{ "summary": { "safetyreportid": "18606804", "receivedate": "20210125", "serious": "1", "seriousnessdeath": null, "age": "65", "sex": "1", "drugs": [ "ACTRAPID INSULIN HUMAN", "SALINE SPRAY", "CHLORINE DIOXIDE", "OMEGA 3 FISH OIL [FISH OIL]", "COENZYME Q10", "CHLORINE DIOXIDE", "ROSUVASTATIN.", "ZINC CREAM" ], "reactions": [ "Rectal haemorrhage", "Diarrhoea" ], "source_url": "/docs/faers/18606804.html" }, "raw": { "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" } } } }