FDA FAERS Adverse Event Reports

111000
Total Reports
60668
Serious Reports
108
Reporter Countries
Clear
25950504 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA314508
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
51.0 yr
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (6)

Condition aggravated (v28.1) Recovered
Urticaria (v28.1) Recovered
Swelling (v28.1) Recovered
Dry skin (v28.1) Recovered
Injection site pain (v28.1) Unknown
Intentional product misuse (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 300 MG, QOW | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251018

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54981", "safetyreportid": "25950504", "authoritynumb": null, "companynumb": "US-SA-2025SA314508", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 51.0, "patientonsetageunit": 801, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Condition aggravated", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Urticaria", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Swelling", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dry skin", "reactionoutcome": 1 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Injection site pain", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Intentional product misuse", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "300 MG, QOW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251018" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950502 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA314478
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Child
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Dry skin (v28.1) Unknown
Product dose omission issue (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 200MG, Q4W | Form: Solution for injection | Indication: Eczema | Action: Not Applicable
Auth#: 761055 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: 04/01/2025 | End: 08/01/2025 | Duration: -- -- | Rechallenge: -- | Additional: 4
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54980", "safetyreportid": "25950502", "authoritynumb": null, "companynumb": "US-SA-2025SA314478", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 3, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Dry skin", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product dose omission issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200MG, Q4W", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Eczema", "drugstartdateformat": "610", "drugstartdate": "2025-04-01T00:00:00", "drugenddateformat": "610", "drugenddate": "2025-08-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 4, "actiondrug": 6, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25950505 Type 1
Non-Serious
DUPIXENT, DUPIXENT, DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA314826
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Incorrect dose administered (v28.1) Unknown

Drugs (3)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 400 MG, 1X | Form: Solution for injection | Indication: Eczema | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 01/01/2020 | End: 01/01/2020 | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 200.000MG Q15D | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 15.0 day | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 200.000MG QOW | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20200101

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5497f", "safetyreportid": "25950505", "authoritynumb": null, "companynumb": "US-SA-2025SA314826", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Incorrect dose administered", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 400.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "400 MG, 1X", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Eczema", "drugstartdateformat": "602", "drugstartdate": "2020-01-01T00:00:00", "drugenddateformat": "602", "drugenddate": "2020-01-01T00:00:00", "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 15.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200.000MG Q15D", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200.000MG QOW", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20200101" }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25950501 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-SA-2025SA312819
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
12.0 yr
Patient Age Group
Adolescent
Patient Sex
Male
Patient Weight
38.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Product prescribing issue (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: 200 MG, Q4W | Form: Solution for injection | Indication: Dermatitis atopic | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 4.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5497e", "safetyreportid": "25950501", "authoritynumb": null, "companynumb": "US-SA-2025SA312819", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": 12.0, "patientonsetageunit": 801, "patientagegroup": 4, "patientweight": 38.4, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product prescribing issue", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": 200.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 4.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "200 MG, Q4W", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Dermatitis atopic", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950506 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-SA-2025SA314189
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
Male
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Accidental exposure to product (v28.1) Unknown
Exposure via skin contact (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761055 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251015

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5497d", "safetyreportid": "25950506", "authoritynumb": null, "companynumb": "US-SA-2025SA314189", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": 1, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Accidental exposure to product", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Exposure via skin contact", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251015" }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950503 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
US-SA-2025SA312170
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Adult
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Drug hypersensitivity (v28.1) Unknown
Product use in unapproved indication (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 058 | Dosage: UNK | Form: Solution for injection | Indication: Urticaria | Action: Unknown
Auth#: 761055 | 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": "69d4357d3b3830196fa5497c", "safetyreportid": "25950503", "authoritynumb": null, "companynumb": "US-SA-2025SA312170", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 5, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Drug hypersensitivity", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Product use in unapproved indication", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": "058", "drugindication": "Urticaria", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950500 Type 2
Serious
FOSCARBIDOPA\FOSLEVODOPA, INDAPAMIDE, BENSERAZIDE\LEVODOPA (+5 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
EU-ABBVIE-6511848
Authority Number
--
Sender Organization
ABBVIE
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
78.0 yr
Patient Age Group
--
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Confusional state (v28.1) Unknown

Drugs (8)

FOSCARBIDOPA\FOSLEVODOPA (FOSCARBIDOPA\FOSLEVODOPA) Suspect
Route: 058 | Dosage: EXTRA DOSE: 0.2, LOW RATE: 0.25, HIGH RATE: 0.29, BASE RATE: 0.29, LOADING DOSE: 0.6 | Form: Solution for infusion | Indication: Parkinson^s disease | Action: Withdrawn
Auth#: 216962 | Batch#: Not Available | Structured Dosage: -- (unit: --) | Separate Dosage#: 1.0 | Interval: -- -- | Cumulative: -- (unit: --)
Start: 08/26/2025 | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
INDAPAMIDE (INDAPAMIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
BENSERAZIDE\LEVODOPA (BENSERAZIDE\LEVODOPA) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
NITROFURANTOIN (NITROFURANTOIN) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
pantomed (--) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
XADAGO (SAFINAMIDE MESYLATE) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --
METOPROLOL (METOPROLOL) Concomitant
Route: -- | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20251020

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa5497b", "safetyreportid": "25950500", "authoritynumb": null, "companynumb": "EU-ABBVIE-6511848", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "EU", "patient": { "patientonsetage": 78.0, "patientonsetageunit": 801, "patientagegroup": null, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Confusional state", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "FOSCARBIDOPA\\FOSLEVODOPA", "drugauthorizationnumb": "216962", "drugbatchnumb": "Not Available", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "EXTRA DOSE: 0.2, LOW RATE: 0.25, HIGH RATE: 0.29, BASE RATE: 0.29, LOADING DOSE: 0.6", "drugdosageform": "Solution for infusion", "drugadministrationroute": "058", "drugindication": "Parkinson^s disease", "drugstartdateformat": "102", "drugstartdate": "2025-08-26T00:00:00", "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": 1, "activesubstance": { "activesubstancename": "FOSCARBIDOPA\\FOSLEVODOPA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "INDAPAMIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "INDAPAMIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "BENSERAZIDE\\LEVODOPA", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "BENSERAZIDE\\LEVODOPA" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "NITROFURANTOIN", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "NITROFURANTOIN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METFORMIN HYDROCHLORIDE", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METFORMIN HYDROCHLORIDE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "pantomed", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": null, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "XADAGO", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "SAFINAMIDE MESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "METOPROLOL", "drugauthorizationnumb": null, "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "METOPROLOL" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20251020" }, "primarysource": { "reportercountry": "EU", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "ABBVIE" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 1, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25950497 Type 1
Non-Serious
DUPIXENT
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/18/2026
Primary Source Country
US
Occurrence Country
US
Reporter Country
US
Reporter Qualification
Consumer
Literature Reference
--
Company Number
US-SA-2025SA314213
Authority Number
--
Sender Organization
SANOFI AVENTIS
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
No
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
Elderly
Patient Sex
Female
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (2)

Weight increased (v28.1) Unknown
Pain in extremity (v28.1) Unknown

Drugs (1)

DUPIXENT (DUPILUMAB) Suspect
Route: 065 | Dosage: UNK | Form: Solution for injection | Indication: Product used for unknown indication | Action: Unknown
Auth#: 761055 | 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": "69d4357d3b3830196fa54978", "safetyreportid": "25950497", "authoritynumb": null, "companynumb": "US-SA-2025SA314213", "duplicate": null, "fulfillexpeditecriteria": 2, "occurcountry": "US", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": 6, "patientweight": null, "patientsex": 2, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Weight increased", "reactionoutcome": 6 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pain in extremity", "reactionoutcome": 6 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "DUPIXENT", "drugauthorizationnumb": "761055", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "UNK", "drugdosageform": "Solution for injection", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "DUPILUMAB" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "US", "qualification": 5, "literaturereference": null }, "primarysourcecountry": "US", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "SANOFI AVENTIS" }, "serious": 2, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 2, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-18T00:00:00", "transmissiondateformat": "102" }
25950496 Type 2
Serious
ADALIMUMAB, ADALIMUMAB, AMLODIPINE (+2 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
CA
Occurrence Country
CA
Reporter Country
CA
Reporter Qualification
Other Health Professional
Literature Reference
--
Company Number
CA-CELLTRION INC.-2025CA038023
Authority Number
--
Sender Organization
CELLTRION
Sender Type
6
Receiver Organization
FDA
Receiver Type
6
Expedite Criteria
Yes
Duplicate
--
FAERS Quarter
2025Q4
Source File
1_ADR25Q4.xml
Patient Age
--
Patient Age Group
--
Patient Sex
--
Patient Weight
--

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (3)

Sleep disorder (v28.1) Recovering
Night sweats (v28.1) Recovering
Pneumonia (v28.1) Recovering

Drugs (5)

ADALIMUMAB (ADALIMUMAB) Suspect
Route: -- | Dosage: 40 MG 1 EVERY 2 WEEKS | Form: Solution for injection | Indication: Colitis ulcerative | Action: Unknown
Auth#: 761219 | Batch#: Unknown | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 2.0 wk | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
ADALIMUMAB (ADALIMUMAB) Suspect
Route: -- | Dosage: -- | Form: Solution for injection | Indication: -- | Action: Unknown
Auth#: 761219 | Batch#: -- | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
AMLODIPINE (AMLODIPINE BESYLATE) Concomitant
Route: 065 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
IRBESARTAN (IRBESARTAN) Concomitant
Route: 065 | Dosage: -- | Form: Tablet | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --
TAMSULOSIN (TAMSULOSIN) Concomitant
Route: -- | Dosage: -- | Form: Unknown | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: Unknown | Structured Dosage: -- (unit: --) | Separate Dosage#: -- | Interval: -- -- | Cumulative: -- (unit: --)
Start: -- | End: -- | Duration: -- -- | Rechallenge: -- | Additional: Unknown
Recurrences: --

Clinical Narrative

--

Report Duplicates (0)

--

Raw JSON (click to expand)

{ "_id": "69d4357d3b3830196fa54976", "safetyreportid": "25950496", "authoritynumb": null, "companynumb": "CA-CELLTRION INC.-2025CA038023", "duplicate": null, "fulfillexpeditecriteria": 1, "occurcountry": "CA", "patient": { "patientonsetage": null, "patientonsetageunit": null, "patientagegroup": null, "patientweight": null, "patientsex": null, "reaction": [ { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Sleep disorder", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Night sweats", "reactionoutcome": 2 }, { "reactionmeddraversionpt": "28.1", "reactionmeddrapt": "Pneumonia", "reactionoutcome": 2 } ], "drug": [ { "drugcharacterization": 1, "medicinalproduct": "ADALIMUMAB", "drugauthorizationnumb": "761219", "drugbatchnumb": "Unknown", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 2.0, "drugintervaldosagedefinition": 803, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": "40 MG 1 EVERY 2 WEEKS", "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": "Colitis ulcerative", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "ADALIMUMAB", "drugauthorizationnumb": "761219", "drugbatchnumb": null, "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Solution for injection", "drugadministrationroute": null, "drugindication": null, "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "ADALIMUMAB" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "AMLODIPINE", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "AMLODIPINE BESYLATE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "IRBESARTAN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Tablet", "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "IRBESARTAN" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "TAMSULOSIN", "drugauthorizationnumb": null, "drugbatchnumb": "Unknown", "drugstructuredosagenumb": null, "drugstructuredosageunit": null, "drugseparatedosagenumb": null, "drugintervaldosageunitnumb": null, "drugintervaldosagedefinition": null, "drugcumulativedosagenumb": null, "drugcumulativedosageunit": null, "drugdosagetext": null, "drugdosageform": "Unknown", "drugadministrationroute": null, "drugindication": "Product used for unknown indication", "drugstartdateformat": null, "drugstartdate": null, "drugenddateformat": null, "drugenddate": null, "drugtreatmentduration": null, "drugtreatmentdurationunit": null, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "TAMSULOSIN" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": null }, "primarysource": { "reportercountry": "CA", "qualification": 3, "literaturereference": null }, "primarysourcecountry": "CA", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [], "reporttype": 2, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "CELLTRION" }, "serious": 1, "seriousnesscongenitalanomali": 2, "seriousnessdeath": 2, "seriousnessdisabling": 2, "seriousnesshospitalization": 2, "seriousnesslifethreatening": 2, "seriousnessother": 1, "source_file": "1_ADR25Q4.xml", "transmissiondate": "2026-01-17T00:00:00", "transmissiondateformat": "102" }
25950491 Type 1
Serious
PREGABALIN, PREGABALIN, PREGABALIN (+57 more)
Report Version
1
Receive Date
10/23/2025
Receipt Date
10/23/2025
Transmission Date
01/17/2026
Primary Source Country
EU
Occurrence Country
EU
Reporter Country
EU
Reporter Qualification
Physician
Literature Reference
--
Company Number
--
Authority Number
EU-BASGAGES-2025-006504
Sender Organization
TEVA
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
Male
Patient Weight
89.4 kg

Seriousness Details

Death Hospitalization Life-Threatening Disabling Congenital Anomaly Other Serious

Reactions (1)

Weight increased (v28.1) Not Recovered

Drugs (60)

PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 525.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 08/05/2025 | End: 08/07/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 350.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/22/2025 | End: 05/27/2025 | Duration: 6.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 375.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 08/13/2025 | End: 08/13/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 200.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/13/2025 | End: 05/13/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 125.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/09/2025 | End: 05/09/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/08/2025 | End: 05/08/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/07/2025 | End: 05/07/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 400.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/28/2025 | End: 06/01/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 450.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 08/08/2025 | End: 08/12/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/20/2025 | End: 05/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 500.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 06/03/2025 | End: 06/04/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 300.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 08/29/2025 | End: 09/05/2025 | Duration: 8.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 450.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 06/02/2025 | End: 06/02/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 225.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/14/2025 | End: 05/14/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 250.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/15/2025 | End: 05/19/2025 | Duration: 5.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 600.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 06/05/2025 | End: 08/04/2025 | Duration: 61.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/10/2025 | End: 05/12/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
PREGABALIN (PREGABALIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 091219 | Batch#: UNKNOWN | Structured Dosage: 325.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 49325.0 (unit: 003)
Start: 05/21/2025 | End: 05/21/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MELATONIN (MELATONIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 4.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 396.0 (unit: 003)
Start: 05/07/2025 | End: 07/29/2025 | Duration: 84.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MELATONIN (MELATONIN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 396.0 (unit: 003)
Start: 07/30/2025 | End: 09/05/2025 | Duration: 38.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
LAVENDER OIL (LAVENDER OIL) Concomitant
Route: 065 | Dosage: -- | Form: Capsule, soft | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 160.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 18240.0 (unit: 003)
Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --
Recurrences: --
MIRTAZAPINE (MIRTAZAPINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076119 | Batch#: UNKNOWN | Structured Dosage: 30.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 4860.0 (unit: 003)
Start: 08/11/2025 | End: 09/05/2025 | Duration: 26.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
MIRTAZAPINE (MIRTAZAPINE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076119 | Batch#: UNKNOWN | Structured Dosage: 45.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 4860.0 (unit: 003)
Start: 05/07/2025 | End: 08/10/2025 | Duration: 96.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/19/2025 | End: 06/19/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 07/28/2025 | End: 07/28/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 05/20/2025 | End: 05/20/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 07/07/2025 | End: 07/07/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/24/2025 | End: 06/24/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/05/2025 | End: 06/05/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 05/27/2025 | End: 05/27/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 05/22/2025 | End: 05/22/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 07/21/2025 | End: 07/21/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/26/2025 | End: 06/26/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/17/2025 | End: 06/17/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 25.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/03/2025 | End: 06/03/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 06/10/2025 | End: 06/10/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 50.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 07/14/2025 | End: 07/14/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 37.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 07/31/2025 | End: 07/31/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 05/15/2025 | End: 05/15/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Ketanest (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 12.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 612.5 (unit: 003)
Start: 05/13/2025 | End: 05/13/2025 | Duration: 1.0 day | Rechallenge: -- | Additional: --
Recurrences: --
NALTREXONE (NALTREXONE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 3.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 114.0 (unit: 003)
Start: 05/07/2025 | End: 06/13/2025 | Duration: 38.0 day | Rechallenge: -- | Additional: --
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076690 | Batch#: UNKNOWN | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 17025.0 (unit: 003)
Start: 08/15/2025 | End: 09/05/2025 | Duration: 22.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076690 | Batch#: UNKNOWN | Structured Dosage: 75.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 17025.0 (unit: 003)
Start: 05/08/2025 | End: 05/14/2025 | Duration: 7.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076690 | Batch#: UNKNOWN | Structured Dosage: 150.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 17025.0 (unit: 003)
Start: 05/15/2025 | End: 07/29/2025 | Duration: 76.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
VENLAFAXINE (VENLAFAXINE HYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 076690 | Batch#: UNKNOWN | Structured Dosage: 187.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 17025.0 (unit: 003)
Start: 07/30/2025 | End: 08/14/2025 | Duration: 16.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
Daflon (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 002) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 114.0 (unit: 002)
Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --
Recurrences: --
GINKGO (GINKGO) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 240.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 10320.0 (unit: 003)
Start: 05/07/2025 | End: 06/18/2025 | Duration: 43.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Temesta (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.25 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 90.0 (unit: 003)
Start: 06/15/2025 | End: 06/18/2025 | Duration: 4.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Temesta (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 90.0 (unit: 003)
Start: 06/19/2025 | End: 07/15/2025 | Duration: 27.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Temesta (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 90.0 (unit: 003)
Start: 05/16/2025 | End: 06/09/2025 | Duration: 25.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Temesta (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.75 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 90.0 (unit: 003)
Start: 06/10/2025 | End: 06/11/2025 | Duration: 2.0 day | Rechallenge: -- | Additional: --
Recurrences: --
Temesta (--) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 1.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 90.0 (unit: 003)
Start: 06/12/2025 | End: 06/14/2025 | Duration: 3.0 day | Rechallenge: -- | Additional: --
Recurrences: --
XYZAL (LEVOCETIRIZINE DIHYDROCHLORIDE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 10.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1140.0 (unit: 003)
Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
IVABRADINE (IVABRADINE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 317.5 (unit: 003)
Start: 05/20/2025 | End: 07/15/2025 | Duration: 57.0 day | Rechallenge: -- | Additional: --
Recurrences: --
IVABRADINE (IVABRADINE) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 317.5 (unit: 003)
Start: 05/07/2025 | End: 05/19/2025 | Duration: 13.0 day | Rechallenge: -- | Additional: --
Recurrences: --
KETOTIFEN (KETOTIFEN) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 2.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 140.0 (unit: 003)
Start: 05/07/2025 | End: 07/15/2025 | Duration: 70.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ASPIRIN (ASPIRIN) Concomitant
Route: 065 | Dosage: -- | Form: Film-coated tablet | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 100.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 11400.0 (unit: 003)
Start: 05/07/2025 | End: 09/05/2025 | Duration: 122.0 day | Rechallenge: -- | Additional: --
Recurrences: --
ARIPIPRAZOLE (ARIPIPRAZOLE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 078607 | Batch#: UNKNOWN | Structured Dosage: 2.5 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 545.0 (unit: 003)
Start: 05/07/2025 | End: 05/16/2025 | Duration: 10.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ARIPIPRAZOLE (ARIPIPRAZOLE) Suspect
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: Unknown
Auth#: 078607 | Batch#: UNKNOWN | Structured Dosage: 5.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 545.0 (unit: 003)
Start: 05/17/2025 | End: 09/05/2025 | Duration: 112.0 day | Rechallenge: -- | Additional: Unknown
Recurrences: --
ENOXAPARIN SODIUM (ENOXAPARIN SODIUM) Concomitant
Route: 065 | Dosage: -- | Form: -- | Indication: Product used for unknown indication | Action: --
Auth#: -- | Batch#: UNKNOWN | Structured Dosage: 40.0 (unit: 003) | Separate Dosage#: 1.0 | Interval: 1.0 day | Cumulative: 1120.0 (unit: 003)
Start: 05/13/2025 | End: 06/09/2025 | Duration: 28.0 day | Rechallenge: -- | Additional: --
Recurrences: --

Clinical Narrative

CASE EVENT DATE: 20250828

Report Duplicates (1)

AGES - ?-sterreichische Agentur f??r Gesundheit...: EU-BASGAGES-2025-006504

Raw JSON (click to expand)

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"drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-05-28T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-06-01T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 450.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-08-08T00:00:00", 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"drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 500.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-06-03T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-06-04T00:00:00", "drugtreatmentduration": 2.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 300.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-08-29T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-09-05T00:00:00", "drugtreatmentduration": 8.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", 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"drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-05-15T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-19T00:00:00", "drugtreatmentduration": 5.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 600.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-06-05T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-08-04T00:00:00", "drugtreatmentduration": 61.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 150.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-05-10T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-12T00:00:00", "drugtreatmentduration": 3.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": 3, "actiondrug": 5, "activesubstance": { "activesubstancename": "PREGABALIN" }, "drugrecurrence": [] }, { "drugcharacterization": 1, "medicinalproduct": "PREGABALIN", "drugauthorizationnumb": "091219", "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 325.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 49325.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-05-21T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-05-21T00:00:00", "drugtreatmentduration": 1.0, "drugtreatmentdurationunit": 804, 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"activesubstancename": "ARIPIPRAZOLE" }, "drugrecurrence": [] }, { "drugcharacterization": 2, "medicinalproduct": "ENOXAPARIN SODIUM", "drugauthorizationnumb": null, "drugbatchnumb": "UNKNOWN", "drugstructuredosagenumb": 40.0, "drugstructuredosageunit": "003", "drugseparatedosagenumb": 1.0, "drugintervaldosageunitnumb": 1.0, "drugintervaldosagedefinition": 804, "drugcumulativedosagenumb": 1120.0, "drugcumulativedosageunit": "003", "drugdosagetext": null, "drugdosageform": null, "drugadministrationroute": "065", "drugindication": "Product used for unknown indication", "drugstartdateformat": "102", "drugstartdate": "2025-05-13T00:00:00", "drugenddateformat": "102", "drugenddate": "2025-06-09T00:00:00", "drugtreatmentduration": 28.0, "drugtreatmentdurationunit": 804, "drugrecurreadministration": null, "drugadditional": null, "actiondrug": null, "activesubstance": { "activesubstancename": "ENOXAPARIN SODIUM" }, "drugrecurrence": [] } ], "summary_narrativeincludeclinical": "CASE EVENT DATE: 20250828" }, "primarysource": { "reportercountry": "EU", "qualification": 1, "literaturereference": null }, "primarysourcecountry": "EU", "quarter": "2025Q4", "receiptdate": "2025-10-23T00:00:00", "receiptdateformat": "102", "receivedate": "2025-10-23T00:00:00", "receivedateformat": "102", "receiver": { "receivertype": 6, "receiverorganization": "FDA" }, "reportduplicate": [ { "duplicatesource": "AGES - ?-sterreichische Agentur f??r Gesundheit...", "duplicatenumb": "EU-BASGAGES-2025-006504" } ], "reporttype": 1, "safetyreportversion": 1, "sender": { "sendertype": 6, "senderorganization": "TEVA" }, "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" }