{ "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": 10, "total": 7792 } }, "results": [ { "safetyreportversion": "2", "safetyreportid": "10012930", "primarysourcecountry": "US", "occurcountry": "US", "transmissiondateformat": "102", "transmissiondate": "20160815", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140314", "receiptdateformat": "102", "receiptdate": "20160422", "fulfillexpeditecriteria": "1", "companynumb": "US-FRI-1000064596", "duplicate": "1", "reportduplicate": { "duplicatesource": "FOREST", "duplicatenumb": "US-FRI-1000064596" }, "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "45", "patientonsetageunit": "801", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Electrocardiogram QT prolonged", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Stomatitis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Weight decreased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Tongue ulceration", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Glossitis", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Psychogenic seizure", "reactionoutcome": "6" }, { "reactionmeddraversionpt": "19.0", "reactionmeddrapt": "Decreased appetite", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "DIABETES MEDICATIONS NOS", "drugindication": "DIABETES MELLITUS" }, { "drugcharacterization": "2", 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"medicinalproduct": "ASPIRIN", "drugdosagetext": "81 MG", "openfda": { "application_number": [ "M013", "M013.50", "part343", "M" ], "brand_name": [ "BAYER GENUINE ASPIRIN", "ASPIRIN", "ENTERIC ASPIRIN", "ADULT LOW DOSE ASPIRIN", "CHEWABLE ASPIRIN", "DRUG MART EFFERVESCENT PAIN RELIEF", "ASPIRIN LOW DOSE", "ASPIRIN ENTERIC COATED", "ASPIRIN 81", "ADULT CHEWABLE ASPIRIN", "ASPIRIN 81MG", "ADULT LOW DOSE ENTERIC COATED ASPIRIN", "ASPIRIN LOW DOSE SAFETY COATED", "GERITREX ASPIRIN", "BUFFERED ASPIRIN", "ENTERIC COATED ASPIRIN", "BUFFERIN REGULAR STRENGTH PAIN RELIEF", "WISPIRIN", "EQUATE ASPIRIN", "LOW DOSE ASPIRIN", "HEB EFFERVESCENT PAIN RELIEF", "PAIN RELIEF ASPIRIN LOW DOSE", "ASPIRIN 81 MG LOW DOSE", "ASPIRIN EXTRA STRENGTH", "BAYER CHEWABLE - ASPIRIN REGIMEN LOW DOSE ASPIRIN CHERRY FLAVORED", "TRAVEL SAVVY ASPIRIN", "CHEWABLE ASPIRIN 81 MG", "TOPCARE ASPIRIN", "RAPIDOL ASPIRIN", "CAREALL ASPIRIN", "ASPIRIN REGULAR STRENGTH", "REGULAR STRENGTH ASPIRIN", "LOW DOSE MINIPRIN ENTERIC 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"Cytochrome P450 2C19 Inhibitors [MoA]" ], "unii": [ "0H73WJJ391" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LEXOTAN", "drugindication": "DYSPHAGIA" }, { "drugcharacterization": "2", "medicinalproduct": "LEXOTAN", "drugindication": "SCHIZOAFFECTIVE DISORDER" }, { "drugcharacterization": "2", "medicinalproduct": "ZETRON", "drugstructuredosagenumb": "150", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "150 MG", "drugdosageform": "TABLET", "drugindication": "DEPRESSION", "drugstartdateformat": "602", "drugstartdate": "2008" }, { "drugcharacterization": "2", "medicinalproduct": "WELLBUTRIN", "drugindication": "SCHIZOAFFECTIVE DISORDER", "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" ] } } ] } } ] }