FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25940043 Type 1
Serious
MIRCERA, MIRCERA, CALCITRIOL
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-BEH-2025221784
Authority Number
--
Sender Organization
CSL BEHRING
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
79.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
63.3 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Dizziness (v28.1) Recovered
Nausea (v28.1) Recovered
Vomiting (v28.1) Recovered

Drugs (3)

MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection in pre-filled syringe | Indication: -- | Action: Unknown
Auth#: 125164 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MIRCERA (METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA) Suspect
Route: 065 | Dosage: 150 ?G | Form: Solution for injection in pre-filled syringe | Indication: -- | Action: Unknown
Auth#: 125164 | Batch#: -- | Structured Dosage: 150.0 (unit: 004) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CALCITRIOL (CALCITRIOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251006

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ec8", "safetyreportid": "25940043", "authoritynumb": null, "companynumb": "US-BEH-2025221784", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 79.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 63.3, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dizziness", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Nausea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRCERA", "drugauthorizationnumb": "125164", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MIRCERA", "drugauthorizationnumb": "125164", "drugbatchnumb": null, "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "150 ?G", "drugdosageform": "Solution for injection in pre-filled syringe", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHOXY POLYETHYLENE GLYCOL-EPOETIN BETA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CALCITRIOL", "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": "CALCITRIOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251006" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CSL BEHRING" }, "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" }
25940045 Type 1
Serious
TRASTUZUMAB DERUXTECAN
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
TH
Occurrence Country
TH
Reporter Country
TH
Reporter Qualification
Physician
Literature Reference
--
Company Number
TH-DSJP-DS-2025-170563-TH
Authority Number
--
Sender Organization
DAIICHI
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

TRASTUZUMAB DERUXTECAN (TRASTUZUMAB DERUXTECAN) Suspect
Route: 065 | Dosage: UNK | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 761139 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251017

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ec9", "safetyreportid": "25940045", "authoritynumb": null, "companynumb": "TH-DSJP-DS-2025-170563-TH", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "TH", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TRASTUZUMAB DERUXTECAN", "drugauthorizationnumb": "761139", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "TRASTUZUMAB DERUXTECAN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251017" }, "primarysource": { "reportercountry": "TH", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "TH", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DAIICHI" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25940036 Type 1
Serious
NINTEDANIB, OXYGEN, MYCOPHENOLIC ACID (+7 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-BoehringerIngelheim-2025-BI-101690
Authority Number
--
Sender Organization
BOEHRINGER INGELHEIM
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
82.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Idiopathic pulmonary fibrosis (v28.1) Not Recovered

Drugs (10)

NINTEDANIB (NINTEDANIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Idiopathic pulmonary fibrosis | Action: Unknown
Auth#: 205832 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OXYGEN (OXYGEN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Idiopathic pulmonary fibrosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MYCOPHENOLIC ACID (MYCOPHENOLIC ACID) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RITUXIMAB (RITUXIMAB) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
OMEPRAZOLE (OMEPRAZOLE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRTAZAPINE (MIRTAZAPINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Calcium/cholecalciferol (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
FOLIC ACID (FOLIC ACID) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
RISEDRONATE SODIUM (RISEDRONATE SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ec5", "safetyreportid": "25940036", "authoritynumb": null, "companynumb": "EU-BoehringerIngelheim-2025-BI-101690", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 6, "patientweight": 82.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Idiopathic pulmonary fibrosis", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NINTEDANIB", "drugauthorizationnumb": "205832", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Idiopathic pulmonary fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NINTEDANIB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OXYGEN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Idiopathic pulmonary fibrosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "OXYGEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MYCOPHENOLIC ACID", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "MYCOPHENOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RITUXIMAB", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OMEPRAZOLE", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "OMEPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MIRTAZAPINE", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "MIRTAZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Calcium/cholecalciferol", "drugauthorizationnumb": null, "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": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FOLIC ACID", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "FOLIC ACID" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RISEDRONATE SODIUM", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "RISEDRONATE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "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": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BOEHRINGER INGELHEIM" }, "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" }
25940035 Type 1
Serious
INFLIXIMAB, INFLIXIMAB, INFLIXIMAB (+54 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-CELLTRION INC.-2025CA036873
Authority Number
--
Sender Organization
CELLTRION
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (27)

Blood pressure systolic increased (v28.1) Not Recovered
Condition aggravated (v28.1) Not Recovered
Cough (v28.1) Not Recovered
Decreased appetite (v28.1) Not Recovered
Drug level below therapeutic (v28.1) Not Recovered
Food poisoning (v28.1) Not Recovered
Malaise (v28.1) Not Recovered
Sinus disorder (v28.1) Not Recovered
Weight decreased (v28.1) Not Recovered
Sneezing (v28.1) Not Recovered
Weight fluctuation (v28.1) Not Recovered
Weight increased (v28.1) Not Recovered
Rectal haemorrhage (v28.1) Not Recovered
Bronchitis (v28.1) Not Recovered
COVID-19 (v28.1) Not Recovered
Dizziness (v28.1) Not Recovered
Fatigue (v28.1) Not Recovered
Insomnia (v28.1) Not Recovered
Illness (v28.1) Not Recovered
Nasopharyngitis (v28.1) Not Recovered
Nausea (v28.1) Not Recovered
Pyrexia (v28.1) Not Recovered
Intentional product use issue (v28.1) Not Recovered
Inappropriate schedule of product administration (v28.1) Not Recovered
Therapeutic response shortened (v28.1) Not Recovered
Off label use (v28.1) Not Recovered
Overdose (v28.1) Unknown

Drugs (57)

INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: Colitis ulcerative | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 2.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 65.0 min | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 750.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 750.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 65.0 min | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 65.0 min | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 65.0 min | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 800.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
INFLIXIMAB (INFLIXIMAB) Suspect
Route: 042 | Dosage: 600.0 MILLIGRAM | Form: Powder for solution for infusion | Indication: -- | Action: Unknown
Auth#: 115544 | Batch#: unknown | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 650.0 MILLIGRAM | Form: -- | Indication: Premedication | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: 650.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: 650.0 MILLIGRAM | Form: Unknown | Indication: Premedication | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: 650.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASACOL (MESALAMINE) Concomitant
Route: 065 | Dosage: 1.0 DOSAGE FORM | Form: Tablet, enteric coated | Indication: -- | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CETIRIZINE HYDROCHLORIDE (CETIRIZINE HYDROCHLORIDE) Concomitant
Route: -- | Dosage: 10.0 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ESCITALOPRAM (ESCITALOPRAM OXALATE) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: 065 | Dosage: 1.0 DOSAGE FORM | Form: Unknown | Indication: -- | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
VYVANSE (LISDEXAMFETAMINE DIMESYLATE) Concomitant
Route: -- | Dosage: -- | Form: Capsule | Indication: -- | Action: Unknown
Auth#: -- | Batch#: unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

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Raw JSON (click to expand)

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"Unknown", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VYVANSE", "drugauthorizationnumb": null, "drugbatchnumb": "unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "LISDEXAMFETAMINE DIMESYLATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CELLTRION" }, "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" }
25940032 Type 1
Non-Serious
FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GSK-US2025AMR110540
Authority Number
--
Sender Organization
GLAXOSMITHKLINE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Off label use (v28.1) Unknown

Drugs (1)

FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE (FLUTICASONE PROPIONATE\SALMETEROL XINAFOATE) Suspect
Route: -- | Dosage: UNK,250/50 MCG, 60 | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 021077 | Batch#: UNK | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

PRASCO: US-PRASCO-28558
PRASCO: US-PRASCO-6907

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ec2", "safetyreportid": "25940032", "authoritynumb": null, "companynumb": "US-GSK-US2025AMR110540", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Off label use", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE", "drugauthorizationnumb": "021077", "drugbatchnumb": "UNK", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK,250/50 MCG, 60", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE PROPIONATE\\SALMETEROL XINAFOATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "PRASCO", "duplicatenumb": "US-PRASCO-28558" }, { "duplicatesource": "PRASCO", "duplicatenumb": "US-PRASCO-6907" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GLAXOSMITHKLINE" }, "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" }
25940030 Type 1
Non-Serious
ALBUTEROL SULFATE
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GSK-US2025AMR127781
Authority Number
--
Sender Organization
GLAXOSMITHKLINE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Wrong technique in product usage process (v28.1) Unknown
Product storage error (v28.1) Unknown

Drugs (1)

ALBUTEROL SULFATE (ALBUTEROL SULFATE) Suspect
Route: -- | Dosage: UNK | Form: Inhaler | Indication: Product used for unknown indication | Action: Unknown
Auth#: 020983 | Batch#: G29N | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251003

Report Duplicates (2)

PRASCO: US-PRASCO-29197
PRASCO: US-PRASCO-7088

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ec0", "safetyreportid": "25940030", "authoritynumb": null, "companynumb": "US-GSK-US2025AMR127781", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wrong technique in product usage process", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product storage error", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ALBUTEROL SULFATE", "drugauthorizationnumb": "020983", "drugbatchnumb": "G29N", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Inhaler", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ALBUTEROL SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251003" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "PRASCO", "duplicatenumb": "US-PRASCO-29197" }, { "duplicatesource": "PRASCO", "duplicatenumb": "US-PRASCO-7088" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GLAXOSMITHKLINE" }, "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" }
25940028 Type 1
Serious
JARDIANCE, DEFERIPRONE, DEFEROXAMINE MESYLATE (+5 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-MINISAL02-1061806
Sender Organization
BOEHRINGER INGELHEIM
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
37.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
41.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hepatitis acute (v28.1) Recovering

Drugs (8)

JARDIANCE (EMPAGLIFLOZIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Cardiac failure | Action: Withdrawn
Auth#: 204629 | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: 09/23/2025 | End: 09/29/2025 | Duration: 7.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
DEFERIPRONE (DEFERIPRONE) Suspect
Route: -- | Dosage: 500 MG 2 CP (AS REPORTED) 3 A DAY | Form: -- | Indication: Haemochromatosis | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 09/17/2025 | End: 09/29/2025 | Duration: 13.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
DEFEROXAMINE MESYLATE (DEFEROXAMINE MESYLATE) Suspect
Route: -- | Dosage: 2 G INTRAVENOUS A DAY BY CONTINUOUS INFUSION | Form: -- | Indication: Haemochromatosis | Action: Dose Reduced
Auth#: -- | Batch#: -- | Structured Dosage: 2.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
SERTRALINE (SERTRALINE HYDROCHLORIDE) Suspect
Route: -- | Dosage: 25 MG A DAY | Form: -- | Indication: Depression | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 24.0 hr | Cumulative: -- (unit: --)
Start: 09/24/2025 | End: 09/29/2025 | Duration: 6.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
FUROSEMIDE (FUROSEMIDE) Concomitant
Route: -- | Dosage: 75 MG A DAY | Form: -- | Indication: Cardiac failure | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
POTASSIO CANRENOATO (--) Concomitant
Route: -- | Dosage: 100 MG A DAY | Form: -- | Indication: Cardiac failure | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant
Route: -- | Dosage: 2000 UI 1 FL TWICE A DAY | Form: -- | Indication: Atrial fibrillation | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 2000.0 (unit: 025) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
IDROXICARBAMIDE (--) Concomitant
Route: -- | Dosage: 500 MG 1 CP (AS REPORTED)A DAY | Form: -- | Indication: Thrombocytosis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250929

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ebe", "safetyreportid": "25940028", "authoritynumb": "EU-MINISAL02-1061806", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 37.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 41.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatitis acute", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "JARDIANCE", "drugauthorizationnumb": "204629", "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 24.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiac failure", "drugstartdateformat": "102", "drugstartdate": "2025-09-23T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-29T00:00:00", "drugtreatmentduration": 7.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "EMPAGLIFLOZIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEFERIPRONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG 2 CP (AS REPORTED) 3 A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Haemochromatosis", "drugstartdateformat": "102", "drugstartdate": "2025-09-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-29T00:00:00", "drugtreatmentduration": 13.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DEFERIPRONE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEFEROXAMINE MESYLATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2 G INTRAVENOUS A DAY BY CONTINUOUS INFUSION", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Haemochromatosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 2, "activesubstance": { "activesubstancename": "DEFEROXAMINE MESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "SERTRALINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 24.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "25 MG A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Depression", "drugstartdateformat": "102", "drugstartdate": "2025-09-24T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-29T00:00:00", "drugtreatmentduration": 6.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "SERTRALINE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "FUROSEMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MG A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiac failure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "FUROSEMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "POTASSIO CANRENOATO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Cardiac failure", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ENOXAPARIN SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 2000.0, "drugstructuredosageunit": "025", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2000 UI 1 FL TWICE A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Atrial fibrillation", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IDROXICARBAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG 1 CP (AS REPORTED)A DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Thrombocytosis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250929" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BOEHRINGER INGELHEIM" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25940031 Type 1
Non-Serious
TRELEGY ELLIPTA
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GSK-US2025130307
Authority Number
--
Sender Organization
GLAXOSMITHKLINE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Wrong technique in device usage process (v28.1) Unknown

Drugs (1)

TRELEGY ELLIPTA (FLUTICASONE FUROATE\UMECLIDINIUM BROMIDE\VILANTEROL TRIFENATATE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 209482 | Batch#: kh5k | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51ebd", "safetyreportid": "25940031", "authoritynumb": null, "companynumb": "US-GSK-US2025130307", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Wrong technique in device usage process", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TRELEGY ELLIPTA", "drugauthorizationnumb": "209482", "drugbatchnumb": "kh5k", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUTICASONE FUROATE\\UMECLIDINIUM BROMIDE\\VILANTEROL TRIFENATATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GLAXOSMITHKLINE" }, "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" }
25940025 Type 1
Non-Serious
MOUNJARO, MOUNJARO, MOUNJARO (+1 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ELI_LILLY_AND_COMPANY-US202510010626
Authority Number
--
Sender Organization
ELI LILLY AND COMPANY
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
73.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Incorrect dose administered (v28.1) Unknown

Drugs (4)

MOUNJARO (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: YJ0088 | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOUNJARO (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: YJ0088 | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOUNJARO (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: YJ0088 | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
MOUNJARO (TIRZEPATIDE) Suspect
Route: 065 | Dosage: 5 MG, UNKNOWN | Form: Solution for injection in pre-filled pen | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: YJ0088 | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51eba", "safetyreportid": "25940025", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510010626", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": "YJ0088", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "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": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": "YJ0088", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "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": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": "YJ0088", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "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": [] }, { "drugcharacterization": 1, "medicinalproduct": "MOUNJARO", "drugauthorizationnumb": "215866", "drugbatchnumb": "YJ0088", "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, UNKNOWN", "drugdosageform": "Solution for injection in pre-filled pen", "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": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "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" }
25940023 Type 2
Serious
ENHERTU
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-DSJP-DS-2025-170579-US
Authority Number
--
Sender Organization
DAIICHI
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
66.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect
Route: 042 | Dosage: 383 MG, OVER 90 MINUTES, ONCE EVERY 3 WK | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 761139 | Batch#: 25212N9C0 | Structured Dosage: 383.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 08/08/2025 | End: 08/08/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251017

Report Duplicates (2)

Daiichi Sankyo Inc. Call Center: CID000000000048434
-20251017: EUY-20251017-3278-0024539

Raw JSON (click to expand)

{ "_id": "69d435493b3830196fa51eb7", "safetyreportid": "25940023", "authoritynumb": null, "companynumb": "US-DSJP-DS-2025-170579-US", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 66.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENHERTU", "drugauthorizationnumb": "761139", "drugbatchnumb": "25212N9C0", "drugstructuredosagenumb": 383.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "383 MG, OVER 90 MINUTES, ONCE EVERY 3 WK", "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "drugadministrationroute": "042", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-08-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-08T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251017" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Daiichi Sankyo Inc. Call Center", "duplicatenumb": "CID000000000048434" }, { "duplicatesource": "-20251017", "duplicatenumb": "EUY-20251017-3278-0024539" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DAIICHI" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }