{ "id": "benicar", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-28", "status": "published_traceable_archive" }, "names": { "brand": "Benicar", "generic": "奥美沙坦酯", "aliases": [ "BENICAR", "olmesartan medoxomil", "olmesartan", "奥美沙坦酯" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "心血管", "sourceArchiveMarket": "美国：DailyMed 有日期公开标签（2023-07 更新）列出 BENICAR 奥美沙坦酯 5 mg、20 mg、40 mg 口服薄膜衣片及各 30 片瓶装。本页只建立这份美国标签的产品身份与阅读入口；不据此推定中国大陆、欧盟、日本或其他市场的批准、供应、可售、原研/仿制关系、真伪或可替代性。", "dosageFormClass": "奥美沙坦酯口服薄膜衣片：5 mg、20 mg、40 mg（美国公开标签所列；各 30 片瓶装）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（美国公开标签所列 Initial U.S. Approval）", "archiveSponsorText": "Cosette Pharmaceuticals, Inc.（所引美国公开标签所列标签方）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "BENICAR HCT", "olmesartan medoxomil hydrochlorothiazide", "奥美沙坦酯氢氯噻嗪", "olmesartan injection" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-benicar-olmesartan-medoxomil-tablet-5mg-30-bottle-ndc-0713086030", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0860-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 5 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 5 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "5 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "5 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "黄色", "en": "yellow" }, "shape": { "zh": "圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "round film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C12", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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-benicar-olmesartan-medoxomil-tablet-20mg-30-bottle-ndc-0713086130", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0861-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 20 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 20 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "20 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "20 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "round film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C14", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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-benicar-olmesartan-medoxomil-tablet-40mg-30-bottle-ndc-0713086230", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（2023-07 更新）；仅为所引公开标签记录，不代表供应", "en": "U.S. DailyMed public label (updated Jul 2023); cited public-label record only, not availability" }, "dosageForm": { "zh": "BENICAR 奥美沙坦酯口服薄膜衣片", "en": "BENICAR olmesartan medoxomil film-coated oral tablet" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 0713-0862-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片奥美沙坦酯 40 mg；30 片瓶装（美国公开标签）", "en": "Olmesartan medoxomil 40 mg per tablet; 30-tablet bottle (U.S. public label)" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美沙坦酯", "en": "olmesartan medoxomil" }, "value": 40, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "40 mg 是每片标签标示量；不是个人片数、频率或换算指令", "en": "40 mg is a labelled amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片", "en": "tablets" } }, "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": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "椭圆形薄膜衣片；无刻痕，外观线索不是分片指令", "en": "oval film-coated tablet; unscored, an appearance clue rather than a splitting instruction" }, "imprint": "Sankyo / C15", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验公开标签文字，但未保留可一一对应的官方原品牌包装图，故不展示包装图片", "en": "The public-label text was reviewed, but no one-to-one official original-brand package image was retained, so no package visual is shown" }, "summary": { "zh": "本档案保留 DailyMed 公开标签中 BENICAR、奥美沙坦酯、5 mg／20 mg／40 mg、三个 NDC、各 30 片瓶装和片剂外观文字。未将零售图、版本不明图、其他市场图或无法对应单一强度/NDC 的图片呈现为准确原品牌包装，因此页面不展示包装图片，只保留可放大阅读的一手标签。", "en": "This dossier retains BENICAR, olmesartan medoxomil, 5 mg/20 mg/40 mg, three NDCs, 30-tablet bottles and tablet-appearance wording from the DailyMed public label. No retail image, version-uncertain image, another-market image or image without a single strength/NDC match is presented as an exact original-brand package, so the page withholds package imagery and retains the primary label for enlarged reading." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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": "BENICAR 说明书放大阅读：先认清奥美沙坦酯、5／20／40 mg 与准确瓶装", "en": "BENICAR label reading: identify olmesartan medoxomil, 5/20/40 mg and the exact bottle first" }, "summary": { "zh": "本模块只阅读所引美国公开标签中的 BENICAR、奥美沙坦酯、每片 5/20/40 mg、三个 NDC、各 30 片瓶装与标签警示。它不提供个人血压目标、片数、漏用、分片、加药、停药、与其他降压药或补充剂联用、替换或购买方案。", "en": "This module reads only the cited U.S. public label: BENICAR, olmesartan medoxomil, 5/20/40 mg per tablet, three NDCs, 30-tablet bottles and label warnings. It does not provide individual blood-pressure targets, tablet counts, missed-use, splitting, adding, stopping, co-use with another blood-pressure medicine or supplement, switching or purchasing plans." }, "checks": [ { "zh": "先同时核对 BENICAR、奥美沙坦酯、每片 5/20/40 mg、NDC、30 片瓶装和目标市场。