytochrome P450 isoenzymes (CYP1A2, CYP2C9, CYP3A4, and CYP2C19) (7.1). Carbamazepine: Elevated carbamazepine levels and symptoms of toxicity with coadministration (7.2).
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Sumatriptan: Rare postmarketing reports of weakness, hyperreflexia, and incoordination following use of an SSRI and sumatriptan. Monitor appropriately if concomitant treatment is clinically warranted (7.2). Tacrine: Coadministration increased tacrine C max and AUC five- and eight-fold and caused nausea, vomiting, sweating, and diarrhea (7.2). Tricyclic Antidepressants (TCAs): Coadministration significantly increased plasma TCA levels. Use caution; monitor plasma TCA levels; reduce TCA dose if indicated (7.2). Tryptophan: Severe vomiting with coadministration (7.2). Diltiazem: Bradycardia with coadministration (7.3). Propranolol or Metoprolol: Reduce dose if coadministered with fluvoxamine and titrate more cautiously (7.3). 7.1 Potential Interactions with Drugs that Inhibit or are Metabolized by Cytochrome P450 Isoenzymes Multiple hepatic cytochrome P450 isoenzymes are involved in the oxidative biotransformation of a large number of structurally different drugs and endogenous compounds. The available knowledge concerning the relationship of fluvoxamine and the cytochrome P450 isoenzyme system has been obtained mostly from pharmacokinetic interaction studies conducted in healthy volunteers, but some preliminary in vitro data are also available. Based on a finding of substantial interactions of fluvoxamine with certain of these drugs (see later parts of this section and also Warnings and Precautions [5] for details) and limited in vitro data for CYP3A4, it appears that fluvoxamine inhibits several cytochrome P450 isoenzymes that are known to be involved in the metabolism of other drugs such as: CYP1A2 (e.g., warfarin, theophylline, propranolol, tizanidine), CYP2C9 (e.g., warfarin), CYP3A4 (e.g., alprazolam), and CYP2C19 (e.g., omeprazole). In vitro data suggest that fluvoxamine is a relatively weak inhibitor of CYP2D6. Approximately 7% of the normal population has a genetic code that leads to reduced levels of activity of CYP2D6 enzyme. Such individuals have been referred to as "poor metabolizers" (PM) of drugs such as debrisoquin, dextromethorphan and tricyclic antidepressants. While none of the drugs studied for drug interactions significantly affected the pharmacokinetics of fluvoxamine, an in vivo study of fluvoxamine single-dose pharmacokinetics in 13 PM subjects demonstrated altered pharmacokinetic properties compared to 16 "extensive metabolizers" (EM): mean C max, AUC, and half-life were increased by 52%, 200% and 62%, respectively, in the PM compared to the EM group. This suggests that fluvoxamine is metabolized, at least in part, by CYP2D6. Caution is indicated in patients known to have reduced levels of cytochrome P450 2D6 activity and those receiving concomitant drugs known to inhibit this cytochrome P450 isoenzyme (e.g., quinidine).
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Fluvoxamina
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.
Adults: Recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum effect, not to exceed 300 mg/day (2.1). Pediatric patients naïve to fluvoxamine maleate: The lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate (2.2). Hepatically impaired: Decreased clearance may require modified dose and titration (2.3).
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Extended treatment: Adjust dose to maintain lowest effective dose; reassess patients periodically (2.4). Discontinuation: Gradual dose reduction is recommended (2.7, see Warnings and Precautions [5.10]). 2.1 OCD (Obsessive Compulsive Disorder) The recommended starting dose is 100 mg at bedtime, with weekly increases of 50 mg as tolerated to maximum therapeutic benefit, not to exceed 300 mg per day. Capsules should not be crushed or chewed. 2.2 Pediatric Patients Naïve to Fluvoxamine Maleate Physicians should consider that the lowest available dose of fluvoxamine maleate extended-release capsules may not be appropriate for pediatric patients naïve to fluvoxamine maleate. 2.3 Dosage for Elderly or Hepatically Impaired Patients Elderly patients and those with hepatic impairment have been observed to have a decreased clearance of fluvoxamine maleate. Consequently, it may be appropriate to titrate slowly following the initial dose of 100 mg in these patient groups. 2.4 Maintenance/Continuation of Extended Treatment Although the efficacy of fluvoxamine maleate extended-release capsules beyond 12 weeks of dosing has not been documented in controlled trials, OCD is a chronic condition, and it is reasonable to consider continuation for a responding patient. The benefit of maintaining patients with OCD on immediate-release fluvoxamine maleate tablets after achieving a response for an average duration of about 4 weeks in a 10-week single-blind phase during which patients were titrated to effect was demonstrated in a controlled trial (see Clinical Studies [14.2]). Dosage adjustments should be made to maintain the patient on the lowest effective dosage, and patients should be periodically reassessed to determine the need for continued treatment. 2.5 Switching a Patient to or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with fluvoxamine maleate extended-release capsules. Conversely, at least 14 days should be allowed after stopping fluvoxamine maleate extended-release capsules before starting an MAOI intended to treat psychiatric disorders (see Contraindications [4.1]). 2.6 Use of Fluvoxamine Maleate Extended-Release Capsules with Other MAOIs such as Linezolid or Methylene Blue Do not start fluvoxamine maleate extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see Contraindications [4.1]).
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Fluvoxamina 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.
Teratogenic Effects – When pregnant rats were given daily doses of fluvoxamine (60 mg/kg, 120 mg/kg or 240 mg/kg) orally throughout the period of organogenesis, developmental toxicity in the form of increased embryofetal death and increased incidences of fetal eye abnormalities (folded retinas) was observed at doses of 120 mg/kg or greater. Decreased fetal body weight was seen at the high dose.
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The no effect dose for developmental toxicity in this study was 60 mg/kg (approximately 2 times the maximum recommended human dose [MRHD] on a mg/m 2 basis). In a study in which pregnant rabbits were administered doses of up to 40 mg/kg (approximately 2 times the MRHD on a mg/m 2 basis) orally during organogenesis, no adverse effects on embryofetal development were observed. In other reproduction studies in which female rats were dosed orally during pregnancy and lactation (5 mg/kg, 20 mg/kg, 80 mg/kg or 160 mg/kg), increased pup mortality at birth was seen at doses of 80 mg/kg or greater and decreases in pup body weight and survival were observed at all doses (low effect dose approximately 0.1 times the MRHD on a mg/m 2 basis). Nonteratogenic Effects: Based on data from published observational studies, exposure to SSRIs, particularly in the month before delivery, has been associated with a less than 2-fold increase in the risk of postpartum hemorrhage [see Warnings and Precautions (5.11) and Clinical Considerations]. Neonates exposed to fluvoxamine maleate tablets and other SSRIs or serotonin and norepinephrine reuptake inhibitors (SNRIs) late in the third trimester have developed complications requiring prolonged hospitalization, respiratory support and tube feeding. Such complications can arise immediately upon delivery. Reported clinical findings have included respiratory distress, cyanosis, apnea, seizures, temperature instability, feeding difficulty, vomiting, hypoglycemia, hypotonia, hypertonia, hyperreflexia, tremor, jitteriness, irritability and constant crying. These features are consistent with either a direct toxic effect of SSRIs or SNRIs or, possibly, a drug discontinuation syndrome. It should be noted that, in some cases, the clinical picture is consistent with serotonin syndrome (see Warnings and Precautions-Serotonin Syndrome [5.2]). Infants exposed to SSRIs in pregnancy may have an increased risk for persistent pulmonary hypertension of the newborn (PPHN). PPHN occurs in 1 to 2 per 1,000 live births in the general population and is associated with substantial neonatal morbidity and mortality. Several recent epidemiologic studies suggest a positive statistical association between SSRI use (fluvoxamine maleate and fluvoxamine maleate extended-release are SSRIs) in pregnancy and PPHN. Other studies do not show a significant statistical association. Physicians should also note the results of a prospective longitudinal study of 201 pregnant women with a history of major depression, who were either on antidepressants or had received antidepressants less than 12 weeks prior to their last menstrual period, and were in remission.
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Fluvoxamina y la lactancia
Cita de la parte sobre lactancia (Nursing Mothers) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Fluvoxamine is secreted in human breast milk. Because of the potential for serious adverse reactions in nursing infants from fluvoxamine maleate extended-release capsules, a decision should be made whether to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother.
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Fluvoxamina
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
Coadministration of thioridazine, tizanidine, pimozide, alosetron, or ramelteon with fluvoxamine maleate extended-release capsules is contraindicated (see Warnings and Precautions [5.4 to 5.8]). Coadministration of thioridazine, tizanidine, pimozide, alosetron or ramelteon (4).
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Serotonin Syndrome and MAOIs: Do not use MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules. Do not use fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start fluvoxamine maleate extended-release capsules in a patient who is being treated with linezolid or intravenous methylene blue (4.1). 4.1 Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with fluvoxamine maleate extended-release capsules or within 14 days of stopping treatment with fluvoxamine maleate extended-release capsules is contraindicated because of an increased risk of serotonin syndrome. The use of fluvoxamine maleate extended-release capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see Dosage and Administration [2.5] and Warnings and Precautions [5.2]). Starting fluvoxamine maleate extended-release capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see Dosage and Administration [2.6] and Warnings and Precautions [5.2]).
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Leer la etiqueta completa en DailyMed →
Sobredosis de Fluvoxamina
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 Experience Exposure to immediate-release fluvoxamine maleate tablets includes over 45,000 patients treated in clinical trials and an estimated exposure of 50,000,000 patients treated during worldwide marketing experience (end of 2005). Of the 539 cases of deliberate or accidental overdose involving fluvoxamine reported from this population, there were 55 deaths.
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Of these, 9 were in patients thought to be taking immediate-release fluvoxamine tablets alone and the remaining 46 were in patients taking fluvoxamine along with other drugs. Among non-fatal overdose cases, 404 patients recovered completely. Five patients experienced adverse sequelae of overdosage, to include persistent mydriasis, unsteady gait, hypoxic encephalopathy, kidney complications (from trauma associated with overdose), bowel infarction requiring a hemicolectomy, and vegetative state. In 13 patients, the outcome was provided as abating at the time of reporting. In the remaining 62 patients, the outcome was unknown. The largest known ingestion of fluvoxamine immediate-release tablets involved 12,000 mg (equivalent to 2 to 3 months' dosage). The patient fully recovered. However, ingestions as low as 1,400 mg have been associated with lethal outcome, indicating considerable prognostic variability. In the controlled clinical trials with 403 patients treated with fluvoxamine maleate extended-release capsules, there was one nonfatal intentional overdose. Commonly (≥ 5%) observed adverse reactions associated with fluvoxamine maleate overdose include gastrointestinal complaints (nausea, vomiting and diarrhea), coma, hypokalemia, hypotension, respiratory difficulties, somnolence and tachycardia. Other notable signs and symptoms seen with immediate-release fluvoxamine maleate overdose (single or multiple drugs) include bradycardia, ECG abnormalities (such as heart arrest, QT interval prolongation, first degree atrioventricular block, bundle branch block and junctional rhythm), convulsions, dizziness, liver function disturbances, tremor and increased reflexes. 10.2 Management of Overdosage Treatment should consist of those general measures employed in the management of overdosage with any antidepressant. Ensure an adequate airway, oxygenation and ventilation. Monitor cardiac rhythm and vital signs. General supportive and symptomatic measures are also recommended. Induction of emesis is not recommended. Gastric lavage with a large-bore orogastric tube with appropriate airway protection, if needed, may be indicated if performed soon after ingestion, or in symptomatic patients. Activated charcoal should be administered. Due to the large volume of distribution of this drug, forced diuresis, dialysis, hemoperfusion, and exchange transfusion are unlikely to be of benefit. No specific antidotes for fluvoxamine are known. A specific caution involves patients taking, or recently having taken, fluvoxamine maleate who might ingest excessive quantities of a tricyclic antidepressant.
