FDA FAERS Adverse Event Reports

{ "_id": "69d435793b3830196fa54490", "safetyreportid": "25949265", "authoritynumb": null, "companynumb": "AU-ELI_LILLY_AND_COMPANY-AU202510012790", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "AU", "patient": { "patientonsetage": 30.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anorexia nervosa", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TIRZEPATIDE", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Weight control", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "AU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "AU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5448f", "safetyreportid": "25949262", "authoritynumb": "FDA-CDER-CTU-2025-71728", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 36.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ectopic pregnancy", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SKYRIZI", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER FREQUENCY : EVERY 12 WEEKS;?I_ I_NJ-ECT 150MG SUBCUTANEOUSLY EVERY 12 WEEKS AS D!RECTED.II?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Psoriasis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "RISANKIZUMAB-RZAA" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5448e", "safetyreportid": "25949261", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510007720", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Bone pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatomegaly", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blister rupture", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Blister", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "VERZENIO", "drugauthorizationnumb": "208716", "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "150 MG, BID", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2025-09-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ABEMACICLIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FULVESTRANT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, UNKNOWN", "drugdosageform": "Injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-24T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FULVESTRANT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250930" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5448c", "safetyreportid": "25949258", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017352", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 3, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Respiratory tract infection", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KALYDECO", "drugauthorizationnumb": "207925", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Granules", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IVACAFTOR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CREON", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pancreatic failure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PANCRELIPASE AMYLASE\\PANCRELIPASE LIPASE\\PANCRELIPASE PROTEASE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "VERTEX" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5448b", "safetyreportid": "25949260", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510015045", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Transient ischaemic attack", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, UNKNOWN", "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": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa54489", "safetyreportid": "25949259", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510014991", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diverticulitis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic enzyme increased", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "R102713?", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Weight control", "drugstartdateformat": "102", "drugstartdate": "2025-08-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-03T00:00:00", "drugtreatmentduration": 15.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ELI LILLY AND COMPANY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa54481", "safetyreportid": "25949254", "authoritynumb": null, "companynumb": "US-VERTEX PHARMACEUTICALS-2025-017518", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anxiety", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Illness", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TRIKAFTA", "drugauthorizationnumb": "212273", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN DOSAGE REGIMEN", "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Cystic fibrosis", "drugstartdateformat": "602", "drugstartdate": "2020-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ELEXACAFTOR\\IVACAFTOR\\TEZACAFTOR" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "VERTEX" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa54484", "safetyreportid": "25949257", "authoritynumb": null, "companynumb": "US-BRISTOL-MYERS SQUIBB COMPANY-2025-143950", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 85.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fall", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin laceration", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ELIQUIS", "drugauthorizationnumb": "202155", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "APIXABAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BRISTOL-MYERS SQUIBB COMPANY" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa54482", "safetyreportid": "25949256", "authoritynumb": "EU-AFSSAPS-AN2025001248", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 85.5, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pancytopenia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug interaction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LANSOPRAZOLE", "drugauthorizationnumb": "077255", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 15.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 1425.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-01-25T00:00:00", "drugtreatmentduration": 95.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "LANSOPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 35.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 3185.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Renal transplant", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-01-20T00:00:00", "drugtreatmentduration": 90.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 2, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEUCOVORIN CALCIUM", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 14.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "LEUCOVORIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CELLCEPT", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 380.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Renal transplant", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 2, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "MYCOPHENOLATE MOFETIL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "KARDEGIC", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, 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"032", "drugdosagetext": "TIME INTERVAL: TOTAL: EVERY 2", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Renal transplant", "drugstartdateformat": "102", "drugstartdate": "2025-01-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-01-24T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "BELATACEPT" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NEBIVOLOL", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "NEBIVOLOL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TACROLIMUS", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 7.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 665.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Renal transplant", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-04-04T00:00:00", "drugtreatmentduration": 164.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "TACROLIMUS" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ATORVASTATIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ATORVASTATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 180.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2024-12-20T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BACTRIM", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 3.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 42.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-01-24T00:00:00", "drugtreatmentduration": 94.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 2, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VALGANCICLOVIR HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 48.0, "drugcumulativedosageunit": "032", "drugdosagetext": null, "drugdosageform": "Film-coated tablet", "drugadministrationroute": "048", "drugindication": "Prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2024-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-01-29T00:00:00", "drugtreatmentduration": 99.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 2, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "VALGANCICLOVIR HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MELATONIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 3, "activesubstance": { "activesubstancename": "MELATONIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250124" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-AN2025001248" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435793b3830196fa5447c", "safetyreportid": "25949253", "authoritynumb": "FDA-CDER-CTU-2025-71727", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 14.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 54.43, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Adenoidectomy", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "COSENTYX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 802, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY : MONTHLY;?INJECT LSOMG (1 PEN) SUBCUTANEOUSLY EVERY 4 WEEKS AS DIRECTED?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Psoriasis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "SECUKINUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }