FDA FAERS Adverse Event Reports

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{ "_id": "69d435d63b3830196fa598ae", "safetyreportid": "25969304", "authoritynumb": "784215", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product quality issue", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ADDYI", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FLIBANSERIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251027" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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": "69d435d63b3830196fa598a4", "safetyreportid": "25964499", "authoritynumb": null, "companynumb": "CA-WINDERLABS-2025WILIT00003", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 35.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Subdural haematoma", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Post lumbar puncture syndrome", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Maternal exposure during delivery", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MORPHINE SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "037", "drugindication": "Spinal anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "MORPHINE SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BUPIVACAINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.6, "drugstructuredosageunit": "012", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.75% HYPERBARIC", "drugdosageform": null, "drugadministrationroute": "037", "drugindication": "Spinal anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BUPIVACAINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FENTANYL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "037", "drugindication": "Spinal anaesthesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FENTANYL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TENOFOVIR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Hepatitis B", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TENOFOVIR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1-2 MG EVERY 4 HOURS", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Postoperative analgesia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HYDROMORPHONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 4.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "HYDROMORPHONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": "Kyrychenko P, et al.Spinal anesthesia for cesarean delivery resulting in postdural puncture headache and intracranial subdural hematoma - a case report.International Journal of Obstetric Anesthesia.2025;64:104739" }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "WINDER LABORATORY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435d63b3830196fa59899", "safetyreportid": "25969285", "authoritynumb": "784213", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 24.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 75.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutrophil count decreased", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CEFTRIAXONE", "drugauthorizationnumb": null, "drugbatchnumb": "24K02784", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 G GRAM(S) DAILY INTRAVENOUS", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Osteomyelitis chronic", "drugstartdateformat": "102", "drugstartdate": "2025-09-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFTRIAXONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CEFTRIAXONE", "drugauthorizationnumb": null, "drugbatchnumb": "24K03724", "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 GRAM(S) DAILY INTRAVENOUS", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Osteomyelitis chronic", "drugstartdateformat": "102", "drugstartdate": "2025-09-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": null, "activesubstance": { "activesubstancename": "CEFTRIAXONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435d63b3830196fa59896", "safetyreportid": "25969283", "authoritynumb": "784210", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 34.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 56.25, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MAVYRET", "drugauthorizationnumb": null, "drugbatchnumb": "1301142", "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG DAILY ORAL ?", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Chronic hepatitis C", "drugstartdateformat": "102", "drugstartdate": "2025-10-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GLECAPREVIR\\PIBRENTASVIR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OPILL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NORGESTREL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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": "69d435d63b3830196fa59895", "safetyreportid": "25969282", "authoritynumb": "784206", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 41.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 123.75, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anger", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anxiety", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Irritability", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "QULIPTA", "drugauthorizationnumb": null, "drugbatchnumb": "1278884", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER QUANTITY : 1 TABLET(S);?FREQUENCY : DAILY;?", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Migraine", "drugstartdateformat": "102", "drugstartdate": "2025-10-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-26T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATOGEPANT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251027" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435d63b3830196fa5988f", "safetyreportid": "25969275", "authoritynumb": "784203", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 66.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Visual impairment", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "XIFAXAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 2.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY : TWICE A DAY;?", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Hepatic encephalopathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": null, "activesubstance": { "activesubstancename": "RIFAXIMIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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": "69d435d63b3830196fa59885", "safetyreportid": "25969262", "authoritynumb": "784201", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic response changed", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "TIRZEPATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251027" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "FDA-CTU" }, "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": "69d435d63b3830196fa59881", "safetyreportid": "25969256", "authoritynumb": "784207", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 28.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Visual impairment", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eye pain", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FAMOTIDINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 803, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": null, "activesubstance": { "activesubstancename": "FAMOTIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MONTELUKAST SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MONTELUKAST SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ALBUTEROL SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240917" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-27T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "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": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435d63b3830196fa59871", "safetyreportid": "25962896", "authoritynumb": null, "companynumb": "EU-ELI_LILLY_AND_COMPANY-IS202510004185", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug-induced liver injury", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PEMETREXED", "drugauthorizationnumb": "202111", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PEMETREXED" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ATEZOLIZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATEZOLIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": "Sigurdarson, S.. DILI Is an Important Cause of Hepatocellular and Mixed Liver Injury-A Nationwide Prospective Study on Elevated Liver Enzymes. Liver International. 2025;45(10):1-11" }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-27T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ELI_LILLY_AND_COMPANY", "duplicatenumb": "EU-ELI_LILLY_AND_COMPANY-IS202510004185" } ], "reporttype": 2, "safetyreportversion": 2, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }