{ "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": "2026-07-30", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "safetyreportversion": "5", "safetyreportid": "22215744", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20250115", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20230416", "receiptdateformat": "102", "receiptdate": "20241114", "fulfillexpeditecriteria": "1", "companynumb": "US-002147023-NVSC2023US086810", "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "1", "senderorganization": "NOVARTIS" }, 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"27.1", "reactionmeddrapt": "Blood glucose increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Carbon dioxide decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Blood sodium decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Platelet count decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "White blood cell count increased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Red blood cell count decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Haemoglobin decreased", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Cognitive disorder", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "PLUVICTO", "drugbatchnumb": "LPS230227B-03, Vial 6", 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"NDA020517", "NDA019732" ], "brand_name": [ "LUPRON DEPOT" ], "generic_name": [ "LEUPROLIDE ACETATE" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-3663", "0074-3641", "0074-3346", "0074-3473", "0074-3683", "0074-3642" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1115472", "1115473", "797544", "1115457", "1115459", "1115257", "1115259", "1115462", "1115464", "1115467", "1115468", "1946521", "1946522" ], "spl_id": [ "fef36994-8fde-4b22-99a9-aa850c147eee", "691f9b76-b15b-47c9-8df9-8ebe91999b45", "d7c452f3-aedd-4c8b-9e8e-46690c56a29c" ], "spl_set_id": [ "60aad237-e1da-4705-cbbb-b3ca79e89ad8", "00c486b0-bd7b-4898-834d-8c656e5e73cb", "cbc8f94e-7330-4465-05ad-16d64493a5dd" ], "package_ndc": [ "0074-3663-03", "0074-3641-03", "0074-3641-71", "0074-3473-03", "0074-3473-55", "0074-9945-01", "0074-0009-01", "0074-3683-03", "0074-3683-55", "0074-9930-01", "0074-3642-03", "0074-3642-55", "0074-9907-01", "0074-3346-03", "0074-3346-55", "0074-9922-01" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LUPRON DEPOT", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "032", "drugdosagetext": "1 DOSAGE FORM, 3 MONTHS (AS DIRECTED), SUSPENSION FOR RECONSTITUTION", "drugdosageform": "Suspension for injection", "drugadministrationroute": "030", "drugstartdateformat": "102", "drugstartdate": "20200617", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "LEUPROLIDE ACETATE" }, "openfda": { "application_number": [ "NDA020708", "NDA020011", "NDA020517", "NDA019732" ], "brand_name": [ "LUPRON DEPOT" ], "generic_name": [ "LEUPROLIDE ACETATE" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-3663", "0074-3641", "0074-3346", "0074-3473", "0074-3683", "0074-3642" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "rxcui": [ "1115472", "1115473", "797544", "1115457", "1115459", "1115257", "1115259", "1115462", "1115464", "1115467", "1115468", "1946521", "1946522" ], "spl_id": [ "fef36994-8fde-4b22-99a9-aa850c147eee", "691f9b76-b15b-47c9-8df9-8ebe91999b45", "d7c452f3-aedd-4c8b-9e8e-46690c56a29c" ], "spl_set_id": [ "60aad237-e1da-4705-cbbb-b3ca79e89ad8", "00c486b0-bd7b-4898-834d-8c656e5e73cb", "cbc8f94e-7330-4465-05ad-16d64493a5dd" ], "package_ndc": [ "0074-3663-03", "0074-3641-03", "0074-3641-71", "0074-3473-03", "0074-3473-55", "0074-9945-01", "0074-0009-01", "0074-3683-03", "0074-3683-55", "0074-9930-01", "0074-3642-03", "0074-3642-55", "0074-9907-01", "0074-3346-03", "0074-3346-55", "0074-9922-01" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20230323" } } } ] }