{ "id": "lexapro", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-23", "status": "published_traceable_archive" }, "names": { "brand": "Lexapro", "generic": "艾司西酞普兰", "aliases": [ "escitalopram" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "精神健康", "sourceArchiveMarket": "美国 DailyMed 公开标签（Allergan，2023-10 更新）。本档案仅建立 5 mg、10 mg、20 mg 各一款 100 片瓶装标签面板；同页口服溶液、单位剂量包装、其他市场和后续版本须分别核对。", "dosageFormClass": "艾司西酞普兰口服薄膜衣片：5 mg、10 mg、20 mg（本页分别展示三个 100 片瓶装）；同页另有 1 mg/mL 口服溶液，不能与片剂混作一种产品", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "2002（DailyMed 2023 美国公开标签所列初始批准）", "archiveSponsorText": "Allergan / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-lexapro-escitalopram-tablet-5mg-100-bottle-ndc-0456200501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram 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 0456-2005-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 5 mg；100 片瓶装", "en": "Escitalopram 5 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-02.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching 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": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "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": "圆形片（约 6 mm）", "en": "round tablet (about 6 mm)" }, "imprint": "FL / 5", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lexapro-escitalopram-tablet-10mg-100-bottle-ndc-0456201001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram 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 0456-2010-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 10 mg；100 片瓶装", "en": "Escitalopram 10 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-03.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching 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": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "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": "圆形片（约 7 mm）", "en": "round tablet (about 7 mm)" }, "imprint": "F / L / 10", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-lexapro-escitalopram-tablet-20mg-100-bottle-ndc-0456202001", "marketCode": "US", "labelVersion": { "zh": "DailyMed 美国公开标签（Allergan；2023-10 更新）；仅为所引公开标签展示面，不代表供应", "en": "U.S. DailyMed public label (Allergan; updated Oct 2023); cited public label panel only, not availability" }, "dosageForm": { "zh": "LEXAPRO 艾司西酞普兰口服薄膜衣片", "en": "LEXAPRO escitalopram 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 0456-2020-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片艾司西酞普兰 20 mg；100 片瓶装", "en": "Escitalopram 20 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-04.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "艾司西酞普兰", "en": "escitalopram" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、分割、转换、停用、联用或换药指令", "en": "labelled amount per tablet; not an individual's tablet count, splitting, conversion, stopping, co-use or switching 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": "2026-08-23", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "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": "圆形片（约 10 mm）", "en": "round tablet (about 10 mm)" }, "imprint": "F / L / 20", "scoreStatus": "scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 艾司西酞普兰美国公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=lexapro-02.jpg&setid=13bb8267-1cab-43e5-acae-55a4d957630a&type=img", "alt": "LEXAPRO 5 mg 艾司西酞普兰片在美国 DailyMed 公开标签中的 AbbVie 100 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Allergan/AbbVie，2023-10 更新）", "presentation": "LEXAPRO 5 mg、100 片瓶装标签图（DailyMed 公开标签所列；AbbVie 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 LEXAPRO 5 mg、100 片装的 AbbVie 标签图，只帮助核对品牌、通用名、标示强度、片剂、包装数量和来源；不用于鉴定真伪，也不证明 10 mg/20 mg、口服溶液、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "LEXAPRO 说明书放大阅读：不同片剂、口服溶液与停药问题不能只看 mg", "en": "LEXAPRO label reading: tablet, oral-solution and stopping questions cannot be answered from mg alone" }, "summary": { "zh": "本模块以 Allergan 的 DailyMed 2023-10 美国公开标签为阅读入口，帮助核对 LEXAPRO、艾司西酞普兰、5/10/20 mg 片剂或 1 mg/mL 口服溶液、包装和目标市场；它不提供个人用量、停药、转换或联用方案。", "en": "This module uses Allergan's October 2023 U.S. DailyMed public label as a reading entry point. It helps check LEXAPRO, escitalopram, 5/10/20 mg tablets or 1 mg/mL oral solution, package and target market; it does not provide an individual's amount, stopping, switching or combination plan." }, "checks": [ { "zh": "5、10、20 mg 是片剂的标示强度；1 mg/mL 是口服溶液的浓度。它们不是同一种标注方式，不能把“几片”自行换成“几毫升”，也不能以相同通用名或相近数字推定产品可以互换。", "en": "5, 10 and 20 mg are labelled tablet strengths; 1 mg/mL is an oral-solution concentration. They are not the same type of label, do not support self-conversion from “tablets” to “millilitres,” and do not make products interchangeable because the generic name or a number looks similar." }, { "zh": "该标签列示 10 mg、20 mg 片有刻痕，5 mg 片无刻痕。刻痕只是这份准确标签中的外观/制剂信息，不是对任何片剂自行掰开、凑量、加减或替换的通用许可；实际包装应请药师或开方团队核对。", "en": "This label lists scored 10 mg and 20 mg tablets and a non-scored 5 mg tablet. A score is appearance/formulation information in this exact label, not universal permission to split, combine, adjust or substitute any tablet; have the actual package checked by a pharmacist or prescribing team." }, { "zh": "公开标签提示停用相关症状，并提出应逐步处理而非突然中断。