FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25950226 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-SA-2025SA314276
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
22.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
79.55 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Eczema (v28.1) Not Recovered
Pruritus (v28.1) Not Recovered
Erythema (v28.1) Not Recovered
Skin exfoliation (v28.1) Not Recovered

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 600 MG, 1X | Form: Solution for injection | Indication: Dermatitis atopic | Action: Unknown
Auth#: 761055 | Batch#: 5F699A | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251007

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54872", "safetyreportid": "25950226", "authoritynumb": null, "companynumb": "US-SA-2025SA314276", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 22.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 79.55, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Eczema", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Erythema", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin exfoliation", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": "5F699A", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MG, 1X", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Dermatitis atopic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251007" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }
25950225 Type 1
Non-Serious
NEMLUVIO, OTEZLA
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025019284
Authority Number
--
Sender Organization
GALDERMA
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (8)

Psoriasis (v28.1) Not Recovered
Neurodermatitis (v28.1) Unknown
Asthenia (v28.1) Not Recovered
Fatigue (v28.1) Not Recovered
Rash (v28.1) Unknown
Pruritus (v28.1) Unknown
Pain in extremity (v28.1) Unknown
Skin warm (v28.1) Unknown

Drugs (2)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Neurodermatitis | Action: Unknown
Auth#: 761390 | Batch#: B000427746 | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: 01/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
OTEZLA (APREMILAST) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (1)

093025: GL-093025-38559-0043214

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54870", "safetyreportid": "25950225", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019284", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Psoriasis", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Neurodermatitis", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Asthenia", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Fatigue", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Rash", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Skin warm", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": "B000427746", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Neurodermatitis", "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2025-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "OTEZLA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "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": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "APREMILAST" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "093025", "duplicatenumb": "GL-093025-38559-0043214" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25950221 Type 1
Serious
KEYTRUDA, PACLITAXEL, CARBOPLATIN
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
JP
Occurrence Country
JP
Reporter Country
JP
Reporter Qualification
Physician
Literature Reference
--
Company Number
JP-009507513-2340600
Authority Number
--
Sender Organization
MERCK SHARP & DOHME LLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Adrenal insufficiency (v28.1) Unknown

Drugs (3)

KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: 041 | Dosage: -- | Form: Injection | Indication: Uterine cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: 041 | Dosage: -- | Form: Injection | Indication: Uterine cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 175.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 041 | Dosage: -- | Form: Injection | Indication: Uterine cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

MR: JP-MSD-M2025-44356

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5486d", "safetyreportid": "25950221", "authoritynumb": null, "companynumb": "JP-009507513-2340600", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "JP", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Adrenal insufficiency", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KEYTRUDA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "041", "drugindication": "Uterine cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PACLITAXEL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 175.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "041", "drugindication": "Uterine cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PACLITAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Injection", "drugadministrationroute": "041", "drugindication": "Uterine cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "JP", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "JP", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MR", "duplicatenumb": "JP-MSD-M2025-44356" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "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" }
25950220 Type 1
Serious
KEYTRUDA
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
TH
Occurrence Country
TH
Reporter Country
TH
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
TH-009507513-2341662
Authority Number
--
Sender Organization
MERCK SHARP & DOHME LLC
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
84.0 yr
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)

KEYTRUDA (PEMBROLIZUMAB) Suspect
Route: 042 | Dosage: 200 MG, IV, 3 WEEKS | Form: Solution for infusion | Indication: Metastatic malignant melanoma | Action: Not Applicable
Auth#: 125514 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 09/18/2025 | End: 09/18/2025 | Duration: 1.0 day | Rechallenge: Unknown | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5486b", "safetyreportid": "25950220", "authoritynumb": null, "companynumb": "TH-009507513-2341662", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "TH", "patient": { "patientonsetage": 84.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "KEYTRUDA", "drugauthorizationnumb": "125514", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG, IV, 3 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Metastatic malignant melanoma", "drugstartdateformat": "102", "drugstartdate": "2025-09-18T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-18T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 3, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "PEMBROLIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "TH", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "TH", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MERCK SHARP & DOHME LLC" }, "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" }
25950215 Type 1
Serious
NEXPLANON
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
--
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-ORGANON-O2510USA001804
Authority Number
--
Sender Organization
ORGANON
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
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Vaginal haemorrhage (v28.1) Not Recovered

Drugs (1)

NEXPLANON (ETONOGESTREL) Suspect
Route: -- | Dosage: 1 IMPLANT, 68 MG, EVERY 3 YEARS | Form: -- | Indication: -- | Action: Dose Not Changed
Auth#: 21529 | Batch#: -- | Structured Dosage: 1.0 (unit: 032) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5486a", "safetyreportid": "25950215", "authoritynumb": null, "companynumb": "US-ORGANON-O2510USA001804", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": null, "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vaginal haemorrhage", "reactionoutcome": 3 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEXPLANON", "drugauthorizationnumb": "21529", "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1 IMPLANT, 68 MG, EVERY 3 YEARS", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "ETONOGESTREL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240101" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ORGANON" }, "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" }
25950214 Type 2
Serious
VENCLEXTA, VENCLEXTA, VENCLEXTA (+14 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-ABBVIE-6511591
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
80.0 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 (17)

VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
VENCLEXTA (VENETOCLAX) Suspect
Route: 048 | Dosage: -- | Form: Tablet | Indication: Anaemia | Action: Not Applicable
Auth#: 208573 | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/08/2023 | End: 12/06/2023 | Duration: 29.0 day | Rechallenge: -- | Additional: 4
Recurrences: --
NORVASC (AMLODIPINE BESYLATE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 18300.0 (unit: 003)
Start: 11/12/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LIPITOR (ATORVASTATIN CALCIUM) Concomitant
Route: 048 | Dosage: EVERY EVENING | Form: -- | Indication: Cerebrovascular accident prophylaxis | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 80.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/22/2022 | End: 11/22/2023 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOVIRAX (ACYCLOVIR) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: 11/14/2023 | End: 12/05/2024 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZYLOPRIM (ALLOPURINOL) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Blood uric acid increased | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 18300.0 (unit: 003)
Start: 11/14/2023 | End: 01/13/2024 | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
VITAMIN D3 (CHOLECALCIFEROL) Concomitant
Route: 048 | Dosage: 1000 UNITS | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 05/01/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
EMLA (LIDOCAINE\PRILOCAINE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 30.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/03/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
ZOFRAN (ONDANSETRON HYDROCHLORIDE) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 8.0 hr | Cumulative: -- (unit: --)
Start: 11/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
MIRALAX (POLYETHYLENE GLYCOL 3350) Concomitant
Route: 048 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 17.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 17153.0 (unit: 002)
Start: 11/23/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PREDNISONE (PREDNISONE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 20.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/14/2023 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
COMPAZINE (PROCHLORPERAZINE MALEATE) Concomitant
Route: 048 | Dosage: -- | Form: -- | Indication: Nausea | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 6.0 hr | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
SUPREP BOWEL PREP (MAGNESIUM SULFATE\POTASSIUM SULFATE\SODIUM SULFATE) Concomitant
Route: 048 | Dosage: ASS DIRECTED | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/22/2022 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250827

Report Duplicates (1)

Genentech: LCN0001004842

Raw JSON (click to expand)

