Respuestas rápidas
- ¿Para qué se usa Benzhydrocodone and acetaminophen?
- La etiqueta aprobada por la FDA (Apadaz, Zevra Therapeutics, Inc., 7 de enero de 2025) dice, en inglés: “APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration […] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid …” 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 Benzhydrocodone and acetaminophen?
- La sección «Adverse Reactions» (reacciones adversas) de la etiqueta de la FDA (Apadaz, Zevra Therapeutics, Inc., 7 de enero de 2025) comienza así, en inglés: «The following serious adverse reactions are described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines and other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.7)] …» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Qué interacciones tiene Benzhydrocodone and acetaminophen?
- La sección «Drug Interactions» (interacciones) de la etiqueta de la FDA (Apadaz, Zevra Therapeutics, Inc., 7 de enero de 2025) comienza así, en inglés: «Table 2. Clinically Significant Drug Interactions with APADAZ. CYP3A4 and 2D6 Inhibitors Clinical Impact: The concomitant use of APADAZ and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects.» … Esta página no es un consejo médico. Hable con su médico o farmacéutico antes de empezar, dejar o cambiar cualquier medicamento.
- ¿Benzhydrocodone and acetaminophen tiene una advertencia en recuadro?
- Sí. La etiqueta de la FDA de Apadaz tiene una advertencia en recuadro («WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF APADAZ»), la advertencia más seria de la FDA. Léala en la etiqueta completa y pregunte a su farmacéutico.
- ¿Hay escasez de Benzhydrocodone and acetaminophen?
- 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 Benzhydrocodone and acetaminophen?
- No aparece ningún retiro vinculado a los productos de este medicamento en los informes de la FDA que usamos.
- ¿Quién fabrica Benzhydrocodone and acetaminophen?
- 1 empresa tiene productos con receta de Benzhydrocodone and acetaminophen en el directorio NDC de la FDA, entre ellas Zevra Therapeutics, Inc.
Para qué se usa Benzhydrocodone and acetaminophen
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.
APADAZ is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate. Limitations of Use Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration […] reserve APADAZ for use in patients for whom alternative treatment options [e.g., non-opioid …
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Leer la etiqueta completa en DailyMed →
Etiqueta citada: la de la presentación más común (tablet, oral), Apadaz, Zevra Therapeutics, Inc.; abarca 3 productos del directorio NDC de la FDA. Las citas sobre efectos secundarios, interacciones, dosis y embarazo de abajo vienen de esta misma etiqueta.
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 APADAZ
. Leerla en la etiqueta completa →
Benzhydrocodone and acetaminophen: 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 APADAZ Addiction, Abuse, and Misuse Because the use of APADAZ 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)].
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Life-Threatening Respiratory Depression Serious, life-threatening, or fatal respiratory depression may occur with use of APADAZ, especially during initiation or following a dosage increase. To reduce the risk of respiratory depression, proper dosing and titration of APADAZ are essential [see Warnings and Precautions (5.2)]. Accidental Ingestion Accidental ingestion of even one dose of APADAZ, especially by children, can result in a fatal overdose of hydrocodone [see Warnings and Precautions (5.2)]. 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 APADAZ 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) If opioid use is required for an extended period of time in a pregnant woman, advise the patient of the risk of NOWS, 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)]. Cytochrome P450 3A4 Interaction The concomitant use of APADAZ with all cytochrome P450 3A4 inhibitors may result in an increase in hydrocodone plasma concentrations, which could increase or prolong adverse reactions and may cause potentially fatal respiratory depression. In addition, discontinuation of a concomitantly used cytochrome P450 3A4 inducer may result in an increase in hydrocodone plasma concentration. Regularly evaluate patients receiving APADAZ and any CYP3A4 inhibitor or inducer [see Warnings and Precautions (5.5), Drug Interactions (7), Clinical Pharmacology (12.3)]. Hepatotoxicity APADAZ contains acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product [see Warnings and Precautions (5.6)]. WARNING: SERIOUS AND LIFE-THREATENING RISKS FROM USE OF APADAZ See full prescribing information for complete boxed warning.
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Efectos secundarios de Benzhydrocodone and acetaminophen
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 described, or described in greater detail, in other sections: Addiction, Abuse, and Misuse [see Warnings and Precautions (5.1)] Life-Threatening Respiratory Depression [see Warnings and Precautions (5.2)] Interactions with Benzodiazepines and other CNS Depressants [see Warnings and Precautions (5.3)] Neonatal Opioid Withdrawal Syndrome [see Warnings and Precautions (5.4)] Hepatotoxicity [see Warnings and Precautions (5.7)] …
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Interacciones de Benzhydrocodone and acetaminophen
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 2. Clinically Significant Drug Interactions with APADAZ. CYP3A4 and 2D6 Inhibitors Clinical Impact: The concomitant use of APADAZ and CYP3A4 inhibitors can increase the plasma concentration of hydrocodone, resulting in increased or prolonged opioid effects.
