FDA FAERS Adverse Event Reports

{ "_id": "69974fc58e900fe3f48c67a7", "safetyreportid": "25973734", "authoritynumb": null, "companynumb": "US-AMNEAL PHARMACEUTICALS-2025-AMRX-01862", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Flatulence", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vaginal haemorrhage", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal distension", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PROGESTERONE", "drugauthorizationnumb": "207724", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 6.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM, 6X/WEEK", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Vaginal haemorrhage", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PROGESTERONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PROGESTERONE", "drugauthorizationnumb": "207724", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PROGESTERONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COMBIPATCH", "drugauthorizationnumb": null, "drugbatchnumb": "98209", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.05/0.25 MILLIGRAM EVERY 4 DAYS", "drugdosageform": null, "drugadministrationroute": "062", "drugindication": "Menopausal symptoms", "drugstartdateformat": "102", "drugstartdate": "2024-12-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESTRADIOL\\NORETHINDRONE ACETATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ESTRADIOL", "drugauthorizationnumb": null, "drugbatchnumb": "94658", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNKNOWN", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Menopausal symptoms", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ESTRADIOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BIOTIN", "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": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BIOTIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMNEAL" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69974fc58e900fe3f48c67a6", "safetyreportid": "25973730", "authoritynumb": null, "companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2025RR-532684", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 63.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Ascites", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CAPECITABINE", "drugauthorizationnumb": "204668", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CAPECITABINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "GEMCITABINE", "drugauthorizationnumb": "78433", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "GEMCITABINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOCETAXEL", "drugauthorizationnumb": "22534", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOCETAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOXORUBICIN", "drugauthorizationnumb": "91418", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "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": null, "activesubstance": { "activesubstancename": "DOXORUBICIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "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": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VINORELBINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "VINORELBINE TARTRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 3, "literaturereference": "Akaishi Y, Tokunaga S, Omori R, Nakatani Y, Tanaka A, Akiyoshi K, et al. Five Cases of Pseudocirrhosis during Eribulin Treatment for Breast Cancer. Gan To Kagaku Ryoho. 2024;51 (7):753-755" }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "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": "69974fc58e900fe3f48c67a5", "safetyreportid": "25973735", "authoritynumb": null, "companynumb": "US-AMNEAL PHARMACEUTICALS-2025-AMRX-02016", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Haemoglobin abnormal", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pallor", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vaginal haemorrhage", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PROGESTERONE", "drugauthorizationnumb": "207724", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Capsule", "drugadministrationroute": "065", "drugindication": "Contraception", "drugstartdateformat": "102", "drugstartdate": "2025-05-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PROGESTERONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COMIRNATY (TOZINAMERAN)", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MCG/0.3ML LNJ BOOSTER DOSE", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-04-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-04-12T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOZINAMERAN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COMIRNATY (TOZINAMERAN)", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "30 MCG/0.3ML LNJ", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-05-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-12T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TOZINAMERAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250415" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AMNEAL" }, "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": "69974fc58e900fe3f48c67a4", "safetyreportid": "25973733", "authoritynumb": null, "companynumb": "GB-MHRA-MED-202510101704437800-KCYQZ", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 34.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Completed suicide", "reactionoutcome": 5 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anxiety", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "SERTRALINE", "drugauthorizationnumb": "077977", "drugbatchnumb": "UNK", "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MILLIGRAM, DAILY", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Mixed anxiety and depressive disorder", "drugstartdateformat": "102", "drugstartdate": "2025-10-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-06T00:00:00", "drugtreatmentduration": 4.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "SERTRALINE HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "GB", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-MED-202510101704437800-KCYQZ" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }

{ "_id": "69974fc58e900fe3f48c67a3", "safetyreportid": "25973724", "authoritynumb": null, "companynumb": "GB-ROCHE-10000405513", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 64.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 77.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lower respiratory tract infection", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "LENALIDOMIDE", "drugauthorizationnumb": "211846", "drugbatchnumb": "1181942", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "START DATE OF MOST RECENT DOSE OF STUDY DRUGPRIOR TO AE: 03-OCT-2025, 15MG", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Mantle cell lymphoma", "drugstartdateformat": "102", "drugstartdate": "2024-11-19T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 2, "actiondrug": 1, "activesubstance": { "activesubstancename": "LENALIDOMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RITUXIMAB", "drugauthorizationnumb": null, "drugbatchnumb": "2803419", "drugstructuredosagenumb": 740.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE LAST STUDY DRUG ADMIN PRIOR AE IS 740 MGDOSE LAST STUDY DRUG ADMIN PRIOR SAE IS 740 MG, 1DOSE/4", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Mantle cell lymphoma", "drugstartdateformat": "102", "drugstartdate": "2024-11-19T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TOBRAMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, 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"drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ATOVAQUONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AZITHROMYCIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "GIVEN FOR PROPHYLAXIS IS YES", "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": "AZITHROMYCIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251003" }, "primarysource": { "reportercountry": "GB", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ROCHE", "duplicatenumb": "GB-ROCHE-10000405513" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "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": "69974fc58e900fe3f48c67a2", "safetyreportid": "25973731", "authoritynumb": null, "companynumb": "CN-SUN PHARMACEUTICAL INDUSTRIES LTD-2025R1-533597", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 49.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 73.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug ineffective", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pustule", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin exfoliation", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ACITRETIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Pruritus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ACITRETIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TRETINOIN", "drugauthorizationnumb": "211645", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Pruritus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TRETINOIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METFORMIN", "drugauthorizationnumb": "202917", "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 MILLIGRAM, DAILY", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Blood glucose", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SODIUM THIOSULFATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Pruritus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "SODIUM THIOSULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": "Lin B, Huang Q, Weng L, Lin L. Semaglutide in the treatment of a patient with type 2 diabetes mellitus, psoriasis, and metabolic dysfunction-associated steatotic liver disease: a case report. Front Med. 2025;12 (0):1684204(1-5)" }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "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" }

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"actiondrug": 1, "activesubstance": { "activesubstancename": "ENOXAPARIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MILLIGRAM", "drugdosageform": "Powder for solution for injection", "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": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ASPIRIN", "drugauthorizationnumb": null, "drugbatchnumb": "UNK", "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MILLIGRAM", "drugdosageform": "Powder for solution for injection", "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": "ASPIRIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251003" }, "primarysource": { "reportercountry": "GB", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-37326950" }, { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-37326950" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "RANBAXY" }, "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": "69974fc58e900fe3f48c679f", "safetyreportid": "25973725", "authoritynumb": null, "companynumb": "JP-SUN PHARMACEUTICAL INDUSTRIES LTD-2025RR-532688", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "PALBOCICLIB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Breast cancer", "drugstartdateformat": 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