{ "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": 171882 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10003351", "primarysourcecountry": "GB", "occurcountry": "GB", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140312", "receiptdateformat": "102", "receiptdate": "20140312", "fulfillexpeditecriteria": "1", "companynumb": "GB-WATSON-2014-04154", "duplicate": "1", "reportduplicate": { "duplicatesource": "WATSON", "duplicatenumb": "GB-WATSON-2014-04154" }, "primarysource": { "reportercountry": "GB", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "46", "patientonsetageunit": "801", "patientweight": "120", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Aggression", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Violence-related symptom", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Anger", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Blepharospasm", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Suicidal ideation", "reactionoutcome": "6" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "MIRTAZAPINE (UNKNOWN)", "drugbatchnumb": "UNCONFIRMED", "drugauthorizationnumb": "076336", "drugstructuredosagenumb": "30", "drugstructuredosageunit": "003", "drugdosagetext": "30 MG, UNKNOWN", "drugdosageform": "Unk", "drugadministrationroute": "048", "drugindication": "DEPRESSION", "drugstartdateformat": "102", "drugstartdate": "20140101", "actiondrug": "4" }, { "drugcharacterization": "2", "medicinalproduct": "LANSOPRAZOLE", "drugdosagetext": "UNK", "drugadministrationroute": "065", "drugindication": "PRODUCT USED FOR UNKNOWN INDICATION", "actiondrug": "5", "drugrecurreadministration": "3", "openfda": { "application_number": [ "ANDA207394", "ANDA202319", "NDA208025", "ANDA091269", "ANDA203187", "ANDA207167", "ANDA210465", "ANDA203083", "ANDA202194", "ANDA203957", "NDA020406", "NDA021428", "ANDA203203", "ANDA208671", "ANDA202396", "ANDA200816", "ANDA090763", "ANDA205868", "ANDA077255", "ANDA208784" ], "brand_name": [ "LANSOPRAZOLE", "BASIC CARE LANSOPRAZOLE", "EQUATE LANSOPRAZOLE DELAYED RELEASE", "EQUATE LANSOPRAZOLE", "PREVACID 24 HR", "TOPCARE LANSOPRAZOLE", "CAREONE ACID REDUCER", "GOOD SENSE LANSOPRAZOLE", "UP AND UP LANSOPRAZOLE", "PREVACID", "PREVACID SOLUTAB", "DG HEALTH LANSOPRAZOLE", "KIRKLAND SIGNATURE LANSOPRAZOLE", "FOSTER AND THRIVE ACID REDUCER", "MEMBERS MARK LANSOPRAZOLE", "SIGNATURE CARE ACID REDUCER", "GOOD NEIGHBOR PHARMACY LANSOPRAZOLE", "EQUALINE LANSOPRAZOLE" ], "generic_name": [ "LANSOPRAZOLE" ], "manufacturer_name": [ "Medcore LLC", "Amazon.com Services LLC", "Wal-Mart Stores Inc", "Padagis Israel Pharmaceuticals Ltd", "L. 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