{ "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": "3", "safetyreportid": "19950561", "primarysourcecountry": "MX", "occurcountry": "MX", "transmissiondateformat": "102", "transmissiondate": "20220721", "reporttype": "2", "serious": "1", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "1", "receivedateformat": "102", "receivedate": "20211013", "receiptdateformat": "102", "receiptdate": "20220425", "fulfillexpeditecriteria": "1", "companynumb": "MX-BAYER-2021A228815", "primarysource": { "reportercountry": "MX", "qualification": "5" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "64", "patientonsetageunit": "801", "patientagegroup": "5", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Alpha 1 foetoprotein decreased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Alpha 1 foetoprotein increased", "reactionoutcome": "3" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Blood pressure increased", "reactionoutcome": "2" }, { "reactionmeddraversionpt": "25.0", "reactionmeddrapt": "Hypertension", "reactionoutcome": "3" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "STIVARGA", "drugbatchnumb": "Not Provided", "drugauthorizationnumb": "203085", "drugstructuredosagenumb": "505", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "120 MG, QD (TO BE TAKEN 3 WEEKS WITH 1 WEEK OFF)", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Hepatocellular carcinoma", "drugstartdateformat": "102", "drugstartdate": "20210809", "actiondrug": "4", "activesubstance": { "activesubstancename": "REGORAFENIB" }, "openfda": { "application_number": [ "NDA203085" ], "brand_name": [ "STIVARGA" ], "generic_name": [ "REGORAFENIB" ], "manufacturer_name": [ "Bayer HealthCare Pharmaceuticals Inc." ], "product_ndc": [ "50419-171" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "REGORAFENIB" ], "rxcui": [ "1312402", "1312408" ], "spl_id": [ "8f47fb28-9855-4482-b807-e98c425c2a4e" ], "spl_set_id": [ "824f19c9-0546-4a8a-8d8f-c4055c04f7c7" ], "package_ndc": [ "50419-171-01", "50419-171-03", "50419-171-00", "50419-171-04", "50419-171-05", "50419-171-06" ], "unii": [ "MGN125FS9D" ] } }, { "drugcharacterization": "2", "medicinalproduct": "LOPERAMIDE", "drugdosagetext": "2 MG EVERY 8 HOURS", "drugindication": "Diarrhoea", "drugstartdateformat": "610", "drugstartdate": "202109", "activesubstance": { "activesubstancename": "LOPERAMIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "SENNOSIDES", "drugdosagetext": "2 TABLETS ORALLY/12 HOURS", "drugindication": "Constipation", "drugstartdateformat": "610", "drugstartdate": "202109", "activesubstance": { "activesubstancename": "SENNOSIDES" }, "openfda": { "application_number": [ "505G(a)(3)", "M007", "M007.60", "M008" ], "brand_name": [ "LAXATIVE", "CAREALL SENNOSIDES", "SENNA LAXATIVE", "SENNOSIDES", "SENNA SYRUP", "VEGETABLE LAXATIVE", "SENNOSIDES 8.6 MG", "MAXIMUM STRENGTH LAXATIVE", "SENNA", "GERI-KOT", "NATURAL SENNA LAXATIVE", "SENNOSIDES NATURAL LAXATIVE", "CHOCOLATED LAXATIVE REGULAR STRENGTH SENNOSIDES STIMULANT LAXATIVE, BEST CHOICE", "SENNA UD", "EX-LAX MAXIMUM STRENGTH STIMULANT LAXATIVE", "EX-LAX REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE", "KROGER SENNA LAXATIVE REGULAR STRENGTH", "GERICARE SENNA SYRUP", "CVS SENNA LAXATIVE", "EQUALINE REGULAR STRENGTH CHOCOLATED STIMULANT LAXATIVE", "HYVEE REGULAR STRENGTH SENNOSIDES LAXATIVE", "MAXIMUM STRENGTH LAXATIVE PILLS", "CHOCOLATED LAXATIVE REGULAR STRENGTH SENNOSIDES STIMULANT LAXATIVE TOPCARE HEALTH", "SENNA-LAX", "CHOCOLATED LAXATIVE REGULAR STRENGTH SENNOSIDES STIMULANT LAXATIVE, DG HEALTH", "STIMULANT LAXATIVE", "CHOCOLATE LAXATIVE REGULAR STRENGTH, SENNOSIDES STIMULANT LAXATIVE, EQUATE", "EX-LAX REGULAR STRENGTH STIMULANT LAXATIVE", "CUREWELL SENNA SYRUP", "LAXATIVE SENNA", "SENNA TIME", "LEADER REGULAR STRENGTH CHOCOLATE LAXATIVE SENNOSIDES", "SENNA NATURAL VEGETABLE", "SENNA LIQUID", "SENNA-S LAXATIVE WITH STOOL SOFTENER", "LAX-TIME", "HEB MAXIMUM STRENGTH LAXATIVE PILLS", "WALGREENS SENNA LAXATIVE", "LAXATIVE REGULAR STRENGTH" ], "generic_name": [ "SENNOSIDES" ], "manufacturer_name": [ "TOPCO ASSOCIATES LLC", "New World Imports, Inc", "United Natural Foods, Inc. dba UNFI", "Dolgencorp, Inc. 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"69238-1205" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "SUBCUTANEOUS", "SUBLINGUAL", "TRANSDERMAL" ], "substance_name": [ "BUPRENORPHINE", "BUPRENORPHINE HYDROCHLORIDE" ], "rxcui": [ "1996184", "1996189", "1996192", "1996193", "351264", "351265", "2639021", "2639027", "2639029", "2639030", "2639031", "2639032", "2639033", "2639034", "2639036", "2639039", "2639041", "2639042", "2639043", "2639044", "904870", "904874", "904876", "904878", "904880", "904882", "1432969", "1432971", "1542997", "1542999" ], "spl_id": [ "5799c0fd-6d82-f48a-e063-6394a90a63d6", "ba293490-0f6f-4400-82cd-3af9774839e8", "4e1985eb-1302-42e0-ac79-10b0a492966a", "cf5d162f-a313-4f27-a292-3ecf640fbea7", "7f83c8aa-7590-e2fe-4998-55323eadd112", "e59c3c4f-a9cc-412b-b001-b9e430f537c5", "5f1402cd-d222-4604-bef0-daa2b15bb4a8", "5090c42d-8c7d-a0b9-e063-6294a90a925d", "606ac164-7172-49b9-b72f-2efb545dcbb2", "db0d877f-2f4d-4cf9-b463-6badf66037a7", "509150ac-3394-c793-e063-6294a90ab2ee", 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"activesubstance": { "activesubstancename": "CHLORINE DIOXIDE" }, "openfda": { "brand_name": [ "PURE O2-S F" ], "generic_name": [ "CHLORINE DIOXIDE" ], "manufacturer_name": [ "Pure O2" ], "product_ndc": [ "75124-0014", "75124-0001" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "CHLORINE DIOXIDE" ], "spl_id": [ "33e25ea9-f6c4-787b-e063-6294a90a3fad", "adfeccac-a851-8cb6-e053-2995a90ac488" ], "spl_set_id": [ "33e26932-15f7-8304-e063-6294a90a7324", "a390128a-0331-0afa-e053-2a95a90a97bc" ], "package_ndc": [ "75124-0014-1", "75124-0001-1" ], "unii": [ "8061YMS4RM" ] } } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20211006" } } } ] }