不要因短期情绪、睡眠、胃肠道不适、余药或网上经验自行突然停用、隔日服用、借用他人的药或换成其他抗抑郁药。", "en": "The public label notes discontinuation-related symptoms and calls for gradual rather than sudden handling. Do not abruptly self-stop, take it on alternating days, use someone else’s medicine or change to another antidepressant because of short-term mood, sleep, gastrointestinal symptoms, leftover medicine or online experience." }, { "zh": "标签列出与其他影响血清素药物、MAOI、止痛药、偏头痛药、草本和其他产品有关的联用风险线索。家中全部处方药、非处方药、补充剂与饮酒情况应一起交给药师或开方团队，网页不能判断个人能否同服或怎样转换。", "en": "The label lists combination-risk clues involving other serotonin-affecting medicines, MAOIs, pain and migraine medicines, herbs and other products. Bring every prescription, OTC product, supplement and alcohol use together to a pharmacist or prescribing team; a webpage cannot determine individual combination or switching." }, { "zh": "出现新的或加重的自伤想法、明显激越/意识变化、昏厥、抽搐，或疑似严重不适时，应使用当地急诊、危机干预或医疗支持渠道；不要等待网页或自行改药。", "en": "With new or worsening self-harm thoughts, marked agitation/mental-status change, fainting, seizure or a suspected serious reaction, use local emergency, crisis or medical-support channels; do not wait for a webpage or self-change a medicine." } ], "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "艾司西酞普兰怎样起作用：它是选择性血清素再摄取抑制剂", "en": "How escitalopram works: it is a selective serotonin reuptake inhibitor" }, "summary": { "zh": "DailyMed 标签将 LEXAPRO 描述为选择性血清素再摄取抑制剂（SSRI）。这解释它影响血清素信号的药理路径，但不预测个人情绪反应，也不决定个人是否适用、应服多少、何时停用或如何换药。", "en": "The DailyMed label describes LEXAPRO as a selective serotonin reuptake inhibitor (SSRI). This explains a pharmacologic pathway involving serotonin signalling, but does not predict an individual's mood response or decide suitability, amount, stopping or switching." }, "checks": [ { "zh": "同为 SSRI，或都“影响血清素”，不表示 LEXAPRO 能与另一种抗抑郁药、止痛药、偏头痛药、镇咳感冒产品、草本或补充剂自行叠加、轮换或替代。所有产品和完整药单都必须由专业人员逐项核对。", "en": "Being an SSRI, or both “affecting serotonin,” does not make LEXAPRO self-combinable, alternatable or substitutable with another antidepressant, pain medicine, migraine medicine, cough/cold product, herb or supplement. Every product and the complete list need item-by-item professional review." }, { "zh": "选择性再摄取抑制的机制不能把 5、10、20 mg 或片剂/溶液转换为个人剂量、减量或换药规则。每种剂型、标示、目标市场、既往情况与其他用药都需回到实际包装、现行标签和开方团队。", "en": "A selective-reuptake-inhibition mechanism cannot turn 5, 10 or 20 mg, or tablet/solution form, into individual dosing, tapering or switching rules. Each form, marking, target market, history and other medicine must return to the actual package, current label and prescribing team." }, { "zh": "机制也不能用来自行解释新的焦躁、睡眠变化、头晕、跌倒风险、意识改变或自伤想法。出现急性或严重问题时，应优先使用当地紧急和专业支持，而不是从药理名词推导操作。", "en": "Mechanism also cannot be used to self-explain new agitation, sleep change, dizziness, fall risk, mental-status change or self-harm thoughts. With an acute or serious concern, prioritise local urgent and professional support rather than derive an action from pharmacology terms." } ], "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Lexapro", "generic": "艾司西酞普兰", "dosageFormClass": "艾司西酞普兰口服薄膜衣片：5 mg、10 mg、20 mg（本页分别展示三个 100 片瓶装）；同页另有 1 mg/mL 口服溶液，不能与片剂混作一种产品" }, "labelSource": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "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": "2026-08-20", "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_da9815ebf7d41137", "label": "FDA：LEXAPRO 2021 美国标签（NDA 021365 / 021323）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "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": "2026-08-20", "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 LEXAPRO（escitalopram）2023 美国公开标签列示 5 mg、10 mg、20 mg 口服片与 1 mg/mL 口服溶液。本页分别建立三个 100 片瓶装片剂面板的品牌、通用名、每片标示量、NDC、外观线索和一手来源核对卡；不把包装数字变成个人片数、分割、停用、联用、转换或购买结论。", "history": "本页的三个包装面板仅对应 LEXAPRO 5 mg（NDC 0456-2005-01）、10 mg（NDC 0456-2010-01）与 20 mg（NDC 0456-2020-01）各 100 片瓶装。10 mg 与 20 mg 的刻痕只是这些准确片剂的外观/制剂线索，不能成为自行分割、加减、换药或把片剂换算为同页口服溶液的许可。涉及突然停用或与其他影响血清素药物联用时，必须回到现行标签和专业团队。", "sourceDocuments": [ { "id": "src_12bf4c52da877ec6", "label": "DailyMed（NLM）：LEXAPRO 公开标签（Allergan，2023-10 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=13bb8267-1cab-43e5-acae-55a4d957630a", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_da9815ebf7d41137", "label": "FDA：LEXAPRO 2021 美国标签（NDA 021365 / 021323）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "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": "NDA 021365 / 021323", "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_da9815ebf7d41137", "label": "FDA: LEXAPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2021-09", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2021-09 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 2021-09 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_da9815ebf7d41137", "label": "FDA: LEXAPRO label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2021/021365s038%2C021323s053lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "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/lexapro/", "en": "https://origindrug.com/en/drugs/lexapro/" }, "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." ] }