{ "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": 14482849 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003301", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140228", "receiptdateformat": "102", "receiptdate": "20140228", "fulfillexpeditecriteria": "2", "companynumb": "US-JNJFOC-20130719067", "duplicate": "1", "reportduplicate": { "duplicatesource": "JANSSEN", "duplicatenumb": "US-JNJFOC-20130719067" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Dyspepsia" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Renal impairment" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "IBUPROFEN", "drugauthorizationnumb": "17463", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "drugrecurreadministration": "3", "drugadditional": "3", "openfda": { "application_number": [ "ANDA078682", "ANDA077349", "505G(a)(3)", "ANDA079174", "ANDA210602", "ANDA202312", "ANDA074937", "ANDA075010", "ANDA076359", "ANDA209179", "ANDA210755", "NDA020944", "ANDA091239", "ANDA075682", "NDA020589", "ANDA202413", "ANDA091237", "NDA020516", "ANDA210149", "ANDA072096", "ANDA220239", "ANDA206568", "ANDA074916", "ANDA075217", "ANDA217261", "ANDA091355", "ANDA207753", "ANDA079233", "ANDA079205", "ANDA206999", "ANDA075139", "NDA020402", "ANDA091625", "NDA022348", "ANDA079129", "ANDA208865", "M", "ANDA078329", "ANDA078558", 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Inc.", "Chain Drug Consortium, LLC", "JHK Inc dba American Safety & First Aid", "Demoulas Super Markets, Inc", "ADVANCED FIRST AID, INC.", "Sam's West Inc", "Family Dollar Services Inc", "DISCOUNT DRUG MART", "Unifirst First Aid", "RANDOB LABS,LTD. 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"pharm_class_epc": [ "Nonsteroidal Anti-inflammatory Drug [EPC]" ], "unii": [ "WK2XYI10QM" ] } } ] } } ] }