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"drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Anaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "VENETOCLAX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENCLEXTA", "drugauthorizationnumb": "208573", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Anaemia", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "VENETOCLAX" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "VENCLEXTA", "drugauthorizationnumb": "208573", "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Anaemia", "drugstartdateformat": "102", "drugstartdate": "2023-11-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-12-06T00:00:00", "drugtreatmentduration": 29.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "VENETOCLAX" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NORVASC", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 18300.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2022-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LIPITOR", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 80.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "EVERY EVENING", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Cerebrovascular accident prophylaxis", "drugstartdateformat": "102", "drugstartdate": "2022-11-22T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-11-22T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ATORVASTATIN CALCIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOVIRAX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-11-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-12-05T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACYCLOVIR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZYLOPRIM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 18300.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Blood uric acid increased", "drugstartdateformat": "102", "drugstartdate": "2023-11-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-01-13T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ALLOPURINOL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "VITAMIN D3", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 UNITS", "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-05-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CHOLECALCIFEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "EMLA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 30.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-11-03T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LIDOCAINE\\PRILOCAINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ZOFRAN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 8.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": "102", "drugstartdate": "2023-11-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ONDANSETRON HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "MIRALAX", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 17.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 17153.0, "drugcumulativedosageunit": "002", "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2022-11-23T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "POLYETHYLENE GLYCOL 3350" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "PREDNISONE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2023-11-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PREDNISONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "COMPAZINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 10.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 6.0, "drugintervaldosagedefinition": 805, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Nausea", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "PROCHLORPERAZINE MALEATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SUPREP BOWEL PREP", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "ASS DIRECTED", "drugdosageform": null, "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2022-06-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "MAGNESIUM SULFATE\\POTASSIUM SULFATE\\SODIUM SULFATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250827" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Genentech", "duplicatenumb": "LCN0001004842" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "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" }
25950213 Type 1
Serious
INVEGA, ARIPIPRAZOLE, LORAZEPAM
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/17/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Physician
Literature Reference
--
Company Number
CN-JNJFOC-20251020419
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
36.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
75.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Hospitalisation (v28.1) Unknown
Coma (v28.1) Not Recovered
Incorrect dose administered (v28.1) Unknown

Drugs (3)

INVEGA (PALIPERIDONE) Suspect
Route: 048 | Dosage: -- | Form: Prolonged-release tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: 021999 | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/01/2023 | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
ARIPIPRAZOLE (ARIPIPRAZOLE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LORAZEPAM (LORAZEPAM) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54868", "safetyreportid": "25950213", "authoritynumb": null, "companynumb": "CN-JNJFOC-20251020419", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 36.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": 75.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hospitalisation", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Coma", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "INVEGA", "drugauthorizationnumb": "021999", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Prolonged-release tablet", "drugadministrationroute": "048", "drugindication": "Product used for unknown indication", "drugstartdateformat": "610", "drugstartdate": "2023-11-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 3, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PALIPERIDONE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ARIPIPRAZOLE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ARIPIPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LORAZEPAM", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LORAZEPAM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "CN", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "JOHNSON AND JOHNSON" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950208 Type 1
Non-Serious
DUPIXENT, DUPIXENT
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
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-SA-2025SA313258
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
17.0 yr
Patient Age Group
Adolescent
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Injection site pain (v28.1) Unknown

Drugs (2)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 600 MG, 1X | Form: Solution for injection | Indication: Eczema | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/01/2025 | End: 08/01/2025 | Duration: 1.0 day | Rechallenge: Yes | Additional: Unknown
Recurrences: --
DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: 01/01/2025 | End: -- | Duration: -- -- | Rechallenge: Yes | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250801

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54865", "safetyreportid": "25950208", "authoritynumb": null, "companynumb": "US-SA-2025SA313258", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 17.0, "patientonsetageunit": 801, "patientagegroup": 4, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site pain", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "600 MG, 1X", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Eczema", "drugstartdateformat": "610", "drugstartdate": "2025-08-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": 1, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, QOW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "602", "drugstartdate": "2025-01-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": 1, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250801" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "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" }
25950211 Type 2
Serious
FOSCARBIDOPA\FOSLEVODOPA, Panadol forte, Madopar Quick (+2 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Consumer
Literature Reference
--
Company Number
EU-ABBVIE-6512921
Authority Number
--
Sender Organization
ABBVIE
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
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (7)

Musculoskeletal disorder (v28.1) Recovering
Therapeutic product effect incomplete (v28.1) Not Recovered
Mobility decreased (v28.1) Not Recovered
Gait inability (v28.1) Recovering
Infusion site erythema (v28.1) Recovering
Infusion site induration (v28.1) Recovering
Freezing phenomenon (v28.1) Unknown

Drugs (5)

FOSCARBIDOPA\FOSLEVODOPA (FOSCARBIDOPA\FOSLEVODOPA) Suspect
Route: 058 | Dosage: SLOW 0,28 ML/H (USED AT NIGHT), BASE 0,36 ML/H (NOT USED AT ALL), HIGH 0,38 ML/H (USED DURING THE... | Form: Solution for infusion | Indication: Parkinson^s disease | Action: Unknown
Auth#: 216962 | Batch#: 1300802 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 06/17/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
Panadol forte (--) Concomitant
Route: -- | Dosage: TIME INTERVAL: 0.33333333 DAYS | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
Madopar Quick (--) Concomitant
Route: -- | Dosage: 100/125, 1/2 TO 1 TABLET 1 TO 2 TIMES A DAY, WHEN NECESSARY | Form: -- | Indication: Parkinson^s disease | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 10/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CALCIUM\CHOLECALCIFEROL (CALCIUM\CHOLECALCIFEROL) Concomitant
Route: -- | Dosage: 1X2 | 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: --
Hypotron (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Hypotension | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 0.5 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54864", "safetyreportid": "25950211", "authoritynumb": null, "companynumb": "EU-ABBVIE-6512921", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Musculoskeletal disorder", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Therapeutic product effect incomplete", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Mobility decreased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait inability", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion site erythema", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion site induration", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Freezing phenomenon", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FOSCARBIDOPA\\FOSLEVODOPA", "drugauthorizationnumb": "216962", "drugbatchnumb": "1300802", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "SLOW 0,28 ML/H (USED AT NIGHT), BASE 0,36 ML/H (NOT USED AT ALL), HIGH 0,38 ML/H (USED DURING THE...", "drugdosageform": "Solution for infusion", "drugadministrationroute": "058", "drugindication": "Parkinson^s disease", "drugstartdateformat": "102", "drugstartdate": "2025-06-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FOSCARBIDOPA\\FOSLEVODOPA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Panadol forte", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "TIME INTERVAL: 0.33333333 DAYS", "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": "Madopar Quick", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100/125, 1/2 TO 1 TABLET 1 TO 2 TIMES A DAY, WHEN NECESSARY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Parkinson^s disease", "drugstartdateformat": "610", "drugstartdate": "2025-10-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "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": "1X2", "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": "CALCIUM\\CHOLECALCIFEROL" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "Hypotron", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 0.5, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Hypotension", "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: 20250101" }, "primarysource": { "reportercountry": "EU", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-22T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-22T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "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" }
25950212 Type 1
Serious
TISLELIZUMAB, TISLELIZUMAB, TISLELIZUMAB (+3 more)
Report Version
1
Receive Date
10/22/2025
Receipt Date
10/22/2025
Transmission Date
01/18/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-BEIGENE-BGN-2025-018059
Authority Number
--
Sender Organization
BEIGENE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
76.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
60.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Hypokalaemia (v28.1) Recovering

Drugs (6)

TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: Colon cancer | Action: Unknown
Auth#: 761232 | Batch#: G202503014 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: Rectal cancer | Action: Unknown
Auth#: 761232 | Batch#: G202503014 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202503014 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G202503014 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CETUXIMAB (CETUXIMAB) Suspect
Route: -- | Dosage: 800 MILLIGRAM | Form: -- | Indication: Colon cancer | Action: Unknown
Auth#: -- | Batch#: C10024320 | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CETUXIMAB (CETUXIMAB) Suspect
Route: -- | Dosage: 800 MILLIGRAM | Form: -- | Indication: Rectal cancer | Action: Unknown
Auth#: -- | Batch#: C10024320 | Structured Dosage: 800.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

NMPACDR: 5325221013218202500750

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54863", "safetyreportid": "25950212", "authoritynumb": null, "companynumb": "CN-BEIGENE-BGN-2025-018059", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 76.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 60.0, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypokalaemia", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TISLELIZUMAB", "drugauthorizationnumb": "761232", "drugbatchnumb": "G202503014", "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MILLIGRAM", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Colon cancer", "drugstartdateformat": null, 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