{ "id": "zofran", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "ZOFRAN / ZOFRAN ODT", "generic": "昂丹司琼", "aliases": [ "Zofran", "ZOFRAN ODT", "ondansetron", "ondansetron hydrochloride", "昂丹司琼", "盐酸昂丹司琼", "昂丹司琼片", "昂丹司琼口崩片", "昂丹司琼口服液", "NDA 020103", "NDA 020605", "NDA 020781", "4 mg/5 mL" ], "marketBrandNames": [ { "name": "ZOFRAN / ZOFRAN ODT", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_approved_label_with_discontinued_product_records", "note": { "zh": "2025 当前批准标签可读；六个 Orange Book 口服 RLD 产品当前列为 Discontinued，不能据此推定库存。", "en": "The current 2025 approved label is readable; six oral Orange Book RLD products are currently listed as Discontinued, which does not establish stock." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：FDA 2025-02 当前批准标签覆盖 ZOFRAN 4/8 mg 普通片、4/8 mg 口崩片及 4 mg/5 mL 口服液；FDA Orange Book 当前数据另记录 NDA 020103、020781 与 020605 的六个口服 RLD 产品均为 Discontinued、RS 为 No，并保留‘并非因安全性或有效性原因停止销售或撤市’的联邦公报判定。当前标签可阅读不等于这些历史产品目前有货、可购买或可替代。", "dosageFormClass": "普通口服片、口崩片与 4 mg/5 mL 口服液必须分开识别；24 mg 普通片是 Orange Book 历史产品身份，未列入 2025 当前标签的供应剂型与强度清单", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1991（美国首次批准）；1992–1999（本页六个口服产品身份）", "archiveSponsorText": "Sandoz Inc.（FDA 当前标签与 Orange Book 申请主体）；GlaxoSmithKline 为历史开发／标签主体" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "ondansetron injection", "ondansetron premixed injection", "昂丹司琼注射液", "generic ondansetron", "其他厂牌昂丹司琼", "apomorphine", "granisetron", "palonosetron" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zofran-ondansetron-conventional-tablet-4mg-nda-020103-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 4 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 4 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-conventional-tablet-8mg-nda-020103-product-002-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 8 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 8 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-conventional-tablet-24mg-nda-020103-product-003-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；并与 2025-02 当前批准标签分开阅读", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026), read separately from the current approved label revised Feb 2025" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼普通口服片（历史 RLD）", "en": "ZOFRAN ondansetron conventional oral tablet (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020103 / Product 003", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 24 mg；历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 24 mg per tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 24, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": false, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-odt-ondansetron-orally-disintegrating-tablet-4mg-nda-020781-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示该剂型和强度", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength" }, "dosageForm": { "zh": "ZOFRAN ODT 昂丹司琼口崩片（历史 RLD）", "en": "ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD)" }, "route": { "zh": "口服／舌上崩解（历史监管产品身份字段）", "en": "oral / disintegrates on the tongue (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020781 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 4 mg；口崩片历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 4 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率、吞服方式或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-odt-ondansetron-orally-disintegrating-tablet-8mg-nda-020781-product-002-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示该剂型和强度", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists this form and strength" }, "dosageForm": { "zh": "ZOFRAN ODT 昂丹司琼口崩片（历史 RLD）", "en": "ZOFRAN ODT ondansetron orally disintegrating tablet (historical RLD)" }, "route": { "zh": "口服／舌上崩解（历史监管产品身份字段）", "en": "oral / disintegrates on the tongue (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020781 / Product 002", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片昂丹司琼 8 mg；口崩片历史 RLD，Orange Book 当前列为 Discontinued", "en": "Ondansetron 8 mg per orally disintegrating tablet; historical RLD currently listed as Discontinued in the Orange Book" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 8, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片监管标示量；不是个人片数、频率、吞服方式或换算指令", "en": "regulatory amount per tablet; not an individual's tablet count, frequency, administration or conversion instruction" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-zofran-ondansetron-oral-solution-4mg-per-5ml-nda-020605-product-001-discontinued-rld", "marketCode": "US", "labelVersion": { "zh": "FDA Orange Book 当前产品身份数据（2026-08-29 核验）；2025-02 当前批准标签仍列示 4 mg/5 mL", "en": "Current FDA Orange Book product-identity data (checked 29 Aug 2026); the current approved label revised Feb 2025 still lists 4 mg/5 mL" }, "dosageForm": { "zh": "ZOFRAN 昂丹司琼口服液（历史 RLD）", "en": "ZOFRAN ondansetron oral solution (historical RLD)" }, "route": { "zh": "口服（历史监管产品身份字段）", "en": "oral (historical regulatory product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDA 020605 / Product 001", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_5_mL", "primaryDisplay": { "zh": "每 5 mL 含昂丹司琼 4 mg；这是浓度，不是个人毫升数", "en": "Ondansetron 4 mg per 5 mL; this is a concentration, not an individual's millilitres" }, "imageUrl": null, "visualStatus": "source_text_only_no_exact_public_package_image", "labeledQuantities": [ { "ingredient": { "zh": "昂丹司琼（以盐酸昂丹司琼二水合物提供）", "en": "ondansetron (as ondansetron hydrochloride dihydrate)" }, "value": 4, "unit": "mg", "basisCode": "per_5_mL", "basisLabel": { "zh": "每 5 mL 监管标示浓度；不是个人毫升数、频率或疗程", "en": "regulatory concentration per 5 mL; not an individual's millilitres, frequency or course" } } ], "concentration": null, "container": null, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "orange_book_discontinued_product", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": null, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "六个官方文字产品身份已建立；暂无逐一匹配的准确公开包装主图", "en": "Six official text product identities are established; exact public principal-display images are not yet mapped one-to-one" }, "summary": { "zh": "Orange Book 可核对三个 NDA、六个产品号、剂型、强度、RLD 与停止销售状态，但本轮官方来源未提供可安全复用并与六个身份逐一对应的准确原品牌包装主图。页面因此保留图片缺口，不用仿制药、零售图、注射剂或另一剂型包装代替。", "en": "The Orange Book verifies three NDAs, six product numbers, forms, strengths, RLD identity and discontinued status, but the reviewed official sources do not supply safely reusable exact originator-brand principal-display images mapped one-to-one to all six identities. The page discloses the image gap and does not substitute a generic, retail image, injection or another dosage form." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "ZOFRAN 说明书放大阅读：先分清普通片、口崩片、口服液与完整药单风险", "en": "ZOFRAN label reading: distinguish conventional tablets, ODTs, oral solution and full-list risks first" }, "summary": { "zh": "2025 FDA 标签覆盖普通片、口崩片与 4 mg/5 mL 口服液。页面只把产品身份、取片方法和需优先核对的风险放大，不决定个人是否使用，也不生成片数、毫升数、频率、补服、开始、停用或疗程。", "en": "The 2025 FDA label covers conventional tablets, orally disintegrating tablets and 4 mg/5 mL oral solution. This page enlarges product identity, handling and priority review cues; it does not decide individual use or generate tablet count, millilitres, frequency, missed-use action, initiation, stopping or course." }, "checks": [ { "zh": "普通片和口崩片都可能写 4 mg 或 8 mg，但剂型与取用方式不同。ZOFRAN ODT 应留在泡罩内直至使用，以干手撕开背膜、轻取药片，不要把脆片从箔面硬推出来；随后立即放在舌上崩解。这个说明不是个人频率或是否可换剂型的依据。", "en": "Conventional tablets and ODTs may both say 4 mg or 8 mg, but their dosage form and handling differ. Keep ZOFRAN ODT in its blister until use, peel back the foil with dry hands, gently remove it rather than push the fragile tablet through the foil, and place it on the tongue immediately to dissolve. This is not an individual frequency or dosage-form switching rule." }, { "zh": "ZOFRAN ODT 含阿斯巴甜并提供少量苯丙氨酸。苯丙酮尿症患者或照护者应核对准确剂型和现行标签；普通片或口服液信息不能替代口崩片的这一成分提示。", "en": "ZOFRAN ODT contains aspartame and supplies a small amount of phenylalanine. A person with phenylketonuria or a caregiver should verify the exact form and current label; conventional-tablet or solution information does not replace this ODT ingredient warning." }, { "zh": "标签提示 QT 间期延长风险。先天性长 QT 综合征者应避免使用；低钾或低镁、充血性心力衰竭、缓慢性心律失常，或同用其他延长 QT 的药时需要专业核对，标签可能要求心电图监测。不要凭网页自行加减、错开或停掉任何药。", "en": "The label warns about QT prolongation. Avoid use in congenital long-QT syndrome; low potassium or magnesium, congestive heart failure, bradyarrhythmia or another QT-prolonging medicine requires professional review and the label may call for ECG monitoring. Do not add, reduce, separate or stop any medicine from this page." }, { "zh": "与影响血清素的药同用可能出现血清素综合征，相关药物可包括部分 SSRI、SNRI、其他抗抑郁药、曲普坦、曲马多、锂盐、芬太尼、圣约翰草等。躁动、意识变化、心跳快、血压波动、发热、多汗、震颤、肌肉僵硬或腹泻等组合表现需要立即医疗评估；严重时使用当地急救服务。", "en": "Serotonin syndrome may occur with serotonergic medicines, including some SSRIs, SNRIs, other antidepressants, triptans, tramadol, lithium, fentanyl and St John's wort. A combination of agitation, mental-status change, rapid heartbeat, blood-pressure change, fever, sweating, tremor, muscle rigidity or diarrhoea needs immediate medical assessment; use local emergency services if severe." }, { "zh": "阿扑吗啡与昂丹司琼合用属于标签禁忌，曾报告严重低血压和意识丧失。若两者都在药单，不要自行尝试、错开或停换药，应立即联系开方团队或药师核对。", "en": "Apomorphine with ondansetron is contraindicated in the label because profound hypotension and loss of consciousness have been reported. If both appear on the medicine list, do not self-try, separate or stop/switch them; contact the prescriber or pharmacist promptly." }, { "zh": "严重胸痛、呼吸困难、晕厥或心律异常可能需要急救；持续便秘、腹胀、呕吐或疑似肠梗阻也需要尽快评估，因为昂丹司琼可能掩盖进行性肠梗阻或胃扩张。网页不判断症状原因，也不安排个人用药。", "en": "Severe chest pain, breathing difficulty, fainting or an abnormal rhythm may require emergency care. Persistent constipation, abdominal distension, vomiting or suspected obstruction also needs prompt assessment because ondansetron may mask progressive ileus or gastric distension. The site does not diagnose the cause or arrange individual use." }, { "zh": "口服液 4 mg/5 mL 是浓度，不表示每个人都使用 5 mL。个人毫升数、量具、频率与疗程必须来自准确处方和药房标签；普通厨房勺不是可靠量具。", "en": "Oral solution 4 mg/5 mL is a concentration and does not mean everyone uses 5 mL. Individual millilitres, measuring device, frequency and course must come from the exact prescription and pharmacy label; an ordinary kitchen spoon is not a reliable measure." } ], "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "昂丹司琼怎样起作用：5-HT3 受体拮抗不能变成个人选药或换药规则", "en": "How ondansetron works: 5-HT3 receptor antagonism is not an individual selection or switching rule" }, "summary": { "zh": "官方标签将昂丹司琼描述为选择性 5-HT3 受体拮抗剂，用于解释其止吐相关药理路径。机制不判断恶心或呕吐的原因，也不能推导个人是否适用、服几片或多少毫升、如何与其他止吐药合用。", "en": "The official label describes ondansetron as a selective 5-HT3 receptor antagonist, explaining an antiemetic pharmacologic pathway. Mechanism does not diagnose the cause of nausea or vomiting or derive individual suitability, tablet count, millilitres or combination with another antiemetic." }, "checks": [ { "zh": "止吐药类别不能替代对脱水、感染、肠梗阻、药物不良反应、心脏问题或其他原因的评估；持续或严重症状应使用当地医疗支持。", "en": "An antiemetic class cannot replace assessment for dehydration, infection, obstruction, adverse drug effects, cardiac problems or another cause; persistent or severe symptoms need local medical support." }, { "zh": "同为止吐药或同样影响血清素，不表示可以与甲氧氯普胺、其他 5-HT3 拮抗剂或精神科药物自行叠加、替换或按毫克换算。", "en": "Being an antiemetic or affecting serotonin does not make it self-combinable, substitutable or milligram-convertible with metoclopramide, another 5-HT3 antagonist or a psychiatric medicine." }, { "zh": "作用机制不能消除 QT、血清素综合征、阿扑吗啡禁忌或肠梗阻掩盖等标签风险；完整药单、准确产品和实际症状必须一并核对。", "en": "Mechanism does not remove the labelled risks of QT prolongation, serotonin syndrome, the apomorphine contraindication or masking obstruction; the complete medicine list, exact product and actual symptoms must be reviewed together." } ], "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "ZOFRAN / ZOFRAN ODT", "generic": "昂丹司琼", "dosageFormClass": "普通口服片、口崩片与 4 mg/5 mL 口服液必须分开识别；24 mg 普通片是 Orange Book 历史产品身份，未列入 2025 当前标签的供应剂型与强度清单" }, "labelSource": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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_0aefe4de9e004d2a", "label": "美国 FDA：ZOFRAN 片、口崩片与口服液历史批准标签（2016）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "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": "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": "2026-08-29", "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": "ZOFRAN / ZOFRAN ODT 是昂丹司琼品牌档案。普通片、口崩片和 4 mg/5 mL 口服液虽然成分相同，却不是凭数字就能自行互换的同一产品；口崩片还涉及泡罩取片和苯丙酮尿症所需的苯丙氨酸核对。若药单有影响 QT 间期、血清素或电解质的药，或使用阿扑吗啡，应先让医生或药师核对完整药单。网页不提供个人片数、毫升数、频率或疗程。", "history": "FDA 当前标签列示 ZOFRAN 于 1991 年首次在美国批准。Orange Book 记录普通片 4/8 mg 于 1992-12-31、口服液 4 mg/5 mL 于 1997-01-24、口崩片 4/8 mg 于 1999-01-27、普通片 24 mg 于 1999-08-27 获批。2025-02 的当前批准标签仍可阅读；2026-08-29 核验的 Orange Book 将六个具体口服 RLD 产品均列为 Discontinued，并保留并非因安全性或有效性原因撤市的判定。", "sourceDocuments": [ { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_0aefe4de9e004d2a", "label": "美国 FDA：ZOFRAN 片、口崩片与口服液历史批准标签（2016）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2016/020103s035_020605s019_020781s019lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 020103（普通片）／NDA 020605（口服液）／NDA 020781（口崩片）", "approvalTimeline": [ { "date": "1991", "title": { "zh": "ZOFRAN 美国首次批准节点", "en": "Initial U.S. ZOFRAN approval milestone" }, "detail": { "zh": "FDA 2025 当前标签把 1991 年列为 ZOFRAN 美国首次批准年份；本档案的产品卡仅覆盖后续六个口服身份。", "en": "The current 2025 FDA label lists 1991 as the initial U.S. approval year; this dossier's product cards cover only the six later oral identities." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1992-12-31", "title": { "zh": "ZOFRAN 4 mg 与 8 mg 普通片", "en": "ZOFRAN 4 mg and 8 mg conventional tablets" }, "detail": { "zh": "Orange Book 将 NDA 020103 产品 001 与 002 列为 RLD；当前产品状态为 Discontinued。", "en": "The Orange Book lists NDA 020103 products 001 and 002 as RLDs; their current product status is Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1997-01-24", "title": { "zh": "ZOFRAN 4 mg/5 mL 口服液", "en": "ZOFRAN 4 mg/5 mL oral solution" }, "detail": { "zh": "Orange Book 将 NDA 020605 产品 001 列为 RLD；当前产品状态为 Discontinued。", "en": "The Orange Book lists NDA 020605 product 001 as an RLD; its current product status is Discontinued." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "1999", "title": { "zh": "ZOFRAN ODT 与 24 mg 历史普通片", "en": "ZOFRAN ODT and the historical 24 mg conventional tablet" }, "detail": { "zh": "4/8 mg 口崩片于 1999-01-27 获批，24 mg 普通片于 1999-08-27 获批。三者当前均列为 Discontinued；24 mg 未列入 2025 当前标签的供应剂型与强度清单。", "en": "The 4/8 mg ODTs were approved on 27 Jan 1999 and the 24 mg conventional tablet on 27 Aug 1999. All three are currently listed as Discontinued; 24 mg is not in the current 2025 label's available dosage-form and strength list." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2025-02", "title": { "zh": "当前批准口服标签修订", "en": "Current approved oral label revised" }, "detail": { "zh": "当前 FDA 标签可阅读普通片 4/8 mg、口崩片 4/8 mg 与口服液 4 mg/5 mL 的产品信息和安全边界。标签可读不表示六个历史 RLD 产品当前供应。", "en": "The current FDA label provides product information and safety boundaries for 4/8 mg conventional tablets, 4/8 mg ODTs and 4 mg/5 mL oral solution. A readable label does not establish current supply of the six historical RLD products." }, "source": { "id": "src_51c6c158a6917fbc", "label": "美国 FDA：ZOFRAN 昂丹司琼片、口崩片与口服液当前批准标签（2025-02 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/020103s039%2C020605s023%2C020781s023lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-08-29", "title": { "zh": "Orange Book 状态核验", "en": "Orange Book status reviewed" }, "detail": { "zh": "六个口服产品均为 RLD、RS 为 No、当前列为 Discontinued；数据保留并非因安全性或有效性原因停止销售或撤市的判定。", "en": "All six oral products are RLDs, RS No and currently listed as Discontinued; the data retain the determination that they were not discontinued or withdrawn for safety or effectiveness reasons." }, "source": { "id": "src_10e511bf83430e3b", "label": "美国 FDA Orange Book 当前数据：ZOFRAN 六个口服 RLD 产品与停止销售状态", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "2025 当前批准标签可读；六个具体口服 RLD 产品当前列为 Discontinued", "en": "Current 2025 approved label readable; six specific oral RLD products currently listed as Discontinued" }, "detail": { "zh": "这两个状态必须分开理解；不据此推定库存、购买渠道、个人适用性或可替代性。", "en": "These states must be read separately and do not establish stock, a purchasing channel, individual suitability or interchangeability." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国品牌、共同成分或毫克数推定当地批准、商品名、包装、供应、原研／仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. brand, shared ingredient or milligram numbers." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "ZOFRAN ODT 和普通片都是 4 mg，可以直接互换吗？", "en": "Can a 4 mg ZOFRAN ODT and a 4 mg conventional tablet be directly interchanged?" }, "answer": { "zh": "不能仅凭相同成分和毫克数自行换。它们是不同剂型，取用方式和辅料提示不同；应核对准确处方、手中产品及当地现行标签，并让药师或开方团队确认。", "en": "Do not self-switch from the shared ingredient and milligram number. They are different dosage forms with different handling and excipient cues; verify the exact prescription, product in hand and current local label with a pharmacist or prescriber." } }, { "question": { "zh": "口服液写 4 mg/5 mL，是否每次都喝 5 mL？", "en": "Does oral solution 4 mg/5 mL mean taking 5 mL every time?" }, "answer": { "zh": "不是。4 mg/5 mL 是浓度，不是个人剂量。个人毫升数、频率和疗程必须来自准确处方和药房标签，并用合适的口服量具。", "en": "No. 4 mg/5 mL is a concentration, not an individual dose. Individual millilitres, frequency and course must come from the exact prescription and pharmacy label and be measured with a suitable oral device." } }, { "question": { "zh": "我同时使用抗抑郁药或影响心律的药，网页能判断是否能一起用吗？", "en": "Can the site decide whether ZOFRAN can be used with my antidepressant or rhythm-affecting medicine?" }, "answer": { "zh": "不能。昂丹司琼标签涉及血清素综合征和 QT 间期风险，判断需要准确药名、剂型、处方原因、疾病、电解质和完整药单。请让医生或药师逐项核对；严重症状使用当地急救服务。", "en": "No. The ondansetron label includes serotonin-syndrome and QT-prolongation risks. Review requires exact names/forms, reasons, conditions, electrolytes and the full list. Ask a clinician or pharmacist to review each item; use local emergency services for severe symptoms." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/zofran/", "en": "https://origindrug.com/en/drugs/zofran/" }, "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." ] }