{ "id": "viagra", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-25", "status": "published_traceable_archive" }, "names": { "brand": "VIAGRA", "generic": "西地那非", "aliases": [ "万艾可", "sildenafil", "sildenafil citrate", "西地那非", "VGR25", "VGR50", "VGR100", "0069-4200-30", "0069-4210-30", "0069-4220-30" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "万艾可®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_3e8b33a11c6fae95", "label": "中国政府网转载食药监总局风险提示：万艾可／西地那非商品名线索（2016）", "url": "https://app.www.gov.cn/govdata/gov/201605/16/380625/article.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_safety_notice", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "泌尿健康", "sourceArchiveMarket": "美国 DailyMed 有日期公开标签（SPL v32，2017-12-15 生效）", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（所引美国公开标签分别列示）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1998（所引美国标签列示 Initial U.S. Approval）", "archiveSponsorText": "Pfizer Laboratories Div Pfizer Inc（美国 DailyMed 公开标签所列）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-viagra-sildenafil-tablet-25mg-30-bottle-ndc-0069-4200-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4200-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 25 mg、30 片瓶装", "en": "VIAGRA sildenafil 25 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-11.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 25, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR25 / PFIZER", "en": "VGR25 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 25 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-viagra-sildenafil-tablet-50mg-30-bottle-ndc-0069-4210-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4210-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 50 mg、30 片瓶装", "en": "VIAGRA sildenafil 50 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-12.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 50, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR50 / PFIZER", "en": "VGR50 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 50 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-viagra-sildenafil-tablet-100mg-30-bottle-ndc-0069-4220-30", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v32（2017-12-15 生效）", "en": "DailyMed SPL v32 (effective 2017-12-15)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [], "productCode": "NDC 0069-4220-30", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "VIAGRA 西地那非 100 mg、30 片瓶装", "en": "VIAGRA sildenafil 100 mg, 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-13.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "西地那非（每片）", "en": "Sildenafil (per tablet)" }, "value": 100, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；不是个人剂量", "en": "Labelled amount per tablet; not an individual dose" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片", "en": "tablets" } }, "physicalClues": { "color": { "zh": "蓝色", "en": "blue" }, "shape": { "zh": "圆角菱形", "en": "rounded diamond" }, "imprint": { "zh": "VGR100 / PFIZER", "en": "VGR100 / PFIZER" }, "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 100 mg、30 片瓶装展示面（Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-viagra-sildenafil-tablet-50mg-30-bottle-ndc-0069-4210-30", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=viagra-12.jpg&setid=0b0be196-0c62-461c-94f4-9a35339b4501&type=img", "alt": "VIAGRA 西地那非在美国 DailyMed Pfizer 公开标签中的 50 mg、NDC 0069-4210-30、30 片瓶装标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v32（2017-12-15 生效）", "presentation": "VIAGRA 西地那非：每片 50 mg，NDC 0069-4210-30，30 片瓶装展示面（DailyMed Pfizer 公开标签所列）。", "notice": "此图只对应所引美国 DailyMed 标签中的 VIAGRA、西地那非 50 mg、NDC 0069-4210-30 与 30 片瓶装。它只帮助核对品牌、通用名、每片标示量、口服片、包装数量、标签外观和来源；不用于鉴定真伪，也不证明 25 mg、100 mg、其他包装、其他市场、当前可得性、原研身份、可替代性或任何个人的片数、开始、停用、联用或换药方案。", "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "VIAGRA 说明书放大阅读：25、50、100 mg 是不同片剂身份，不是自行加减片数的公式", "en": "VIAGRA label reading: 25, 50 and 100 mg identify different tablets; they are not a formula for self-adjusting tablet count" }, "summary": { "zh": "本模块以所引美国 DailyMed 有日期公开标签为阅读入口，帮助核对 VIAGRA、西地那非、每片 25/50/100 mg、蓝色圆角菱形外观、刻印、NDC 与 30 片瓶装。它不提供任何人的服用片数、开始、停用、联用、换药或与其他西地那非产品的换算方案。", "en": "This module uses the cited dated U.S. DailyMed label to check VIAGRA, sildenafil, 25/50/100 mg per tablet, blue rounded-diamond appearance, imprints, NDCs and 30-tablet bottles. It does not provide an individual's tablet count, start, stop, combination, switch or conversion plan with another sildenafil product." }, "checks": [ { "zh": "先把 VIAGRA、西地那非、每片 25、50 或 100 mg、口服片、NDC、瓶装数量和目标市场作为一组核对。毫克数是这一准确片剂的标示量，不是从网页计算个人片数、加量、补用或由一盒换成另一盒的规则。", "en": "Check VIAGRA, sildenafil, 25, 50 or 100 mg per tablet, oral-tablet form, NDC, bottle count and target market as one set. Milligrams are the labelled amount in an exact tablet, not a web rule for personal tablet count, escalation, make-up use or replacing one pack with another." }, { "zh": "所引标签将三种强度均描述为蓝色圆角菱形薄膜衣片，并以 VGR25、VGR50 或 VGR100 及 PFIZER 刻印区分。颜色、形状或单个数字只能作为身份线索；不能凭照片、外观或相同成分确认真伪、当前包装或可替代性。", "en": "The cited label describes all three strengths as blue rounded-diamond film-coated tablets and distinguishes them with VGR25, VGR50 or VGR100 plus PFIZER. Colour, shape or a single number are identity clues only; a photograph, appearance or shared ingredient cannot authenticate a product, establish current packaging or establish interchangeability." }, { "zh": "标签将任何形式的有机硝酸酯或一氧化氮供体列为禁忌，并提示其他可能影响血压或药物暴露的产品需要专业核对。正在用心血管药、泌尿药、非处方药、补充剂或草本时，应带完整药单请药师或开方团队逐项核对；不要从网页自行停用、错开、叠加或借用药物。", "en": "The label lists organic nitrates or nitric-oxide donors in any form as a contraindication and flags other products that can affect blood pressure or drug exposure for professional review. With cardiovascular, urinary, OTC, supplement or herbal products, take the complete medicine list to a pharmacist or prescriber for item-by-item review; do not self-stop, separate, stack or borrow medicines from a webpage." }, { "zh": "出现胸痛、晕厥、突发视力或听力变化，或其他急性严重不适时，应优先按当地紧急医疗渠道处理；不要等待网页检索，也不要用另一盒药自行抵消、调整或补用。", "en": "With chest pain, fainting, sudden vision or hearing changes, or another acute serious concern, prioritise local emergency care; do not wait for a website search or self-counteract, adjust or make up use with another pack." } ], "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "西地那非怎样起作用：它选择性抑制 PDE5，但机制不决定个人是否适用", "en": "How sildenafil works: it selectively inhibits PDE5, but mechanism does not decide individual suitability" }, "summary": { "zh": "所引美国标签将西地那非描述为环磷酸鸟苷特异性磷酸二酯酶 5 型（PDE5）的选择性抑制剂。它解释药物作用路径，不判断任何人的勃起、胸痛、血压、心血管风险、是否适用、片数或与其他产品的联用方案。", "en": "The cited U.S. label describes sildenafil as a selective inhibitor of cyclic guanosine monophosphate-specific phosphodiesterase type 5 (PDE5). It explains a drug-action pathway; it does not determine anyone's erection, chest pain, blood pressure, cardiovascular risk, suitability, tablet count or combination plan with another product." }, "checks": [ { "zh": "把 PDE5 理解为这一药物作用的一条生物学路径即可。机制文字不能反推某个人症状的原因，也不能替代对心血管状况、血压、既往反应、完整药单和准确产品标签的专业评估。", "en": "Read PDE5 as one biological pathway through which this medicine acts. Mechanism wording cannot infer the cause of a person's symptoms or replace professional review of cardiovascular status, blood pressure, prior reactions, the complete medicine list and exact product label." }, { "zh": "同样含西地那非、同样写着 PDE5 或看起来都有相近颜色的产品，并不自动成为可互换、可叠加或可按毫克换算的关系。剂型、市场、强度、其他成分和现行标签都要逐项核对。", "en": "Products that share sildenafil, mention PDE5 or look similarly coloured do not automatically become interchangeable, combinable or milligram-convertible. Dosage form, market, strength, other ingredients and the current label all need item-by-item review." }, { "zh": "对相互作用、既往不适、心血管问题或正在使用硝酸酯等产品的担忧，最有用的下一步是携带准确药盒和完整药单联系药师或医生；机制说明不能替代这一核对。", "en": "For concerns about interactions, prior effects, cardiovascular issues or products such as nitrates, the most useful next step is to bring the exact pack and complete medicine list to a pharmacist or clinician; a mechanism explanation cannot replace that review." } ], "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Clinical Pharmacology；Pfizer，SPL v32）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "VIAGRA", "generic": "西地那非", "dosageFormClass": "口服薄膜衣片：25 mg、50 mg、100 mg（所引美国公开标签分别列示）" }, "labelSource": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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." } } ], "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": "美国 DailyMed 的 VIAGRA 公开标签将其列为西地那非柠檬酸盐口服薄膜衣片，分别列示 25 mg、50 mg、100 mg 三种每片标示量及对应的 30 片瓶装展示面。此页帮助核对品牌、通用名、每片强度、外观、NDC 与来源；不把毫克、瓶数或产品名称变成任何人的服用片数、开始、停用、换药或联用方案。", "history": "所引 DailyMed 标签由 Pfizer Laboratories Div Pfizer Inc 作为品牌标签人列示，标签注明 Initial U.S. Approval: 1998。该档案为有日期的美国公开文件，不证明中国大陆或其他市场的当前品牌、包装、批准、供应、原研/仿制关系或可售资格。", "sourceDocuments": [ { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "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": "DailyMed SPL setid 0b0be196-0c62-461c-94f4-9a35339b4501（美国有日期公开标签记录；本档案不据此推定其他市场状态）", "approvalTimeline": [ { "date": "1998", "title": { "zh": "所引美国标签列示初始批准年份", "en": "Initial U.S. approval year listed in the cited label" }, "detail": { "zh": "所引 VIAGRA 美国 DailyMed 公开标签列示 Initial U.S. Approval: 1998。该年份只定位此美国标签的历史信息；不建立中国大陆、欧盟、日本或其他市场的批准、供应、可售资格、原研/仿制关系、可替代性或个人适用性。", "en": "The cited U.S. DailyMed public label for VIAGRA lists Initial U.S. Approval: 1998. This year only locates the history of this U.S. label; it does not establish approval, supply, sale eligibility, originator/generic relationship, interchangeability or individual suitability in Mainland China, the EU, Japan or another market." }, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2017-12-15", "title": { "zh": "所引 DailyMed SPL v32 生效日期", "en": "Effective date of the cited DailyMed SPL v32" }, "detail": { "zh": "所引 VIAGRA 标签为 SPL v32，Effective Time 为 2017-12-15。本页分别展示 25 mg、NDC 0069-4200-30；50 mg、NDC 0069-4210-30；100 mg、NDC 0069-4220-30 的 30 片瓶装标签身份。该有日期记录不建立当前在售、库存、购买、个人片数、联用、停用、换药或其他市场状态。", "en": "The cited VIAGRA label is SPL v32 with an effective time of 15 Dec 2017. This page separately displays the label identities for the 30-tablet bottles: 25 mg/NDC 0069-4200-30, 50 mg/NDC 0069-4210-30 and 100 mg/NDC 0069-4220-30. This dated record does not establish current marketing, stock, purchase, individual tablet count, co-use, stopping, switching or another-market status." }, "source": { "id": "src_2fdb4edd1fba9d51", "label": "DailyMed（NLM）：VIAGRA 西地那非美国公开标签（Pfizer；SPL v32，2017-12-15 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0b0be196-0c62-461c-94f4-9a35339b4501", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接有日期公开标签与三组准确 30 片瓶装身份", "en": "Dated public label and three exact 30-tablet bottle identities linked" }, "detail": { "zh": "本页分别记录 VIAGRA 西地那非 25 mg、NDC 0069-4200-30；50 mg、NDC 0069-4210-30；100 mg、NDC 0069-4220-30 的 30 片瓶装标签面板。它只用于品牌、通用名、每片标示量、NDC、包装和来源阅读，不用于鉴定真伪，也不建立当前在售、库存、购买、个人片数、开始、停用、联用、换药或可替代性。", "en": "This page records the label panels for VIAGRA sildenafil 25 mg/NDC 0069-4200-30, 50 mg/NDC 0069-4210-30 and 100 mg/NDC 0069-4220-30 30-tablet bottles. They are only for reading brand, generic name, labelled amount per tablet, NDC, package and source; they do not authenticate a product or establish current marketing, stock, purchase, individual tablet count, initiation, stopping, co-use, switching 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": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国历史标签、SPL、NDC、英文商品名、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 historical U.S. label, SPL, NDC, English brand, package image or label holder; every market requires separate checking against current local regulatory material." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "25、50、100 mg 或 30 片瓶装能否告诉我该吃几片、能否加减、或换成另一种西地那非产品？", "en": "Can 25, 50 or 100 mg, or a 30-tablet bottle, tell me how many to take, whether to adjust, or whether I can change to another sildenafil product?" }, "answer": { "zh": "不能。这些字段只识别所引美国标签中的准确产品和包装。共同成分、相近毫克数、外观或包装照片都不建立自行开始、增加、补用、停用、联用、轮换或替代关系；请带实际药盒、现行处方和完整药单请药师或开方团队复核。", "en": "No. These fields only identify exact products and packs in the cited U.S. label. A shared ingredient, nearby milligram number, appearance or package photo does not establish self-initiation, increase, make-up use, stopping, co-use, alternation or substitution; have a pharmacist or prescriber review the actual pack, current prescription and complete medicine list." } }, { "question": { "zh": "为什么页面提到硝酸酯、胸痛和急性不适，却不告诉我是否该停用？", "en": "Why does the page mention nitrates, chest pain and acute concerns without telling me whether to stop?" }, "answer": { "zh": "这些是所引美国标签中禁忌和警示段落的阅读入口，不是个体化风险判断或治疗决策。出现胸痛、晕厥、突发视力或听力变化，或其他急性严重不适时，应优先使用当地紧急医疗支持；任何产品变更需由了解实际处方、病史和完整药单的专业人员核对。", "en": "These are reading entry points for contraindications and warnings in the cited U.S. label, not an individual risk assessment or treatment decision. With chest pain, fainting, sudden vision or hearing changes, or another acute serious concern, prioritise local emergency medical support; any product change needs review by a professional who knows the actual prescription, history 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/viagra/", "en": "https://origindrug.com/en/drugs/viagra/" }, "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." ] }