FDA FAERS Adverse Event Reports

{ "_id": "69d435293b3830196fa5070f", "safetyreportid": "25934341", "authoritynumb": null, "companynumb": "US-MRZWEB-2025090000152", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XEOMIN", "drugauthorizationnumb": "125360", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Powder for solution for injection", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INCOBOTULINUMTOXINA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERZ" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435293b3830196fa5070e", "safetyreportid": "25934343", "authoritynumb": null, "companynumb": "CN-ROCHE-10000410830", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 83.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Epilepsy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Progressive multifocal leukoencephalopathy", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MABTHERA", "drugauthorizationnumb": null, "drugbatchnumb": "Asked But Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "B-cell lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230101" }, "primarysource": { "reportercountry": "CN", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435293b3830196fa5070d", "safetyreportid": "25934339", "authoritynumb": null, "companynumb": "US-AstraZeneca-CH-00971830A", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wheezing", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SYMBICORT", "drugauthorizationnumb": "21929", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BUDESONIDE\\FORMOTEROL FUMARATE DIHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435293b3830196fa5070c", "safetyreportid": "25934340", "authoritynumb": null, "companynumb": "US-BAUSCHBL-2025BNL030363", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 80.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIEBO", "drugauthorizationnumb": "216675", "drugbatchnumb": "2508004", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "031", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "INSTILL ONE DROP INTO BOTH EYES FOUR TIMES DAILY. BOTTLE PREPARATION IS REQUIRED. REFER TO PACKAGE", "drugdosageform": "Eye drops, solution", "drugadministrationroute": "047", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-11-04T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PERFLUOROHEXYLOCTANE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAUSCH AND LOMB" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435293b3830196fa5070a", "safetyreportid": "25934337", "authoritynumb": null, "companynumb": "CA-DRL-USA-CAN/2025/10/015762", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "AZACITIDINE", "drugauthorizationnumb": "201537", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DAYS EVERY 28 DAYS", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Acute myeloid leukaemia", "drugstartdateformat": "102", "drugstartdate": "2024-12-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "AZACITIDINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DR REDDYS" }, "serious": 1, "seriousnesscongenitalanomali": null, "seriousnessdeath": 1, "seriousnessdisabling": null, "seriousnesshospitalization": null, "seriousnesslifethreatening": null, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435293b3830196fa50705", "safetyreportid": "25934330", "authoritynumb": "EU-GKKIN-20180227-PI363437-1", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 56.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 55.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Red blood cell count decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Chromaturia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ear infection", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Somatic delusion", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Flushing", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dry mouth", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urine odour abnormal", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Musculoskeletal discomfort", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Aphasia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abnormal faeces", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swollen tongue", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal motility disorder", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oral discomfort", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lip swelling", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Heart rate increased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Alopecia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "White blood cell count decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug interaction", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 3, "medicinalproduct": "IVERMECTIN", "drugauthorizationnumb": "050742", "drugbatchnumb": null, "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : 12 MG, UNK", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Acarodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "IVERMECTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 3, "medicinalproduct": "PROPRANOLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PROPRANOLOL HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 3, "medicinalproduct": "DIAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TERBINAFINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Acarodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TERBINAFINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TERBINAFINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : 12 MG, ONCE ; IN TOTAL?DAILY DOSE : 12 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Acarodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TERBINAFINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NORTRIPTYLINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NORTRIPTYLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NORTRIPTYLINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NORTRIPTYLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TRAZODONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TRAZODONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE DESCRIPTION : UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMOXICILLIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMOXICILLIN", "drugauthorizationnumb": null, "drugbatchnumb": null, 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Serious neurological adverse events after Ivermectin-do they occur beyond the Indication of onchocerciasis?. AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE. 2018;98(2):328-82; Chandler RE. Ivermectin and serious neurological events WHO-Pharm-News. WHO PHARMACEUTICALS NEWSLETTER. 2018;1:21-6; Chandler RE. Serious neurological adverse events after Ivermectin-do they occur beyond the Indication of onchocerciasis?.. AMERICAN JOURNAL OF TROPICAL MEDICINE AND HYGIENE.. 2018;98(2):32..." }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-17T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-17T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ORG100006023", "duplicatenumb": "EU-SANDOZ-PHHY2018SE035062" }, { "duplicatesource": "002147023", "duplicatenumb": "EU-002147023-PHHY2018SE035062" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018033027" }, { "duplicatesource": "STADA", "duplicatenumb": "EU-STADA-158295" }, { "duplicatesource": "009507513", "duplicatenumb": "EU-009507513-1803SWE011112" }, { "duplicatesource": "Adis", "duplicatenumb": "NZ-Adis-3302615-154837" }, { "duplicatesource": "002147023", "duplicatenumb": "EU-002147023-PHHY2018SE040021" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018043404" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018046060" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018060035" }, { "duplicatesource": "DESITIN", "duplicatenumb": "EU-DESITIN-2018-00366" }, { "duplicatesource": "BAYER", "duplicatenumb": "EU-BAYER-2018-042485" }, { "duplicatesource": "TEVA", "duplicatenumb": "EU-TEVA-2018-SE-872104" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018045042" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018047917" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018060034" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018043393" }, { "duplicatesource": "STADA", "duplicatenumb": "EU-STADA-158275" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018062071" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018045030" }, { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-DD-20180416-ajevhp-155256" }, { "duplicatesource": "GKKIN", "duplicatenumb": "EU-GKKIN-20180227-PI363437-1" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018062067" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018062067" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018045030" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018062071" }, { "duplicatesource": "STADA", "duplicatenumb": "EU-STADA-158275" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018060034" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018047917" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018045042" }, { "duplicatesource": "TEVA", "duplicatenumb": "EU-TEVA-2018-SE-872104" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018060035" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018046060" }, { "duplicatesource": "GLAXOSMITHKLINE", "duplicatenumb": "EU-GLAXOSMITHKLINE-SE2018043404" }, { "duplicatesource": "STADA", "duplicatenumb": "EU-STADA-158295" }, { "duplicatesource": "002147023", "duplicatenumb": "EU-002147023-PHHY2018SE022023" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

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