Bupropion

Para qué se usa Bupropion

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.

Bupropion Hydrobromide Extended-Release Tablets are an aminoketone antidepressant, indicated for the treatment of major depressive disorder (MDD) and seasonal affective disorder (SAD). Periodically reevaluate long-term usefulness for the individual patient. …

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, extended release, oral), Bupropion Hydrobromide, Oceanside Pharmaceuticals; 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 226 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: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS. Leerla en la etiqueta completa →

222 de 226 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Bupropion: 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: SUICIDAL THOUGHTS AND BEHAVIORS SUICIDALITY AND ANTIDEPRESSANT DRUGS Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects aged 65 and older [see Warnings and Precautions (5.1)].

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In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [see Warnings and Precautions (5.1)]. WARNING: SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed warning.

• Increased risk of suicidal thinking and behavior in children, adolescents, and young adults taking antidepressants. Monitor for worsening and emergence of suicidal thoughts and behaviors. (5.1)

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Bupropion

Cita de la sección «Adverse Reactions» (reacciones adversas) de la etiqueta aprobada por la FDA. Se muestra en inglés. Avise a su médico de cualquier efecto secundario que le preocupe.

The following adverse reactions are discussed in greater detail in other sections of the labeling:

• Suicidal thoughts and behaviors in children, adolescents, and young adults [see Warnings and Precautions (5.1)]
• Neuropsychiatric adverse events and suicide risk in smoking cessation treatment [see Warnings and Precautions (5.2)]
• Seizure [see Warnings and Precautions (5.3)]
• Hypertension [see Warnings and Precautions (5.4)]
• Activation of mania or hypomania [see Warnings …

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Bupropion

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.

• CYP2B6 inducers: Dose increase may be necessary if coadministered with CYP2B6 inducers (e.g., ritonavir, lopinavir, efavirenz, carbamazepine, phenobarbital, phenytoin) based on clinical exposure, but should not exceed the maximum dose.

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(7.1)

• Drugs metabolized by CYP2D6: Bupropion inhibits CYP2D6 and can increase concentrations of: antidepressants (e.g., venlafaxine, nortriptyline, imipramine, desipramine, paroxetine, fluoxetine, sertraline), antipsychotics (e.g., haloperidol, risperidone, thioridazine), beta-blockers (e.g., metoprolol), and Type 1C antiarrhythmics (e.g., propafenone, flecainide). Consider dose reduction when using with bupropion. (7.2)
• Drugs that lower seizure threshold: Dose bupropion hydrobromide extended-release tablets with caution. (5.3, 7.3)
• Dopaminergic Drugs (levodopa and amantadine): CNS toxicity can occur when used concomitantly with bupropion hydrobromide extended-release tablets. (7.4)
• MAOIs: Increased risk of hypertensive reactions can occur when used concomitantly with bupropion hydrobromide extended-release tablets. (7.6)
• Drug-laboratory test interactions: Bupropion Hydrobromide Extended-Release Tablets can cause false-positive urine test results for amphetamines. (7.7) 7.1 Potential for Other Drugs to Affect Bupropion Hydrobromide Extended-Release Tablets Bupropion is primarily metabolized to hydroxybupropion by CYP2B6. Therefore, the potential exists for drug interactions between bupropion hydrobromide extended-release tablets and drugs that are inhibitors or inducers of CYP2B6. Inhibitors of CYP2B6 Ticlopidine and Clopidogrel: Concomitant treatment with these drugs can increase bupropion exposures but decrease hydroxybupropion exposure. Based on clinical response, dosage adjustment of bupropion hydrobromide extended-release tablets may be necessary when coadministered with CYP2B6 inhibitors (e.g., ticlopidine or clopidogrel) [see Clinical Pharmacology (12.3)]. Inducers of CYP2B6 Ritonavir, Lopinavir, and Efavirenz: Concomitant treatment with these drugs can decrease bupropion and hydroxybupropion exposure. Dosage increase of bupropion hydrobromide extended-release tablets may be necessary when coadministered with ritonavir, lopinavir, or efavirenz but should not exceed the maximum recommended dose [see Clinical Pharmacology (12.3)]. Carbamazepine, Phenobarbital, Phenytoin: While not systemically studied, these drugs may induce metabolism of bupropion and may decrease bupropion exposure [see Clinical Pharmacology (12.3)]. If bupropion is used concomitantly with a CYP inducer, it may be necessary to increase the dose of bupropion, but the maximum recommended dose should not be exceeded. 7.2 Potential for Bupropion Hydrobromide Extended-Release Tablets to Affect Other Drugs Drugs Metabolized by CYP2D6 Bupropion and its metabolites (erythrohydrobupropion, threohydrobupropion, hydroxybupropion) are CYP2D6 inhibitors.

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Bupropion

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

• Increase dose gradually to reduce seizure risk. (2.1, 5.3) Major Depressive Disorder
• Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl). (2.3)
• After 4 days, may increase the dose to 348 mg once daily. (2.3) Seasonal Affective Disorder
• Initiate treatment in the autumn prior to onset of seasonal depressive symptoms.

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(2.4)

• Starting dose: 174 mg once daily (equivalent to 150 mg bupropion HCl). Usual target dose: 348 mg once daily (equivalent to 300 mg bupropion HCl). (2.4)
• After one week, may increase the dose to 348 mg once daily. (2.4)
• Continue treatment through the winter season. (2.4) Hepatic Impairment
• Moderate to severe hepatic impairment: Maximum dose 174 mg every other day (2.6)
• Mild hepatic impairment: Consider reducing the dose and/or frequency of dosing. (2.2, 2.6, 8.7) Renal Impairment
• Consider reducing the dose and/or frequency of dosing. (2.2, 2.7, 8.6) 2.1 General Instructions for Use To minimize the risk of seizure, increase the dose gradually [see Warnings and Precautions (5.3)]. Bupropion Hydrobromide Extended-Release Tablets should be swallowed whole and not crushed, divided, or chewed. Bupropion Hydrobromide Extended-Release Tablets should be administered in the morning and may be taken with or without regard to meals. 2.2 Equivalent Daily Doses of Bupropion hydrobromide and Bupropion hydrochloride See Table 1 for equivalent daily doses of bupropion hydrobromide and bupropion hydrochloride. Table 1: Equivalent Daily Doses of Bupropion hydrobromide and Bupropion hydrochloride Bupropion hydrobromide Bupropion hydrochloride 522 mg 450 mg 348 mg 300 mg 174 mg 150 mg 2.3 Dosage for Major Depressive Disorder (MDD) The recommended starting dose for MDD is 174 mg once daily in the morning. After 4 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. It is generally agreed that acute episodes of depression require several months or longer of antidepressant treatment beyond the response in the acute episode. It is unknown whether the bupropion hydrobromide extended-release tablets dose needed for maintenance treatment is identical to the dose that provided an initial response. Periodically reassess the need for maintenance treatment and the appropriate dose for such treatment. 2.4 Dosage for Seasonal Affective Disorder (SAD) The recommended starting dose for SAD is 174 mg once daily. After 7 days of dosing, the dose may be increased to the target dose of 348 mg once daily in the morning. Doses above 300 mg of bupropion HCl extended-release (equivalent to bupropion hydrobromide extended-release tablets 348 mg) were not assessed in the SAD trials. For the prevention of seasonal MDD episodes associated with SAD, initiate bupropion hydrobromide extended-release tablets in the autumn, prior to the onset of depressive symptoms. Continue treatment through the winter season. Taper and discontinue bupropion hydrobromide extended-release tablets in early spring.

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Bupropion en el embarazo

Cita de la parte sobre embarazo (Pregnancy) de la etiqueta aprobada por la FDA. Se muestra en inglés. Pregunte a su médico antes de tomar cualquier medicamento si está embarazada o planea estarlo.

Pregnancy Exposure Registry There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to antidepressants during pregnancy. Healthcare providers are encouraged to register patients by calling the National Pregnancy Registry for Antidepressants at 1-844-405-6185 or visiting online at https://womensmentalhealth.org/clinical-and-research-programs/pregnancyregistry/antidepressants/.

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Risk Summary Data from epidemiological studies of pregnant women exposed to bupropion in the first trimester have not identified an increased risk of congenital malformations overall (see Data). There are risks to the mother associated with untreated depression (see Clinical Considerations). When bupropion was administered to pregnant rats during organogenesis, there was no evidence of fetal malformations at doses up to approximately 10 times the maximum recommended human dose (MRHD) of 450 mg/day. When given to pregnant rabbits during organogenesis, non-dose-related increases in incidence of fetal malformations and skeletal variations were observed at doses approximately equal to the MRHD and greater. Decreased fetal weights were seen at doses twice the MRHD and greater (see Data). The estimated background risk for major birth defects and miscarriage are unknown for the indicated population. All pregnancies have a background rate 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% to 4% and 15% to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk A prospective, longitudinal study followed 201 pregnant women with a history of major depressive disorder who were euthymic and taking antidepressants during pregnancy at the beginning of pregnancy. The women who discontinued antidepressants during pregnancy were more likely to experience a relapse of major depression than women who continued antidepressants. Consider the risks to the mother of untreated depression and potential effects on the fetus when discontinuing or changing treatment with antidepressant medications during pregnancy and postpartum. Data Human Data Data from the international bupropion Pregnancy Registry (675 first trimester exposures) and a retrospective cohort study using the United Healthcare database (1,213 first trimester exposures) did not show an increased risk for malformations overall. The Registry was not designed or powered to evaluate specific defects but suggested a possible increase in cardiac malformations. No increased risk for cardiovascular malformations overall has been observed after bupropion exposure during the first trimester. The prospectively observed rate of cardiovascular malformations in pregnancies with exposure to bupropion in the first trimester from the international Pregnancy Registry was 1.3% (9 cardiovascular malformations/675 first-trimester maternal bupropion exposures), which is similar to the background rate of cardiovascular malformations (approximately 1%).

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Bupropion

Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.

• Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a seizure disorder.
• Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with a current or prior diagnosis of bulimia or anorexia nervosa as a higher incidence of seizures was observed in such patients treated with bupropion hydrobromide extended-release tablets [see Warnings and Precautions (5.3)].

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• Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs [see Warnings and Precautions (5.3) and Drug Interactions (7.3)].
• The use of MAOIs (intended to treat psychiatric disorders) concomitantly with bupropion hydrobromide extended-release tablets or within 14 days of discontinuing treatment with bupropion hydrobromide extended-release tablets is contraindicated. There is an increased risk of hypertensive reactions when bupropion hydrobromide extended-release tablets are used concomitantly with MAOIs. The use of bupropion hydrobromide extended-release tablets within 14 days of discontinuing treatment with an MAOI is also contraindicated. Starting bupropion hydrobromide extended-release tablets in a patient treated with reversible MAOIs such as linezolid or intravenous methylene blue is contraindicated [see Dosage and Administration (2.5, 2.6, 2.9), Warnings and Precautions (5.4), and Drug Interactions (7.6)].
• Bupropion Hydrobromide Extended-Release Tablets are contraindicated in patients with known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets. Anaphylactoid/anaphylactic reactions and Stevens-Johnson Syndrome have been reported [see Warnings and Precautions (5.8)].
• Seizure disorder. (4, 5.3)
• Current or prior diagnosis of bulimia or anorexia nervosa. (4, 5.3)
• Abrupt discontinuation of alcohol, benzodiazepines, barbiturates, antiepileptic drugs. (4, 5.3)
• Monoamine Oxidase Inhibitors (MAOIs): Do not use MAOIs intended to treat psychiatric disorders with bupropion hydrobromide extended-release tablets or within 14 days of stopping an MAOI intended to treat psychiatric disorders. In addition, do not start bupropion hydrobromide extended-release tablets in a patient who is being treated with linezolid or intravenous methylene blue. (4, 7.6)
• Known hypersensitivity to bupropion or other ingredients of bupropion hydrobromide extended-release tablets. (4, 5.8)

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Bupropion

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 Overdoses of up to 30 grams or more of bupropion have been reported. Seizure was reported in approximately one third of all cases. Other serious reactions reported with overdoses of bupropion alone included hallucinations, loss of consciousness, mental status changes, sinus tachycardia, ECG changes such as conduction disturbances or arrhythmias, clonus, myoclonus, and hyperreflexia.

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Fever, muscle rigidity, rhabdomyolysis, hypotension, stupor, coma, and respiratory failure have been reported mainly when bupropion was part of multiple drug overdoses. Although most patients recovered without sequelae, deaths associated with overdoses of bupropion alone have been reported in patients ingesting large doses of the drug. Multiple uncontrolled seizures, bradycardia, cardiac failure, and cardiac arrest prior to death were reported in these patients. 10.2 Overdosage Management Consult a Certified Poison Control Center for up-to-date guidance and advice. Call 1-800-222-1222 or refer to www.poison.org. There are no known antidotes for bupropion. In case of an overdose, provide supportive care, including close medical supervision and monitoring. Consider the possibility of multiple drug overdose.

— Etiqueta de la FDA: Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

Mismo medicamento, otras formas y combinaciones

Páginas de medicamentos con receta de este sitio que comparten un principio activo con este, según el directorio NDC de la FDA. Una combinación es un medicamento distinto: pregunte a su farmacéutico antes de cambiar.

Otros medicamentos que contienen Bupropion

• Dextromethorphan hydrobromide, bupropion hydrochlorideAuvelity · 2 productos
• Naltrexone hydrochloride and bupropion hydrochlorideContrave Extended-Release · 1 producto

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.

• Bryant Ranch Prepack38 productos
• A-S Medication Solutions27 productos
• Proficient Rx LP21 productos
• Remedyrepack Inc.20 productos
• Epic Pharma, LLC11 productos
• Coupler LLC11 productos
• Preferred Pharmaceuticals Inc.10 productos
• PD-Rx Pharmaceuticals, Inc.9 productos
• Cipla USA Inc.9 productos
• Aphena Pharma Solutions - Tennessee, LLC8 productos
• NuCare Pharmaceuticals, Inc.8 productos
• Major Pharmaceuticals8 productos
• Dr.Reddys Laboratories Inc8 productos
• Aurobindo Pharma Limited7 productos
• Direct_Rx6 productos
• Actavis Pharma, Inc.6 productos
• NCS HealthCare of KY, LLC dba Vangard Labs6 productos
• BluePoint Laboratories6 productos
• American Health Packaging6 productos
• Northwind Health Company, LLC6 productos
• ScieGen Pharmaceuticals, Inc.6 productos
• Radha Pharmaceuticals, Inc.5 productos
• Camber Pharmaceuticals, Inc.5 productos
• Slate Run Pharmaceuticals, LLC5 productos
• Granules Pharmaceuticals Inc.5 productos
• Bausch Health US, LLC5 productos
• AvPAK4 productos
• Chartwell RX, LLC4 productos
• Macleods Pharmaceuticals Limited3 productos
• Solco Healthcare US, LLC3 productos
• GlaxoSmithKline LLC3 productos
• Cardinal Health 107, LLC3 productos
• Advanced Rx of Tennessee, LLC3 productos
• Oceanside Pharmaceuticals3 productos
• Exelan Pharmaceuticals Inc.2 productos
• Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.2 productos
• Amneal Pharmaceuticals of New York LLC2 productos
• Alembic Pharmaceuticals Limited2 productos
• Zydus Lifesciences Limited2 productos
• Oryza Pharmaceuticals Inc.2 productos
• Accord Healthcare Inc.2 productos
• Golden State Medical Supply, Inc.2 productos
• Apotex Corp.2 productos
• Upsher-Smith Laboratories, LLC2 productos
• Lannett Company, Inc.2 productos
• Quallent Pharmaceuticals Health LLC2 productos
• Amici Pharma, Inc.2 productos
• Vitruvias Therapeutics2 productos
• Cadila Pharmaceuticals Limited2 productos
• Alembic Pharmaceuticals Inc.2 productos
• Lupin Pharmaceuticals, Inc.2 productos
• Zydus Pharmaceuticals USA Inc.2 productos
• Rising Pharma Holdings, Inc.2 productos
• Modavar Pharmaceuticals LLC2 productos
• Mullan Pharmaceutical Inc.2 productos
• Asclemed USA, Inc.2 productos
• Hawaii Repack, Inc.1 producto
• QPharma, Inc.1 producto
• Sun Pharmaceutical Industries, Inc.1 producto
• Lifestar Pharma LLC1 producto
• NuCare Pharmacueticals, Inc.1 producto
• Quality Care Products, LLC1 producto
• Unit Dose Solutions, Inc.1 producto
• St. Mary's Medical Park Pharmacy1 producto
• Advanced Rx Pharmacy of Tennessee, LLC1 producto
• DirectRx1 producto
• Dr. Reddy's Laboratories Inc.1 producto
• DriectRx1 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.

Aprobaciones de genéricos (40)

• ANDA075584Pharmazone · 7 de febrero de 2000
• ANDA075491Aurobindo Pharma USA · 17 de abril de 2000
• ANDA075932Epic Pharma LLC · 25 de noviembre de 2003
• ANDA076711Impax Labs · 3 de diciembre de 2004
• ANDA076143Apotex · 17 de enero de 2006
• ANDA077415Impax Labs · 15 de diciembre de 2006
• ANDA077715Actavis Labs Fl Inc · 13 de junio de 2007
• ANDA077285Watson Labs Inc · 15 de agosto de 2008
• ANDA079094Actavis Labs Fl Inc · 24 de marzo de 2009
• ANDA079095Actavis Labs Fl Inc · 24 de marzo de 2009
• ANDA078866Sun Pharm · 6 de abril de 2010
• ANDA090325Aurobindo Pharma USA · 8 de abril de 2010
• ANDA201567Zydus Pharms · 17 de enero de 2014
• ANDA200695Sun Pharm · 18 de diciembre de 2014
• ANDA202304Prinston Inc · 26 de mayo de 2015
• ANDA206674Invagen Pharms · 9 de febrero de 2016
• ANDA205794Sciegen Pharms · 1 de marzo de 2016
• ANDA206122Sciegen Pharms · 17 de agosto de 2016
• ANDA206975Heritage Pharma · 19 de agosto de 2016
• ANDA206556Invagen Pharms · 26 de agosto de 2016
• ANDA090693Lupin · 6 de abril de 2017
• ANDA207479Sciegen Pharms · 12 de abril de 2017
• ANDA207224Anbison Lab · 30 de junio de 2017
• ANDA208652Sinotherapeutics Inc · 21 de agosto de 2017
• ANDA207389Invagen Pharms · 18 de septiembre de 2017
• ANDA210081Twi Pharms · 3 de noviembre de 2017
• ANDA203013Alembic · 8 de junio de 2018
• ANDA210015Yichang Humanwell · 14 de junio de 2018
• ANDA211347Yichang Humanwell · 16 de octubre de 2018
• ANDA210497Accord Hlthcare · 31 de octubre de 2018
• ANDA211020Graviti Pharms · 28 de enero de 2019
• ANDA211200Zhejiang Jutai Pharm · 5 de septiembre de 2019
• ANDA208606Cadila Pharms Ltd · 16 de enero de 2020
• ANDA215568Granules · 2 de febrero de 2022
• ANDA216766Yichang Humanwell · 9 de enero de 2023
• ANDA216800Annora Pharma · 31 de mayo de 2023
• ANDA218385Granules · 17 de octubre de 2024
• ANDA217898Annora Pharma · 1 de octubre de 2025
• ANDA218567Macleods Pharms · 23 de junio de 2026
• ANDA216051Aurobindo Pharma Ltd · 21 de julio de 2026

Escasez

La lista de escasez de la FDA no incluye estos productos.

Base de datos de escasez de medicamentos de la FDA →

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.

1. 15 de septiembre de 2025 · Clase II · En curso · D-0037-2026

   Failed Tablet/Capsule Specifications

   Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals Private Limited, Sangareddy, Telangana, India, Dist. by: Rising Phar, NDC 16571-863-03. — Graviti Pharmaceuticals Private Limited

2. 24 de junio de 2024 · Clase II · En curso · D-0590-2024

   Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

   buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217, NDC: 60687-782-01. — Amerisource Health Services LLC

3. 29 de diciembre de 2023 · Clase II · En curso · D-0222-2024

   Presence of Foreign Tablets/Capsules

   buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc. East Brunswick, NJ 08816 Manufactured by: Graviti Pharmaceuticals Pvt. Ltd. Tela — Rising Pharma Holding, Inc.

4. 27 de diciembre de 2022 · Clase II · Cerrado por la FDA · D-0328-2023

   Failed Impurities/Degradation Specifications

   BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-340-01; NDC Blister Pack: 60687-340-11 — Amerisource Health Services LLC

5. 15 de marzo de 2021 · Clase II · Cerrado por la FDA · D-0489-2021

   CGMP Deviations: Intermittent exposure to temperature excursion during storage.

   bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc. Eatontown, NJ 07724 — Cardinal Health Inc.

6. 6 de septiembre de 2018 · Clase III · Cerrado por la FDA · D-1212-2018

   Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.

   Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68 — InvaGen Pharmaceuticals, Inc.

7. 15 de marzo de 2018 · Clase III · Cerrado por la FDA · D-0618-2018

   Failed Dissolution Specifications; during stability testing

   buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, — InvaGen Pharmaceuticals, Inc.

8. 15 de marzo de 2018 · Clase III · Cerrado por la FDA · D-0619-2018

   Failed Dissolution Specifications; during stability testing

   buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Su — InvaGen Pharmaceuticals, Inc.

9. 2 de noviembre de 2016 · Clase III · Cerrado por la FDA · D-0207-2017

   Failed Dissolution Specifications; 6 month time point

   BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distrib — Zydus Pharmaceuticals USA Inc

10. 3 de agosto de 2016 · Clase III · Cerrado por la FDA · D-0149-2017

    Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.

    BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA inc. Pennington, NJ 08534, — Zydus Pharmaceuticals USA Inc

11. 15 de noviembre de 2013 · Clase III · Cerrado por la FDA · D-1043-2014

    Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

    BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count bottle (NDC 0591-3331-19), c) 500 count bottle (NDC 0591-3331-05), Manufactactred By: Watson Laborato — Actavis Inc

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Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Bupropion Hydrobromide, Oceanside Pharmaceuticals, vigente desde el 1 de junio de 2026; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
2. 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
3. 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
4. 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
5. Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026

La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →

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