{ "summary": { "safetyreportid": "24986615", "receivedate": "20250214", "serious": "2", "seriousnessdeath": "2", "age": "73", "sex": "2", "drugs": [ "CHLORINE DIOXIDE", "LEVOTHYROXINE", "ROSUVASTATIN", "LISINOPRIL", "COENZYME Q10", "PreserVision Eye Vitamin" ], "reactions": [ "Oral discomfort", "Oral discomfort", "Dry mouth" ], "source_url": "/docs/faers/24986615.html" }, "raw": { "safetyreportversion": "1", "safetyreportid": "24986615", "primarysourcecountry": "US", "transmissiondateformat": "102", "transmissiondate": "20250408", "reporttype": "1", "serious": "2", "seriousnessdeath": "2", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20250214", "receiptdateformat": "102", "receiptdate": "20250214", "fulfillexpeditecriteria": "3", "authoritynumb": "740778", "primarysource": { "reportercountry": "US", "qualification": "5" }, "sender": { "sendertype": "6", "senderorganization": "FDA-CTU" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "73", "patientonsetageunit": "801", "patientweight": "83.25", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Oral discomfort" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Oral discomfort" }, { "reactionmeddraversionpt": "27.1", "reactionmeddrapt": "Dry mouth" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "CHLORINE DIOXIDE", "drugseparatedosagenumb": "2", "drugintervaldosageunitnumb": "1", "drugintervaldosagedefinition": "804", "drugdosagetext": "OTHER QUANTITY : 3 PUMPS EACH PART;?FREQUENCY : TWICE A DAY;?OTHER ROUTE : MOUTH RINSE;?", "drugadministrationroute": "050", "drugindication": "Dental plaque", "drugstartdateformat": "102", "drugstartdate": "20241101", "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": "LEVOTHYROXINE", "activesubstance": { "activesubstancename": "LEVOTHYROXINE" } }, { "drugcharacterization": "2", "medicinalproduct": "ROSUVASTATIN", "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": "LISINOPRIL", "activesubstance": { "activesubstancename": "LISINOPRIL" }, "openfda": { "application_number": [ "ANDA212041", "ANDA208920", "NDA208401", "ANDA076102", "ANDA076164", "ANDA075903", "ANDA076059", "ANDA077321", "ANDA075743", "ANDA203508", "NDA019777", "ANDA077622" ], "brand_name": [ "LISINOPRIL", "QBRELIS", "ZESTRIL" ], "generic_name": [ "LISINOPRIL" ], "manufacturer_name": [ "Chartwell RX, LLC", "Azurity Pharmaceuticals, Inc.", "Heritage Pharmaceuticals Inc. d/b/a Avet Pharmaceuticals Inc.(780779901)", "Solco healthcare U.S., LLC", "Camber Pharmaceuticals, Inc.", "Actavis Pharma, Inc.", "Lupin Pharmaceuticals, Inc.", "XLCare Pharmaceuticals Inc.", "Exelan Pharmaceuticals, Inc", "Exelan Pharmaceuticals Inc.", "Upsher-Smith Laboratories, LLC", "Aurobindo Pharma Limited" ], "product_ndc": [ "62135-640", "62135-641", "62135-642", "62135-643", "62135-644", "62135-645", "52652-3001", "23155-876", "23155-877", "23155-878", "23155-879", "23155-880", "23155-881", "43547-351", "43547-352", "43547-353", "43547-354", "43547-355", "43547-356", "31722-172", "31722-176", "31722-177", "31722-178", "31722-179", "31722-180", "0591-0885", "0591-0405", "0591-0406", "0591-0407", "0591-0408", "0591-0409", "68180-512", "68180-513", "68180-517", "68180-980", "68180-981", 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"62135-640-31", "62135-640-90", "62135-641-31", "62135-641-90", "62135-642-31", "62135-642-90", "62135-643-31", "62135-643-90", "62135-644-31", "62135-644-90", "62135-645-31", "62135-645-90", "52652-3001-1", "23155-876-01", "23155-876-05", "23155-877-01", "23155-877-10", "23155-878-01", "23155-878-10", "23155-879-01", "23155-879-10", "23155-880-01", "23155-880-05", "23155-881-01", "23155-881-10", "43547-351-50", "43547-351-10", "43547-351-03", "43547-352-11", "43547-352-10", "43547-353-11", "43547-353-10", "43547-353-03", "43547-354-11", "43547-354-10", "43547-354-03", "43547-355-11", "43547-355-10", "43547-355-03", "43547-355-50", "43547-356-11", "43547-356-10", "31722-172-01", "31722-172-05", "31722-176-01", "31722-176-10", "31722-177-01", "31722-177-10", "31722-178-01", "31722-178-10", "31722-179-01", "31722-179-05", "31722-180-01", "31722-180-10", "0591-0405-01", "0591-0405-05", "0591-0406-01", "0591-0406-10", "0591-0407-01", "0591-0407-10", "0591-0408-01", "0591-0408-10", 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"76282-420-50", "76282-421-30", "76282-421-45", "76282-421-90", "76282-421-01", "76282-421-18", "76282-421-05", "76282-421-10", "76282-422-30", "76282-422-45", "76282-422-90", "76282-422-01", "76282-422-18", "76282-422-05", "76282-422-10", "24979-238-07", "24979-239-07", "24979-240-07", "24979-241-07", "24979-242-07", "24979-243-07", "65862-037-30", "65862-037-01", "65862-037-00", "65862-037-05", "65862-037-99", "65862-038-30", "65862-038-01", "65862-038-00", "65862-038-05", "65862-038-99", "65862-039-30", "65862-039-01", "65862-039-00", "65862-039-05", "65862-039-99", "65862-040-30", "65862-040-01", "65862-040-00", "65862-040-05", "65862-040-99", "65862-041-30", "65862-041-01", "65862-041-00", "65862-041-05", "65862-041-99", "65862-042-30", "65862-042-01", "65862-042-00", "65862-042-05", "65862-042-99", "31722-172-31", "31722-176-31", "31722-177-31", "31722-178-31", "31722-179-31", "31722-180-31" ], "unii": [ "E7199S1YWR" ] } }, { "drugcharacterization": "2", "medicinalproduct": "COENZYME Q10", "activesubstance": { "activesubstancename": "DIETARY SUPPLEMENT\\UBIDECARENONE" } }, { "drugcharacterization": "2", "medicinalproduct": "PreserVision Eye Vitamin" } ], "summary": { "narrativeincludeclinical": "CASE EVENT DATE: 20250209" } } } }