FDA FAERS Adverse Event Reports

110500
Total Reports
60546
Serious Reports
108
Reporter Countries
Clear
25966369 Type 1
Non-Serious
ZEPBOUND
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
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-US202510020538
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
58.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Accidental underdose (v28.1) Unknown

Drugs (1)

ZEPBOUND (TIRZEPATIDE) Suspect
Route: 058 | Dosage: 2.5 MG, UNKNOWN | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 215866 | Batch#: 2172179 | Structured Dosage: 2.5 (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": "69974fa98e900fe3f48c4c1a", "safetyreportid": "25966369", "authoritynumb": null, "companynumb": "US-ELI_LILLY_AND_COMPANY-US202510020538", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 58.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Accidental underdose", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ZEPBOUND", "drugauthorizationnumb": "215866", "drugbatchnumb": "2172179", "drugstructuredosagenumb": 2.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "2.5 MG, UNKNOWN", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "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": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "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" }
25966365 Type 1
Serious
GLUCOPHAGE
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
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-AFSSAPS-NC2025001539
Sender Organization
EMD SERONO INC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
67.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
81.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Lactic acidosis (v28.1) Recovered
Prescribed overdose (v28.1) Recovered

Drugs (1)

GLUCOPHAGE (METFORMIN HYDROCHLORIDE) Suspect
Route: -- | Dosage: 850 MG X 3/DAY | Form: -- | Indication: Type 2 diabetes mellitus | Action: Withdrawn
Auth#: 020357 | Batch#: -- | Structured Dosage: 2550.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 10/13/2020 | End: 07/22/2025 | Duration: 1743.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20201013

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-NC2025001539

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c14", "safetyreportid": "25966365", "authoritynumb": "EU-AFSSAPS-NC2025001539", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 67.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": 81.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lactic acidosis", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Prescribed overdose", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "GLUCOPHAGE", "drugauthorizationnumb": "020357", "drugbatchnumb": null, "drugstructuredosagenumb": 2550.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "850 MG X 3/DAY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "102", "drugstartdate": "2020-10-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-07-22T00:00:00", "drugtreatmentduration": 1743.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20201013" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-NC2025001539" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "EMD SERONO INC" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25966363 Type 1
Serious
METFORMIN, PIPERACILLIN AND TAZOBACTAM, VILDAGLIPTIN (+4 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-AM2025000152
Sender Organization
EMD SERONO INC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
52.0 yr
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
58.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Renal failure (v28.1) Recovering
Diarrhoea (v28.1) Recovered

Drugs (7)

METFORMIN (METFORMIN HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Type 2 diabetes mellitus | Action: Withdrawn
Auth#: 020357 | Batch#: -- | Structured Dosage: 2800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 12/30/2024 | Duration: -- -- | Rechallenge: Unknown | Additional: Yes
Recurrences: --
PIPERACILLIN AND TAZOBACTAM (PIPERACILLIN SODIUM\TAZOBACTAM SODIUM) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pyelonephritis | Action: Not Applicable
Auth#: -- | Batch#: -- | Structured Dosage: 12.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/11/2024 | End: 12/25/2024 | Duration: 14.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
VILDAGLIPTIN (VILDAGLIPTIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Type 2 diabetes mellitus | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/17/2024 | End: 12/30/2024 | Duration: 13.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
TRAMADOL HYDROCHLORIDE (TRAMADOL HYDROCHLORIDE) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Pain | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 12/17/2024 | End: 12/30/2024 | Duration: 13.0 day | Rechallenge: Unknown | Additional: Yes
Recurrences: --
OMNIPAQUE (IOHEXOL) Suspect
Route: -- | Dosage: 350 MG I/ML, SOLUTION INJECTABLE | Form: -- | Indication: Computerised tomogram | Action: Not Applicable
Auth#: -- | Batch#: 16844768 | Structured Dosage: 70.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/15/2024 | End: 12/15/2024 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --
TINZAPARIN [TINZAPARIN 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: --
AMLODIPINE (AMLODIPINE BESYLATE) 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

CASE EVENT DATE: 20241218

Report Duplicates (6)

EVDUP#ORG100006023: EU-SANDOZ-SDZ2025FR018266
EVDUP#ORG100006023: EU-AFSSAPS-AM2025000152
EVDUP#AFSSAPS: EU-AFSSAPS-AM2025000152
EMA: EU-EMA-20251015-AUTODUP-1760564858051
AFSSAPS: EU-AFSSAPS-AM2025000153
FR-AFSSAPS-AM2025000633: EU-AFSSAPS-AM2025000633

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c12", "safetyreportid": "25966363", "authoritynumb": "EU-AFSSAPS-AM2025000152", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 52.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 58.0, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Renal failure", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "METFORMIN", "drugauthorizationnumb": "020357", "drugbatchnumb": null, "drugstructuredosagenumb": 2800.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2024-12-30T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PIPERACILLIN AND TAZOBACTAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 12.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pyelonephritis", "drugstartdateformat": "102", "drugstartdate": "2024-12-11T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-12-25T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PIPERACILLIN SODIUM\\TAZOBACTAM SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VILDAGLIPTIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Type 2 diabetes mellitus", "drugstartdateformat": "102", "drugstartdate": "2024-12-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-12-30T00:00:00", "drugtreatmentduration": 13.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "VILDAGLIPTIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TRAMADOL HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Pain", "drugstartdateformat": "102", "drugstartdate": "2024-12-17T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-12-30T00:00:00", "drugtreatmentduration": 13.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "TRAMADOL HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "OMNIPAQUE", "drugauthorizationnumb": null, "drugbatchnumb": "16844768", "drugstructuredosagenumb": 70.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "350 MG I/ML, SOLUTION INJECTABLE", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Computerised tomogram", "drugstartdateformat": "102", "drugstartdate": "2024-12-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-12-15T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "IOHEXOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TINZAPARIN [TINZAPARIN 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": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE", "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": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20241218" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "EVDUP#ORG100006023", "duplicatenumb": "EU-SANDOZ-SDZ2025FR018266" }, { "duplicatesource": "EVDUP#ORG100006023", "duplicatenumb": "EU-AFSSAPS-AM2025000152" }, { "duplicatesource": "EVDUP#AFSSAPS", "duplicatenumb": "EU-AFSSAPS-AM2025000152" }, { "duplicatesource": "EMA", "duplicatenumb": "EU-EMA-20251015-AUTODUP-1760564858051" }, { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-AM2025000153" }, { "duplicatesource": "FR-AFSSAPS-AM2025000633", "duplicatenumb": "EU-AFSSAPS-AM2025000633" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "EMD SERONO INC" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25966362 Type 1
Serious
OXALIPLATIN, CAPECITABINE
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AEMPS-1751008
Sender Organization
ACCORD
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
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 (3)

Administration site extravasation (v28.1) Recovering
Vascular access site cellulitis (v28.1) Recovering
Breast cellulitis (v28.1) Recovering

Drugs (2)

OXALIPLATIN (OXALIPLATIN) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Colon cancer | Action: Withdrawn
Auth#: 207474 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/07/2025 | End: 08/28/2025 | Duration: 22.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
CAPECITABINE (CAPECITABINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Colon cancer | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/07/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250828

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c11", "safetyreportid": "25966362", "authoritynumb": "EU-AEMPS-1751008", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Administration site extravasation", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vascular access site cellulitis", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Breast cellulitis", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "OXALIPLATIN", "drugauthorizationnumb": "207474", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": "102", "drugstartdate": "2025-08-07T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-28T00:00:00", "drugtreatmentduration": 22.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "OXALIPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CAPECITABINE", "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": "Colon cancer", "drugstartdateformat": "102", "drugstartdate": "2025-08-07T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CAPECITABINE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250828" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ACCORD" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25966361 Type 2
Serious
CILTACABTAGENE AUTOLEUCEL, CILTACABTAGENE AUTOLEUCEL
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-JNJFOC-20251025783
Authority Number
--
Sender Organization
JOHNSON AND JOHNSON
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
70.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Lung neoplasm malignant (v28.1) Unknown

Drugs (2)

CILTACABTAGENE AUTOLEUCEL (CILTACABTAGENE AUTOLEUCEL) Suspect
Route: 065 | Dosage: -- | Form: Dispersion for infusion | Indication: Plasma cell myeloma | Action: Not Applicable
Auth#: 125746 | Batch#: 24HC6718 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
CILTACABTAGENE AUTOLEUCEL (CILTACABTAGENE AUTOLEUCEL) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Plasma cell disorder | Action: Not Applicable
Auth#: 125746 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c10", "safetyreportid": "25966361", "authoritynumb": null, "companynumb": "US-JNJFOC-20251025783", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": 70.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lung neoplasm malignant", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CILTACABTAGENE AUTOLEUCEL", "drugauthorizationnumb": "125746", "drugbatchnumb": "24HC6718", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Dispersion for infusion", "drugadministrationroute": "065", "drugindication": "Plasma cell myeloma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CILTACABTAGENE AUTOLEUCEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CILTACABTAGENE AUTOLEUCEL", "drugauthorizationnumb": "125746", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Plasma cell disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "CILTACABTAGENE AUTOLEUCEL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "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" }
25966359 Type 1
Serious
ESOMEPRAZOLE
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510202042004680-KYHFD
Sender Organization
ALEXION PHARMACEUTICALS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
75.0 yr
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Gastrointestinal motility disorder (v28.1) Not Recovered

Drugs (1)

ESOMEPRAZOLE (ESOMEPRAZOLE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 22101 | Batch#: ASKU | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

MHRA: GB-MHRA-MED-202510202042004680-KYHFD
HALEON: GB-HALEON-2269152

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c0f", "safetyreportid": "25966359", "authoritynumb": "GB-MHRA-MED-202510202042004680-KYHFD", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "GB", "patient": { "patientonsetage": 75.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gastrointestinal motility disorder", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ESOMEPRAZOLE", "drugauthorizationnumb": "22101", "drugbatchnumb": "ASKU", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "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, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESOMEPRAZOLE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-MED-202510202042004680-KYHFD" }, { "duplicatesource": "HALEON", "duplicatenumb": "GB-HALEON-2269152" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ALEXION PHARMACEUTICALS" }, "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" }
25966360 Type 1
Serious
BRUKINSA
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
BR
Occurrence Country
BR
Reporter Country
BR
Reporter Qualification
Physician
Literature Reference
--
Company Number
BR-BEIGENE-BGN-2025-018147
Authority Number
--
Sender Organization
BEIGENE
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 (1)

Disease progression (v28.1) Unknown

Drugs (1)

BRUKINSA (ZANUBRUTINIB) Suspect
Route: -- | Dosage: -- | Form: -- | Indication: Mantle cell lymphoma | Action: Withdrawn
Auth#: 213217 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c0e", "safetyreportid": "25966360", "authoritynumb": null, "companynumb": "BR-BEIGENE-BGN-2025-018147", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "BR", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Disease progression", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "BRUKINSA", "drugauthorizationnumb": "213217", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Mantle cell lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ZANUBRUTINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "BR", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "BR", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BEIGENE" }, "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" }
25966352 Type 2
Serious
HERCEPTIN, HERCEPTIN
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
PK
Occurrence Country
PK
Reporter Country
PK
Reporter Qualification
Consumer
Literature Reference
--
Company Number
PK-ROCHE-10000418987
Authority Number
--
Sender Organization
ROCHE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
50.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Immune-mediated encephalopathy (v28.1) Unknown

Drugs (2)

HERCEPTIN (TRASTUZUMAB) Suspect
Route: 058 | Dosage: PATIENT RECEIVED TOTAL 10 CYCLES TILL JULY 2025 | Form: -- | Indication: Breast cancer metastatic | Action: Withdrawn
Auth#: -- | Batch#: B1906B02 | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 01/08/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
HERCEPTIN (TRASTUZUMAB) Suspect
Route: 058 | Dosage: -- | Form: -- | Indication: -- | Action: Withdrawn
Auth#: -- | Batch#: B1902B07 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251024

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c0b", "safetyreportid": "25966352", "authoritynumb": null, "companynumb": "PK-ROCHE-10000418987", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "PK", "patient": { "patientonsetage": 50.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Immune-mediated encephalopathy", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "HERCEPTIN", "drugauthorizationnumb": null, "drugbatchnumb": "B1906B02", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "PATIENT RECEIVED TOTAL 10 CYCLES TILL JULY 2025", "drugdosageform": null, "drugadministrationroute": "058", "drugindication": "Breast cancer metastatic", "drugstartdateformat": "102", "drugstartdate": "2025-01-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "HERCEPTIN", "drugauthorizationnumb": null, "drugbatchnumb": "B1902B07", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251024" }, "primarysource": { "reportercountry": "PK", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "PK", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ROCHE" }, "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" }
25966350 Type 1
Serious
MIRTAZAPINE, MIRTAZAPINE, PAROXETINE (+9 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-AUROBINDO-AUR-APL-2025-054041
Authority Number
--
Sender Organization
AUROBINDO
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
35.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hepatic function abnormal (v28.1) Recovering

Drugs (12)

MIRTAZAPINE (MIRTAZAPINE) Suspect
Route: 048 | Dosage: 10 MILLIGRAM, ONCE A DAY | Form: Tablet | Indication: Anxiety | Action: Withdrawn
Auth#: 76921 | Batch#: AHKB24003A | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 160.0 (unit: 003)
Start: 09/18/2025 | End: 10/14/2025 | Duration: 27.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
MIRTAZAPINE (MIRTAZAPINE) Suspect
Route: -- | Dosage: -- | Form: Tablet | Indication: Sleep disorder | Action: Withdrawn
Auth#: 76921 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: 160.0 (unit: 003)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
PAROXETINE (PAROXETINE) Concomitant
Route: 048 | Dosage: 20 MILLIGRAM, DAILY | Form: Tablet | Indication: Anxiety | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) Concomitant
Route: 065 | Dosage: UNK | Form: Tablet | Indication: Anxiety | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
QUETIAPINE FUMARATE (QUETIAPINE FUMARATE) Concomitant
Route: -- | Dosage: -- | Form: Tablet | Indication: Sleep disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHYLCOBALAMIN (METHYLCOBALAMIN) Concomitant
Route: 048 | Dosage: 0.5 MILLIGRAM, 3 TIMES A DAY | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 0.5 (unit: 003) | Separate Dosage#: 3.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CITICOLINE (CITICOLINE) Concomitant
Route: 048 | Dosage: 0.2 GRAM, 3 TIMES A DAY | Form: Capsule | Indication: Nutritional supplementation | Action: Withdrawn
Auth#: -- | Batch#: -- | Structured Dosage: 0.2 (unit: 002) | Separate Dosage#: 3.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
BUSPIRONE HYDROCHLORIDE (BUSPIRONE HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: 5 MILLIGRAM, 3 TIMES A DAY | Form: Tablets | Indication: Gait disturbance | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 3.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Concomitant
Route: 042 | Dosage: 10 MILLIGRAM | Form: Injection | Indication: Affective disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DIAZEPAM (DIAZEPAM) Concomitant
Route: 042 | Dosage: 5 MILLIGRAM | Form: Injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/23/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 042 | Dosage: (250 ML:12.5 G (5%)) 250 ML | Form: Injection | Indication: Affective disorder | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 042 | Dosage: 250 ML:12.5 G (5%)) 250 ML IV DRIP QD | Form: Injection | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/08/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251003

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c0a", "safetyreportid": "25966350", "authoritynumb": null, "companynumb": "CN-AUROBINDO-AUR-APL-2025-054041", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 35.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatic function abnormal", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRTAZAPINE", "drugauthorizationnumb": "76921", "drugbatchnumb": "AHKB24003A", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 160.0, "drugcumulativedosageunit": "003", "drugdosagetext": "10 MILLIGRAM, ONCE A DAY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Anxiety", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-14T00:00:00", "drugtreatmentduration": 27.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "MIRTAZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "MIRTAZAPINE", "drugauthorizationnumb": "76921", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": 160.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Sleep disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "MIRTAZAPINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PAROXETINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20 MILLIGRAM, DAILY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Anxiety", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PAROXETINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "QUETIAPINE FUMARATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Anxiety", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "QUETIAPINE FUMARATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "QUETIAPINE FUMARATE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": null, "drugindication": "Sleep disorder", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "QUETIAPINE FUMARATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METHYLCOBALAMIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 3.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.5 MILLIGRAM, 3 TIMES A DAY", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHYLCOBALAMIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "CITICOLINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 0.2, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 3.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.2 GRAM, 3 TIMES A DAY", "drugdosageform": "Capsule", "drugadministrationroute": "048", "drugindication": "Nutritional supplementation", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "CITICOLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BUSPIRONE HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 3.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MILLIGRAM, 3 TIMES A DAY", "drugdosageform": "Tablets", "drugadministrationroute": "048", "drugindication": "Gait disturbance", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BUSPIRONE HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DIAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "10 MILLIGRAM", "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Affective disorder", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DIAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MILLIGRAM", "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DIAZEPAM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "(250 ML:12.5 G (5%)) 250 ML", "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": "Affective disorder", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "250 ML:12.5 G (5%)) 250 ML IV DRIP QD", "drugdosageform": "Injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-10-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251003" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "AUROBINDO" }, "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" }
25966351 Type 1
Serious
CABLIVI, CABLIVI, CABLIVI (+11 more)
Report Version
1
Receive Date
10/28/2025
Receipt Date
10/28/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-DialogSolutions-SAAVPROD-PI821649-C1
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
20.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
80.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Condition aggravated (v28.1) Recovered

Drugs (14)

CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 042 | Dosage: 10 MG, QD (FIRST DOSE: 1ST DAY:2 AMP) GIVEN IMMEDIATELY AFTER EACH PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/09/2023 | End: 06/09/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 042 | Dosage: 10 MG, QD (FIRST DOSE: 1ST DAY:2 AMP) GIVEN IMMEDIATELY AFTER EACH PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/09/2023 | End: 06/09/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 042 | Dosage: 10 MG, QD (FIRST DOSE: 1ST DAY:2 AMP) GIVEN IMMEDIATELY AFTER EACH PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/09/2023 | End: 06/09/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 042 | Dosage: 10 MG, QD (FIRST DOSE: 1ST DAY:2 AMP) GIVEN IMMEDIATELY AFTER EACH PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/09/2023 | End: 06/09/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 058 | Dosage: 10 MG, QD CONTINUED AFTER DISCONTINUATION OF PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: -- | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/10/2023 | End: 06/27/2023 | Duration: 18.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 058 | Dosage: 10 MG, QD CONTINUED AFTER DISCONTINUATION OF PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: -- | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/10/2023 | End: 06/27/2023 | Duration: 18.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 058 | Dosage: 10 MG, QD CONTINUED AFTER DISCONTINUATION OF PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: -- | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/10/2023 | End: 06/27/2023 | Duration: 18.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
CABLIVI (CAPLACIZUMAB-YHDP) Suspect
Route: 058 | Dosage: 10 MG, QD CONTINUED AFTER DISCONTINUATION OF PLASMA EXCHANGE | Form: Powder and solvent for solution for injection | Indication: -- | Action: Unknown
Auth#: 761112 | Batch#: AOA82202 | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 190.0 (unit: 003)
Start: 06/10/2023 | End: 06/27/2023 | Duration: 18.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FRESH FROZEN PLASMA (HUMAN PLASMA) Concomitant
Route: -- | Dosage: 2-3 UNITS | Form: Infusion | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: 08/11/2023 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
HUMAN PLASMA (HUMAN PLASMA) Concomitant
Route: -- | Dosage: 1?1.5 | Form: -- | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ALBUMIN HUMAN (ALBUMIN HUMAN) Concomitant
Route: -- | Dosage: 5 % | Form: -- | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 030) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHYLPREDNISOLONE (METHYLPREDNISOLONE) Concomitant
Route: 042 | Dosage: 1-2 MG/KG, QD | Form: -- | Indication: Immune thrombocytopenia | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
FOLATE SODIUM (FOLATE SODIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
POTASSIUM (POTASSIUM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20230703

Report Duplicates (1)

DialogSolutions: EU-DialogSolutions-SAAVPROD-PI821649-C1

Raw JSON (click to expand)

{ "_id": "69974fa98e900fe3f48c4c09", "safetyreportid": "25966351", "authoritynumb": null, "companynumb": "EU-DialogSolutions-SAAVPROD-PI821649-C1", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 20.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 80.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CABLIVI", "drugauthorizationnumb": "761112", "drugbatchnumb": "AOA82202", "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 190.0, "drugcumulativedosageunit": "003", "drugdosagetext": "10 MG, QD (FIRST DOSE: 1ST DAY:2 AMP) GIVEN IMMEDIATELY AFTER EACH PLASMA EXCHANGE", "drugdosageform": "Powder and solvent for solution for 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"drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "POTASSIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20230703" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-28T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-28T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "DialogSolutions", "duplicatenumb": "EU-DialogSolutions-SAAVPROD-PI821649-C1" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }