{ "id": "ultram", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-30", "status": "published_traceable_archive" }, "names": { "brand": "ULTRAM", "generic": "盐酸曲马多片", "aliases": [ "Ultram", "tramadol hydrochloride", "tramadol", "盐酸曲马多片", "曲马多片", "曲马多", "NDA 020281", "ANDA 076003", "50458-659-60", "60219-2348-1", "ULTRAM 06 59", "AN 627" ], "marketBrandNames": [ { "name": "ULTRAM", "market": { "zh": "美国（历史）", "en": "United States (historical)" }, "evidenceStatus": "historical_public_record", "note": { "zh": "历史品牌 50 mg、100 片瓶装；已停止营销并撤回 NDA，不代表当前供应。", "en": "Historical 50 mg brand product in a 100-tablet bottle; marketing ended and the NDA was withdrawn, so this is not current-supply evidence." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国历史 ULTRAM 品牌标签列示曲马多盐酸盐 50 mg、NDC 50458-659-60、100 片瓶装，营销终止日为 2022-09-30；FDA 记录 NDA 020281 于 2023-10-05 撤回，并注明不是因安全性或有效性原因撤市。当前 Amneal 通用药标签另列 50 mg、NDC 60219-2348-1、100 片瓶装。本页把历史品牌和当前 ANDA 比较项分开，不证明实时库存、购买资格、中国大陆或其他市场批准、真伪或可替代性。", "dosageFormClass": "曲马多盐酸盐即释包衣口服片：历史 ULTRAM 与当前 Amneal 通用药比较项均为每片 50 mg；ULTRACET 复方、ULTRAM ER／其他缓释曲马多及其他阿片产品不并入本档案。刻痕只作为产品身份线索，不自动构成可自行分片许可。", "dosageFormClassCode": "oral_modified_release", "route": "口服（高风险即释阿片产品身份字段）", "routeCode": "oral", "historicalApprovalEntry": "1995（当前通用药标签所列美国初始批准；ULTRAM NDA 020281 已于 2023-10-05 撤回）", "archiveSponsorText": "Janssen Pharmaceuticals, Inc.（历史 ULTRAM NDA 020281）；Amneal Pharmaceuticals NY LLC（当前 ANDA 076003 比较项）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ULTRAM", "Ultram", "盐酸曲马多片", "曲马多片" ], "excludedProductCues": [ "ULTRACET", "tramadol and acetaminophen", "曲马多对乙酰氨基酚复方", "ULTRAM ER", "tramadol extended-release", "曲马多缓释片" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-ultram-tramadol-hydrochloride-50mg-100-bottle-ndc-50458-659-60-historical", "marketCode": "US", "labelVersion": { "zh": "DailyMed 历史美国品牌标签（2023-03 修订；营销终止 2022-09-30）", "en": "Historical U.S. DailyMed brand label (revised Mar 2023; marketing ended 30 Sep 2022)" }, "dosageForm": { "zh": "ULTRAM 曲马多盐酸盐包衣口服片", "en": "ULTRAM tramadol hydrochloride coated oral tablet" }, "route": { "zh": "口服（历史品牌产品身份字段）", "en": "oral (historical brand product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 50458-659-60", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片曲马多盐酸盐 50 mg；100 片瓶装；美国历史品牌产品", "en": "Tramadol hydrochloride 50 mg per tablet; 100-tablet bottle; historical U.S. brand product" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲马多盐酸盐", "en": "tramadol hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片历史标签标示量；不是个人片数、频率、疗程、转换或补服指令", "en": "historical labelled amount per tablet; not an individual's tablet count, frequency, course, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "marketing_ended", "marketingStartDate": null, "marketingEndDate": "2022-09-30", "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形（胶囊形）包衣片", "en": "oval (capsule-shaped) coated tablet" }, "imprint": "ULTRAM / 06 / 59", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amneal-tramadol-hydrochloride-50mg-100-bottle-ndc-60219-2348-1-current-anda", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国通用药标签（SPL v4，2026-05-21 发布）", "en": "Current U.S. DailyMed generic label (SPL v4, published 21 May 2026)" }, "dosageForm": { "zh": "Amneal 曲马多盐酸盐 50 mg 包衣口服片（通用药比较项）", "en": "Amneal tramadol hydrochloride 50 mg coated oral tablet (generic comparator)" }, "route": { "zh": "口服（当前通用药产品身份字段）", "en": "oral (current generic product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 60219-2348-1", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片曲马多盐酸盐 50 mg；100 片瓶装；ANDA 076003 通用药比较项", "en": "Tramadol hydrochloride 50 mg per tablet; 100-tablet bottle; ANDA 076003 generic comparator" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tramadol-hydrochloride-tablets-usp-50-mg-4.jpg&setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "曲马多盐酸盐", "en": "tramadol hydrochloride" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片当前标签标示量；不是个人片数、频率、疗程、转换或补服指令", "en": "current labelled amount per tablet; not an individual's tablet count, frequency, course, conversion or missed-use instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-30", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片", "en": "round film-coated tablet" }, "imprint": "AN / 627", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-amneal-tramadol-hydrochloride-50mg-100-bottle-ndc-60219-2348-1-current-anda", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tramadol-hydrochloride-tablets-usp-50-mg-4.jpg&setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d&type=img", "alt": "Amneal 曲马多盐酸盐 50 mg、NDC 60219-2348-1、100 片瓶装当前美国通用药标签面板", "archiveMarket": "美国", "labelVersion": "DailyMed 当前通用药 SPL v4（2026-05-21 发布）", "presentation": "Amneal 曲马多盐酸盐 50 mg；NDC 60219-2348-1；100 片瓶装；ANDA 076003 比较项", "notice": "此图是当前美国通用药比较项，不是历史 ULTRAM 原品牌包装图。它只对应所引 NDC、强度和瓶装，不用于鉴定真伪，也不证明当前库存、购买资格、个人适用或可与 ULTRAM、ULTRAM ER、ULTRACET 或其他阿片自行替换。", "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ULTRAM／曲马多说明书放大阅读：先核对镇静、呼吸、癫痫与血清素风险", "en": "ULTRAM / tramadol label reading: prioritise sedation, breathing, seizure and serotonin risks" }, "summary": { "zh": "本模块用历史品牌身份和当前通用药标签解释即释曲马多的准确产品边界与高风险药单线索；不决定个人是否使用，也不生成片数、频率、疗程、转换、补服、减量或停药方案。", "en": "This module combines the historical brand identity with a current generic label to explain immediate-release tramadol and higher-risk medicine-list cues. It does not decide individual use or generate tablet count, frequency, course, conversion, missed-use, tapering or stopping." }, "checks": [ { "zh": "异常嗜睡、叫不醒、呼吸慢浅、嘴唇发青、意识改变或疑似误服／过量属于急症线索，应立即使用当地急救或毒物咨询服务。老人、虚弱者、慢性肺病患者和同时使用镇静药者尤其需要优先核对。", "en": "Unusual sleepiness, inability to wake, slow or shallow breathing, blue lips, altered consciousness or suspected accidental ingestion/overdose are emergency cues requiring local emergency or poison services. Older or frail people, those with chronic lung disease and people also taking sedatives need priority review." }, { "zh": "苯二氮卓类安眠／抗焦虑药、其他镇静催眠药、酒精、加巴喷丁类、其他阿片或麻醉药可能共同增加深度镇静、呼吸抑制、昏迷和死亡风险。错开时间不自动证明安全，必须核对完整药单。", "en": "Benzodiazepine sleeping/anxiety medicines, other sedative-hypnotics, alcohol, gabapentinoids, other opioids or anaesthetics may add to profound sedation, respiratory depression, coma and death. Separating clock times does not prove safety; review the complete medicine list." }, { "zh": "部分 SSRI、SNRI、三环类抗抑郁药、曲普坦、MAO 抑制剂、利奈唑胺、锂盐、圣约翰草及其他影响血清素的药可能增加血清素综合征风险。躁动、发热、多汗、震颤、肌肉僵硬、腹泻或意识变化等组合表现需要及时医疗评估，严重时使用急救服务。", "en": "Some SSRIs, SNRIs, tricyclic antidepressants, triptans, MAO inhibitors, linezolid, lithium, St John's wort and other serotonergic medicines may increase serotonin-syndrome risk. A combination of agitation, fever, sweating, tremor, muscle rigidity, diarrhoea or mental-status change needs prompt medical assessment and emergency services if severe." }, { "zh": "曲马多可增加癫痫发作风险；既往癫痫、头部损伤、戒酒／戒镇静药，或同用会降低惊厥阈值的药时更需要专业核对。不要因疼痛加重自行叠加片数或与另一止痛药轮换。", "en": "Tramadol can increase seizure risk. A seizure history, head injury, alcohol/sedative withdrawal or another medicine that lowers the seizure threshold requires professional review. Do not self-add tablets or alternate another pain medicine because pain worsens." }, { "zh": "CYP2D6 与 CYP3A4 相关药物或个体代谢差异可能改变曲马多及其活性代谢物暴露；这不是让网页根据基因、药名或症状计算个人用法的依据。是否需要药物基因检测必须结合临床问题由专业人员判断。", "en": "CYP2D6- and CYP3A4-related medicines or metabolic variation can alter tramadol and active-metabolite exposure. This does not let a webpage calculate individual use from a gene, medicine name or symptom. Whether pharmacogenetic testing is useful requires a specific clinical question and professional judgement." }, { "zh": "历史 ULTRAM 与当前通用药片都有刻痕记录，但刻痕不是对所有人自行掰片、减半、拼规格或改变频率的通用许可。请以手中准确产品的当前说明书、处方和药师／医生核对为准。", "en": "Both the historical ULTRAM and current generic tablet have scored appearances, but a score is not universal permission to split, halve, assemble a strength or change frequency. Use the current label for the exact product in hand and the prescription, pharmacist or clinician review." }, { "zh": "儿童或未被开具者误服可能致命。药品应上锁、不得分享，并按当地回收或官方处置渠道处理；怀疑误服时不要等待网页判断。", "en": "Accidental ingestion by a child or person for whom it was not prescribed can be fatal. Store it locked, never share it and use local take-back or official disposal routes; do not wait for a webpage if ingestion is suspected." } ], "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "曲马多怎样起作用：弱阿片受体作用与单胺再摄取影响不能变成个人换算表", "en": "How tramadol works: opioid-receptor activity and monoamine-reuptake effects are not a personal conversion table" }, "summary": { "zh": "曲马多及其活性代谢物具有阿片受体相关作用，同时影响去甲肾上腺素和血清素再摄取。这能解释镇痛、嗜睡、呼吸抑制、癫痫和血清素风险，却不能推导个人应服几片、与另一阿片如何换算、是否需要基因筛查或何时减停。", "en": "Tramadol and its active metabolite have opioid-receptor activity and also affect norepinephrine and serotonin reuptake. This helps explain analgesia, sedation, respiratory depression, seizure and serotonin risks, but cannot derive an individual's tablet count, conversion from another opioid, need for genetic screening or taper/stopping timing." }, "checks": [ { "zh": "“作用较弱”不等于没有阿片风险；同类、共同用途或相近毫克数也不表示可与 OXYCONTIN、可待因、吗啡或其他止痛药自行叠加、轮换或替换。", "en": "‘Weaker’ does not mean free of opioid risk. A shared class, purpose or similar milligram number does not permit self-combination, alternation or substitution with OXYCONTIN, codeine, morphine or another pain medicine." }, { "zh": "CYP2D6 差异可能改变活性代谢物形成，但基因结果不是单独的选药或片数答案；还需准确产品、完整药单、肝肾功能、呼吸状况与治疗目标。", "en": "CYP2D6 variation may alter active-metabolite formation, but a gene result alone is not a medicine-selection or tablet-count answer. The exact product, full medicine list, hepatic/renal and respiratory status and treatment goal still matter." }, { "zh": "出现疼痛变化、嗜睡、跌倒、意识或呼吸改变、震颤、发热或疑似戒断时，机制页不能判断原因。不要同时改变多种药；联系负责治疗的团队，严重表现使用当地急救服务。", "en": "A mechanism page cannot determine the cause of pain change, sleepiness, a fall, altered consciousness or breathing, tremor, fever or suspected withdrawal. Do not change several medicines at once; contact the treating team and use local emergency services for severe signs." } ], "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ULTRAM", "generic": "盐酸曲马多片", "dosageFormClass": "曲马多盐酸盐即释包衣口服片：历史 ULTRAM 与当前 Amneal 通用药比较项均为每片 50 mg；ULTRACET 复方、ULTRAM ER／其他缓释曲马多及其他阿片产品不并入本档案。刻痕只作为产品身份线索，不自动构成可自行分片许可。" }, "labelSource": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-30", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "ULTRAM 是美国历史曲马多盐酸盐 50 mg 即释品牌片，品牌产品已停止营销并撤回 NDA；美国仍有通用药标签作为当前安全阅读比较项。曲马多既有阿片相关的嗜睡、呼吸抑制、依赖和误服风险，也会影响去甲肾上腺素和血清素通路，因此与安眠镇静药、酒精、其他阿片、部分抗抑郁药或诱发癫痫的药同在一张药单时必须优先核对。网页只帮助识别产品和风险，不提供个人片数、频率、换算、加减量或停药方案。", "history": "ULTRAM NDA 020281 于 1995 年进入美国市场；历史 DailyMed 标签记录 50 mg、NDC 50458-659-60、100 片瓶装和 2022-09-30 营销终止日。FDA 后续审评记载 NDA 于 2023-10-05 撤回，并说明不是因安全性或有效性原因撤市。当前标签阅读采用 2026 年 Amneal ANDA 076003 通用药资料，并与历史品牌包装身份明确分开。", "sourceDocuments": [ { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_d459573b676f174f", "label": "FDA：ULTRAM NDA 020281 撤回及通用药参比标签审评记录（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208708Orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } ], "applicationNumber": "FDA NDA 020281（ULTRAM，已撤回）／ANDA 076003（当前通用药比较项）", "approvalTimeline": [ { "date": "1995", "title": { "zh": "ULTRAM 美国初始批准", "en": "Initial U.S. approval of ULTRAM" }, "detail": { "zh": "历史品牌标签列出 Initial U.S. Approval: 1995，并与 50 mg 产品身份相连。", "en": "The historical brand label states Initial U.S. Approval: 1995 and links it to the 50 mg product identity." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2022-09-30", "title": { "zh": "历史品牌营销终止", "en": "Historical brand marketing ended" }, "detail": { "zh": "DailyMed 历史产品表列 NDC 50458-659-60 的营销终止日；不据此推断个人应停药或当前通用药状态。", "en": "The historical DailyMed product table gives the marketing end date for NDC 50458-659-60; this does not direct an individual to stop or establish current generic status." }, "source": { "id": "src_b4e1e8bd42b55fe9", "label": "DailyMed（NLM）：ULTRAM 曲马多盐酸盐 50 mg 历史美国品牌标签（Janssen；NDA 020281；2023-03 修订）", "url": "https://dailymed.nlm.nih.gov/dailymed/downloadpdffile.cfm?setId=45f59e6f-1794-40a4-8f8b-3a9415924468", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2023-10-05", "title": { "zh": "NDA 020281 撤回生效", "en": "Withdrawal of NDA 020281 became effective" }, "detail": { "zh": "FDA 审评记录注明该产品不是因安全性或有效性原因撤市，并把当前标签承接问题与通用药参比记录分开讨论。", "en": "The FDA review states the product was not withdrawn for safety or effectiveness reasons and separately discusses current model labelling through generic-reference records." }, "source": { "id": "src_d459573b676f174f", "label": "FDA：ULTRAM NDA 020281 撤回及通用药参比标签审评记录（2024）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2024/208708Orig1s016.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-05-21", "title": { "zh": "当前通用药标签发布", "en": "Current generic label published" }, "detail": { "zh": "Amneal SPL v4 提供当前警示、Medication Guide、50 mg 产品和准确 100 片瓶装面板。", "en": "Amneal SPL v4 provides current warnings, a Medication Guide, the 50 mg product and an exact 100-tablet bottle panel." }, "source": { "id": "src_defef78920be450d", "label": "DailyMed（NLM）：曲马多盐酸盐 50 mg 当前美国通用药标签（Amneal；SPL v4，2026-05-21 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8ec4e4e5-a56e-4198-8428-6b770b9bf27d", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "历史品牌已停止；当前通用药比较项已建立", "en": "Historical brand ended; current generic comparator established" }, "detail": { "zh": "品牌、通用药、NDA、ANDA、NDC 和包装必须分别核对。", "en": "Brand, generic, NDA, ANDA, NDC and package must be checked separately." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "现行监管记录待逐项建立", "en": "Current regulatory records not yet established" }, "detail": { "zh": "不从美国历史品牌或通用药包装推定当地批准、供应、原研／仿制关系或合法购药渠道。", "en": "No local approval, supply, originator/generic relationship or lawful purchasing route is inferred from a historical U.S. brand or generic pack." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "有刻痕就可以掰半吗？", "en": "Does a score mean I can split it in half?" }, "answer": { "zh": "不能只凭刻痕这样决定。刻痕是产品身份线索；是否可分、分后是否符合处方及能否安全操作，需要核对手中准确产品、当前说明书和专业意见。网页不把 50 mg 自动换成个人的两份 25 mg 用法。", "en": "Not from the score alone. It is a product-identity clue. Whether splitting is permitted, matches the prescription and can be done safely requires the exact product, current label and professional review. The site does not turn 50 mg into two personal 25 mg instructions." } }, { "question": { "zh": "曲马多和安眠药错开吃就安全吗？", "en": "Is tramadol safe with a sleeping medicine if times are separated?" }, "answer": { "zh": "网页不能确认。两类药的镇静和呼吸抑制作用可能重叠，错开时间本身不证明安全；应把完整药单、酒精使用和实际服用时间交给医生或药师核对。", "en": "A webpage cannot confirm that. Sedation and respiratory-depression effects may overlap, and separate timing does not prove safety. Have a clinician or pharmacist review the complete list, alcohol exposure and actual timing." } }, { "question": { "zh": "要不要先做 CYP2D6 基因检测？", "en": "Should CYP2D6 testing be done first?" }, "answer": { "zh": "不是人人都能从全基因或单基因筛查得到可直接执行的选药答案。是否检测取决于具体临床问题、既往反应、完整药单及可用解释路径，应由专业人员判断；出现严重不适先处理急症，不等待基因结果。", "en": "Not everyone obtains an actionable medicine-selection answer from whole-genome or single-gene screening. Testing depends on the clinical question, prior response, full medicine list and an available interpretation pathway. Severe symptoms require urgent care rather than waiting for a genetic result." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "polypharmacy-safety-guide", "dosage-forms-are-part-of-medicine-identity", "pharmacogenomics-drug-response" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/ultram/", "en": "https://origindrug.com/en/drugs/ultram/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }