{ "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": "2", "safetyreportid": "24323753", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20250114", "reporttype": "2", "serious": "1", "seriousnessdeath": "1", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20240916", "receiptdateformat": "102", "receiptdate": "20241008", "fulfillexpeditecriteria": "2", "companynumb": "US-JAZZ PHARMACEUTICALS-2024-US-015068", "primarysource": { "reportercountry": "US", "qualification": "3" }, "sender": { "sendertype": "1", "senderorganization": "JAZZ" 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"47335-712-18", "69097-122-03", "69097-122-12", "69097-122-15", "69097-123-03", "69097-123-15", "69097-123-12", "69097-124-03", "69097-124-15", "69097-124-12", "69097-125-03", "69097-125-15", "69097-125-12", "31722-547-30", "31722-548-30", "31722-549-30", "31722-550-30" ], "nui": [ "N0000008486", "N0000185506", "N0000182140" ], "pharm_class_pe": [ "Decreased Central Nervous System Disorganized Electrical Activity [PE]" ], "pharm_class_moa": [ "Cytochrome P450 3A4 Inducers [MoA]", "Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "0H73WJJ391" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20240910" } } } ] }