{ "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": "2026-01-27", "results": { "skip": 0, "limit": 1, "total": 121891 } }, "results": [ { "safetyreportversion": "3", "safetyreportid": "10004454", "primarysourcecountry": "IT", "occurcountry": "IT", "transmissiondateformat": "102", "transmissiondate": "20150326", "reporttype": "1", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140912", "fulfillexpeditecriteria": "1", "companynumb": "IT-ABBVIE-14P-083-1211706-00", "duplicate": "1", "reportduplicate": { "duplicatesource": "ABBVIE", "duplicatenumb": "IT-ABBVIE-14P-083-1211706-00" }, "primarysource": { "reportercountry": "IT", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "23", "patientonsetageunit": "801", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Drug interaction", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Oedematous pancreatitis", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Amylase increased", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "17.1", "reactionmeddrapt": "Lipase increased", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "PEGASYS", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131206", "drugenddateformat": "102", "drugenddate": "20140225", "activesubstance": { "activesubstancename": "PEGINTERFERON ALFA-2A" }, "openfda": { "application_number": [ "BLA103964" ], "brand_name": [ "PEGASYS" ], "generic_name": [ 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"drugstartdateformat": "102", "drugstartdate": "20140110", "drugenddateformat": "102", "drugenddate": "20140225", "actiondrug": "1", "activesubstance": { "activesubstancename": "TELAPREVIR" } }, { "drugcharacterization": "2", "medicinalproduct": "COPEGUS", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131206", "drugenddateformat": "102", "drugenddate": "20140225", "activesubstance": { "activesubstancename": "RIBAVIRIN" } }, { "drugcharacterization": "2", "medicinalproduct": "SUBOXONE", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "602", "drugstartdate": "2012", "activesubstance": { "activesubstancename": "BUPRENORPHINE HYDROCHLORIDE\\NALOXONE HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA022410" ], "brand_name": [ "SUBOXONE" ], "generic_name": [ "BUPRENORPHINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE" ], "manufacturer_name": [ "INDIVIOR INC." ], "product_ndc": [ "12496-1202", "12496-1204", "12496-1208", "12496-1212" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "BUCCAL", "SUBLINGUAL" ], "substance_name": [ "BUPRENORPHINE HYDROCHLORIDE", "NALOXONE HYDROCHLORIDE" ], "rxcui": [ "1010600", "1010603", "1010604", "1010606", "1307056", "1307058", "1307061", "1307063" ], "spl_id": [ "ad5a289a-6285-4b2d-b7ad-e4812169dd58" ], "spl_set_id": [ "8a5edcf9-828c-4f97-b671-268ab13a8ecd" ], "package_ndc": [ "12496-1202-1", "12496-1202-3", "12496-1204-1", "12496-1204-3", "12496-1208-1", "12496-1208-3", "12496-1212-1", "12496-1212-3" ], "unii": [ "F850569PQR", "56W8MW3EN1" ] } }, { "drugcharacterization": "1", "medicinalproduct": "DEPAKINE CHRONO", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "018081", "drugstructuredosagenumb": "1", "drugstructuredosageunit": "002", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "EXTENDED RELEASE TABLET", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131001", "actiondrug": "4", "activesubstance": { "activesubstancename": "VALPROATE SODIUM" } }, { "drugcharacterization": "3", "medicinalproduct": "ZYPREXA", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosageform": "COATED TABLET", "drugadministrationroute": "048", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugstartdateformat": "102", "drugstartdate": "20131001", "actiondrug": "4", "activesubstance": { "activesubstancename": "OLANZAPINE" }, "openfda": { "application_number": [ "NDA021253", "NDA020592", "NDA021086", "NDA022173" ], "brand_name": [ "ZYPREXA INTRAMUSCULAR", "ZYPREXA", "ZYPREXA ZYDIS", "ZYPREXA RELPREVV" ], "generic_name": [ "OLANZAPINE", "OLANZAPINE PAMOATE" ], "manufacturer_name": [ "Eli Lilly and Company", "H2-Pharma LLC", "UNITAX-Pharmalogistik GmbH" ], "product_ndc": [ "0002-7597", "0002-4112", "0002-4115", "0002-4116", "0002-4117", "0002-4415", "0002-4420", "0002-4453", "0002-4454", "0002-4455", "0002-4456", "61269-630", "61269-631", "61269-632", "61269-633", "61269-634", "61269-635", "61269-650", "61269-651", "61269-652", "61269-653", "61269-640", "87315-001", "61269-660", "61269-661", "61269-662" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAMUSCULAR", "ORAL" ], "substance_name": [ "OLANZAPINE" ], "rxcui": [ "153046", "153047", "153048", "200034", "212405", "261337", "283639", "284514", "312076", "312077", "312078", "312079", "314154", "314155", "351107", "351108", "485968", "545353", "754503", "754504", "754505", "754506", "1718925", "1718928", "1718930", "1718932", "1718934", "1718936" ], "spl_id": [ "9073f34c-307c-4a3a-8273-580ef5742229", "40d4ed67-c51d-40d0-8a32-ecfdbf069f9a", "4c607f76-42b3-1152-e063-6394a90a6648", "f5327148-84aa-46ea-b464-71fd3b59e6d9" ], "spl_set_id": [ "d5051fbc-846b-4946-82df-341fb1216341", "b418946a-1ab4-4d89-a012-d94fc361a3c4", "3609727e-21e1-4e39-b158-ec3518a3ff09", "11544cba-64a9-49cb-8d74-da228053b252" ], "package_ndc": [ "0002-4112-30", "0002-4115-30", "0002-4116-30", "0002-4117-30", "0002-4415-30", "0002-4420-30", "0002-4453-01", "0002-4453-85", "0002-4454-01", "0002-4454-85", "0002-4455-01", "0002-4455-85", "0002-4456-01", "0002-4456-85", "0002-7597-01", "61269-630-30", "61269-631-30", "61269-632-30", "61269-633-30", "61269-634-30", "61269-635-30", "61269-650-01", "61269-650-35", "61269-651-01", "61269-651-35", "61269-652-01", "61269-652-35", "61269-653-01", "61269-653-35", "61269-640-20", "87315-001-01", "61269-660-20", "61269-661-20", "61269-662-20" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "N7U69T4SZR" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140224" } } } ] }