{ "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": "2", "safetyreportid": "18606804", "primarysourcecountry": "AU", "occurcountry": "AU", "transmissiondateformat": "102", "transmissiondate": "20210419", "reporttype": "2", "serious": "1", "seriousnesshospitalization": "1", "receivedateformat": "102", "receivedate": "20201211", "receiptdateformat": "102", "receiptdate": "20210125", "fulfillexpeditecriteria": "1", "companynumb": "AU-JNJFOC-20201203791", "duplicate": "1", "reportduplicate": { "duplicatesource": "JOHNSON AND JOHNSON", "duplicatenumb": "AU-JNJFOC-20201203791" }, "primarysource": { "reportercountry": "AU", "qualification": "1" }, "sender": { "sendertype": "2", "senderorganization": "FDA-Public Use" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "65", "patientonsetageunit": "801", "patientagegroup": "6", "patientweight": "72", "patientsex": "1", "reaction": [ { "reactionmeddraversionpt": "23.1", "reactionmeddrapt": "Rectal haemorrhage", "reactionoutcome": "1" }, { "reactionmeddraversionpt": "23.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": "1" } ], "drug": [ { "drugcharacterization": "2", "medicinalproduct": "ACTRAPID INSULIN HUMAN", "drugindication": "TYPE 1 DIABETES MELLITUS", "drugstartdateformat": "602", "drugstartdate": "2018" }, { "drugcharacterization": "2", "medicinalproduct": "SALINE SPRAY", "drugindication": "NASAL DRYNESS", "drugstartdateformat": "102", "drugstartdate": "20201015", "activesubstance": { "activesubstancename": "SODIUM CHLORIDE" } }, { "drugcharacterization": "2", "medicinalproduct": "CHLORINE DIOXIDE", "drugindication": "GLOSSODYNIA", "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "OMEGA 3 FISH OIL [FISH OIL]", "drugindication": "VITAMIN SUPPLEMENTATION", "drugstartdateformat": "602", "drugstartdate": "2019" }, { "drugcharacterization": "2", "medicinalproduct": "COENZYME Q10", "drugindication": "VITAMIN SUPPLEMENTATION", "drugstartdateformat": "602", "drugstartdate": "2015", "activesubstance": { "activesubstancename": "DIETARY SUPPLEMENT\\UBIDECARENONE" } }, { "drugcharacterization": "2", "medicinalproduct": "CHLORINE DIOXIDE", "drugindication": "NASAL DRYNESS", "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" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ROSUVASTATIN.", "drugindication": "HYPERCHOLESTEROLAEMIA", "drugstartdateformat": "602", "drugstartdate": "2010", "activesubstance": { "activesubstancename": "ROSUVASTATIN" }, "openfda": { "application_number": [ "ANDA207616", "ANDA206434", "ANDA206381", "ANDA207296", "ANDA206465", "ANDA206513" ], "brand_name": [ "ROSUVASTATIN" ], "generic_name": [ "ROSUVASTATIN" ], "manufacturer_name": [ "Camber Pharmaceuticals, Inc.", "Accord Healthcare Inc.", "ScieGen Pharmaceuticals, Inc.", "Macleods Pharmaceuticals Limited", "Quallent Pharmaceuticals Health LLC", "AiPing Pharmaceutical, Inc." ], "product_ndc": [ "31722-882", "31722-883", "31722-884", "31722-885", "16729-284", "16729-285", "16729-286", "16729-287", "50228-116", "50228-117", "50228-118", "50228-119", "33342-261", "33342-262", "33342-263", "33342-264", "82009-188", "82009-189", "82009-190", "82009-191", "11788-130", "11788-131", "11788-132", "11788-133" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ROSUVASTATIN CALCIUM", "ROSUVASTATIN" ], "rxcui": [ "859419", "859424", "859747", "859751" ], "spl_id": [ "546deb8e-1be9-e850-e063-6294a90a0ae2", "4390ed19-e509-95ab-e063-6294a90a2b08", "10c76ffa-add0-467f-b3ed-84a3bbdee84c", "093ea34a-0a0b-4642-8e8e-62d6fc5c37d4", "0d12ae85-71bd-4818-a82d-fd068530bd87", "42b21540-4538-4c56-adb7-b9cfe8b2b2d5" ], "spl_set_id": [ "7778df5a-82c1-4a86-8867-a3325da025ec", "3ffe0294-3997-2755-e054-00144ff8d46c", "ee4933c5-0d97-494d-ac0f-2083e0100836", "d7b9f280-bda6-40d4-9778-e45efb87ab23", "0d12ae85-71bd-4818-a82d-fd068530bd87", "913067e8-723b-4ce2-9ebc-3e10b0f0cf7a" ], "package_ndc": [ "31722-882-90", "31722-882-31", "31722-882-05", "31722-882-10", "31722-883-90", "31722-883-31", "31722-884-90", "31722-884-31", "31722-885-30", "31722-885-31", "31722-885-05", "31722-885-10", "16729-284-10", "16729-284-15", "16729-284-17", "16729-285-10", "16729-285-15", "16729-285-17", "16729-286-10", "16729-286-15", "16729-286-17", "16729-287-10", "16729-287-15", "16729-287-17", "50228-116-30", "50228-116-90", "50228-116-05", "50228-116-10", "50228-117-30", "50228-117-90", "50228-117-05", "50228-117-10", "50228-118-30", "50228-118-90", "50228-118-05", "50228-118-10", "50228-119-30", "50228-119-90", "50228-119-05", "50228-119-10", "33342-261-07", "33342-261-10", "33342-261-44", "33342-261-12", "33342-262-07", "33342-262-10", "33342-262-44", "33342-262-12", "33342-263-07", "33342-263-10", "33342-263-44", "33342-263-12", "33342-264-07", "33342-264-10", "33342-264-44", "33342-264-12", "82009-188-05", "82009-189-05", "82009-190-05", "82009-191-05", "11788-130-90", "11788-130-05", "11788-130-10", "11788-131-90", "11788-131-05", "11788-131-10", "11788-132-90", "11788-132-05", "11788-132-10", "11788-133-90", "11788-133-05", "11788-133-10" ], "unii": [ "83MVU38M7Q", "413KH5ZJ73" ], "nui": [ "N0000175589", "N0000000121" ], "pharm_class_epc": [ "HMG-CoA Reductase Inhibitor [EPC]" ], "pharm_class_moa": [ "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]" ] } }, { "drugcharacterization": "2", "medicinalproduct": "ZINC CREAM", "drugindication": "PENILE RASH", "drugstartdateformat": "102", "drugstartdate": "20201125", "openfda": { "application_number": [ "M006" ], "brand_name": [ "MARGARITE ZINC CREAM" ], "generic_name": [ "ZINC CREAM" ], "manufacturer_name": [ "Renu Laboratories, LLC" ], "product_ndc": [ "76348-413" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "TOPICAL" ], "substance_name": [ "SULFUR" ], "rxcui": [ "247817" ], "spl_id": [ "373b8aa5-564e-3e75-e063-6394a90af372" ], "spl_set_id": [ "3ca3b7d8-702a-036b-e054-00144ff8d46c" ], "package_ndc": [ "76348-413-01", "76348-413-02" ], "unii": [ "70FD1KFU70" ] } }, { "drugcharacterization": "2", "medicinalproduct": "INSULIN", "drugindication": "TYPE 1 DIABETES MELLITUS", "drugstartdateformat": "610", "drugstartdate": "197704", "activesubstance": { "activesubstancename": "INSULIN NOS" }, "openfda": { "brand_name": [ "INSULIN 1556" ], "generic_name": [ "INSULIN" ], "manufacturer_name": [ "Professional Complementary Health Formulas" ], "product_ndc": [ "63083-1556" ], "product_type": [ "HUMAN OTC DRUG" ], "route": [ "ORAL" ], "substance_name": [ "INSULIN GLARGINE" ], "spl_id": [ "c3c5ae59-b449-474d-8b9c-80f1e5e4eb7b" ], "spl_set_id": [ "88170080-374d-456e-90bc-48e873878ce7" ], "package_ndc": [ "63083-1556-1" ], "nui": [ "M0011417", "N0000175453" ], "pharm_class_cs": [ "Insulin [CS]" ], "pharm_class_epc": [ "Insulin Analog [EPC]" ], "unii": [ "2ZM8CX04RZ" ] } }, { "drugcharacterization": "2", "medicinalproduct": "SALIVA", "drugindication": "DRY MOUTH", "drugstartdateformat": "102", "drugstartdate": "20201023" }, { "drugcharacterization": "1", "medicinalproduct": "ERDAFITINIB.", "drugbatchnumb": "050?0468, 565?6330", "drugauthorizationnumb": "212018", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "8 MG TITRATED UP TO 9 MG (28?OCT?02DEC?2020), THEN RESTARTED AT 9 MG (09DEC)", "drugdosageform": "TABLET", "drugadministrationroute": "048", "drugindication": "CHOLANGIOCARCINOMA", "drugstartdateformat": "102", "drugstartdate": "20201013", "drugenddateformat": "102", "drugenddate": "20201027", "actiondrug": "1", "drugadditional": "1", "activesubstance": { "activesubstancename": "ERDAFITINIB" }, "openfda": { "application_number": [ "NDA212018" ], "brand_name": [ "BALVERSA" ], "generic_name": [ "ERDAFITINIB" ], "manufacturer_name": [ "Janssen Products LP" ], "product_ndc": [ "59676-030", "59676-040", "59676-050" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "ERDAFITINIB" ], "rxcui": [ "2123131", "2123137", "2123139", "2123141", "2123143", "2123145" ], "spl_id": [ "41ec18e6-999d-f298-e063-6294a90aa2dc" ], "spl_set_id": [ "2a8aa5c0-6c92-4566-8c45-e8f4d1fc20ee" ], "package_ndc": [ "59676-040-28", "59676-040-56", "59676-030-56", "59676-030-84", "59676-050-28" ], "nui": [ "N0000175605", "N0000194026", "N0000182141", "N0000185506", "N0000185503", "N0000187061" ], "pharm_class_epc": [ "Kinase Inhibitor [EPC]" ], "pharm_class_moa": [ "Fibroblast Growth Factor Receptor Inhibitors [MoA]", "Cytochrome P450 3A4 Inhibitors [MoA]", "Cytochrome P450 3A4 Inducers [MoA]", "P-Glycoprotein Inhibitors [MoA]", "Organic Cation Transporter 2 Inhibitors [MoA]" ], "unii": [ "890E37NHMV" ] } }, { "drugcharacterization": "2", "medicinalproduct": "CHLORINE DIOXIDE", "drugindication": "DRY MOUTH", "drugstartdateformat": "610", "drugstartdate": "202011", "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: 20201202" } } } ] }