{ "id": "bactrim", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Bactrim", "generic": "复方磺胺甲噁唑", "aliases": [ "sulfamethoxazole and trimethoprim", "sulfamethoxazole/trimethoprim", "sulfamethoxazole", "trimethoprim" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "感染", "sourceArchiveMarket": "美国公开监管标签档案", "dosageFormClass": "口服片剂：BACTRIM 400 mg/80 mg；BACTRIM DS 800 mg/160 mg（DailyMed 2024-12 公开标签所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "美国初始批准年份待逐项核验", "archiveSponsorText": "Sun Pharmaceutical Industries, Inc. / DailyMed 公开监管标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-bactrim-ds-tablet-800mg-160mg-ndc-49708-146-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed 公开标签，2024-12-30 更新；仅为所引公开标签展示面，不代表供应", "en": "DailyMed public label, updated 30 Dec 2024; cited label panel only, not availability" }, "dosageForm": { "zh": "BACTRIM DS 复方磺胺甲噁唑/甲氧苄啶口服片", "en": "BACTRIM DS sulfamethoxazole/trimethoprim oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 49708-146-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片磺胺甲噁唑 800 mg / 甲氧苄啶 160 mg；100 片瓶装", "en": "Sulfamethoxazole 800 mg / trimethoprim 160 mg per tablet; 100-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bactrim-05.jpg&setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "磺胺甲噁唑", "en": "sulfamethoxazole" }, "value": 800, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与甲氧苄啶一同核对，不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; check together with trimethoprim, not an individual tablet count, course or self-conversion" } }, { "ingredient": { "zh": "甲氧苄啶", "en": "trimethoprim" }, "value": 160, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标示量；必须与磺胺甲噁唑一同核对，不是个人片数、疗程或自行换算", "en": "labelled amount per tablet; check together with sulfamethoxazole, not an individual tablet count, course or self-conversion" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 100, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": false, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01；Sun Pharmaceutical Industries；2024-12-30 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": null, "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Bactrim-05.jpg&setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62&type=img", "alt": "BACTRIM DS 800 mg/160 mg 复方磺胺甲噁唑片在美国 DailyMed 公开标签中的 Sun Pharma 100 片瓶装标签图", "archiveMarket": "美国", "labelVersion": "DailyMed 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新；图稿修订 2020-07）", "presentation": "BACTRIM DS 800 mg 磺胺甲噁唑/160 mg 甲氧苄啶、100 片瓶装标签图（NDC 49708-146-01；DailyMed 公开标签所列；Sun Pharma 标签图）。", "notice": "此为美国 DailyMed 公开标签中明确对应 BACTRIM DS 800 mg 磺胺甲噁唑/160 mg 甲氧苄啶、100 片瓶装（NDC 49708-146-01）的 Sun Pharma 标签图，只帮助核对品牌、两种通用名、每片标示强度、口服片、包装数量和来源；不用于鉴定真伪，也不证明 BACTRIM 400 mg/80 mg、静脉用制剂、其他包装、其他市场标签、当前包装、原研身份、目标市场批准或可售资格。", "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "BACTRIM 说明书放大阅读：400/80 与 DS 800/160 是两种成分、强度与包装的组合核对", "en": "BACTRIM label reading: 400/80 and DS 800/160 require joint checks of two ingredients, strength and pack" }, "summary": { "zh": "本模块以 Sun Pharmaceutical Industries, Inc. 的 DailyMed 2024-12 美国公开标签为阅读入口，严格对应 BACTRIM 400 mg 磺胺甲噁唑/80 mg 甲氧苄啶片，以及 BACTRIM DS 800 mg/160 mg 片。图示仅为 DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01）；不提供个人片数、疗程、补用、转换或与其他抗感染药联用的方案。", "en": "This module uses Sun Pharmaceutical Industries, Inc.'s Dec 2024 U.S. DailyMed public label as a reading entry point. It distinguishes BACTRIM 400 mg sulfamethoxazole/80 mg trimethoprim tablets from BACTRIM DS 800 mg/160 mg tablets. The visual is limited to the DS 800 mg/160 mg, 100-tablet bottle (NDC 49708-146-01); it does not provide an individual's tablet count, course, make-up, switching or combination plan with another anti-infective." }, "checks": [ { "zh": "“400 mg/80 mg”与“800 mg/160 mg”各自同时标示两种活性成分，不是一个可自行相加、拆分或换算的单一数字。