Oximorfona (oxymorphone hydrochloride)

Para qué se usa Oximorfona

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.

Oxymorphone Hydrochloride Extended-Release Tablets are indicated for the management of severe and persistent pain that requires an opioid analgesic and that cannot be adequately treated with alternative options, including immediate-release opioids. …

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Leer la etiqueta completa en DailyMed →

Etiqueta citada: la de la presentación más común (tablet, film coated, extended release, oral), Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC; abarca 7 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 8 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.

Esta etiqueta tiene una advertencia en recuadro. Su título: WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS. Leerla en la etiqueta completa →

8 de 8 etiquetas de la FDA de este medicamento tienen advertencia en recuadro.

Oximorfona: 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: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS Addiction, Abuse, and Misuse Because the use of Oxymorphone Hydrochloride Extended-Release Tablets exposes patients and other users to the risks of opioid addiction, abuse, and misuse, which can lead to overdose and death, assess each patient’s risk prior to prescribing and reassess all patients regularly for the development of these behaviors and conditions [see Warnings and Precautions (5.1)].

Leer más de esta sección

Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of Oxymorphone Hydrochloride Extended-Release Tablets, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of Oxymorphone Hydrochloride Extended-Release Tablets are essential. Instruct patients to swallow Oxymorphone Hydrochloride Extended-Release Tablets whole; crushing, chewing, or dissolving Oxymorphone Hydrochloride Extended-Release Tablets can cause rapid release and absorption of a potentially fatal dose of oxymorphone [see Dosage and Administration (2.1) and Warnings and Precautions (5.2)]. Accidental Ingestion Accidental ingestion of even one dose of Oxymorphone Hydrochloride Extended-Release Tablets, especially by children, can result in a fatal overdose of oxymorphone [see Warnings and Precautions (5.2)]. Interaction with Alcohol Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products that contain alcohol while taking Oxymorphone Hydrochloride Extended-Release Tablets. The co-ingestion of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets may result in increased plasma levels and a potentially fatal overdose of oxymorphone [see Warnings and Precautions (5.2, 5.3)]. Risks From Concomitant Use with Benzodiazepines or Other CNS Depressants Concomitant use of opioids with benzodiazepines or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death. Reserve concomitant prescribing of Oxymorphone Hydrochloride Extended-Release Tablets and benzodiazepines or other CNS depressants for use in patients for whom alternative treatment options are inadequate [see Warnings and Precautions (5.3), Drug Interactions (7)]. Neonatal Opioid Withdrawal Syndrome (NOWS) Advise pregnant women using opioids for an extended period of time of the risk of Neonatal Opioid Withdrawal Syndrome, which may be life-threatening if not recognized and treated. Ensure that management by neonatology experts will be available at delivery [see Warnings and Precautions (5.4)]. Opioid Analgesic Risk Evaluation and Mitigation Strategy (REMS) Healthcare providers are strongly encouraged to complete a REMS-compliant education program and to counsel patients and caregivers on serious risks, safe use, and the importance of reading the Medication Guide with each prescription [see Warnings and Precautions (5.5)]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF OXYMORPHONE HYDROCHLORIDE EXTENDED-RELEASE TABLETS See full prescribing information for complete boxed warning.

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Efectos secundarios de Oximorfona

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 serious adverse reactions are discussed elsewhere in the labeling: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines or Other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Opioid-Induced Hyperalgesia and Allodynia [see Warnings and Precautions (5.6)] …

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Interacciones de Oximorfona

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.

Table 5 includes clinically significant drug interactions with Oxymorphone Hydrochloride Extended-Release Tablets. Table 5: Clinically Significant Drug Interactions with Oxymorphone Hydrochloride Extended-Release Tablets Alcohol Clinical Impact: The concomitant use of alcohol with Oxymorphone Hydrochloride Extended-Release Tablets can result in an increase of oxymorphone plasma levels and potentially fatal overdose of oxymorphone.

Leer más de esta sección

Intervention: Instruct patients not to consume alcoholic beverages or use prescription or non-prescription products containing alcohol while on Oxymorphone Hydrochloride Extended-Release Tablets therapy [see Warnings and Precautions (5.3) and Clinical Pharmacology (12.3)]. Benzodiazepines and other Central Nervous System (CNS) Depressants Clinical Impact: Due to additive pharmacologic effect, the concomitant use of benzodiazepines or other CNS depressants including alcohol, can increase the risk of hypotension, respiratory depression, profound sedation, coma, and death [see Warnings and Precautions (5.3)]. Intervention: Reserve concomitant prescribing of these drugs for use in patients for whom alternative treatment options are inadequate. Limit dosages and durations to the minimum required. Inform patients and caregivers of this potential interaction and educate them on the signs and symptoms of respiratory depression (including sedation). If concomitant use is warranted, consider recommending or prescribing an opioid overdose reversal agent [see Dosage and Administration (2.2) and Warnings and Precautions (5.1, 5.2, 5.3)]. Examples: Benzodiazepines and other sedatives/hypnotics, anxiolytics, tranquilizers, muscle relaxants, general anesthetics, antipsychotics, gabapentinoids (gabapentin or pregabalin), other opioids, alcohol. Serotonergic Drugs Clinical Impact: The concomitant use of opioids with other drugs that affect the serotonergic neurotransmitter system has resulted in serotonin syndrome. Intervention: If concomitant use is warranted, frequently evaluate the patient, particularly during treatment initiation and dose adjustment. Discontinue Oxymorphone Hydrochloride Extended-Release Tablets if serotonin syndrome is suspected. Examples: Selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs), tricyclic antidepressants (TCAs), triptans, 5-HT3 receptor antagonists, drugs that affect the serotonin neurotransmitter system (e.g., mirtazapine, trazodone, tramadol), certain muscle relaxants (i.e., cyclobenzaprine, metaxalone), monoamine oxidase inhibitors (those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue). Monoamine Oxidase Inhibitors (MAOIs) Clinical Impact: MAOI interactions with opioids may manifest as serotonin syndrome or opioid toxicity (e.g., respiratory depression, coma) [see Warnings and Precautions (5.2)]. Intervention: The use of Oxymorphone Hydrochloride Extended-Release Tablets are not recommended for patients taking MAOIs or within 14 days of stopping such treatment.

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Dosis de Oximorfona

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.

Oxymorphone Hydrochloride Extended-Release Tablets should be prescribed only by healthcare professionals who are knowledgeable about the use of extended-release/long-acting opioids and how to mitigate the associated risks. (2.1) Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals.

Leer más de esta sección

Reserve titration to higher doses of Oxymorphone Hydrochloride Extended-Release Tablets for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks. (2.1, 5) Initiate the dosing regimen for each patient individually, taking into account the patient’s underlying cause and severity of pain, prior analgesic treatment and response, and risk factors for addiction, abuse, and misuse. (2.1, 5.1) Respiratory depression can occur at any time during opioid therapy, especially when initiating and following dosage increases with Oxymorphone Hydrochloride Extended-Release Tablets. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.1) Discuss opioid overdose reversal agents and options for acquiring them with the patient and/or caregiver, both when initiating and renewing treatment with Oxymorphone Hydrochloride Extended-Release Tablets, especially if the patient has additional risk factors for overdose, or close contacts at risk for exposure and overdose. (2.2, 5.1, 5.2, 5.3). Oxymorphone Hydrochloride Extended-Release Tablets are administered orally twice daily (every 12 hours), on an empty stomach, at least 1 hour prior to or 2 hours after eating. (2.1, 2.3) For patients who are not opioid tolerant, initiate treatment with 5 mg tablets orally every 12 hours. (2.3) To convert to Oxymorphone Hydrochloride Extended-Release Tablets from another opioid, use available conversion factors to obtain estimated dose. (2.3) Dose can be increased every 3 to 7 days, using increments of 5 mg to 10 mg every 12 hours (i.e., 10 mg to 20 mg per day). (2.4) Periodically reassess patients receiving Oxymorphone Hydrochloride Extended-Release Tablets to evaluate the continued need for opioid analgesics to maintain pain control, for the signs or symptoms of adverse reactions, and for the development of addiction, abuse, or misuse. (2.4) Mild Hepatic Impairment: For patients who are not opioid tolerant, initiate treatment with 5 mg and titrate slowly. For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Evaluate for signs of respiratory and central nervous system depression. (2.6) Renal Impairment: For patients who are not opioid tolerant, initiate treatment with 5 mg and titrate slowly. For patients on prior opioid therapy, reduce starting dose by 50% and titrate slowly. Evaluate for signs of respiratory and central nervous system depression. (2.7) Geriatric Patients: Initiate dosing with 5 mg, titrate slowly, and evaluate for signs of respiratory and central nervous system depression.

