{ "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": "1", "safetyreportid": "20535144", "primarysourcecountry": "FR", "occurcountry": "FR", "transmissiondateformat": "102", "transmissiondate": "20220423", "reporttype": "1", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20220302", "receiptdateformat": "102", "receiptdate": "20220302", "fulfillexpeditecriteria": "1", "companynumb": "FR-AFSSAPS-AVPO20220048", "primarysource": { "reportercountry": "FR", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "58", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Drug abuse", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Retinal detachment", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "24.1", "reactionmeddrapt": "Vitreous haemorrhage", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "3", "medicinalproduct": "ESOMEPRAZOLE", "drugauthorizationnumb": "205606", "drugdosagetext": "UNSPECIFIED", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "actiondrug": "5", "drugadditional": "3", "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "openfda": { "application_number": [ "ANDA207193", "ANDA212866", "ANDA208511", "ANDA212507" ], "brand_name": [ "KIRKLAND SIGNATURE ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE MAGNESIUM", "ESOMEPRAZOLE", "DG HEALTH ESOMEPRAZOLE MAGNESIUM", "LEADER ESOMEPRAZOLE MAGNESIUM", "GOOD NEIGHBOR PHARMACY ESOMEPRAZOLE MAGNESIUM", "EQUATE ESOMEPRAZOLE MAGNESIUM", "SIGNATURE CARE ESOMEPRAZOLE MAGNESIUM", "BASIC CARE ESOMEPRAZOLE MAGNESIUM", "GOOD SENSE ESOMEPRAZOLE MAGNESIUM", "MEMBERS MARK ESOMEPRAZOLE MAGNESIUM", "EXCHANGE SELECT ESOMEPRAZOLE MAGNESIUM", "UP AND UP ESOMEPRAZOLE MAGNESIUM", "CAREONE ESOMEPRAZOLE MAGNESIUM", "BERKLEY AND JENSEN HEARTBURN TREATMENT", "FOSTER AND THRIVE ACID REDUCER", "RIOPAN" ], "generic_name": [ "ESOMEPRAZOLE", "ESOMEPRAZOLE MAGNESIUM" ], "manufacturer_name": [ "Costco Wholesale Company", "CVS WOONSOCKET PRESCRIPTION CENTER, INCORPORATED", "INNOVUS PHARMACEUTICALS, INC.", "Dolgencorp, LLC", "YYBA CORP", "Macleods Pharmaceuticals Limited", "Cardinal Health 110, LLC. dba Leader", "Amerisource Bergen", "CVS Pharmacy", "Wal-Mart Stores Inc", "HyVee Inc", "Dolgencorp Inc", "Safeway", "H E B", "Amazon.com Services LLC", "VALU MERCHANDISERS COMPANY", "THE KROGER COMPANY", "L. 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