FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25974668 Type 1
Serious
RUXIENCE, RUXIENCE, RUXIENCE (+4 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-202500211895
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
38.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Obstructive airways disorder (v28.1) Unknown

Drugs (7)

RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 1000 MG, 2 DOSES | Form: Solution for infusion | Indication: Granulomatosis with polyangiitis | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: 1000.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 04/25/2022 | End: 06/08/2022 | Duration: 45.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 500 MG, SINGLE DOSE | Form: Solution for infusion | Indication: -- | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/16/2023 | End: 03/16/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 500 MG, SINGLE DOSE | Form: Solution for infusion | Indication: -- | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/14/2023 | End: 09/14/2023 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 500 MG, IV X 1 | Form: Solution for infusion | Indication: -- | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/15/2024 | End: 03/15/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 500 MG, SINGLE DOSE | Form: Solution for infusion | Indication: -- | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/20/2024 | End: 09/20/2024 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
RUXIENCE (RITUXIMAB-PVVR) Suspect
Route: 042 | Dosage: 500 MG, SINGLE DOSE | Form: Solution for infusion | Indication: -- | Action: Unknown
Auth#: 761103 | Batch#: LL0668 | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 03/12/2025 | End: 03/12/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
SULFATRIM (SULFAMETHOXAZOLE\TRIMETHOPRIM) Concomitant
Route: -- | Dosage: UNK | Form: -- | 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": "69e7691c5eb43a53b3ff1f3f", "safetyreportid": "25974668", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500211895", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": 38.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Obstructive airways disorder", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "1000 MG, 2 DOSES", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Granulomatosis with polyangiitis", "drugstartdateformat": "102", "drugstartdate": "2022-04-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2022-06-08T00:00:00", "drugtreatmentduration": 45.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, SINGLE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-03-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-03-16T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, SINGLE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-09-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2023-09-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, IV X 1", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-03-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-03-15T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, SINGLE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-09-20T00:00:00", "drugenddateformat": "102", "drugenddate": "2024-09-20T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "RUXIENCE", "drugauthorizationnumb": "761103", "drugbatchnumb": "LL0668", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "500 MG, SINGLE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2025-03-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-03-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB-PVVR" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "SULFATRIM", "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": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SULFAMETHOXAZOLE\\TRIMETHOPRIM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "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" }
25974665 Type 1
Serious
MEROPENEM
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
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-PFIZER INC-PV202500126608
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
29.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Purpura (v28.1) Recovering
Drug eruption (v28.1) Recovering
Abdominal pain lower (v28.1) Recovering
Abdominal pain (v28.1) Recovering
Pruritus (v28.1) Unknown

Drugs (1)

MEROPENEM (MEROPENEM) Suspect
Route: 041 | Dosage: 1 G, 1X/DAY | Form: Powder for injection | Indication: Pneumonia | Action: Withdrawn
Auth#: 050706 | Batch#: 2747C | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 2.0 (unit: 002)
Start: 10/08/2025 | End: 10/10/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251009

Report Duplicates (2)

Dainippon Sumitomo: 2025-SMPC-00856
2025SMP009316: 2025SMP009316

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f3e", "safetyreportid": "25974665", "authoritynumb": null, "companynumb": "CN-PFIZER INC-PV202500126608", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CN", "patient": { "patientonsetage": 29.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Purpura", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug eruption", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain lower", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "MEROPENEM", "drugauthorizationnumb": "050706", "drugbatchnumb": "2747C", "drugstructuredosagenumb": 1.0, "drugstructuredosageunit": "002", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 2.0, "drugcumulativedosageunit": "002", "drugdosagetext": "1 G, 1X/DAY", "drugdosageform": "Powder for injection", "drugadministrationroute": "041", "drugindication": "Pneumonia", "drugstartdateformat": "102", "drugstartdate": "2025-10-08T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-10T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "MEROPENEM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251009" }, "primarysource": { "reportercountry": "CN", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CN", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Dainippon Sumitomo", "duplicatenumb": "2025-SMPC-00856" }, { "duplicatesource": "2025SMP009316", "duplicatenumb": "2025SMP009316" } ], "reporttype": 1, "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" }
25974669 Type 1
Serious
TOVIAZ, COMIRNATY (BNT162B2 OMICRON (LP.8.1))
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
EU-FAMHP-DHH-N2025-125729
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
73.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (5)

Urticaria (v28.1) Recovering
Dyspnoea (v28.1) Recovering
Heart rate increased (v28.1) Recovering
Vertigo (v28.1) Recovering
Gait disturbance (v28.1) Recovering

Drugs (2)

TOVIAZ (FESOTERODINE FUMARATE) Suspect
Route: 048 | Dosage: 0.5 DF, 1X/DAY | Form: Prolonged-release tablet | Indication: Micturition urgency | Action: Withdrawn
Auth#: 22030 | Batch#: -- | Structured Dosage: 0.5 (unit: 032) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 5.5 (unit: 032)
Start: 09/16/2025 | End: 09/27/2025 | Duration: 12.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --
COMIRNATY (BNT162B2 OMICRON (LP.8.1)) (BNT162B2 OMICRON (LP.8.1)) Suspect
Route: -- | Dosage: DOSE 1, SINGLE | Form: Solution for injection | Indication: COVID-19 immunisation | Action: Not Applicable
Auth#: 125742 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 09/25/2025 | End: 09/25/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250926

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f3d", "safetyreportid": "25974669", "authoritynumb": "EU-FAMHP-DHH-N2025-125729", "companynumb": null, "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 73.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Heart rate increased", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vertigo", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Gait disturbance", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TOVIAZ", "drugauthorizationnumb": "22030", "drugbatchnumb": null, "drugstructuredosagenumb": 0.5, "drugstructuredosageunit": "032", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 5.5, "drugcumulativedosageunit": "032", "drugdosagetext": "0.5 DF, 1X/DAY", "drugdosageform": "Prolonged-release tablet", "drugadministrationroute": "048", "drugindication": "Micturition urgency", "drugstartdateformat": "102", "drugstartdate": "2025-09-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-27T00:00:00", "drugtreatmentduration": 12.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "FESOTERODINE FUMARATE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "COMIRNATY (BNT162B2 OMICRON (LP.8.1))", "drugauthorizationnumb": "125742", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "DOSE 1, SINGLE", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "COVID-19 immunisation", "drugstartdateformat": "102", "drugstartdate": "2025-09-25T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-25T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "BNT162B2 OMICRON (LP.8.1)" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250926" }, "primarysource": { "reportercountry": "EU", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25974664 Type 1
Serious
RIMEGEPANT
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Pharmacist
Literature Reference
--
Company Number
--
Authority Number
EU-AEMPS-1765598
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
30.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Anaphylactic reaction (v28.1) Recovered

Drugs (1)

RIMEGEPANT (RIMEGEPANT) Suspect
Route: 048 | Dosage: 75 MG, ALTERNATE DAY | Form: Orodispersible tablet | Indication: Migraine | Action: Withdrawn
Auth#: 212728 | Batch#: -- | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 day | Cumulative: -- (unit: --)
Start: 10/16/2025 | End: 10/16/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Yes
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251016

Report Duplicates (1)

AEMPS: EU-AEMPS-1765598

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f3c", "safetyreportid": "25974664", "authoritynumb": "EU-AEMPS-1765598", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 30.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Anaphylactic reaction", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RIMEGEPANT", "drugauthorizationnumb": "212728", "drugbatchnumb": null, "drugstructuredosagenumb": 75.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "75 MG, ALTERNATE DAY", "drugdosageform": "Orodispersible tablet", "drugadministrationroute": "048", "drugindication": "Migraine", "drugstartdateformat": "102", "drugstartdate": "2025-10-16T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-10-16T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "RIMEGEPANT" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251016" }, "primarysource": { "reportercountry": "EU", "qualification": 2, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AEMPS", "duplicatenumb": "EU-AEMPS-1765598" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 1, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974659 Type 1
Serious
EPIRUBICIN HYDROCHLORIDE, DOCETAXEL, FLUOROURACIL (+8 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/19/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
EU-ROCHE-1155510
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
65.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
84.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Infusion related reaction (v28.1) Recovered
Diarrhoea (v28.1) Recovered
Vomiting (v28.1) Recovered

Drugs (11)

EPIRUBICIN HYDROCHLORIDE (EPIRUBICIN HYDROCHLORIDE) Suspect
Route: 042 | Dosage: 100 MG/M2, EVERY 3 WEEKS (LAST DOSE PRIOR TO SAE) | Form: Powder and solvent for solution for injection | Indication: Breast cancer female | Action: Unknown
Auth#: 50778 | Batch#: -- | Structured Dosage: 100.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 08/28/2012 | End: 10/09/2012 | Duration: 43.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOCETAXEL (DOCETAXEL) Suspect
Route: 042 | Dosage: LAST DOSE PRIOR TO SAE: 14/NOV/2012. WITHDRAWN FROM STUDY.FREQUENCY TEXT:200 UNITS | Form: -- | Indication: Breast cancer female | Action: Unknown
Auth#: 022234 | Batch#: -- | Structured Dosage: 1000.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: 11/27/2012 | Duration: 14.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
FLUOROURACIL (FLUOROURACIL) Suspect
Route: 042 | Dosage: UNIT: 1000, LAST DOSE PRIOR TO SAE: 09/OCT/2012 | Form: -- | Indication: Breast cancer female | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 08/28/2012 | End: 10/09/2012 | Duration: 43.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PERTUZUMAB (PERTUZUMAB) Suspect
Route: 042 | Dosage: LOADING DOSE AS PER PROTOCOL. LAST DOSE PRIOR TO SAE: 12/NOV/2012. WITHDRAWN FROM STUDY | Form: Solution for infusion | Indication: Breast cancer female | Action: Dose Not Changed
Auth#: -- | Batch#: 128045 | Structured Dosage: 840.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 11/12/2012 | End: 11/27/2012 | Duration: 16.0 day | Rechallenge: -- | Additional: --
Recurrences: --
PERTUZUMAB (PERTUZUMAB) Suspect
Route: 042 | Dosage: MAINTENANCE DOSE | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 420.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
PERTUZUMAB (PERTUZUMAB) Suspect
Route: 042 | Dosage: UNK UNK, EVERY 3 WEEKS | Form: Solution for infusion | Indication: -- | Action: Dose Not Changed
Auth#: -- | Batch#: 114124 | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
TRASTUZUMAB (TRASTUZUMAB) Suspect
Route: 042 | Dosage: 840 MG. WITHDRAWN FROM STUDY. LAST DOSE PRIOR TO SAE ON 12/NOV/2012FREQUENCY TEXT:8 MG/KG | Form: -- | Indication: Breast cancer female | Action: Dose Not Changed
Auth#: -- | Batch#: -- | Structured Dosage: 8.0 (unit: 007) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 11/12/2012 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: 042 | Dosage: WITHDRAWN FROM STUDY | Form: -- | Indication: Breast cancer female | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: 500.0 (unit: 009) | Separate Dosage#: 1.0 | Interval: 3.0 wk | Cumulative: -- (unit: --)
Start: 08/28/2012 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ACETAMINOPHEN (ACETAMINOPHEN) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/12/2012 | End: 11/12/2012 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
RANITIDINE (RANITIDINE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/14/2012 | End: 11/14/2012 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Concomitant
Route: -- | Dosage: UNK | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/14/2012 | End: 11/14/2012 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20121112

Report Duplicates (1)

ROCHE: EU-ROCHE-1155510

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f3b", "safetyreportid": "25974659", "authoritynumb": null, "companynumb": "EU-ROCHE-1155510", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 65.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": 84.0, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Infusion related reaction", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Vomiting", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "EPIRUBICIN HYDROCHLORIDE", "drugauthorizationnumb": "50778", "drugbatchnumb": null, "drugstructuredosagenumb": 100.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "100 MG/M2, EVERY 3 WEEKS (LAST DOSE PRIOR TO SAE)", "drugdosageform": "Powder and solvent for solution for injection", "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2012-08-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-10-09T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "EPIRUBICIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOCETAXEL", "drugauthorizationnumb": "022234", "drugbatchnumb": null, "drugstructuredosagenumb": 1000.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "LAST DOSE PRIOR TO SAE: 14/NOV/2012. WITHDRAWN FROM STUDY.FREQUENCY TEXT:200 UNITS", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": "102", "drugenddate": "2012-11-27T00:00:00", "drugtreatmentduration": 14.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOCETAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "FLUOROURACIL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNIT: 1000, LAST DOSE PRIOR TO SAE: 09/OCT/2012", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2012-08-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-10-09T00:00:00", "drugtreatmentduration": 43.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "FLUOROURACIL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERTUZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "128045", "drugstructuredosagenumb": 840.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "LOADING DOSE AS PER PROTOCOL. LAST DOSE PRIOR TO SAE: 12/NOV/2012. WITHDRAWN FROM STUDY", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2012-11-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-11-27T00:00:00", "drugtreatmentduration": 16.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERTUZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 420.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "MAINTENANCE DOSE", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PERTUZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": "114124", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK UNK, EVERY 3 WEEKS", "drugdosageform": "Solution for infusion", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "PERTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "TRASTUZUMAB", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 8.0, "drugstructuredosageunit": "007", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "840 MG. WITHDRAWN FROM STUDY. LAST DOSE PRIOR TO SAE ON 12/NOV/2012FREQUENCY TEXT:8 MG/KG", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2012-11-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 4, "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "009", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 3.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "WITHDRAWN FROM STUDY", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Breast cancer female", "drugstartdateformat": "102", "drugstartdate": "2012-08-28T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ACETAMINOPHEN", "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": null, "drugstartdateformat": "102", "drugstartdate": "2012-11-12T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-11-12T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ACETAMINOPHEN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "RANITIDINE", "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": null, "drugstartdateformat": "102", "drugstartdate": "2012-11-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-11-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "RANITIDINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "DEXAMETHASONE", "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": null, "drugstartdateformat": "102", "drugstartdate": "2012-11-14T00:00:00", "drugenddateformat": "102", "drugenddate": "2012-11-14T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20121112" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "ROCHE", "duplicatenumb": "EU-ROCHE-1155510" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25974662 Type 3
Serious
TRASTUZUMAB, DOXORUBICIN HYDROCHLORIDE, DOCETAXEL (+2 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-202500212488
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acute hepatic failure (v28.1) Unknown
Hepatitis B (v28.1) Unknown

Drugs (5)

TRASTUZUMAB (TRASTUZUMAB) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: 761081 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOXORUBICIN HYDROCHLORIDE (DOXORUBICIN HYDROCHLORIDE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: 50467 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DOCETAXEL (DOCETAXEL) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: 022234 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CYCLOPHOSPHAMIDE (CYCLOPHOSPHAMIDE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DEXAMETHASONE (DEXAMETHASONE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Breast cancer | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08138186
Unknown MAH: 2025AP008472

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f39", "safetyreportid": "25974662", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500212488", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute hepatic failure", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatitis B", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "TRASTUZUMAB", "drugauthorizationnumb": "761081", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TRASTUZUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOXORUBICIN HYDROCHLORIDE", "drugauthorizationnumb": "50467", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOXORUBICIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOCETAXEL", "drugauthorizationnumb": "022234", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DOCETAXEL" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CYCLOPHOSPHAMIDE", "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": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CYCLOPHOSPHAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DEXAMETHASONE", "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": "Breast cancer", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DEXAMETHASONE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Health Canada", "duplicatenumb": "E2B_08138186" }, { "duplicatesource": "Unknown MAH", "duplicatenumb": "2025AP008472" } ], "reporttype": 3, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974663 Type 1
Serious
CARBOPLATIN, CARBOPLATIN, CARBOPLATIN
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-MA2025001363
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
38.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Hot flush (v28.1) Recovered
Palpitations (v28.1) Recovered
Dyspnoea (v28.1) Recovered
Erythema (v28.1) Recovered
Abdominal pain (v28.1) Recovered
Diarrhoea (v28.1) Recovered

Drugs (3)

CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: UNK, 3RD COURSE | Form: Solution for injection | Indication: Ovarian cancer | Action: Unknown
Auth#: 076517 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 11/22/2023 | End: -- | Duration: 1.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: UNK, 4TH COURSE | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 076517 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 12/12/2023 | End: -- | Duration: 1.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: UNK, 5TH COURSE | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 076517 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/02/2024 | End: -- | Duration: 2.0 hr | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20231122

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-MA2025001363

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f38", "safetyreportid": "25974663", "authoritynumb": "EU-AFSSAPS-MA2025001363", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 38.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hot flush", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Palpitations", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dyspnoea", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Erythema", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Diarrhoea", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 3RD COURSE", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": "Ovarian cancer", "drugstartdateformat": "102", "drugstartdate": "2023-11-22T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 805, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 4TH COURSE", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2023-12-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 805, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 5TH COURSE", "drugdosageform": "Solution for injection", "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-01-02T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 805, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20231122" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-MA2025001363" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "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" }
25974655 Type 1
Serious
CARBOPLATIN, CARBOPLATIN
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/19/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-AFSSAPS-MA2025001376
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
80.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Throat irritation (v28.1) Recovered
Malaise (v28.1) Recovered
Pruritus (v28.1) Recovered
Abdominal pain (v28.1) Recovered

Drugs (2)

CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: UNK, 2ND CURE | Form: -- | Indication: Ovarian cancer | Action: Unknown
Auth#: 076517 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 07/17/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
CARBOPLATIN (CARBOPLATIN) Suspect
Route: 042 | Dosage: UNK, 3RD CURE | Form: -- | Indication: -- | Action: Unknown
Auth#: 076517 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/08/2024 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20240717

Report Duplicates (1)

AFSSAPS: EU-AFSSAPS-MA2025001376

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f37", "safetyreportid": "25974655", "authoritynumb": "EU-AFSSAPS-MA2025001376", "companynumb": null, "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 80.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Throat irritation", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Malaise", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pruritus", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Abdominal pain", "reactionoutcome": 1 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 2ND CURE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": "Ovarian cancer", "drugstartdateformat": "102", "drugstartdate": "2024-07-17T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "CARBOPLATIN", "drugauthorizationnumb": "076517", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK, 3RD CURE", "drugdosageform": null, "drugadministrationroute": "042", "drugindication": null, "drugstartdateformat": "102", "drugstartdate": "2024-08-08T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "CARBOPLATIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20240717" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AFSSAPS", "duplicatenumb": "EU-AFSSAPS-MA2025001376" } ], "reporttype": 1, "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": "2026-01-19T00:00:00", "transmissiondateformat": "102" }
25974661 Type 3
Serious
RITUXIMAB, METHOTREXATE SODIUM, TEMOZOLOMIDE
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-PFIZER INC-202500213235
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
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Acute hepatic failure (v28.1) Unknown
Hepatitis B (v28.1) Unknown

Drugs (3)

RITUXIMAB (RITUXIMAB) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Central nervous system lymphoma | Action: Unknown
Auth#: 761103 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
METHOTREXATE SODIUM (METHOTREXATE SODIUM) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Central nervous system lymphoma | Action: Unknown
Auth#: 011719 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TEMOZOLOMIDE (TEMOZOLOMIDE) Suspect
Route: -- | Dosage: UNK | Form: -- | Indication: Central nervous system lymphoma | Action: Unknown
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (2)

Health Canada: E2B_08121931
Unknown MAH: 2025AP008417

Raw JSON (click to expand)

{ "_id": "69e7691c5eb43a53b3ff1f36", "safetyreportid": "25974661", "authoritynumb": null, "companynumb": "CA-PFIZER INC-202500213235", "duplicate": 1, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Acute hepatic failure", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Hepatitis B", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "RITUXIMAB", "drugauthorizationnumb": "761103", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Central nervous system lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "RITUXIMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "METHOTREXATE SODIUM", "drugauthorizationnumb": "011719", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Central nervous system lymphoma", "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": "TEMOZOLOMIDE", "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": "Central nervous system lymphoma", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TEMOZOLOMIDE" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "Health Canada", "duplicatenumb": "E2B_08121931" }, { "duplicatesource": "Unknown MAH", "duplicatenumb": "2025AP008417" } ], "reporttype": 3, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "PFIZER" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25974654 Type 1
Serious
DOXYCYCLINE, DOXYCYCLINE, CANDESARTAN (+2 more)
Report Version
1
Receive Date
10/29/2025
Receipt Date
10/29/2025
Transmission Date
01/18/2026
Primary Source Country
GB
Occurrence Country
GB
Reporter Country
GB
Reporter Qualification
Consumer
Literature Reference
--
Company Number
--
Authority Number
GB-MHRA-MED-202510251155308280-MKHYQ
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
81.0 yr
Patient Age Group
--
Patient Sex
Male
Patient Weight
92.0 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (4)

Intestinal obstruction (v28.1) Recovered
Defaecation urgency (v28.1) Recovered
Dyschezia (v28.1) Recovered
Off label use (v28.1) Unknown

Drugs (5)

DOXYCYCLINE (DOXYCYCLINE) Suspect
Route: -- | Dosage: 50MG DAILY FOR 12 WEEKS | Form: Dispersible tablet | Indication: Eye infection | Action: Withdrawn
Auth#: 50006 | Batch#: PL30684/0241 | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: 09/12/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
DOXYCYCLINE (DOXYCYCLINE) Suspect
Route: -- | Dosage: 50MG DAILY FOR 12 WEEKS | Form: Dispersible tablet | Indication: -- | Action: Withdrawn
Auth#: 50006 | Batch#: 5 050114624123 | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: 10/05/2025 | Duration: -- -- | Rechallenge: -- | Additional: Yes
Recurrences: --
CANDESARTAN (CANDESARTAN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Blood pressure management | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
LEVOTHYROXINE (LEVOTHYROXINE) Concomitant
Route: -- | Dosage: 125 MG, DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BISOPROLOL (BISOPROLOL) Concomitant
Route: -- | Dosage: 5 MG, DAILY | Form: -- | Indication: -- | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: -- | Interval: 1.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250912

Report Duplicates (1)

MHRA: GB-MHRA-MED-202510251155308280-MKHYQ

Raw JSON (click to expand)

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null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "50MG DAILY FOR 12 WEEKS", "drugdosageform": "Dispersible tablet", "drugadministrationroute": null, "drugindication": "Eye infection", "drugstartdateformat": "102", "drugstartdate": "2025-09-12T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 1, "actiondrug": 1, "activesubstance": { "activesubstancename": "DOXYCYCLINE" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DOXYCYCLINE", "drugauthorizationnumb": "50006", "drugbatchnumb": "5 050114624123", "drugstructuredosagenumb": 50.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, 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management", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "CANDESARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "LEVOTHYROXINE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 125.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "125 MG, DAILY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "LEVOTHYROXINE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BISOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": 5.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "5 MG, DAILY", "drugdosageform": null, "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BISOPROLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250912" }, "primarysource": { "reportercountry": "GB", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "GB", "quarter": "2025Q4", "receiptdate": "2025-10-29T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-29T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "MHRA", "duplicatenumb": "GB-MHRA-MED-202510251155308280-MKHYQ" } ], "reporttype": 1, "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" }