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These effects could be more pronounced with concomitant use of APADAZ and CYP2D6 and CYP3A4 inhibitors, particularly when an inhibitor is added after a stable dose of APADAZ is achieved [see Warnings and Precautions (5.5)]. After stopping a CYP3A4 inhibitor, as the effects of the inhibitor decline, the hydrocodone plasma concentration will decrease [see Clinical Pharmacology (12.3)], resulting in decreased opioid efficacy or a withdrawal syndrome in patients who had developed physical dependence to hydrocodone. Intervention: If concomitant use is necessary, consider dosage reduction of APADAZ until stable drug effects are achieved. Evaluate patients at frequent intervals for respiratory depression and sedation at. If a CYP3A4 inhibitor is discontinued, consider increasing the APADAZ dosage until stable drug effects are achieved. Assess for signs of opioid withdrawal. Examples: Macrolide antibiotics (e.g., erythromycin), azole-antifungal agents (e.g., ketoconazole), protease inhibitors (e.g., ritonavir) etc. CYP3A4 Inducers Clinical Impact: The concomitant use of APADAZ and CYP3A4 inducers can decrease the plasma concentration of hydrocodone [see Clinical Pharmacology (12.3)], resulting in decreased efficacy or onset of a withdrawal syndrome in patients who have developed physical dependence to hydrocodone [see Warnings and Precautions (5.16)]. After stopping a CYP3A4 inducer, as the effects of the inducer decline, the hydrocodone plasma concentration will increase [see Clinical Pharmacology (12.3)], which could increase or prolong both the therapeutic effects and adverse reactions, and may cause serious respiratory depression. Intervention: If concomitant use is necessary, consider increasing the APADAZ dosage until stable drug effects are achieved [see Dosage and Administration (2)]. Assess for signs of opioid withdrawal. If a CYP3A4 inducer is discontinued, consider APADAZ dosage reduction and evaluate patients at frequent intervals for signs of respiratory depression and sedation. Examples: Rifampin, carbamazepine, phenytoin etc. 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, increases the risk of hypotension, respiratory depression, profound sedation, coma, and death. 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).
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Dosis de Benzhydrocodone and acetaminophen
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.
APADAZ should be prescribed only by healthcare professionals who are knowledgeable about the use of 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.
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Reserve titration to higher doses of APADAZ 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) Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic. Clinical guidelines on opioid prescribing for some acute pain conditions are available. (2.1) 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 APADAZ. Consider this risk when selecting an initial dose and when making dose adjustments. (2.1, 5.2) Discuss availability of naloxone with the patient and caregiver and assess each patient’s need for access to naloxone, both when initiating and renewing treatment with APADAZ. Consider prescribing naloxone based on the patient’s risk factors for overdose (2.2, 5.1, 5.3, 5.7). Initiate treatment with APADAZ at 1 or 2 tablets every 4 to 6 hours as needed for pain, and at the lowest dose necessary to achieve adequate analgesia. Titrate the dose based upon the individual patient’s response to their initial dose of APADAZ. Dosage should not exceed 12 tablets in a 24- hour period. (2.5) See full prescribing information for conversion from hydrocodone bitartrate/acetaminophen. (2.4) Do not abruptly discontinue APADAZ in a physically-dependent patient because rapid discontinuation of opioid analgesics has resulted in serious withdrawal symptoms, uncontrolled pain, and suicide. (2.6, 5.16) 2.1 Important Dosage and Administration Instructions APADAZ should be prescribed only by healthcare professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks. Use the lowest effective dosage for the shortest duration of time consistent with individual patient treatment goals [see Warnings and Precautions (5)]. Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses of APADAZ 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. The total dosage of APADAZ and any concomitant acetaminophen-containing products should not exceed 4000 mg of acetaminophen in a 24-hour period.
Tabla de la etiqueta
| Hydrocodone bitartrate doses (mg) | APADAZ equivalent (mg benzhydrocodone) |
|---|---|
| 5 | 4.08 |
| 7.5 | 6.12 |
| 10 | 8.16 |
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Benzhydrocodone and acetaminophen 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)]. There are no available human data on hydrocodone or APADAZ use during pregnancy to inform any drug associated risks. However, neonatal opioid withdrawal and other adverse reactions during pregnancy and labor can occur with use of APADAZ [see Clinical Considerations].
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Published studies with oral acetaminophen use during pregnancy have not reported an association with major congenital malformations. No reproductive or developmental toxicology studies in animals have been conducted with benzhydrocodone or the combination of benzhydrocodone and acetaminophen. Reproductive and developmental studies in rats and mice from the published literature identified adverse events at clinically relevant doses with acetaminophen. Treatment of pregnant rats with doses of acetaminophen approximately equal to the maximum human daily dose (MHDD) showed evidence of fetotoxicity and increases in bone variations in the fetuses. In another study, necrosis was observed in the liver and kidney of both pregnant rats and fetuses at doses approximately equal to the MHDD. In mice and rats treated with acetaminophen at doses within the clinical dosing range, cumulative adverse effects on reproductive capacity were reported. In mice, a reduction in number of litters of the parental mating pair was observed as well as retarded growth, abnormal sperm in their offspring, and reduced birth weight in the next generation. In rats, female fertility was decreased following in utero exposure to acetaminophen [see Data]. 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 clinically recognized pregnancies is 2 to 4% and 15 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 antagonist, such as naloxone, must be available for reversal of opioid-induced respiratory depression in the neonate.
