{ "id": "tenormin", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "TENORMIN", "generic": "阿替洛尔", "aliases": [ "TENORMIN", "atenolol", "阿替洛尔", "24979-244-07", "24979-245-07", "24979-246-07" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国 DailyMed TENORMIN（atenolol）口服片公开标签。本档案仅对应标签展示的 25 mg、50 mg、100 mg 三个 90 片瓶装与对应 NDC；不推定中国大陆或其他市场的当前批准、持有人、供应、可得性或个人适用性。", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（DailyMed 美国公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国公开标签记录（初始批准日期待逐项核验）", "archiveSponsorText": "Upsher-Smith Laboratories, LLC / DailyMed 美国公开标签" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "TENORMIN injection", "atenolol injection", "阿替洛尔注射液" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-tenormin-atenolol-tablet-25mg-90-bottle-ndc-2497924407", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-244-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 25 mg；90 片瓶装", "en": "Atenolol 25 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-25mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；无刻痕", "en": "round, flat tablet; unscored" }, "imprint": "T / 107", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tenormin-atenolol-tablet-50mg-90-bottle-ndc-2497924507", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-245-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 50 mg；90 片瓶装", "en": "Atenolol 50 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-50mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；双刻痕仅为外观线索，不是分片指令", "en": "round, flat tablet; score is an appearance clue, not a splitting instruction" }, "imprint": "TENORMIN / 105", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-tenormin-atenolol-tablet-100mg-90-bottle-ndc-2497924607", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）；仅为标签记录，不代表供应", "en": "U.S. DailyMed public label (access verified 23 Aug 2026); cited label record only, not availability" }, "dosageForm": { "zh": "TENORMIN 阿替洛尔口服片", "en": "TENORMIN atenolol oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 24979-246-07", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片阿替洛尔 100 mg；90 片瓶装", "en": "Atenolol 100 mg per tablet; 90-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-100mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿替洛尔", "en": "atenolol" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、频率、分片或换算指令", "en": "labelled amount per tablet; not an individual's tablet count, frequency, splitting or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 90, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 90, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形扁平片；无刻痕", "en": "round, flat tablet; unscored" }, "imprint": "TENORMIN / 101", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-tenormin-atenolol-tablet-50mg-90-bottle-ndc-2497924507", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=tenormin-50mg.jpg&setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a&type=img", "alt": "TENORMIN 阿替洛尔美国 DailyMed 公开标签中的 50 mg、NDC 24979-245-07、90 片瓶装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed 美国公开标签（所引页面于 2026-08-23 核验）", "presentation": "TENORMIN 阿替洛尔：每片 50 mg，NDC 24979-245-07，90 片瓶装。", "notice": "此图只对应美国 DailyMed 公开标签中的 TENORMIN、阿替洛尔、每片 50 mg、NDC 24979-245-07 与 90 片瓶装。50 mg 片上的刻痕只作为标签外观线索展示，并不表示可以自行掰开、改变片数或换成另一种规格；此图也不用于鉴定真伪，不证明其他规格、包装、市场、当前可得性、原研身份、可替代性或个人治疗方案。", "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "TENORMIN 说明书放大阅读：25、50、100 mg 是片剂身份，不是“该吃几片”", "en": "TENORMIN label reading: 25, 50 and 100 mg identify tablets; they do not answer “how many tablets”" }, "summary": { "zh": "本模块只阅读 DailyMed 美国公开标签中的 TENORMIN、阿替洛尔、口服片、每片标示量、NDC、包装与重要警示。它不提供个人片数、服用时间、分片、联用、停用、换药或购买方案。", "en": "This module reads only TENORMIN, atenolol, oral tablets, labelled amount per tablet, NDCs, packaging and key warnings in the U.S. DailyMed public label. It provides no individual tablet count, timing, splitting, co-use, stopping, switching or purchase plan." }, "checks": [ { "zh": "先把 TENORMIN、阿替洛尔、口服片、每片 25／50／100 mg、实际 NDC、90 片瓶装和目标市场一起核对。mg 是准确片剂的标示量，不是网页可换算成个人每天应服几片，或把另一个规格、品牌、剂型或 β 受体阻断剂自行互换的规则。", "en": "Check TENORMIN, atenolol, oral-tablet form, the stated 25/50/100 mg per tablet, actual NDC, 90-tablet bottle and target market together. Mg is the labelled amount in an exact tablet, not a web rule for an individual's daily tablet count or for self-exchanging another strength, brand, form or beta blocker." }, { "zh": "50 mg 片在标签外观描述中有双刻痕；这只帮助识别该准确片剂。是否可掰开、如何处理吞咽困难或是否需要另一种规格，必须由实际处方、该产品现行说明书和药师或开方团队确认，不能由刻痕、上一盒药或网页自行决定。", "en": "The label's appearance description shows a bisect score on the 50 mg tablet; that only helps identify this exact tablet. Whether it may be split, how to address swallowing difficulty, or whether another strength is needed must be confirmed from the actual prescription, current label and a pharmacist or prescriber—not from a score, a prior pack or this webpage." }, { "zh": "标签对突然停用、心率/血压、肾功能、呼吸系统疾病、妊娠/哺乳及与其他药物同在清单上时的风险提示，需要由专业人员结合实际情况复核。不要因感觉变化或看见另一种同类药，就自行开始、加减、停用、叠加、隔天轮换或替换。", "en": "The label contains cautions involving sudden discontinuation, heart rate/blood pressure, kidney function, respiratory disease, pregnancy/breastfeeding and the presence of other medicines on the list. These need professional review in the actual context. Do not self-start, adjust, stop, combine, alternate or replace it because of a feeling or another same-class pack." }, { "zh": "出现晕厥、呼吸困难、明显心悸/心率异常、胸痛、严重过敏或其他急性严重不适时，应优先使用当地紧急医疗服务；不要等待网页检索，也不要用另一盒药自行抵消或试探。", "en": "With fainting, breathing difficulty, marked palpitations/abnormal heart rate, chest pain, a severe allergic reaction or another acute serious concern, prioritise local emergency medical care. Do not wait for a web search or self-counteract or test with another pack." } ], "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；口服片身份、警示与产品说明）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿替洛尔怎样起作用：标签所述 β1 受体阻断路径", "en": "How atenolol works: the beta-1 receptor-blocking pathway described in the label" }, "summary": { "zh": "美国公开标签将 TENORMIN 描述为偏向 β1 的 β 受体阻断剂，并明确这种选择性不是绝对的。这个机制帮助理解药物类别和标签警示；它不判断个人心率、血压、呼吸状态、肾功能、适用性、片数或任何联用方案。", "en": "The U.S. public label describes TENORMIN as a preferential beta-1 selective beta blocker and explicitly notes that this selectivity is not absolute. This mechanism helps read drug class and label cautions; it does not determine an individual's heart rate, blood pressure, breathing status, kidney function, suitability, tablet count or any combination plan." }, "checks": [ { "zh": "“β1 选择性”或“β 受体阻断剂”是机制和类别线索，不代表与其他 β 受体阻断剂可以自行叠加、轮换、替代或按 mg 换算。准确产品、强度、剂型、目标市场标签、既往反应和完整药单都需一起核对。", "en": "“Beta-1 selective” and “beta blocker” are mechanism and class clues; they do not permit self-combining, alternating, substituting or milligram-converting with another beta blocker. The exact product, strength, dosage form, target-market label, prior reactions and complete medicine list all need review together." }, { "zh": "看到药物机制或某项标签适应症，不能从网页判断某个人是否适合该药或是否应改变用药。涉及心率、血压、呼吸症状、肾功能或新增药物时，请由能看到完整病史、检查和药单的专业人员核对。", "en": "A mechanism or a labelled indication cannot let a webpage decide whether a person is suitable for this medicine or should change use. For heart rate, blood pressure, breathing symptoms, kidney function or an added medicine, obtain review from a professional who can see the complete history, tests and medicine list." }, { "zh": "机制解释不能替代药物警戒、相互作用核对或紧急评估。