DS（double strength）是该准确包装的产品身份词；不能因名称相同或数字成倍，就自行把常规片与 DS 片互换、拼量或补用。", "en": "“400 mg/80 mg” and “800 mg/160 mg” each label two active ingredients, not one number to self-add, split or convert. DS (double strength) is an identity term for the exact pack; the shared name or doubled numbers do not permit self-substitution, combining or make-up use between regular and DS tablets." }, { "zh": "图示的 NDC 49708-146-01、100 片与“BACTRIM DS 800 mg/160 mg”是同一美国瓶装的组合线索。包装数量不是疗程天数，包装外观也不能鉴定真伪或证明另一种包装、另一市场或另一剂型相同。", "en": "The pictured NDC 49708-146-01, 100-tablet count and “BACTRIM DS 800 mg/160 mg” are combined clues for one U.S. bottle. Pack count is not a course length, and appearance cannot authenticate a medicine or establish that another pack, market or dosage form is the same." }, { "zh": "本页对应口服片剂；它不能覆盖 BACTRIM 的静脉用历史标签或其他含磺胺甲噁唑/甲氧苄啶产品。即使通用名相同，也不能从口服片页面推导输注、转换、分装或其他给药途径的操作。", "en": "This page covers oral tablets; it does not cover BACTRIM's historical intravenous label or another sulfamethoxazole/trimethoprim product. Even with the same generic names, an oral-tablet page cannot derive infusion, conversion, division or another route of administration." }, { "zh": "该标签含严重皮肤反应、血液、肾脏、钾水平及多种联用相关警示。正在使用抗凝药、降糖药、利尿/降压药、甲氨蝶呤、补充剂或多种药物，或出现广泛皮疹、口腔/眼部黏膜问题、发热、明显乏力或其他严重不适时，应及时使用当地医疗支持并让专业人员核对完整药单；不要自行重复、叠加、停换或借用抗菌药。", "en": "The label includes warnings related to serious skin reactions, blood, kidney, potassium and multiple co-medications. With an anticoagulant, glucose-lowering medicine, diuretic/blood-pressure medicine, methotrexate, supplement or multiple medicines, or with widespread rash, mouth/eye mucosal problems, fever, marked weakness or another severe concern, use timely local medical support and have professionals review the complete list; do not self-repeat, combine, stop/switch or share an antibacterial." } ], "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "复方磺胺甲噁唑怎样起作用：两种成分连续阻断细菌叶酸合成路径", "en": "How sulfamethoxazole/trimethoprim works: two ingredients block consecutive steps in bacterial folate synthesis" }, "summary": { "zh": "DailyMed 的 BACTRIM 标签说明，磺胺甲噁唑与对氨基苯甲酸竞争，抑制细菌二氢叶酸合成；甲氧苄啶则可逆性抑制二氢叶酸还原酶，阻断四氢叶酸形成。它们作用于许多细菌核酸与蛋白质生物合成中的连续步骤。这个机制概述不诊断感染，也不决定个人是否需要抗菌药、选择哪种产品、强度、片数或疗程。", "en": "The BACTRIM DailyMed label explains that sulfamethoxazole competes with para-aminobenzoic acid to inhibit bacterial dihydrofolic-acid synthesis, while trimethoprim reversibly inhibits dihydrofolate reductase and blocks tetrahydrofolic-acid formation. They act at consecutive steps in nucleic-acid and protein biosynthesis in many bacteria. This overview does not diagnose an infection or decide whether an individual needs an antibacterial, which product to use, strength, tablet count or course." }, "checks": [ { "zh": "“双重阻断叶酸路径”是解释两种成分为何写在同一标签上的药理概念，不代表所有发热、咳嗽、腹泻、排尿不适、皮疹或其他症状都是细菌感染，更不表示都适合这一产品。原因、检测（如适用）、市场标签与专业评估必须分开核对。", "en": "“Two-step folate-pathway blockade” is a pharmacology concept explaining why two ingredients appear on one label. It does not mean every fever, cough, diarrhoea, urinary symptom, rash or other symptom is bacterial or suitable for this product. Cause, testing when relevant, market label and professional assessment must be checked separately." }, { "zh": "与其他抗菌药的作用路径相似、不同或名称中都含“磺胺”或“甲氧苄啶”，都不能说明可以自行叠加、轮换、按 mg 等量换算或用余药续用。准确产品、感染评估、肾功能相关情况、完整药单和现行标签需要由专业人员逐项核对。", "en": "A related or different pathway with another antibacterial, or a name containing “sulfa” or “trimethoprim,” does not permit self-combination, alternation, milligram conversion or use of leftovers. The exact product, infection assessment, kidney-related context, complete medicine list and current label need item-by-item professional review." }, { "zh": "机制不能消除严重皮肤反应、血液、肾脏、钾水平或药物相互作用的风险，也不能用于决定是否突然自行停药。出现广泛皮疹、黏膜异常、呼吸困难、晕厥、明显虚弱或其他急性严重问题，应优先使用当地医疗支持。", "en": "Mechanism does not remove the possibility of serious skin reactions, blood, kidney, potassium or interaction risks, and it cannot decide abrupt self-stopping. With widespread rash, mucosal abnormality, breathing difficulty, fainting, marked weakness or another acute serious concern, prioritise local medical support." } ], "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新；Clinical Pharmacology）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Bactrim", "generic": "复方磺胺甲噁唑", "dosageFormClass": "口服片剂：BACTRIM 400 mg/80 mg；BACTRIM DS 800 mg/160 mg（DailyMed 2024-12 公开标签所列）" }, "labelSource": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_964cf20e87f57c4a", "label": "FDA：BACTRIM 2020 美国静脉用注射剂历史标签（NDA 018374；不等同于本页口服包装）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-faers-sulfamethoxazole-trimethoprim-2023-hlh-label-update", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：磺胺甲噁唑/甲氧苄啶的标签更新线索", "en": "FDA FAERS record: labelling-update information for sulfamethoxazole/trimethoprim" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面更新至 2026-03-13）列出 Bactrim、Bactrim DS 等磺胺甲噁唑/甲氧苄啶产品，并说明标签“警告和注意事项”及“不良反应”部分已于 2025 年 2 月加入噬血细胞性淋巴组织细胞增多症（HLH）信息。它是监管安全信号及标签更新记录，不用来判断个人是否发生该情况，也不提供自行停药或换药结论。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Bactrim, Bactrim DS and related sulfamethoxazole/trimethoprim products and states that Warnings and Precautions and Adverse Reactions were updated in February 2025 with hemophagocytic lymphohistiocytosis (HLH) information. It is a regulatory safety-signal and labelling-update record, not a way to determine an individual event or self-stop/switch treatment." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（磺胺甲噁唑/甲氧苄啶标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-hosted-amneal-2025-sulfamethoxazole-trimethoprim-recall", "issuedAt": "2025-06-04", "status": "fda_hosted_company_recall_announcement", "title": { "zh": "FDA 托管的企业召回公告：特定 Amneal 复方磺胺甲噁唑/甲氧苄啶片", "en": "FDA-hosted company recall announcement: specific Amneal sulfamethoxazole/trimethoprim tablets" }, "summary": { "zh": "FDA 页面明确说明这是其作为公共服务托管的企业公告，并不表示 FDA 认可企业或产品。公告仅涉及美国 Amneal 的磺胺甲噁唑/甲氧苄啶 400 mg/80 mg 片、3 个批号（AM241019、AM241019A、AM241020）及列明 NDC/包装；不适用于 Bactrim 品牌、Bactrim DS、800 mg/160 mg、其他生产商、其他批号、其他市场或任何当前产品状态结论。", "en": "FDA explicitly says this is a company announcement it posts as a public service and does not endorse the company or product. The announcement concerns only U.S. Amneal sulfamethoxazole/trimethoprim 400 mg/80 mg tablets, three named lots (AM241019, AM241019A, AM241020), and the listed NDCs/packs. It does not apply to Bactrim brand, Bactrim DS, 800 mg/160 mg, another manufacturer, another lot, another market, or any current-product-status conclusion." }, "source": { "id": "src_bc33da5bc62a9c5f", "label": "FDA 托管：Amneal 磺胺甲噁唑/甲氧苄啶片 400 mg/80 mg 特定批次召回企业公告（2025-06-04）", "url": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/amneal-pharmaceutical-llc-issues-nationwide-recall-sulfamethoxazole-trimethoprim-tablets-usp-400", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 Sun Pharmaceutical Industries, Inc. BACTRIM 公开标签列示口服 BACTRIM 400 mg/80 mg 片和 BACTRIM DS（double strength）800 mg/160 mg 片。本页包装图严格对应 DS 800 mg/160 mg、100 片瓶装（NDC 49708-146-01）；不把该包装延伸为注射剂、其他规格、其他市场批准、原研关系、供应、价格或可售资格结论。", "history": "同一品牌下的常规片与 DS 片包含相同两种活性成分，但每片标示量不同；口服标签也不能与此前的静脉用历史文件自动等同。产品身份、实际包装、目标市场、标签版本与专业使用信息须分别核验。", "sourceDocuments": [ { "id": "src_aa35f64fb63f1003", "label": "DailyMed（NLM）：BACTRIM / BACTRIM DS 公开标签（Sun Pharmaceutical Industries, Inc.，2024-12 更新）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_964cf20e87f57c4a", "label": "FDA：BACTRIM 2020 美国静脉用注射剂历史标签（NDA 018374；不等同于本页口服包装）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/018374s027lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 017377（DailyMed 公开标签所列美国市场标识）", "approvalTimeline": [ { "date": "2024-12", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2024-12 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the 2024-12 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_aa35f64fb63f1003", "label": "DailyMed: BACTRIM / BACTRIM DS public label archive", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f59d0c04-9c66-4d53-a0e1-cb55570deb62", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/bactrim/", "en": "https://origindrug.com/en/drugs/bactrim/" }, "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." ] }