{ "summary": { "safetyreportid": "24238563", "receivedate": "20240822", "serious": "1", "seriousnessdeath": "1", "age": "1", "sex": "2", "drugs": [ "AMOXICILLIN", "CHLORINE DIOXIDE" ], "reactions": [ "Hypoplastic left heart syndrome", "Foetal exposure during pregnancy" ], "source_url": "/docs/faers/24238563.html" }, "raw": { "safetyreportversion": "1", "safetyreportid": "24238563", "primarysourcecountry": "ES", "occurcountry": "ES", "transmissiondateformat": "102", "transmissiondate": "20241017", "reporttype": "1", "serious": "1", "seriousnessdeath": "1", "seriousnesslifethreatening": "2", "seriousnesshospitalization": "2", "seriousnessdisabling": "2", "seriousnesscongenitalanomali": "2", "seriousnessother": "2", "receivedateformat": "102", "receivedate": "20240822", "receiptdateformat": "102", "receiptdate": "20240822", "fulfillexpeditecriteria": "1", "authoritynumb": "ES-AEMPS-1557509", "duplicate": "1", "reportduplicate": { "duplicatesource": "AGEMED", "duplicatenumb": "ES-AEMPS-1557509" }, "primarysource": { "reportercountry": "ES", "qualification": "1" }, "sender": { "sendertype": "1", "senderorganization": "TEVA" }, "receiver": { "receivertype": "6", "receiverorganization": "FDA" }, "patient": { "patientonsetage": "1", "patientonsetageunit": "805", "patientweight": "3", "patientsex": "2", "reaction": [ { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Hypoplastic left heart syndrome", "reactionoutcome": "5" }, { "reactionmeddraversionpt": "27.0", "reactionmeddrapt": "Foetal exposure during pregnancy", "reactionoutcome": "5" } ], "drug": [ { "drugcharacterization": "1", "medicinalproduct": "AMOXICILLIN", "drugbatchnumb": "UNKNOWN", "drugauthorizationnumb": "61926", "drugstructuredosagenumb": "750", "drugstructuredosageunit": "003", "drugseparatedosagenumb": "1", "drugintervaldosageunitnumb": "8", "drugintervaldosagedefinition": "805", "drugdosagetext": "AMOXICILINA (108A)", "drugadministrationroute": "064", "drugindication": "Respiratory tract infection", "drugstartdateformat": "102", "drugstartdate": "20230130", "drugenddateformat": "102", "drugenddate": "20230204", "drugtreatmentduration": "6", "drugtreatmentdurationunit": "804", "actiondrug": "1", "activesubstance": { "activesubstancename": "AMOXICILLIN" }, "openfda": { "application_number": [ "ANDA065255", "ANDA062216", "ANDA065271", "ANDA065256", "ANDA065322", "ANDA065319", "ANDA065056", "ANDA064013", "ANDA061926", "ANDA061931", "ANDA065119", "ANDA065291", "ANDA064076", "ANDA065228", "ANDA065387", "ANDA065378", "ANDA207471", "ANDA065334", "NDA050760", "ANDA062058", "ANDA204030", "ANDA062059", "ANDA065325" ], "brand_name": [ "AMOXICILLIN" ], "generic_name": [ "AMOXICILLIN" ], "manufacturer_name": [ "Hikma Pharmaceuticals USA Inc.", "USAntibiotics, LLC", "American Health Packaging", "NorthStar Rx LLC", "Rising Pharma Holdings, Inc.", "Chartwell RX, LLC", "Teva Pharmaceuticals USA, Inc.", "Aurobindo Pharma Limited", "Sandoz Inc", "Micro Labs Limited", "Chartwell Governmental & Specialty RX, LLC" ], "product_ndc": [ "0143-9285", "81964-205", "81964-225", "81964-350", "60687-776", "60687-787", "16714-298", "16714-299", "57237-028", "57237-029", "0143-9888", "0143-9889", "62135-815", "0093-2263", "0093-2264", "0093-4160", "0093-4155", "0093-4161", "0093-2267", "0093-2268", "0093-3107", "0093-3109", "65862-014", "65862-015", "0143-9939", "0781-2020", "0781-2613", "0781-5060", "0781-5061", "0781-6039", "0781-6156", "0781-6041", "0781-6157", "57237-030", "57237-031", "42571-233", "42571-234", "57237-032", "57237-033", "65862-016", "65862-017", "81964-207", "62135-824", "62135-825", "65862-070", "65862-071", "60687-798", "60687-809", "68999-824", "68999-825", "65862-706", "65862-707", "62135-776", "62135-777", "0143-9886", "0143-9887" ], "product_type": [ "HUMAN PRESCRIPTION DRUG" ], "route": [ "ORAL" ], "substance_name": [ "AMOXICILLIN" ], "rxcui": [ "308194", "308182", "308191", "308192", "239191", "313797", "308189", "308177", "313850", "598025" ], "spl_id": [ "a4cd19b3-f938-4afe-9409-3bdea10deb63", "5253eb61-6d82-8057-e063-6294a90a5c84", "2f75b1e8-87b4-bd7d-e063-6294a90a0587", "3fb9b318-8cd3-46e0-bf2d-cf23f8dd58e0", "679691e2-bbbf-4ed0-a31b-e538b3df75c0", "c2fa2c99-c735-4834-a8a5-04a30da8a002", "4690e611-3a29-35ce-e063-6294a90a5e9e", "31223839-1653-4906-826a-f9d6af179334", "ee0e12cd-e881-4048-a0fb-74bd771cb9aa", "ed305c7b-0cf6-4dc6-b584-a68b7bd3245b", "f4681ad2-fcc2-41f6-9100-90fb4524cd28", "4e6f21c7-0e2a-4361-9549-ab42efd08d5b", "238f9a44-0678-eb7c-e063-6394a90a4c73", "62bfc65c-04fe-43b5-b659-d37067b280c0", "4dc94f3c-990d-476f-a88e-df9967570eec", "52498bbe-c0d7-4bea-e063-6394a90aafd0", "4690ed91-8da8-2e62-e063-6294a90a0ab2", "3e3ca279-1838-4348-a01c-df10a8bcb8b9", "4ee4fb77-9fd6-ea5e-e063-6394a90a0d9c", "46911108-ba5e-8cba-e063-6294a90adccc", "f4a410c9-3a78-48f9-8195-915896a974ff", "4690a5fd-79cc-e1fd-e063-6294a90a009c", "606474e1-adba-4ffa-83d5-6565fc12c892" ], "spl_set_id": [ "c8591c2a-92ef-4432-b19a-bb46063047ee", "110ba6b1-f175-48a1-8e30-616c02212538", "ecb439f7-434a-4e4c-b899-943d83346f09", "843f6053-63d9-47d2-81f1-b6aa78a7c20c", "bb7733f8-6aad-4273-84a0-ef472630203f", "077f4a65-3cfb-4cb1-99f2-e27ffc5939c0", "1b9c0a98-2a31-4b23-ac4f-7c3f14b6f92f", "4c0f348a-a65d-409c-8668-207c82a5e3cb", "99103779-6d2f-4e4b-9b7f-0b24d7c6bf4e", "4fb7837e-964c-4d38-a3a5-b384b1bd6e08", "13bd4214-9b7f-425b-af5f-fc1ddc678230", "bbe590a0-4196-4885-b679-cc1833af567f", "42f935ca-45ba-4b3e-8b40-9b2d4eb56281", "554239db-69fe-405a-910a-d9f9e3f8b6ed", "7e3a4517-1934-4e03-b96b-4ad65ab076c5", "06e5c07d-d95c-4955-8d35-a4703ca2359e", "5002cce4-0abc-4446-888c-47396549d4da", "3cacd754-73f4-496e-a529-9ca39fa6692d", "d339ea0f-8797-460f-a3b7-b8455c250366", "f9062321-ffb3-42e8-8f98-453cd30f5282", "234d0dfc-cb24-413f-b798-129c73eb848e", "9ce26893-c7a1-47e9-98f9-f5d998cac418", "d46f1091-33dc-4f8f-9c34-75dcfedb4b4c" ], "package_ndc": [ "0143-9285-01", "0143-9285-20", "81964-225-01", "81964-225-05", "81964-205-01", "81964-205-05", "81964-205-10", "81964-205-60", "81964-350-98", "81964-350-10", "81964-350-60", "60687-776-11", "60687-776-01", "60687-787-11", "60687-787-01", "16714-298-01", "16714-298-02", "16714-299-01", "16714-299-02", "16714-299-03", "16714-299-04", "57237-028-20", "57237-028-01", "57237-029-20", "57237-029-01", "0143-9888-80", "0143-9888-01", "0143-9888-15", "0143-9889-80", "0143-9889-01", "0143-9889-15", "62135-815-42", "0093-2263-01", "0093-2264-01", "0093-4160-76", "0093-4160-78", "0093-4160-73", "0093-4155-79", "0093-4155-73", "0093-4155-80", "0093-4161-76", "0093-4161-78", "0093-4161-73", "0093-2267-01", "0093-2268-01", "0093-3107-01", "0093-3107-05", "0093-3109-53", "0093-3109-05", "65862-014-20", "65862-014-01", "65862-014-05", "65862-015-20", "65862-015-01", "65862-015-05", "0143-9939-05", "0143-9939-28", "0781-2020-31", "0781-2020-76", "0781-2020-01", "0781-2020-05", "0781-2613-31", "0781-2613-76", "0781-2613-01", "0781-2613-05", "0781-5060-20", "0781-5060-01", "0781-5061-20", "0781-5061-01", "0781-6039-58", "0781-6039-46", "0781-6039-55", "0781-6156-52", "0781-6156-57", "0781-6156-46", "0781-6041-58", "0781-6041-46", "0781-6041-55", "0781-6157-52", "0781-6157-57", "0781-6157-46", "57237-030-01", "57237-030-05", "57237-031-01", "57237-031-05", "42571-233-30", "42571-233-01", "42571-233-05", "42571-233-10", "42571-234-30", "42571-234-01", "42571-234-05", "42571-234-10", "57237-032-50", "57237-032-75", "57237-032-01", "57237-033-50", "57237-033-75", "57237-033-01", "65862-016-20", "65862-016-30", "65862-016-50", "65862-016-01", "65862-016-05", "65862-017-20", "65862-017-30", "65862-017-50", "65862-017-01", "65862-017-05", "81964-207-50", "81964-207-51", "81964-207-52", "62135-824-01", "62135-824-05", "62135-825-60", "62135-825-05", "65862-070-50", "65862-070-75", "65862-070-01", "65862-071-50", "65862-071-75", "65862-071-01", "60687-798-95", "60687-798-25", "60687-809-18", "60687-809-28", "68999-824-01", "68999-825-60", "68999-825-01", "65862-706-80", "65862-706-01", "65862-706-55", "65862-707-80", "65862-707-01", "65862-707-55", "62135-777-68", "62135-777-42", "62135-777-38", "62135-776-68", "62135-776-42", "62135-776-38", "0143-9886-01", "0143-9886-50", "0143-9886-75", "0143-9887-01", "0143-9887-50", "0143-9887-75" ], "unii": [ "804826J2HU" ] } }, { "drugcharacterization": "1", "medicinalproduct": "CHLORINE DIOXIDE", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": "10", "drugstructuredosageunit": "012", "drugseparatedosagenumb": "1", "drugcumulativedosagenumb": "10", "drugcumulativedosageunit": "012", "drugdosagetext": "TIME INTERVAL: TOTAL: CHLORINE DIOXIDE (OTHER)", "drugadministrationroute": "064", "drugindication": "Respiratory tract infection", "drugstartdateformat": "102", "drugstartdate": "20230130", "drugenddateformat": "102", "drugenddate": "20230130", "drugtreatmentduration": "1", "drugtreatmentdurationunit": "804", "actiondrug": "1", "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: 20230130" } } } }