FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25940423 Type 1
Serious
TISLELIZUMAB, TISLELIZUMAB, TISLELIZUMAB (+15 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/19/2026
Primary Source Country
CN
Occurrence Country
CN
Reporter Country
CN
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CN-BEIGENE-BGN-2025-018006
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
65.0 yr
Patient Age Group
--
Patient Sex
--
Patient Weight
50.5 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Myelosuppression (v28.1) Not Recovered

Drugs (18)

TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM, Q3WK | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: 761232 | Batch#: G2025050 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G2025050 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: 041 | Dosage: 200 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G2025050 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
TISLELIZUMAB (TISLELIZUMAB) Suspect
Route: -- | Dosage: 200 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: 761232 | Batch#: G2025050 | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: Unknown | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: -- | Dosage: 400 MILLIGRAM, Q3WK | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: 5H081CA4 | Structured Dosage: 400.0 (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: 400 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 5H081CA4 | Structured Dosage: 400.0 (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: 400 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 5H081CA4 | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: -- | Dosage: 400 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: 5H081CA4 | Structured Dosage: 400.0 (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: 350 MILLIGRAM, Q3WK | Form: -- | Indication: Lung neoplasm malignant | Action: Unknown
Auth#: -- | Batch#: AK1P502 | Structured Dosage: 350.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PACLITAXEL (PACLITAXEL) Suspect
Route: -- | Dosage: 350 MILLIGRAM, Q3WK | Form: -- | Indication: -- | Action: Unknown
Auth#: -- | Batch#: AK1P502 | Structured Dosage: 350.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: 100 MILLILITER, Q3WK | Form: -- | Indication: Vehicle solution use | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 100.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 100.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: 041 | Dosage: 100 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 100.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
SODIUM CHLORIDE (SODIUM CHLORIDE) Concomitant
Route: -- | Dosage: 100 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 100.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 100.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: -- | Dosage: 500 MILLILITER, Q3WK | Form: -- | Indication: Vehicle solution use | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 500.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 041 | Dosage: 500 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 500.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: 041 | Dosage: 500 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 500.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXTROSE (DEXTROSE MONOHYDRATE) Concomitant
Route: -- | Dosage: 500 MILLILITER, Q3WK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 012) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: 500.0 (unit: 012)
Start: -- | End: -- | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

NMPACDR: 3601011959817202500283

Raw JSON (click to expand)

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"activesubstancename": "SODIUM CHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 MILLILITER, Q3WK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Vehicle solution use", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 MILLILITER, Q3WK", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 MILLILITER, Q3WK", "drugdosageform": null, "drugadministrationroute": "041", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXTROSE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "012", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": 500.0, "drugcumulativedosageunit": "012", "drugdosagetext": "500 MILLILITER, Q3WK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXTROSE MONOHYDRATE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "NMPACDR", "duplicatenumb": "3601011959817202500283" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BEIGENE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25940422 Type 1
Non-Serious
NEMLUVIO, NEMLUVIO
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025019007
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 (2)

Product dose omission issue (v28.1) Recovered
Device malfunction (v28.1) Recovered

Drugs (2)

NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Product used for unknown indication | Action: Not Applicable
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --
NEMLUVIO (NEMOLIZUMAB-ILTO) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: -- | Action: Not Applicable
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250925

Report Duplicates (1)

092625: GL-092625-37823

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa52021", "safetyreportid": "25940422", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025019007", "duplicate": 1, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device malfunction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NEMLUVIO", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "NEMOLIZUMAB-ILTO" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250925" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "092625", "duplicatenumb": "GL-092625-37823" } ], "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": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940420 Type 2
Serious
NEMOLIZUMAB, NEMOLIZUMAB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-GALDERMA-US2025020120
Authority Number
--
Sender Organization
GALDERMA
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
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Lower respiratory tract infection (v28.1) Not Recovered
Infection susceptibility increased (v28.1) Not Recovered
Immune system disorder (v28.1) Not Recovered
Inappropriate schedule of product administration (v28.1) Recovered

Drugs (2)

NEMOLIZUMAB (NEMOLIZUMAB) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: Neurodermatitis | Action: Unknown
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
NEMOLIZUMAB (NEMOLIZUMAB) Suspect
Route: 058 | Dosage: UNK | Form: Injection | Indication: -- | Action: Unknown
Auth#: 761390 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/29/2025 | End: 09/29/2025 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250924

Report Duplicates (1)

100925: GL-100925-42411-0043754

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa52020", "safetyreportid": "25940420", "authoritynumb": null, "companynumb": "US-GALDERMA-US2025020120", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Lower respiratory tract infection", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infection susceptibility increased", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Immune system disorder", "reactionoutcome": 3 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Inappropriate schedule of product administration", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "NEMOLIZUMAB", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": "Neurodermatitis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEMOLIZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "NEMOLIZUMAB", "drugauthorizationnumb": "761390", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-29T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "NEMOLIZUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250924" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "100925", "duplicatenumb": "GL-100925-42411-0043754" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "GALDERMA" }, "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" }
25940421 Type 1
Non-Serious
MIRENA
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Physician
Literature Reference
--
Company Number
US-BAYER-2025A138120
Authority Number
--
Sender Organization
BAYER HEALTHCARE PHARMACEUTICALS INC.
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
30.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Device expulsion (v28.1) Recovered