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Oximorfona 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 Use of opioid analgesics for an extended period of time during pregnancy may cause neonatal opioid withdrawal syndrome [see Warnings and Precautions (5.4)]. Available data with Oxymorphone Hydrochloride Extended-Release Tablets in pregnant women are insufficient to inform a drug-associated risk for major birth defects and miscarriage.

Leer más de esta sección

In animal reproduction studies, reduced postnatal survival of pups and an increased incidence of stillborn pups were observed following oral treatment of pregnant rats with oxymorphone during gestation and through lactation at doses 2.4 and 12 times the human daily dose of 20 mg/day (HDD), respectively. Reduced fetal weights were observed with oral administration of oxymorphone to pregnant rats and rabbits during organogenesis at exposures up to 4.9 and 48.8 times the HDD, respectively [see Data]. Based on animal data, advise pregnant women of the potential risk to a fetus. The 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 clinical recognized pregnancies is 2% to 4% and 14% to 20%, respectively. Clinical Considerations Fetal/Neonatal adverse reactions Use of opioid analgesics for an extended period of time during pregnancy for medical or nonmedical purposes can result in physical dependence in the neonate and neonatal opioid withdrawal syndrome shortly after birth. Neonatal opioid withdrawal syndrome presents as irritability, hyperactivity and abnormal sleep pattern, high pitched cry, tremor, vomiting, diarrhea, and failure to gain weight. The onset, duration, and severity of neonatal opioid withdrawal syndrome vary based on the specific opioid used, duration of use, timing and amount of last maternal use, and rate of elimination of the drug by the newborn. Observe newborns for symptoms of neonatal opioid withdrawal syndrome and manage accordingly [see Warnings and Precautions (5.4)]. Labor or delivery Opioids cross the placenta and may produce respiratory depression and psycho-physiologic effects in neonates. An opioid overdose reversal agent, such as naloxone or nalmefene, must be available for reversal of opioid-induced respiratory depression in the neonate. Oxymorphone Hydrochloride Extended-Release Tablets are not recommended for use in women during and immediately prior to labor, when use of shorter acting analgesics or other analgesic techniques are more appropriate. Opioid analgesics, including Oxymorphone Hydrochloride Extended-Release Tablets, can prolong labor through actions which temporarily reduce the strength, duration, and frequency of uterine contractions. However, this effect is not consistent and may be offset by an increased rate of cervical dilatation, which tends to shorten labor. Monitor neonates exposed to opioid analgesics during labor for signs of excess sedation and respiratory depression.

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →

Cuándo no se debe usar Oximorfona

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

Oxymorphone Hydrochloride Extended-Release Tablets are contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.7)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.7)] Hypersensitivity (e.g., anaphylaxis) to oxymorphone, any other ingredients in Oxymorphone Hydrochloride Extended-Release Tablets [see Warnings and Precautions (5.8) and Adverse Reactions (6)].

Leer más de esta sección

Moderate and severe hepatic impairment [see Warnings and Precautions (5.10), Clinical Pharmacology (12.3)] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.13)] Significant respiratory depression (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment (4) Hypersensitivity to oxymorphone (4) Moderate or severe hepatic impairment (4) Known or suspected gastrointestinal obstruction, including paralytic ileus (4)

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Leer la etiqueta completa en DailyMed →

Sobredosis de Oximorfona

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).

Clinical Presentation Acute overdosage with oxymorphone can be manifested by respiratory depression, somnolence progressing to stupor or coma, skeletal muscle flaccidity, cold and clammy skin, constricted pupils, and in some cases, pulmonary edema, bradycardia, hypotension, hypoglycemia, partial or completed airway obstruction, atypical snoring, and death.

Leer más de esta sección

Marked mydriasis rather than miosis may be seen with severe hypoxia in overdose situations [see Clinical Pharmacology (12.2)]. Toxic leukoencephalopathy has been reported after opioid overdose and can present hours, days, or weeks after apparent recovery from the initial intoxication. Treatment of Overdose In case of overdose, priorities are the reestablishment of a patent and protected airway and institution of assisted or controlled ventilation, if needed. Employ other supportive measures (including oxygen, vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life support measures. For clinically significant respiratory or circulatory depression secondary to oxymorphone overdose, administer an opioid overdose reversal agent such as naloxone or nalmefene. Because the duration of opioid reversal is expected to be less than the duration of action of oxymorphone in Oxymorphone Hydrochloride Extended-Release Tablets, carefully monitor the patient until spontaneous respiration is reliably re-established. Oxymorphone Hydrochloride Extended-Release Tablets will continue to release oxymorphone and add to the oxymorphone load for 24 to 48 hours or longer following ingestion, necessitating prolonged monitoring. If the response to an opioid overdose reversal agent is suboptimal or only brief in nature, administer additional reversal agent as directed by product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the opioid overdose reversal agent will precipitate an acute withdrawal syndrome. The severity of the withdrawal symptoms experienced will depend on the degree of physical dependence and the dose of the reversal agent administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the reversal agent should be initiated with care and by titration with smaller than usual doses of the reversal agent.

— Etiqueta de la FDA: Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero de 2026. Leer la etiqueta completa en DailyMed →

Presentaciones y vía de administración

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.

• Amneal Pharmaceuticals LLC7 productos
• Amneal Pharmaceuticals of New York LLC7 productos
• XLCare Pharmaceuticals, Inc.2 productos
• KVK-Tech, Inc.2 productos
• Hikma Pharmaceuticals USA Inc.2 productos
• Aurolife Pharma, LLC2 productos
• Camber Pharmaceuticals, Inc.2 productos
• Epic Pharma, LLC2 productos
• Bryant Ranch Prepack1 producto

Historial de aprobación de la FDA

• ANDA: Solicitud abreviada (ANDA): así se aprueba una versión genérica.

Aprobaciones de genéricos (6)

• ANDA079087Impax Labs · 14 de junio de 2010
• ANDA090964Hikma · 27 de septiembre de 2010
• ANDA203601Avanthi Inc · 30 de enero de 2013
• ANDA201187Epic Pharma LLC · 15 de diciembre de 2014
• ANDA204459Aurolife Pharma LLC · 26 de abril de 2016
• ANDA210175Ascent Pharms Inc · 2 de febrero de 2018

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

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
• Amneal Pharmaceuticals LLCFabricante o distribuidor
• Amneal Pharmaceuticals of New York LLCFabricante o distribuidor
• XLCare Pharmaceuticals, Inc.Fabricante o distribuidor
• Todos los medicamentos con receta de la A a la ZBusque por nombre genérico, de marca o en español

Fuentes

1. Etiqueta aprobada por la FDA en DailyMed (Biblioteca Nacional de Medicina) — Oxymorphone hydrochloride, Amneal Pharmaceuticals LLC, vigente desde el 15 de enero 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
6. 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 →

Informar un error → · Información para fabricantes de medicamentos