— Etiqueta de la FDA: Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Cápsula, de liberación prolongada · Tableta · Tableta, recubierta · Tableta, recubierta con película |
|---|---|
| Vía | Oral |
| Productos con receta | 44 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 |
|---|---|---|
| fluvoxamine maleate 100 mg cápsula, de liberación prolongada | Genérico | $3.66 por cápsula |
| fluvoxamine maleate 100 mg tableta | Genérico | $0.2482 por tableta |
| fluvoxamine maleate 100 mg tableta, recubierta | Genérico | $0.2482 por tableta |
| fluvoxamine maleate 100 mg tableta, recubierta con película | Genérico | $0.2482 por tableta |
| fluvoxamine maleate 150 mg cápsula, de liberación prolongada | Genérico | $3.52 por cápsula |
| fluvoxamine maleate 25 mg tableta | Genérico | $0.1525 por tableta |
| fluvoxamine maleate 25 mg tableta, recubierta | Genérico | $0.1525 por tableta |
| fluvoxamine maleate 25 mg tableta, recubierta con película | Genérico | $0.1525 por tableta |
| fluvoxamine maleate 50 mg tableta | Genérico | $0.1949 por tableta |
| fluvoxamine maleate 50 mg tableta, recubierta | Genérico | $0.1949 por tableta |
| fluvoxamine maleate 50 mg tableta, recubierta con película | Genérico | $0.1949 por tableta |
Lista NADAC del 4 de noviembre de 2026; estos precios rigen desde entre el 21 de octubre de 2026 y el 28 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.
- Bionpharma Inc.7 productos
- ANI Pharmaceuticals, Inc.3 productos
- Bryant Ranch Prepack3 productos
- Apotex Corp.3 productos
- Preferred Pharmaceuticals Inc.3 productos
- Chartwell RX, LLC3 productos
- Remedyrepack Inc.2 productos
- Camber Pharmaceuticals, Inc.2 productos
- A-S Medication Solutions2 productos
- Zydus Pharmaceuticals USA Inc.2 productos
- Upsher-Smith Laboratories, LLC2 productos
- Par Health USA, LLC2 productos
- Zydus Lifesciences Limited2 productos
- Ajanta Pharma USA Inc.2 productos
- Actavis Pharma, Inc.2 productos
- AvKARE2 productos
- PD-Rx Pharmaceuticals, Inc.1 producto
- American Health Packaging1 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 |
|---|---|---|---|
| NDA021519 LUVOX | Ani Pharms | 20 de diciembre de 2007 | 13, el último 18 de agosto de 2023 2023: Etiquetado · 2022: Fabricación (CMC) · 2021: Etiquetado |
Aprobaciones de genéricos (10)
- ANDA075902Apotex · 7 de mayo de 2001
- ANDA075900Chartwell Rx · 23 de febrero de 2006
- ANDA091476Ph Health · 13 de marzo de 2013
- ANDA091482Actavis Elizabeth · 23 de abril de 2013
- ANDA212182Bionpharma · 11 de mayo de 2020
- ANDA217917Bionpharma · 22 de enero de 2024
- ANDA219055Ajanta Pharma Ltd · 17 de octubre de 2024
- ANDA217024Annora Pharma · 30 de julio de 2025
- ANDA220328Appco · 30 de abril de 2026
- ANDA220447Zydus Pharms · 21 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
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
- Trastorno obsesivo-compulsivo (TOC)Enfermedad que menciona la etiqueta: hospitales que la tratan
- Bionpharma Inc.Fabricante o distribuidor
- ANI Pharmaceuticals, Inc.Fabricante o distribuidor
- Bryant Ranch PrepackFabricante 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) — Fluvoxamine maleate extended-release, Zydus Pharmaceuticals USA Inc., vigente desde el 27 de junio de 2026; 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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