急性严重不适请优先使用当地紧急医疗渠道；其他问题请带实际药盒和完整药单联系药师或开方团队。", "en": "Mechanism information does not replace pharmacovigilance, interaction review or emergency assessment. For an acute serious problem, prioritise local emergency care; for other questions, contact a pharmacist or prescribing team with the actual pack and complete medicine list." } ], "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "TENORMIN", "generic": "阿替洛尔", "dosageFormClass": "口服片：25 mg、50 mg、100 mg（DailyMed 美国公开标签所列）" }, "labelSource": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "productRoutes": [ { "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" }, "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": "2026-08-23", "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": "2026-08-23", "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": "DailyMed 美国公开标签列示 TENORMIN（atenolol）为口服片，并展示每片 25 mg、50 mg、100 mg、各 90 片瓶装及相应 NDC。本页帮助把商品名、通用名、每片标示量、准确包装面板、现行说明书和药物警戒入口放在一起核对；毫克数只用于产品身份，不能换算为个人片数、频率、分片、联用、换药、停用或购买结论。", "history": "本页只锚定所列美国 DailyMed 公开标签。标签中的产品警示、停用相关文字、心率/血压、肾功能、呼吸系统疾病、妊娠/哺乳和完整用药清单等均需由专业人员结合实际情况阅读；不同剂型、包装、市场或同类产品不能按名称或毫克数自行换算、叠加、轮换或替换。", "sourceDocuments": [ { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } ], "applicationNumber": "NDA 018240（DailyMed 所引美国公开标签记录）", "approvalTimeline": [ { "date": "2026-08-23", "title": { "zh": "DailyMed 美国公开标签核验", "en": "U.S. DailyMed public-label access verified" }, "detail": { "zh": "本页于 2026-08-23 核验 DailyMed 的 TENORMIN（atenolol）美国公开标签。该记录列示 25 mg、50 mg、100 mg 口服片以及 NDC 24979-244-07、24979-245-07、24979-246-07 的 90 片瓶装展示面；这只用于标签与产品身份核对，不建立实际在售、库存、购买、个人片数、分片、联用、换药或其他市场状态。", "en": "On 23 Aug 2026, this page verified the U.S. DailyMed public label for TENORMIN (atenolol). The record lists 25 mg, 50 mg and 100 mg oral tablets and the 90-tablet bottle panels for NDC 24979-244-07, 24979-245-07 and 24979-246-07; this only supports label and product-identity checking, not actual marketing, stock, purchase, individual tablet count, splitting, co-use, switching or another-market status." }, "source": { "id": "src_ec756e687ccd4384", "label": "DailyMed（NLM）：TENORMIN 阿替洛尔美国公开标签（Upsher-Smith；所引页面于 2026-08-23 核验）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=6e850b1e-28a4-4ff8-8ed7-bb0b29faa28a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-23", "reviewedAt": "2026-08-23" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签与三组准确 90 片瓶装面板", "en": "Public label and three exact 90-tablet bottle panels linked" }, "detail": { "zh": "页面分别展示 TENORMIN 阿替洛尔 25 mg、50 mg、100 mg 的指定 NDC 与 90 片瓶装。50 mg 的刻痕只作外观线索，不建立分片、个人片数、实际在售、库存、购买、真伪或可替代性结论。", "en": "The page separately displays the specified NDC and 90-tablet bottle for TENORMIN atenolol 25 mg, 50 mg and 100 mg. The 50 mg score is only an appearance clue; it does not establish splitting, individual tablet count, actual marketing, stock, purchase, authenticity or interchangeability." } }, { "market": { "zh": "中国大陆、欧盟、日本及其他市场", "en": "Mainland China, EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签、NDA、NDC、英文品牌、包装图或标签主体推定当地商品名、批准、包装、供应、可售资格、原研/仿制关系或可替代性；每个市场均须按当地现行监管资料单独核对。", "en": "No local trade name, approval, packaging, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDA, NDC, English brand, package image or label entity; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "50 mg 片有刻痕，是否就可以自行掰半或用两种规格凑出另一个毫克数？", "en": "The 50 mg tablet has a score. Does that mean I can split it myself or combine strengths to make another milligram number?" }, "answer": { "zh": "不能据此决定。刻痕与 25、50、100 mg 都是该美国标签下准确片剂的身份或外观信息；它们不建立个人片数、分片、补用、换算、同日叠加、隔天轮换或与另一种 β 受体阻断剂替代的规则。请让药师或开方团队按实际药盒、处方和完整药单核对。", "en": "No decision follows from that. The score and the 25, 50 and 100 mg values are identity or appearance information for exact tablets in this U.S. label; they do not establish an individual's tablet count, splitting, make-up use, conversion, same-day combination, alternate-day use or replacement with another beta blocker. Have a pharmacist or prescribing team check the actual pack, prescription and complete medicine list." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/tenormin/", "en": "https://origindrug.com/en/drugs/tenormin/" }, "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." ] }