Drugs (1)

MIRENA (LEVONORGESTREL) Suspect
Route: 015 | Dosage: 20?G/DAY | Form: Intrauterine delivery system | Indication: -- | Action: Not Applicable
Auth#: 021225 | Batch#: TU042C0 | Structured Dosage: 20.0 (unit: 004) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/23/2025 | End: 09/23/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250923

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa5201d", "safetyreportid": "25940421", "authoritynumb": null, "companynumb": "US-BAYER-2025A138120", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 30.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Device expulsion", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MIRENA", "drugauthorizationnumb": "021225", "drugbatchnumb": "TU042C0", "drugstructuredosagenumb": 20.0, "drugstructuredosageunit": "004", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "20?G/DAY", "drugdosageform": "Intrauterine delivery system", "drugadministrationroute": "015", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-09-23T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-23T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "LEVONORGESTREL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250923" }, "primarysource": { "reportercountry": "US", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BAYER HEALTHCARE PHARMACEUTICALS INC." }, "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" }
25940416 Type 2
Serious
ENHERTU
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
IN
Occurrence Country
IN
Reporter Country
IN
Reporter Qualification
Consumer
Literature Reference
--
Company Number
IN-AstraZeneca-CH-00971700A
Authority Number
--
Sender Organization
DAIICHI
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Death (v28.1) Fatal

Drugs (1)

ENHERTU (FAM-TRASTUZUMAB DERUXTECAN-NXKI) Suspect
Route: 041 | Dosage: 200 MG, ONCE EVERY 3 WK | Form: INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION | Indication: HER2 positive breast cancer | Action: Not Applicable
Auth#: 761139 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

--

Report Duplicates (1)

ASTRAZENECA: IN-ASTRAZENECA-202510ASI012335IN

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa5201a", "safetyreportid": "25940416", "authoritynumb": null, "companynumb": "IN-AstraZeneca-CH-00971700A", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "IN", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Death", "reactionoutcome": 5 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENHERTU", "drugauthorizationnumb": "761139", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG, ONCE EVERY 3 WK", "drugdosageform": "INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION", "drugadministrationroute": "041", "drugindication": "HER2 positive breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "FAM-TRASTUZUMAB DERUXTECAN-NXKI" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "IN", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "IN", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ASTRAZENECA", "duplicatenumb": "IN-ASTRAZENECA-202510ASI012335IN" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "DAIICHI" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 1, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940417 Type 1
Non-Serious
ESTRADIOL TRANSDERMAL SYSTEM
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-MYLANLABS-2025M1084873
Authority Number
--
Sender Organization
MYLAN
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Swelling (v28.1) Unknown
Product adhesion issue (v28.1) Unknown

Drugs (1)

ESTRADIOL TRANSDERMAL SYSTEM (ESTRADIOL) Suspect
Route: -- | Dosage: 0.075 MILLIGRAM, QD (PER DAY, TWICE WEEKLY) | Form: -- | Indication: Menopausal symptoms | Action: Unknown
Auth#: 201675 | Batch#: 8200876 | Structured Dosage: 0.075 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 07/01/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa52018", "safetyreportid": "25940417", "authoritynumb": null, "companynumb": "US-MYLANLABS-2025M1084873", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swelling", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product adhesion issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ESTRADIOL TRANSDERMAL SYSTEM", "drugauthorizationnumb": "201675", "drugbatchnumb": "8200876", "drugstructuredosagenumb": 0.075, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "0.075 MILLIGRAM, QD (PER DAY, TWICE WEEKLY)", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Menopausal symptoms", "drugstartdateformat": "610", "drugstartdate": "2025-07-01T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ESTRADIOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "MYLAN" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940415 Type 1
Non-Serious
AYVAKIT
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-Blueprint Medicines Corporation-2025-AER-02258
Authority Number
--
Sender Organization
BLUEPRINT MEDICINES
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
65.0 yr
Patient Age Group
Elderly
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Headache (v28.1) Unknown
Melanocytic naevus (v28.1) Unknown

Drugs (1)

