FDA FAERS Adverse Event Reports

{ "_id": "69d435b93b3830196fa57eca", "safetyreportid": "25962779", "authoritynumb": "783945", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sexual dysfunction", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RISPERIDONE", "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": "RISPERIDONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": 1, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435b93b3830196fa57ec9", "safetyreportid": "25962777", "authoritynumb": "FDA-CDER-CTU-2025-72677", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 30.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 60.6, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cholecystitis acute", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-05-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TAXOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 288.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-05-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250624" }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435b93b3830196fa57ec8", "safetyreportid": "25962776", "authoritynumb": "FDA-CDER-CTU-2025-72617", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 62.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 81.2, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hyponatraemia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypophosphataemia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neutropenia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pyrexia", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cough", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Liver function test increased", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "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": "102", "drugenddate": "2025-09-23T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE HYDROCHLORIDE", "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": "102", "drugenddate": "2025-09-23T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GEMCITABINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 585.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-10-14T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435b93b3830196fa57ec6", "safetyreportid": "25962772", "authoritynumb": "783943", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 31.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 99.9, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lip swelling", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Oral mucosal blistering", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swollen tongue", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SULFAMETHOXAZOLE\\TRIMETHOPRIM", "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": "Urinary tract infection", "drugstartdateformat": "102", "drugstartdate": "2025-10-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-23T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": null, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251023" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "69d435b93b3830196fa57ec4", "safetyreportid": "25962773", "authoritynumb": "FDA-CDER-CTU-2025-72618", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 64.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Aortic occlusion", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SIMPONI ARIA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "OTHER QUANTITY : 2MG/KG;?OTHER FREQUENCY : EVERY 8 WEEKS;?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Psoriatic arthropathy", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "GOLIMUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "69d435b93b3830196fa57ec3", "safetyreportid": "25962774", "authoritynumb": "FDA-CDER-CTU-2025-72619", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 82.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neoplasm malignant", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HUMIRA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY : EVERY OTHER WEEK;?", "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": "ADALIMUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "69d435b93b3830196fa57ec2", "safetyreportid": "25962771", "authoritynumb": "FDA-CDER-CTU-2025-72675", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 58.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 71.5, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Delirium", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug screen positive", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Substance use", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SPRYCEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 700.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-10-17T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DASATINIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VINCRISTINE SULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2025-10-08T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "VINCRISTINE SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251018" }, "primarysource": { "reportercountry": "US", "qualification": null, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "2026-01-19T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435b93b3830196fa57ec1", "safetyreportid": "25962770", "authoritynumb": "FDA-CDER-CTU-2025-72685", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Surgery", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TYMLOS", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "020", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "FREQUENCY : DAILY;?", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Senile osteoporosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ABALOPARATIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": "2026-01-19T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69d435b93b3830196fa57ebc", "safetyreportid": "25962766", "authoritynumb": "783952", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 3, "occurcountry": null, "patient": { "patientonsetage": 18.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 54.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Affective disorder", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypomania", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Depression", "reactionoutcome": null }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Educational problem", "reactionoutcome": null } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PROZAC", "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": "Depression", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": null, "activesubstance": { "activesubstancename": "FLUOXETINE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20210425" }, "primarysource": { "reportercountry": "IL", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "IL", "quarter": "2025Q4", "receiptdate": "2025-10-25T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-25T00:00:00", "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": 1, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

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