{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-04-28", "results": { "skip": 0, "limit": 1, "total": 37008 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003706", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "PHEH2014US004981", "duplicate": "1", "reportduplicate": { "duplicatesource": "NOVARTIS", "duplicatenumb": "PHEH2014US004981" }, "primarysource": { "reportercountry": "COUNTRY NOT SPECIFIED", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "17", "patientonsetageunit": "801", "patientweight": "115", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Lung infection", "reactionoutcome": "2" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "TOBI", "drugauthorizationnumb": "050753", "drugstructuredosagenumb": "300", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "300 MG/5ML", "drugdosageform": "Sol. Aerosol Metered Dose Inh.", "drugadministrationroute": "055", "drugindication": "CYSTIC FIBROSIS", "drugstartdateformat": "602", "drugstartdate": "2009", "drugenddateformat": "602", "drugenddate": "2013", "actiondrug": "1", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA050753" ], "brand_name": [ "TOBI" ], "generic_name": [ "TOBRAMYCIN" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "49502-345" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "RESPIRATORY (INHALATION)" ], "substance_name": [ "TOBRAMYCIN" ], "rxcui": [ "213194", "348719" ], "spl_id": [ "99c630df-5e03-4944-8225-26940d0ae737" ], "spl_set_id": [ "6a3c3871-1d3a-44d6-8be3-526b30123ef7" ], "package_ndc": [ "49502-345-99", "49502-345-73" ], "nui": [ "N0000175477", "M0000946" ], "pharm_class_epc": [ "Aminoglycoside Antibacterial [EPC]" ], "pharm_class_cs": [ "Aminoglycosides [CS]" ], "unii": [ "VZ8RRZ51VK" ] } }, { "drugcharacterization": "1", "medicinalproduct": "TOBI PODHALER", "drugstructuredosagenumb": "112", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "112 MG, BID", "drugadministrationroute": "055", "drugindication": "CYSTIC FIBROSIS", "drugstartdateformat": "602", "drugstartdate": "2013", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA201688" ], "brand_name": [ "TOBI PODHALER" ], "generic_name": [ "TOBRAMYCIN" ], "manufacturer_name": [ "Viatris Specialty LLC" ], "product_ndc": [ "49502-401" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "RESPIRATORY (INHALATION)" ], "substance_name": [ "TOBRAMYCIN" ], "rxcui": [ "1374569", "1374570", "1374573", "1374574", "1661466", "1661559", "1661560", "1661567" ], "spl_id": [ "0ebb786f-98a7-47b4-a0ef-06c0412ca3da" ], "spl_set_id": [ "c4b5bb1f-e158-4ac1-9c35-e98a416c743a" ], "package_ndc": [ "49502-401-24", "49502-401-56", "49502-401-08", "49502-401-57", "49502-401-09" ], "nui": [ "N0000175477", "M0000946" ], "pharm_class_epc": [ "Aminoglycoside Antibacterial [EPC]" ], "pharm_class_cs": [ "Aminoglycosides [CS]" ], "unii": [ "VZ8RRZ51VK" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ADVAIR", "drugdosagetext": "UNK", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA021077" ], "brand_name": [ "ADVAIR DISKUS" ], "generic_name": [ "FLUTICASONE PROPIONATE AND SALMETEROL" ], "manufacturer_name": [ "GlaxoSmithKline LLC" ], "product_ndc": [ "0173-0695", "0173-0696", "0173-0697" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "RESPIRATORY (INHALATION)" ], "substance_name": [ "FLUTICASONE PROPIONATE", "SALMETEROL XINAFOATE" ], "rxcui": [ "896161", "896165", "896184", "896185", "896186", "896190", "896209", "896212", "896218", "896222", "896228", "896229" ], "spl_id": [ "0add9a7a-38ae-489a-9635-7b85c20ba985" ], "spl_set_id": [ "4eeb5f6a-593f-4a9e-9692-adefa2caf8fc" ], "package_ndc": [ "0173-0695-00", "0173-0695-04", "0173-0696-00", "0173-0696-04", "0173-0697-00", "0173-0697-04" ], "unii": [ "6EW8Q962A5", "O2GMZ0LF5W" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VENTOLINE", "drugdosagetext": "UNK", "actiondrug": "5", "drugrecurreadministration": "3" }, { "drugcharacterization": "2", "medicinalproduct": "CREON", "drugdosagetext": "UNK", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "BLA020725" ], "brand_name": [ "CREON" ], "generic_name": [ "PANCRELIPASE" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0032-0045", "0032-1203", "0032-1206", "0032-1212", "0032-1224", "0032-3016", "0032-0046", "0032-0047", "0032-2636", "0032-2637" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "PANCRELIPASE AMYLASE", "PANCRELIPASE LIPASE", "PANCRELIPASE PROTEASE" ], "rxcui": [ "855495", "855499", "855503", "863829", "863836", "863841", "1113042", "1113046", "1373325", "1373327" ], "spl_id": [ "94463229-9296-4640-854f-41d76386d312" ], "spl_set_id": [ "073201aa-556d-4a70-918e-84e9616fd88d" ], "package_ndc": [ "0032-1203-70", "0032-1203-64", "0032-1206-07", "0032-1206-01", "0032-1206-56", "0032-1212-07", "0032-1212-01", "0032-1212-46", "0032-1212-13", "0032-1224-07", "0032-1224-01", "0032-1224-46", "0032-3016-28", "0032-3016-13", "0032-3016-50", "0032-3016-12", "0032-0045-70", "0032-0045-30", "0032-0046-30", "0032-0046-70", "0032-0047-30", "0032-0047-70", "0032-2636-70", "0032-2636-01", "0032-2636-30", "0032-2637-70", "0032-2637-01", "0032-2637-30" ], "unii": [ "3560D81V50", "YOJ58O116E", "8MYC33932O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "NASONEX", "drugdosagetext": "UNK", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "NDA215712" ], "brand_name": [ "NASONEX" ], "generic_name": [ "MOMETASONE FUROATE" ], "manufacturer_name": [ "L. Perrigo Company" ], "product_ndc": [ "0113-1720" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "NASAL" ], "substance_name": [ "MOMETASONE FUROATE MONOHYDRATE" ], "rxcui": [ "1797865", "1797870" ], "spl_id": [ "4a696e8d-0746-47ea-8369-ebfcb8312d96" ], "spl_set_id": [ "13696a8b-366a-4a5e-adea-d5b7bff9e46f" ], "package_ndc": [ "0113-1720-01", "0113-1720-11", "0113-1720-02", "0113-1720-03", "0113-1720-06", "0113-1720-04", "0113-1720-05", "0113-1720-07" ], "unii": [ "MTW0WEG809" ] } } ] } } ] }