AYVAKIT (AVAPRITINIB) Suspect
Route: 065 | Dosage: -- | Form: Unknown | Indication: Mast cell activation syndrome | Action: Dose Not Changed
Auth#: 212608 | Batch#: TCSDFN1R | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 11/14/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa52017", "safetyreportid": "25940415", "authoritynumb": null, "companynumb": "US-Blueprint Medicines Corporation-2025-AER-02258", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": 6, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Headache", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Melanocytic naevus", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "AYVAKIT", "drugauthorizationnumb": "212608", "drugbatchnumb": "TCSDFN1R", "drugstructuredosagenumb": 25.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "drugadministrationroute": "065", "drugindication": "Mast cell activation syndrome", "drugstartdateformat": "102", "drugstartdate": "2024-11-14T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "AVAPRITINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "BLUEPRINT MEDICINES" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25940414 Type 2
Serious
METHOTREXATE SODIUM, PLAQUENIL, ETANERCEPT (+1 more)
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-202500203990
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
1
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Coating in mouth (v28.1) Recovered
Dysphagia (v28.1) Recovered
Hepatitis B (v28.1) Recovered
Illness (v28.1) Recovered
Peritonsillar abscess (v28.1) Recovered
Stomatitis (v28.1) Recovered

Drugs (4)

METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: 037 | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 011719 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
PLAQUENIL (HYDROXYCHLOROQUINE SULFATE) Suspect
Route: 065 | Dosage: -- | Form: Tablet | Indication: -- | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ETANERCEPT (ETANERCEPT) Suspect
Route: 058 | Dosage: 50 MG, WEEKLY; 1 EVERY 1 WEEKS | Form: Solution for injection | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ETANERCEPT (ETANERCEPT) Suspect
Route: -- | Dosage: 50 MG, WEEKLY; 1 EVERY 1 WEEKS | Form: Solution for injection in pre-filled pen | Indication: Rheumatoid arthritis | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08124538
Unknown: SB-2025-20754

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa52012", "safetyreportid": "25940414", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500203990", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Coating in mouth", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dysphagia", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatitis B", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Illness", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Peritonsillar abscess", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Stomatitis", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE SODIUM", "drugauthorizationnumb": "011719", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": "037", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "METHOTREXATE SODIUM" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PLAQUENIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "HYDROXYCHLOROQUINE SULFATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MG, WEEKLY; 1 EVERY 1 WEEKS", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Rheumatoid arthritis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETANERCEPT" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ETANERCEPT", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50 MG, WEEKLY; 1 EVERY 1 WEEKS", "drugdosageform": "Solution for injection in pre-filled pen", "drugadministrationroute": null, "drugindication": "Rheumatoid arthritis", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ETANERCEPT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Health Canada", "duplicatenumb": "E2B_08124538" }, { "duplicatesource": "Unknown", "duplicatenumb": "SB-2025-20754" } ], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }
25940412 Type 2
Serious
ENCORAFENIB, BINIMETINIB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
--
Company Number
CA-PFIZER INC-202500204135
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
68.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Retinopathy (v28.1) Unknown
Visual impairment (v28.1) Unknown

Drugs (2)

ENCORAFENIB (ENCORAFENIB) Suspect
Route: -- | Dosage: UNK | Form: Capsule | Indication: Metastatic malignant melanoma | Action: Unknown
Auth#: 210496 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
BINIMETINIB (BINIMETINIB) Suspect
Route: -- | Dosage: UNK | Form: Film-coated tablet | Indication: Metastatic malignant melanoma | Action: Unknown
Auth#: 210498 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa5200f", "safetyreportid": "25940412", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500204135", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 68.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Retinopathy", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Visual impairment", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENCORAFENIB", "drugauthorizationnumb": "210496", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Metastatic malignant melanoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ENCORAFENIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BINIMETINIB", "drugauthorizationnumb": "210498", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": null, "drugindication": "Metastatic malignant melanoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "BINIMETINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }
25940408 Type 2
Serious
ENCORAFENIB, BINIMETINIB
Report Version
1
Receive Date
10/20/2025
Receipt Date
10/20/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Physician
Literature Reference
--
Company Number
CA-PFIZER INC-202500204125
Authority Number
--
Sender Organization
PFIZER
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
55.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Cardiotoxicity (v28.1) Unknown
Hypertension (v28.1) Unknown

Drugs (2)

ENCORAFENIB (ENCORAFENIB) Suspect
Route: -- | Dosage: UNK | Form: Capsule | Indication: Metastatic malignant melanoma | Action: Withdrawn
Auth#: 210496 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BINIMETINIB (BINIMETINIB) Suspect
Route: -- | Dosage: UNK | Form: Film-coated tablet | Indication: Metastatic malignant melanoma | Action: Withdrawn
Auth#: 210498 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4354c3b3830196fa5200b", "safetyreportid": "25940408", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500204125", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 55.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Cardiotoxicity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hypertension", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ENCORAFENIB", "drugauthorizationnumb": "210496", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Capsule", "drugadministrationroute": null, "drugindication": "Metastatic malignant melanoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "ENCORAFENIB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "BINIMETINIB", "drugauthorizationnumb": "210498", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Film-coated tablet", "drugadministrationroute": null, "drugindication": "Metastatic malignant melanoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "BINIMETINIB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-20T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-20T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }