{ "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": 100048 } }, "results": [ { "safetyreportversion": "4", "safetyreportid": "10004135", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20150821", "reporttype": "1", "serious": "2", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20150525", "fulfillexpeditecriteria": "2", "companynumb": "US-JNJFOC-20140303748", "duplicate": "1", "reportduplicate": { "duplicatesource": "JANSSEN", "duplicatenumb": "US-JNJFOC-20140303748" }, "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, 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"manufacturer_name": [ "Organon LLC" ], "product_ndc": [ "78206-160", "78206-161", "78206-156", "78206-158", "78206-159" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "MIRTAZAPINE" ], "rxcui": [ "211322", "211323", "283406", "283407", "283485", "311725", "314111", "752869", "752870", "752871" ], "spl_id": [ "8b121c7c-9bcd-4504-b789-3f551a0fe514" ], "spl_set_id": [ "98ad1917-a094-44f5-a28f-a64a8cfcd887" ], "package_ndc": [ "78206-160-01", "78206-161-01", "78206-156-99", "78206-156-01", "78206-158-99", "78206-158-01", "78206-159-99", "78206-159-01" ], "unii": [ "A051Q2099Q" ] } }, { "drugcharacterization": "2", "medicinalproduct": "PRISTIQ EXTENDED RELEASE", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "DESVENLAFAXINE SUCCINATE" } }, { "drugcharacterization": "2", "medicinalproduct": "LITHIUM ASPARTATE", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "LITHIUM ASPARTATE" } }, { "drugcharacterization": "1", "medicinalproduct": "STELARA", "drugbatchnumb": "DIS36MB", "drugauthorizationnumb": "125261", "drugstructuredosagenumb": "90", "drugstructuredosageunit": "003", "drugdosageform": "SOLUTION FOR INJECTION", "drugadministrationroute": "058", "drugindication": "PSORIASIS", "drugstartdateformat": "102", "drugstartdate": "20131010", "drugenddateformat": "102", "drugenddate": "20140218", "actiondrug": "1", "drugrecurreadministration": "2", "activesubstance": { "activesubstancename": "USTEKINUMAB" }, "openfda": { "application_number": [ "BLA761044", "BLA125261" ], "brand_name": [ "STELARA" ], "generic_name": [ "USTEKINUMAB" ], "manufacturer_name": [ "Janssen Biotech, Inc." ], "product_ndc": [ "57894-054", "57894-061", "57894-060" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "INTRAVENOUS", "SUBCUTANEOUS" ], "substance_name": [ "USTEKINUMAB" ], "rxcui": [ "853350", "853354", "853355", "853356", "1654077", "1654079", "1811255", "1811257" ], "spl_id": [ "ff62ab2e-9413-4e22-95ad-74b582c14dc6" ], "spl_set_id": [ "c77a9664-e3bb-4023-b400-127aa53bca2b" ], "package_ndc": [ "57894-061-02", "57894-061-03", "57894-061-04", "57894-054-27", "57894-054-16", "57894-060-02", "57894-060-03", "57894-060-04" ], "nui": [ "N0000192797", "N0000192796", "N0000192799", "N0000192798" ], "pharm_class_epc": [ "Interleukin-12 Antagonist [EPC]", "Interleukin-23 Antagonist [EPC]" ], "pharm_class_moa": [ "Interleukin-12 Antagonists [MoA]", "Interleukin-23 Antagonists [MoA]" ], "unii": [ "FU77B4U5Z0" ] } }, { "drugcharacterization": "2", "medicinalproduct": "VALIUM", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "DIAZEPAM" }, "openfda": { "application_number": [ "NDA013263" ], "brand_name": [ "VALIUM" ], "generic_name": [ "DIAZEPAM" ], "manufacturer_name": [ "Roche Laboratories Inc." ], "product_ndc": [ "0140-0004", "0140-0005" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIAZEPAM" ], "rxcui": [ "104699", "104700", "197590", "197591" ], "spl_id": [ "ea505cdb-6d89-4b8c-8007-ec5a5fe920ce" ], "spl_set_id": [ "554baee5-b171-4452-a50a-41a0946f956c" ], "package_ndc": [ "0140-0004-01", "0140-0005-01", "0140-0005-14" ], "nui": [ "N0000175694", "M0002356" ], "pharm_class_epc": [ "Benzodiazepine [EPC]" ], "pharm_class_cs": [ "Benzodiazepines [CS]" ], "unii": [ "Q3JTX2Q7TU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "WELLBUTRIN", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "BUPROPION HYDROCHLORIDE" }, "openfda": { "application_number": [ "NDA021515", "NDA020358" ], "brand_name": [ "WELLBUTRIN XL", "WELLBUTRIN SR" ], "generic_name": [ "BUPROPION HYDROCHLORIDE" ], "manufacturer_name": [ "Bausch Health US LLC", "GlaxoSmithKline LLC" ], "product_ndc": [ "0187-0730", "0187-0731", "0173-0135", "0173-0947", "0173-0722" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "BUPROPION HYDROCHLORIDE" ], "rxcui": [ "993541", "993545", "993557", "993564", "993503", "993511", "993518", "993528", "993536", "993537" ], "spl_id": [ "22308f71-fc56-430d-b559-bed47e17a46c", "5ffc8b63-7d69-4f3a-bf05-a9c138724a91" ], "spl_set_id": [ "a435da9d-f6e8-4ddc-897d-8cd2bf777b21", "cbc8c074-f080-4489-a5ae-207b5fadeba3" ], "package_ndc": [ "0187-0730-30", "0187-0730-90", "0187-0730-07", "0187-0731-30", "0187-0731-07", "0173-0947-55", "0173-0135-55", "0173-0722-00" ], "unii": [ "ZG7E5POY8O" ] } }, { "drugcharacterization": "2", "medicinalproduct": "GEODON", "drugdosageform": "UNKNOWN", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "ZIPRASIDONE HYDROCHLORIDE\\ZIPRASIDONE MESYLATE" }, "openfda": { "application_number": [ "NDA020825", "NDA020919" ], "brand_name": [ "GEODON" ], "generic_name": [ "ZIPRASIDONE", "ZIPRASIDONE MESYLATE", "ZIPRASIDONE HYDROCHLORIDE" ], "manufacturer_name": [ "Viatris Specialty LLC", "ROERIG" ], "product_ndc": [ "58151-131", "58151-132", "58151-133", "58151-134", "58151-137", "0049-0056", "0049-3960", "0049-3980", "0049-3990", "0049-3920", "0049-0052", "0049-0054", "0049-0058", "0049-0352", "0049-0354", "0049-0356", "0049-0358" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL", "INTRAMUSCULAR" ], "substance_name": [ "ZIPRASIDONE", "ZIPRASIDONE MESYLATE", "ZIPRASIDONE HYDROCHLORIDE" ], "rxcui": [ "284548", "284549", "284550", "285127", "313776", "313777", "313778", "314286", "351223", "352228" ], "spl_id": [ "8351d3a9-c9f8-4ae0-be80-ae3a4ef02820", "c717f8ab-3351-4caa-b1fa-86c2fa415189" ], "spl_set_id": [ "a2b4cc65-6a6d-49c4-adfc-a4458562a167", "8326928a-2cb6-4f7f-9712-03a425a14c37" ], "package_ndc": [ "58151-131-91", "58151-132-91", "58151-133-91", "58151-134-91", "58151-137-81", "0049-3960-60", "0049-3980-60", "0049-3990-60", "0049-3920-20", "0049-3920-83", "0049-3920-01", "0049-3920-10", "0049-0052-60", "0049-0054-60", "0049-0056-60", "0049-0058-60", "0049-0352-60", "0049-0354-60", "0049-0356-60", "0049-0358-60" ], "nui": [ "N0000175430" ], "pharm_class_epc": [ "Atypical Antipsychotic [EPC]" ], "unii": [ "6UKA5VEJ6X", "3X6SAX83JZ", "216X081ORU" ] } }, { "drugcharacterization": "2", "medicinalproduct": "DEPAKOTE", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "DIVALPROEX SODIUM" }, "openfda": { "application_number": [ "NDA021168", "NDA018723", "NDA019680" ], "brand_name": [ "DEPAKOTE ER", "DEPAKOTE", "DEPAKOTE SPRINKLES" ], "generic_name": [ "DIVALPROEX SODIUM" ], "manufacturer_name": [ "AbbVie Inc." ], "product_ndc": [ "0074-7401", "0074-3826", "0074-7126", "0074-7402", "0074-7325", "0074-6212", "0074-6214", "0074-6215", "0074-7327", "0074-7326", "0074-6114" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DIVALPROEX SODIUM" ], "rxcui": [ "1099563", "1099565", "1099569", "1099571", "1099625", "1099626", "1099678", "1099679", "1099870", "1099871", "1099596", "1099598" ], "spl_id": [ "0ee65b66-ead3-44ef-911f-14965b067903", "7cc3a0b3-93f8-4825-88e1-bf6ddb0db23d", "d038b7e9-b014-4771-93be-90aeeaece03d" ], "spl_set_id": [ "0dc024ce-efc8-4690-7cb5-639c728fccac", "08a65cf4-7749-4ceb-6895-8f4805e2b01f", "4619aff4-0f80-444f-858d-42e4137aa809" ], "package_ndc": [ "0074-3826-13", "0074-3826-11", "0074-7401-13", "0074-7126-13", "0074-7126-53", "0074-7126-11", "0074-7126-72", "0074-7402-13", "0074-6212-13", "0074-6214-13", "0074-6214-53", "0074-6215-13", "0074-6215-53", "0074-7325-13", "0074-7327-13", "0074-7326-13", "0074-6114-13", "0074-6114-11" ], "unii": [ "644VL95AO6" ] } }, { "drugcharacterization": "2", "medicinalproduct": "TRAZODONE", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "DEXEDRINE", "drugdosageform": "UNSPECIFIED", "drugadministrationroute": "065", "activesubstance": { "activesubstancename": "DEXTROAMPHETAMINE SULFATE" }, "openfda": { "application_number": [ "NDA017078" ], "brand_name": [ "DEXEDRINE SPANSULE" ], "generic_name": [ "DEXTROAMPHETAMINE SULFATE" ], "manufacturer_name": [ "Amneal Pharmaceuticals LLC" ], "product_ndc": [ "64896-673", "64896-674", "64896-675" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "DEXTROAMPHETAMINE SULFATE" ], "rxcui": [ "884520", "884528", "884532", "884534", "884535", "884537" ], "spl_id": [ "d5d5a976-872f-4849-b222-1fb433511511" ], "spl_set_id": [ "cc717b9b-22ea-4c60-a1d4-ee38a40bce78" ], "package_ndc": [ "64896-673-10", "64896-674-10", "64896-675-10" ], "unii": [ "JJ768O327N" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20140304" } } } ] }