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Cuándo no se debe usar Benzhydrocodone and acetaminophen
Cita de la sección «Contraindications» (contraindicaciones) de la etiqueta aprobada por la FDA. Se muestra en inglés.
APADAZ is contraindicated in patients with: Significant respiratory depression [see Warnings and Precautions (5.3)] Acute or severe bronchial asthma in an unmonitored setting or in the absence of resuscitative equipment [see Warnings and Precautions (5.8)] Known or suspected gastrointestinal obstruction, including paralytic ileus [see Warnings and Precautions (5.14)] Hypersensitivity to hydrocodone or acetaminophen, or any other component of this product (e.g., anaphylaxis) [see Warnings and Precautions (5.13), Adverse Reactions (6)] Significant respiratory depression (4) Acute or severe bronchial asthma in an unmonitored setting or in absence of resuscitative equipment (4) Known or suspected gastrointestinal obstruction, including paralytic ileus (4) Hypersensitivity to hydrocodone or acetaminophen (4)
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Leer la etiqueta completa en DailyMed →
Sobredosis de Benzhydrocodone and acetaminophen
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 Hydrocodone Acute overdose with hydrocodone 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, partial or complete airway obstruction, atypical snoring, and death. Marked mydriasis rather than miosis may be seen with hypoxia in overdose situations [see Clinical Pharmacology (12.2)].
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Acetaminophen In acute acetaminophen overdosage, dose-dependent, potentially fatal hepatic necrosis is the most serious adverse effect. Renal tubular necrosis, hypoglycemic coma, and thrombocytopenia also occur. Plasma acetaminophen levels > 300 mcg/mL at 4 hours after oral ingestion were associated with hepatic damage in 90% of patients; minimal hepatic damage is anticipated if plasma levels at 4 hours are < 150 mcg/mL or < 37.5 mcg/mL at 12 hours after ingestion. Early symptoms following a potentially hepatotoxic overdose may include: nausea, vomiting, diaphoresis, and general malaise. Clinical and laboratory evidence of hepatic toxicity may not be apparent until 48 to 72 hours post-ingestion. Treatment of Overdose A single or multiple drug overdose with hydrocodone and acetaminophen is a potentially lethal polydrug overdose, and consultation with a regional poison control center is recommended. Immediate treatment includes support of cardiorespiratory function and measures to reduce drug absorption. Oxygen, intravenous fluids, vasopressors, assisted ventilation, and other supportive measures should be employed as indicated. Hydrocodone 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 and vasopressors) in the management of circulatory shock and pulmonary edema as indicated. Cardiac arrest or arrhythmias will require advanced life-support measures. Opioid antagonists, such as naloxone, are specific antidotes to respiratory depression resulting from opioid overdose. For clinically significant respiratory or circulatory depression secondary to opioid overdose, administer an opioid antagonist. Because the duration of opioid reversal is expected to be less than the duration of action of hydrocodone from APADAZ, carefully monitor the patient until spontaneous respiration is reliably re-established. If the response to an opioid antagonist is suboptimal or only brief in nature, administer additional antagonist as directed by the product’s prescribing information. In an individual physically dependent on opioids, administration of the recommended usual dosage of the antagonist 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 antagonist administered. If a decision is made to treat serious respiratory depression in the physically dependent patient, administration of the antagonist should be begun with care and by titration with smaller than usual doses of the antagonist.
— Etiqueta de la FDA: Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025. Esto es solo una parte de la sección. Leer la etiqueta completa en DailyMed →
Presentaciones y vía de administración
| Formas farmacéuticas | Tableta |
|---|---|
| Vía | Oral |
| Productos con receta | 3 en el directorio NDC de la FDA |
| Nombres de marca | Apadaz |
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.
- Zevra Therapeutics, Inc.3 productos
Historial de aprobación de la FDA
- NDA: Solicitud de nuevo medicamento (NDA): así se aprueba un medicamento nuevo, normalmente de marca.
| Solicitud | Patrocinador | Aprobada | Cambios aprobados después |
|---|---|---|---|
| NDA208653 APADAZ | Zevra Therap | 23 de febrero de 2018 | 6, el último 31 de octubre de 2024 2024: REMS · 2023: Etiquetado · 2021: Etiquetado |
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
- Zevra Therapeutics, 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) — Apadaz, Zevra Therapeutics, Inc., vigente desde el 7 de enero de 2025; vía openFDA, datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- NDC Directory (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drugs@FDA (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug recall enforcement reports (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 27 de octubre de 2026, consultados el 31 de octubre de 2026
- Drug shortages (openFDA) — Administración de Alimentos y Medicamentos de los EE. UU. (FDA), datos de la FDA exportados el 30 de octubre de 2026, consultados el 31 de octubre de 2026
La FDA ofrece los datos de openFDA tal cual; pueden estar incompletos. Guíese siempre por la etiqueta que viene con su medicamento. Buscador de informes de retiros de la FDA →
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