mg 只是这一准确片剂的标签标示量；不是网页可换算成个人片数、把不同强度相加或以另一种降压药替代的规则。", "en": "Check BENICAR, olmesartan medoxomil, 5/20/40 mg per tablet, NDC, the 30-tablet bottle and target market together. mg is only the labelled amount in an exact tablet, not a web rule for tablet counts, adding strengths or replacing another blood-pressure medicine." }, { "zh": "标签将这三种片剂描述为无刻痕；颜色、形状和压印是药盒/药片核对线索，不是自行掰开、调量、混用或由一种强度替代另一种的指令。", "en": "The label describes all three tablets as unscored. Color, shape and imprint are pack/tablet checking clues, not instructions to self-split, change use, combine products or replace one strength with another." }, { "zh": "标签含胎儿毒性警告，并列出低血压、肾功能变化、高钾和与某些药物相互作用等需要核对的内容。怀孕/备孕、肾脏问题、脱水不适、其他降压药、止痛药、锂盐、补钾产品或盐替代品等情形，应由了解完整病史和药单的医生或药师逐项核对；页面不据此决定继续、暂停、补用或改变治疗。", "en": "The label includes a fetal-toxicity warning and material to review about hypotension, renal-function changes, high potassium and interactions with certain medicines. Pregnancy or planning pregnancy, kidney problems, dehydration symptoms, another blood-pressure medicine, pain medicine, lithium, potassium product or salt substitute require item-by-item review by a clinician or pharmacist who knows the full history and medicine list; this page does not decide continuation, pausing, make-up use or a treatment change." }, { "zh": "出现晕厥、呼吸困难、意识改变、严重过敏表现或其他急性严重不适时，应使用当地紧急与医疗渠道；不要等待网页检索，也不要依据本页自行加药、停药或以另一盒药抵消。", "en": "For fainting, breathing difficulty, altered consciousness, serious allergic features or another acute severe concern, use local urgent and medical pathways; do not wait for a web search or self-add, stop or counteract with another pack based on this page." } ], "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Warnings, interactions and product identity）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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": "奥美沙坦酯怎样起作用：阻断血管紧张素 II 的 AT1 受体作用路径", "en": "How olmesartan medoxomil works: it blocks an angiotensin II AT1-receptor pathway" }, "summary": { "zh": "所引标签将奥美沙坦描述为血管紧张素 II 受体阻断剂，并说明它选择性阻断血管平滑肌上的 AT1 受体结合。这个机制说明药物类别和标签阅读线索，不预测个人血压、肾功能、血钾、适用性、片数或联合方案。", "en": "The cited label describes olmesartan as an angiotensin II receptor blocker and says it selectively blocks binding at AT1 receptors in vascular smooth muscle. This explains a drug class and label-reading clue; it does not predict an individual's blood pressure, renal function, potassium, suitability, tablet count or combination plan." }, "checks": [ { "zh": "“AT1 受体阻断剂”是机制类别，不是从网页判断血压读数、头晕、化验异常或是否需要调整的工具。任何治疗决定都需要由专业人员结合准确诊断、检查、现行标签和完整药单作出。", "en": "“AT1 receptor blocker” is a mechanism class, not a website tool for interpreting a blood-pressure reading, dizziness, an abnormal test or a need for adjustment. Treatment decisions need a professional with the exact diagnosis, tests, current label and complete medicine list." }, { "zh": "同属 ARB、同有 AT1 机制、名称相近或包装上都有 mg，均不证明可以自行叠加、轮换、补用或替换。请把所有处方药、非处方药、补充剂及实际药盒交由药师或开方团队核对。", "en": "Being ARBs, sharing an AT1 mechanism, having similar names or showing mg on packages does not establish that products can be self-combined, alternated, made up or replaced. Take all prescription medicines, OTC products, supplements and actual packs for pharmacist or prescriber review." }, { "zh": "这份美国公开标签的机制资料不能建立中国大陆、欧盟、日本或其他市场的产品状态，也不能替代当前说明书、血压监测计划或个体化治疗。", "en": "This U.S. public label's mechanism material does not establish product status in Mainland China, the EU, Japan or another market and cannot replace a current leaflet, blood-pressure monitoring plan or individualised care." } ], "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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": "Benicar", "generic": "奥美沙坦酯", "dosageFormClass": "奥美沙坦酯口服薄膜衣片：5 mg、20 mg、40 mg（美国公开标签所列；各 30 片瓶装）" }, "labelSource": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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 的 BENICAR（olmesartan medoxomil）公开标签列有 5 mg、20 mg、40 mg 口服薄膜衣片、各自 30 片瓶装、NDC 与片剂外观线索。本页帮助读者把药盒上的品牌、通用名、每片标示量和公开电子说明书放在一起核对；不把 mg、包装数字、颜色或“降压药”类别转换为个人片数、开始、加减、联用、替换、停用或购买结论。", "history": "该档案以 DailyMed 的 BENICAR 美国公开标签为产品身份锚点。标签列示 Initial U.S. Approval: 2002，并列有 5 mg（NDC 0713-0860-30）、20 mg（NDC 0713-0861-30）、40 mg（NDC 0713-0862-30）各 30 片瓶装。相同通用名、相近 mg、颜色、瓶装数量或同为血压相关药物，都不能证明可自行换用、叠加、拆分、补用或改变任何现有治疗。", "sourceDocuments": [ { "id": "src_44ef083a89cdfd0e", "label": "DailyMed（NLM）：BENICAR 奥美沙坦酯美国公开标签（Cosette；2023-07 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口（BENICAR）", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "DailyMed 美国公开标签列有 Initial U.S. Approval: 2002（本档案不另行断言申请号）", "approvalTimeline": [ { "date": "2002", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 2002。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 2002. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed: BENICAR olmesartan medoxomil U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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" } }, { "date": "2023-07 updated public label", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2023-07 updated public label 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2023-07 updated public label FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_44ef083a89cdfd0e", "label": "DailyMed: BENICAR olmesartan medoxomil U.S. public label", "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=5b6f8a18-8f8a-4521-81c3-3a39c73c6646", "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": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/benicar/", "en": "https://origindrug.com/en/drugs/benicar/" }, "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." ] }