{ "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": 64339 } }, "results": [ { "safetyreportversion": "1", "safetyreportid": "10029646", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20141002", "reporttype": "1", "serious": "1", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20140320", "receiptdateformat": "102", "receiptdate": "20140320", "fulfillexpeditecriteria": "2", "primarysource": { "reportercountry": "US", "qualification": "2" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "78", "patientonsetageunit": "801", "patientweight": "73", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Rash macular" }, { "reactionmeddraversionpt": "17.0", "reactionmeddrapt": "Eosinophil count increased" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "APIXABAN", "drugbatchnumb": "1L65685C", "drugstructuredosagenumb": "5", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugadministrationroute": "048", "drugindication": "CEREBROVASCULAR ACCIDENT PROPHYLAXIS", "drugstartdateformat": "102", "drugstartdate": "20140308", "drugenddateformat": "102", "drugenddate": "20140308", "drugadditional": "1", "openfda": { "application_number": [ "ANDA209810", "ANDA209898", "ANDA210067" ], "brand_name": [ "APIXABAN" ], "generic_name": [ "APIXABAN" ], "manufacturer_name": [ "Amneal Pharmaceuticals of New York LLC", "Indoco Remedies Limited", "Macleods Pharmaceuticals Limited" ], "product_ndc": [ "0115-1721", "0115-1722", "14445-149", "14445-150", "33342-337", "33342-338" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "APIXABAN" ], "rxcui": [ "1364435", "1364445" ], "spl_id": [ "ac3db938-22a3-42a0-ac3a-8628d9e0a7cf", "6a6e421b-6ed3-403c-b07d-09dbbd6a487c", "396912c0-9f68-47ed-ba3f-8d9ace755a48" ], "spl_set_id": [ "19a60552-374d-4b8b-a8ce-ceae252ea5ba", "095a08ac-cf0e-497e-a682-ddef38d6b29c", "396912c0-9f68-47ed-ba3f-8d9ace755a48" ], "package_ndc": [ "0115-1721-13", "0115-1721-03", "0115-1721-15", "0115-1721-01", "0115-1722-13", "0115-1722-03", "0115-1722-15", "0115-1722-01", "14445-149-60", "14445-149-18", "14445-149-05", "14445-149-14", "14445-149-10", "14445-150-60", "14445-150-18", "14445-150-05", "14445-150-10", "33342-337-09", "33342-337-15", "33342-337-12", "33342-338-09", "33342-338-15", "33342-338-12" ], "nui": [ "N0000175637", "N0000175635" ], "pharm_class_epc": [ "Factor Xa Inhibitor [EPC]" ], "pharm_class_moa": [ "Factor Xa Inhibitors [MoA]" ], "unii": [ "3Z9Y7UWC1J" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ACETAMINOPHIN" }, { "drugcharacterization": "2", "medicinalproduct": "DOCUSATE SODIUM", "openfda": { "application_number": [ "M007", "M" ], "brand_name": [ "DOCUSATE SODIUM 100MG TWO-TONE", "STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM", "WINCO STOOL SOFTENER", "GENTLE STOOL SOFTENER", "TOPCARE STOOL SOFTENER", "STOOL SOFTENER", "GERICARE DOCUSATE SODIUM LIQUID", "COLACE", "HEB STOOL SOFTENER", "DOCUSATE SODIUM LIQUID", "DOCUSATE SODIUM, EXTRA STRENGTH 250 MG", "DULCOLAX STOOL SOFTENER", "ENEMEEZ KIDS", "H E B STOOL SOFTENER LAXATIVE", "EXCHANGE SELECT STOOL SOFTENER", "STOOL SOFTENER EXTRA STRENGTH", "DOCUSATE MINI ENEMA", "GOOD SENSE STOOL SOFTENER", "DOCUSATE SODIUM - STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM 100MG", "PREFERRED STOOL SOFTENER", "COLACE EXTRA STRENGTH STOOL SOFTNER", "STOOL SOFTENER LAXATIVE EXTRA STRENGTH", "ENEMEEZ", "WALGREENS STOOL SOFTENER FRUIT PUNCH", "FLEET", "GOOD NEIGHBOR STOOL SOFTENER LAXATIVE", "PHILLIPS STOOL SOFTENER BULK DOCUSATE", "BASIC CARE STOOL SOFTENER", "STOOL SOFTENER REGULAR STRENGTH", "DOK", "PREFERRED STOOL SOFTENER LAXATIVE", "QUALITY CHOICE STOOL SOFTENER", "FEVIA CONSTIPATION CONTROL", "STOOL SOFTENER DOCUSATE SODIUM", "CVS STOOL SOFTENER FRUIT PUNCH", "GOOD NEIGHBOR STOOL SOFTENER", "KROGER STOOL SOFTENER FRUIT PUNCH", "DULCOLAX PINK STOOL SOFTENER", "QUALITY CHOICE STOOL SOFTENER LAXATIVE", "TOPCARE STOOL SOFTENER LAXATIVE", "DOCUSATE SODIUM 50 MG", "PEDIA-LAX", "DOCUSATE SODIUM 50MG SOFTGEL (RED)", "DOCUSATE SODIUM SOFTGELS 50MG (DYE FREE)" ], "generic_name": [ "DOCUSATE SODIUM", "DOCUSATE SODIUM 100MG" ], "manufacturer_name": [ "Humanwell PuraCap Pharmaceutical (Wuhan), Ltd.", "TARGET Corporation", "United Natural Foods, Inc. dba UNFI", "EQUATE (Wal-Mart Stores, Inc.) 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Perrigo Company", "Geri-Care Pharmaceutical Corp", "Care One (Retail Business Services, LLC.)", "Humanwell PuraCap Pharmaceutical (Wuhan) Co., Ltd.", "Walgreen Co.", "Reese Pharmaceutical Co", "BJWC (Berkley & Jensen / BJ's)", "Atlantis Consumer Healthcare Inc.", "WALMART INC. (see also Equate)", "Quest Products, LLC", "WALGREENS CO.", "Strategic Sourcing Services LLC", "MEIJER, INC.", "The Kroger Co.", "Allegiant Health", "Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd", "RMT HEALTH LLC", "C.B. 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